Research ArticleArticle
Toreforant, A Histamine H4 Receptor Antagonist, in Patients with Active Rheumatoid Arthritis Despite Methotrexate Therapy: Results of 2 Phase II Studies
Robin L. Thurmond, Andrew Greenspan, Waldemar Radziszewski, Xie L. Xu, Ye Miao, Bin Chen, TingTing Ge, Bei Zhou, Daniel G. Baker, Dace Pavlova, Christopher T. Ritchlin, Yoshiya Tanaka, Tsutomu Takeuchi and Josef S. Smolen
The Journal of Rheumatology July 2016, jrheum.160164; DOI: https://doi.org/10.3899/jrheum.160164
Robin L. Thurmond
From the Immunology department, Janssen Research & Development, LLC, San Diego, California; the Medical Affairs department, Janssen Research & Development, LLC, Horsham, Pennsylvania; the Biostatistics department and the Immunology department, Janssen Research & Development, LLC, Spring House, Pennsylvania, USA; Early Development, Janssen China Research and Development, Shanghai, China; the Biostatistics department, Janssen Research & Development, LLC, Belmont, Massachusetts, USA; Rheumatology Department, M&M Centers LTD., Adazi, Latvia; Immunology Department, University of Rochester, Rochester, New York, USA; Internal Medicine, University of Occupational and Environmental Health, Kitakyushu; Rheumatology, Keio University Hospital, Tokyo, Japan; Rheumatology, Medical University of Vienna and Hietzing Hospital, Vienna, Austria. Sponsored by Janssen Research & Development, LLC. R. Thurmond, A. Greenspan, W. Radziszewski (previously employed by Janssen, currently employed by Sandoz Inc., Princeton, New Jersey, USA), X.L. Xu, Y. Miao, B. Chen, T. Ge, B. Zhou, and D.G. Baker are/were employees of Janssen, a Johnson and Johnson (J&J) Pharmaceutical Company, and own stock in J&J. D. Pavlova has received research grant support from Janssen. C.T. Ritchlin has received research grant support from AbbVie, Amgen, and UCB. He has received honoraria from AbbVie, Amgen, Janssen, Novartis, Sanofi, and UCB. Y. Tanaka has received consulting fees, speaking fees, and/or honoraria from AbbVie, Asahi Kasei Medical KK Pharma, Astellas Pharma, AstraZeneca, Bristol-Myers KK, Celltrion, Chugai, Daiichi-Sankyo, Eisai, Eli Lilly, Janssen Pharmaceutical, Mitsubishi-Tanabe, MSD, Novartis, Pfizer, Santen, and Takeda Pharmaceutical, and has received research grants from Asahi Kasei Pharma, AbbVie GK, Astellas Pharma, Bristol-Myers KK, Chugai, Daiichi, Eisai, Kyowa-Kirin, Mitsubishi-Tanabe, Nippon Kayaku, Pfizer Japan, Santen Pharmaceutical, Teijin, SymBio Pharmaceuticals, Takeda Pharmaceutical, and Taisho-Toyama Pharmaceutical. T. Takeuchi has received research grants, speaking fees, and/or consulting fees from AbbVie GK, Asahi Kasei Medical KK, Asahi Kasei Pharma, Astra Zeneca KK, Astellas Pharma, Bristol-Myers KK, Celtrion, Chugai Pharmaceutical, Daiichi-Sankyo, Eisai, Janssen Pharmaceutical, Eli Lilly Japan KK, Mitsubishi Tanabe Pharma, Nipponkayaku, Novartis Pharma KK, Pfizer Japan, Santen Pharmaceutical, SymBio Pharmaceuticals, Taisho Toyama Pharmaceutical, Takeda Pharmaceutical, and Teijin Pharma. J.S. Smolen has received research grant support from Abbott, BMS, MSD, Pfizer, Roche, and UCB and consultation and/or speaking honoraria from Abbott, Astra-Zeneca, BMS, Celgene, Glaxo, Janssen, MSD, Novo-Nordisk, Pfizer, Roche, Sanofi-Aventis, and UCB. R.L. Thurmond, PhD, Immunology Department, Janssen Research & Development, LLC; A. Greenspan, MD, Medical Affairs Department, Janssen Research & Development, LLC; W. Radziszewski, MD, PhD, Immunology Department, Janssen Research & Development, LLC; X.L. Xu, PhD, Immunology Department, Janssen Research & Development, LLC; Y. Miao, MS, Biostatistics Department, Janssen Research & Development, LLC; B. Chen, PhD, Early Development, Janssen China Research and Development; T. Ge, PhD, Biostatistics Department, Janssen Research & Development, LLC; B. Zhou, PhD, Biostatistics, Janssen Research & Development, LLC; D.G. Baker, MD, Immunology Department, Janssen Research & Development, LLC; D. Pavlova, MD, Rheumatology, M&M Centers Ltd.; C.T. Ritchlin, MD, Immunology Department, University of Rochester; Y. Tanaka, MD, PhD, Internal Medicine, University of Occupational and Environmental Health; T. Takeuchi, MD, PhD, Rheumatology, Keio University Hospital; J.S. Smolen, MD, Rheumatology, Medical University of Vienna and Hietzing Hospital. Address correspondence to R.L. Thurmond, Janssen Research & Development, LLC, 3210 Merryfield Row, San Diego, California 92121, USA. E-mail: RThurmon@its.jnj.com. Accepted for publication May 20, 2016.
Andrew Greenspan
From the Immunology department, Janssen Research & Development, LLC, San Diego, California; the Medical Affairs department, Janssen Research & Development, LLC, Horsham, Pennsylvania; the Biostatistics department and the Immunology department, Janssen Research & Development, LLC, Spring House, Pennsylvania, USA; Early Development, Janssen China Research and Development, Shanghai, China; the Biostatistics department, Janssen Research & Development, LLC, Belmont, Massachusetts, USA; Rheumatology Department, M&M Centers LTD., Adazi, Latvia; Immunology Department, University of Rochester, Rochester, New York, USA; Internal Medicine, University of Occupational and Environmental Health, Kitakyushu; Rheumatology, Keio University Hospital, Tokyo, Japan; Rheumatology, Medical University of Vienna and Hietzing Hospital, Vienna, Austria. Sponsored by Janssen Research & Development, LLC. R. Thurmond, A. Greenspan, W. Radziszewski (previously employed by Janssen, currently employed by Sandoz Inc., Princeton, New Jersey, USA), X.L. Xu, Y. Miao, B. Chen, T. Ge, B. Zhou, and D.G. Baker are/were employees of Janssen, a Johnson and Johnson (J&J) Pharmaceutical Company, and own stock in J&J. D. Pavlova has received research grant support from Janssen. C.T. Ritchlin has received research grant support from AbbVie, Amgen, and UCB. He has received honoraria from AbbVie, Amgen, Janssen, Novartis, Sanofi, and UCB. Y. Tanaka has received consulting fees, speaking fees, and/or honoraria from AbbVie, Asahi Kasei Medical KK Pharma, Astellas Pharma, AstraZeneca, Bristol-Myers KK, Celltrion, Chugai, Daiichi-Sankyo, Eisai, Eli Lilly, Janssen Pharmaceutical, Mitsubishi-Tanabe, MSD, Novartis, Pfizer, Santen, and Takeda Pharmaceutical, and has received research grants from Asahi Kasei Pharma, AbbVie GK, Astellas Pharma, Bristol-Myers KK, Chugai, Daiichi, Eisai, Kyowa-Kirin, Mitsubishi-Tanabe, Nippon Kayaku, Pfizer Japan, Santen Pharmaceutical, Teijin, SymBio Pharmaceuticals, Takeda Pharmaceutical, and Taisho-Toyama Pharmaceutical. T. Takeuchi has received research grants, speaking fees, and/or consulting fees from AbbVie GK, Asahi Kasei Medical KK, Asahi Kasei Pharma, Astra Zeneca KK, Astellas Pharma, Bristol-Myers KK, Celtrion, Chugai Pharmaceutical, Daiichi-Sankyo, Eisai, Janssen Pharmaceutical, Eli Lilly Japan KK, Mitsubishi Tanabe Pharma, Nipponkayaku, Novartis Pharma KK, Pfizer Japan, Santen Pharmaceutical, SymBio Pharmaceuticals, Taisho Toyama Pharmaceutical, Takeda Pharmaceutical, and Teijin Pharma. J.S. Smolen has received research grant support from Abbott, BMS, MSD, Pfizer, Roche, and UCB and consultation and/or speaking honoraria from Abbott, Astra-Zeneca, BMS, Celgene, Glaxo, Janssen, MSD, Novo-Nordisk, Pfizer, Roche, Sanofi-Aventis, and UCB. R.L. Thurmond, PhD, Immunology Department, Janssen Research & Development, LLC; A. Greenspan, MD, Medical Affairs Department, Janssen Research & Development, LLC; W. Radziszewski, MD, PhD, Immunology Department, Janssen Research & Development, LLC; X.L. Xu, PhD, Immunology Department, Janssen Research & Development, LLC; Y. Miao, MS, Biostatistics Department, Janssen Research & Development, LLC; B. Chen, PhD, Early Development, Janssen China Research and Development; T. Ge, PhD, Biostatistics Department, Janssen Research & Development, LLC; B. Zhou, PhD, Biostatistics, Janssen Research & Development, LLC; D.G. Baker, MD, Immunology Department, Janssen Research & Development, LLC; D. Pavlova, MD, Rheumatology, M&M Centers Ltd.; C.T. Ritchlin, MD, Immunology Department, University of Rochester; Y. Tanaka, MD, PhD, Internal Medicine, University of Occupational and Environmental Health; T. Takeuchi, MD, PhD, Rheumatology, Keio University Hospital; J.S. Smolen, MD, Rheumatology, Medical University of Vienna and Hietzing Hospital. Address correspondence to R.L. Thurmond, Janssen Research & Development, LLC, 3210 Merryfield Row, San Diego, California 92121, USA. E-mail: RThurmon@its.jnj.com. Accepted for publication May 20, 2016.
Waldemar Radziszewski
From the Immunology department, Janssen Research & Development, LLC, San Diego, California; the Medical Affairs department, Janssen Research & Development, LLC, Horsham, Pennsylvania; the Biostatistics department and the Immunology department, Janssen Research & Development, LLC, Spring House, Pennsylvania, USA; Early Development, Janssen China Research and Development, Shanghai, China; the Biostatistics department, Janssen Research & Development, LLC, Belmont, Massachusetts, USA; Rheumatology Department, M&M Centers LTD., Adazi, Latvia; Immunology Department, University of Rochester, Rochester, New York, USA; Internal Medicine, University of Occupational and Environmental Health, Kitakyushu; Rheumatology, Keio University Hospital, Tokyo, Japan; Rheumatology, Medical University of Vienna and Hietzing Hospital, Vienna, Austria. Sponsored by Janssen Research & Development, LLC. R. Thurmond, A. Greenspan, W. Radziszewski (previously employed by Janssen, currently employed by Sandoz Inc., Princeton, New Jersey, USA), X.L. Xu, Y. Miao, B. Chen, T. Ge, B. Zhou, and D.G. Baker are/were employees of Janssen, a Johnson and Johnson (J&J) Pharmaceutical Company, and own stock in J&J. D. Pavlova has received research grant support from Janssen. C.T. Ritchlin has received research grant support from AbbVie, Amgen, and UCB. He has received honoraria from AbbVie, Amgen, Janssen, Novartis, Sanofi, and UCB. Y. Tanaka has received consulting fees, speaking fees, and/or honoraria from AbbVie, Asahi Kasei Medical KK Pharma, Astellas Pharma, AstraZeneca, Bristol-Myers KK, Celltrion, Chugai, Daiichi-Sankyo, Eisai, Eli Lilly, Janssen Pharmaceutical, Mitsubishi-Tanabe, MSD, Novartis, Pfizer, Santen, and Takeda Pharmaceutical, and has received research grants from Asahi Kasei Pharma, AbbVie GK, Astellas Pharma, Bristol-Myers KK, Chugai, Daiichi, Eisai, Kyowa-Kirin, Mitsubishi-Tanabe, Nippon Kayaku, Pfizer Japan, Santen Pharmaceutical, Teijin, SymBio Pharmaceuticals, Takeda Pharmaceutical, and Taisho-Toyama Pharmaceutical. T. Takeuchi has received research grants, speaking fees, and/or consulting fees from AbbVie GK, Asahi Kasei Medical KK, Asahi Kasei Pharma, Astra Zeneca KK, Astellas Pharma, Bristol-Myers KK, Celtrion, Chugai Pharmaceutical, Daiichi-Sankyo, Eisai, Janssen Pharmaceutical, Eli Lilly Japan KK, Mitsubishi Tanabe Pharma, Nipponkayaku, Novartis Pharma KK, Pfizer Japan, Santen Pharmaceutical, SymBio Pharmaceuticals, Taisho Toyama Pharmaceutical, Takeda Pharmaceutical, and Teijin Pharma. J.S. Smolen has received research grant support from Abbott, BMS, MSD, Pfizer, Roche, and UCB and consultation and/or speaking honoraria from Abbott, Astra-Zeneca, BMS, Celgene, Glaxo, Janssen, MSD, Novo-Nordisk, Pfizer, Roche, Sanofi-Aventis, and UCB. R.L. Thurmond, PhD, Immunology Department, Janssen Research & Development, LLC; A. Greenspan, MD, Medical Affairs Department, Janssen Research & Development, LLC; W. Radziszewski, MD, PhD, Immunology Department, Janssen Research & Development, LLC; X.L. Xu, PhD, Immunology Department, Janssen Research & Development, LLC; Y. Miao, MS, Biostatistics Department, Janssen Research & Development, LLC; B. Chen, PhD, Early Development, Janssen China Research and Development; T. Ge, PhD, Biostatistics Department, Janssen Research & Development, LLC; B. Zhou, PhD, Biostatistics, Janssen Research & Development, LLC; D.G. Baker, MD, Immunology Department, Janssen Research & Development, LLC; D. Pavlova, MD, Rheumatology, M&M Centers Ltd.; C.T. Ritchlin, MD, Immunology Department, University of Rochester; Y. Tanaka, MD, PhD, Internal Medicine, University of Occupational and Environmental Health; T. Takeuchi, MD, PhD, Rheumatology, Keio University Hospital; J.S. Smolen, MD, Rheumatology, Medical University of Vienna and Hietzing Hospital. Address correspondence to R.L. Thurmond, Janssen Research & Development, LLC, 3210 Merryfield Row, San Diego, California 92121, USA. E-mail: RThurmon@its.jnj.com. Accepted for publication May 20, 2016.
Xie L. Xu
From the Immunology department, Janssen Research & Development, LLC, San Diego, California; the Medical Affairs department, Janssen Research & Development, LLC, Horsham, Pennsylvania; the Biostatistics department and the Immunology department, Janssen Research & Development, LLC, Spring House, Pennsylvania, USA; Early Development, Janssen China Research and Development, Shanghai, China; the Biostatistics department, Janssen Research & Development, LLC, Belmont, Massachusetts, USA; Rheumatology Department, M&M Centers LTD., Adazi, Latvia; Immunology Department, University of Rochester, Rochester, New York, USA; Internal Medicine, University of Occupational and Environmental Health, Kitakyushu; Rheumatology, Keio University Hospital, Tokyo, Japan; Rheumatology, Medical University of Vienna and Hietzing Hospital, Vienna, Austria. Sponsored by Janssen Research & Development, LLC. R. Thurmond, A. Greenspan, W. Radziszewski (previously employed by Janssen, currently employed by Sandoz Inc., Princeton, New Jersey, USA), X.L. Xu, Y. Miao, B. Chen, T. Ge, B. Zhou, and D.G. Baker are/were employees of Janssen, a Johnson and Johnson (J&J) Pharmaceutical Company, and own stock in J&J. D. Pavlova has received research grant support from Janssen. C.T. Ritchlin has received research grant support from AbbVie, Amgen, and UCB. He has received honoraria from AbbVie, Amgen, Janssen, Novartis, Sanofi, and UCB. Y. Tanaka has received consulting fees, speaking fees, and/or honoraria from AbbVie, Asahi Kasei Medical KK Pharma, Astellas Pharma, AstraZeneca, Bristol-Myers KK, Celltrion, Chugai, Daiichi-Sankyo, Eisai, Eli Lilly, Janssen Pharmaceutical, Mitsubishi-Tanabe, MSD, Novartis, Pfizer, Santen, and Takeda Pharmaceutical, and has received research grants from Asahi Kasei Pharma, AbbVie GK, Astellas Pharma, Bristol-Myers KK, Chugai, Daiichi, Eisai, Kyowa-Kirin, Mitsubishi-Tanabe, Nippon Kayaku, Pfizer Japan, Santen Pharmaceutical, Teijin, SymBio Pharmaceuticals, Takeda Pharmaceutical, and Taisho-Toyama Pharmaceutical. T. Takeuchi has received research grants, speaking fees, and/or consulting fees from AbbVie GK, Asahi Kasei Medical KK, Asahi Kasei Pharma, Astra Zeneca KK, Astellas Pharma, Bristol-Myers KK, Celtrion, Chugai Pharmaceutical, Daiichi-Sankyo, Eisai, Janssen Pharmaceutical, Eli Lilly Japan KK, Mitsubishi Tanabe Pharma, Nipponkayaku, Novartis Pharma KK, Pfizer Japan, Santen Pharmaceutical, SymBio Pharmaceuticals, Taisho Toyama Pharmaceutical, Takeda Pharmaceutical, and Teijin Pharma. J.S. Smolen has received research grant support from Abbott, BMS, MSD, Pfizer, Roche, and UCB and consultation and/or speaking honoraria from Abbott, Astra-Zeneca, BMS, Celgene, Glaxo, Janssen, MSD, Novo-Nordisk, Pfizer, Roche, Sanofi-Aventis, and UCB. R.L. Thurmond, PhD, Immunology Department, Janssen Research & Development, LLC; A. Greenspan, MD, Medical Affairs Department, Janssen Research & Development, LLC; W. Radziszewski, MD, PhD, Immunology Department, Janssen Research & Development, LLC; X.L. Xu, PhD, Immunology Department, Janssen Research & Development, LLC; Y. Miao, MS, Biostatistics Department, Janssen Research & Development, LLC; B. Chen, PhD, Early Development, Janssen China Research and Development; T. Ge, PhD, Biostatistics Department, Janssen Research & Development, LLC; B. Zhou, PhD, Biostatistics, Janssen Research & Development, LLC; D.G. Baker, MD, Immunology Department, Janssen Research & Development, LLC; D. Pavlova, MD, Rheumatology, M&M Centers Ltd.; C.T. Ritchlin, MD, Immunology Department, University of Rochester; Y. Tanaka, MD, PhD, Internal Medicine, University of Occupational and Environmental Health; T. Takeuchi, MD, PhD, Rheumatology, Keio University Hospital; J.S. Smolen, MD, Rheumatology, Medical University of Vienna and Hietzing Hospital. Address correspondence to R.L. Thurmond, Janssen Research & Development, LLC, 3210 Merryfield Row, San Diego, California 92121, USA. E-mail: RThurmon@its.jnj.com. Accepted for publication May 20, 2016.
Ye Miao
From the Immunology department, Janssen Research & Development, LLC, San Diego, California; the Medical Affairs department, Janssen Research & Development, LLC, Horsham, Pennsylvania; the Biostatistics department and the Immunology department, Janssen Research & Development, LLC, Spring House, Pennsylvania, USA; Early Development, Janssen China Research and Development, Shanghai, China; the Biostatistics department, Janssen Research & Development, LLC, Belmont, Massachusetts, USA; Rheumatology Department, M&M Centers LTD., Adazi, Latvia; Immunology Department, University of Rochester, Rochester, New York, USA; Internal Medicine, University of Occupational and Environmental Health, Kitakyushu; Rheumatology, Keio University Hospital, Tokyo, Japan; Rheumatology, Medical University of Vienna and Hietzing Hospital, Vienna, Austria. Sponsored by Janssen Research & Development, LLC. R. Thurmond, A. Greenspan, W. Radziszewski (previously employed by Janssen, currently employed by Sandoz Inc., Princeton, New Jersey, USA), X.L. Xu, Y. Miao, B. Chen, T. Ge, B. Zhou, and D.G. Baker are/were employees of Janssen, a Johnson and Johnson (J&J) Pharmaceutical Company, and own stock in J&J. D. Pavlova has received research grant support from Janssen. C.T. Ritchlin has received research grant support from AbbVie, Amgen, and UCB. He has received honoraria from AbbVie, Amgen, Janssen, Novartis, Sanofi, and UCB. Y. Tanaka has received consulting fees, speaking fees, and/or honoraria from AbbVie, Asahi Kasei Medical KK Pharma, Astellas Pharma, AstraZeneca, Bristol-Myers KK, Celltrion, Chugai, Daiichi-Sankyo, Eisai, Eli Lilly, Janssen Pharmaceutical, Mitsubishi-Tanabe, MSD, Novartis, Pfizer, Santen, and Takeda Pharmaceutical, and has received research grants from Asahi Kasei Pharma, AbbVie GK, Astellas Pharma, Bristol-Myers KK, Chugai, Daiichi, Eisai, Kyowa-Kirin, Mitsubishi-Tanabe, Nippon Kayaku, Pfizer Japan, Santen Pharmaceutical, Teijin, SymBio Pharmaceuticals, Takeda Pharmaceutical, and Taisho-Toyama Pharmaceutical. T. Takeuchi has received research grants, speaking fees, and/or consulting fees from AbbVie GK, Asahi Kasei Medical KK, Asahi Kasei Pharma, Astra Zeneca KK, Astellas Pharma, Bristol-Myers KK, Celtrion, Chugai Pharmaceutical, Daiichi-Sankyo, Eisai, Janssen Pharmaceutical, Eli Lilly Japan KK, Mitsubishi Tanabe Pharma, Nipponkayaku, Novartis Pharma KK, Pfizer Japan, Santen Pharmaceutical, SymBio Pharmaceuticals, Taisho Toyama Pharmaceutical, Takeda Pharmaceutical, and Teijin Pharma. J.S. Smolen has received research grant support from Abbott, BMS, MSD, Pfizer, Roche, and UCB and consultation and/or speaking honoraria from Abbott, Astra-Zeneca, BMS, Celgene, Glaxo, Janssen, MSD, Novo-Nordisk, Pfizer, Roche, Sanofi-Aventis, and UCB. R.L. Thurmond, PhD, Immunology Department, Janssen Research & Development, LLC; A. Greenspan, MD, Medical Affairs Department, Janssen Research & Development, LLC; W. Radziszewski, MD, PhD, Immunology Department, Janssen Research & Development, LLC; X.L. Xu, PhD, Immunology Department, Janssen Research & Development, LLC; Y. Miao, MS, Biostatistics Department, Janssen Research & Development, LLC; B. Chen, PhD, Early Development, Janssen China Research and Development; T. Ge, PhD, Biostatistics Department, Janssen Research & Development, LLC; B. Zhou, PhD, Biostatistics, Janssen Research & Development, LLC; D.G. Baker, MD, Immunology Department, Janssen Research & Development, LLC; D. Pavlova, MD, Rheumatology, M&M Centers Ltd.; C.T. Ritchlin, MD, Immunology Department, University of Rochester; Y. Tanaka, MD, PhD, Internal Medicine, University of Occupational and Environmental Health; T. Takeuchi, MD, PhD, Rheumatology, Keio University Hospital; J.S. Smolen, MD, Rheumatology, Medical University of Vienna and Hietzing Hospital. Address correspondence to R.L. Thurmond, Janssen Research & Development, LLC, 3210 Merryfield Row, San Diego, California 92121, USA. E-mail: RThurmon@its.jnj.com. Accepted for publication May 20, 2016.
Bin Chen
From the Immunology department, Janssen Research & Development, LLC, San Diego, California; the Medical Affairs department, Janssen Research & Development, LLC, Horsham, Pennsylvania; the Biostatistics department and the Immunology department, Janssen Research & Development, LLC, Spring House, Pennsylvania, USA; Early Development, Janssen China Research and Development, Shanghai, China; the Biostatistics department, Janssen Research & Development, LLC, Belmont, Massachusetts, USA; Rheumatology Department, M&M Centers LTD., Adazi, Latvia; Immunology Department, University of Rochester, Rochester, New York, USA; Internal Medicine, University of Occupational and Environmental Health, Kitakyushu; Rheumatology, Keio University Hospital, Tokyo, Japan; Rheumatology, Medical University of Vienna and Hietzing Hospital, Vienna, Austria. Sponsored by Janssen Research & Development, LLC. R. Thurmond, A. Greenspan, W. Radziszewski (previously employed by Janssen, currently employed by Sandoz Inc., Princeton, New Jersey, USA), X.L. Xu, Y. Miao, B. Chen, T. Ge, B. Zhou, and D.G. Baker are/were employees of Janssen, a Johnson and Johnson (J&J) Pharmaceutical Company, and own stock in J&J. D. Pavlova has received research grant support from Janssen. C.T. Ritchlin has received research grant support from AbbVie, Amgen, and UCB. He has received honoraria from AbbVie, Amgen, Janssen, Novartis, Sanofi, and UCB. Y. Tanaka has received consulting fees, speaking fees, and/or honoraria from AbbVie, Asahi Kasei Medical KK Pharma, Astellas Pharma, AstraZeneca, Bristol-Myers KK, Celltrion, Chugai, Daiichi-Sankyo, Eisai, Eli Lilly, Janssen Pharmaceutical, Mitsubishi-Tanabe, MSD, Novartis, Pfizer, Santen, and Takeda Pharmaceutical, and has received research grants from Asahi Kasei Pharma, AbbVie GK, Astellas Pharma, Bristol-Myers KK, Chugai, Daiichi, Eisai, Kyowa-Kirin, Mitsubishi-Tanabe, Nippon Kayaku, Pfizer Japan, Santen Pharmaceutical, Teijin, SymBio Pharmaceuticals, Takeda Pharmaceutical, and Taisho-Toyama Pharmaceutical. T. Takeuchi has received research grants, speaking fees, and/or consulting fees from AbbVie GK, Asahi Kasei Medical KK, Asahi Kasei Pharma, Astra Zeneca KK, Astellas Pharma, Bristol-Myers KK, Celtrion, Chugai Pharmaceutical, Daiichi-Sankyo, Eisai, Janssen Pharmaceutical, Eli Lilly Japan KK, Mitsubishi Tanabe Pharma, Nipponkayaku, Novartis Pharma KK, Pfizer Japan, Santen Pharmaceutical, SymBio Pharmaceuticals, Taisho Toyama Pharmaceutical, Takeda Pharmaceutical, and Teijin Pharma. J.S. Smolen has received research grant support from Abbott, BMS, MSD, Pfizer, Roche, and UCB and consultation and/or speaking honoraria from Abbott, Astra-Zeneca, BMS, Celgene, Glaxo, Janssen, MSD, Novo-Nordisk, Pfizer, Roche, Sanofi-Aventis, and UCB. R.L. Thurmond, PhD, Immunology Department, Janssen Research & Development, LLC; A. Greenspan, MD, Medical Affairs Department, Janssen Research & Development, LLC; W. Radziszewski, MD, PhD, Immunology Department, Janssen Research & Development, LLC; X.L. Xu, PhD, Immunology Department, Janssen Research & Development, LLC; Y. Miao, MS, Biostatistics Department, Janssen Research & Development, LLC; B. Chen, PhD, Early Development, Janssen China Research and Development; T. Ge, PhD, Biostatistics Department, Janssen Research & Development, LLC; B. Zhou, PhD, Biostatistics, Janssen Research & Development, LLC; D.G. Baker, MD, Immunology Department, Janssen Research & Development, LLC; D. Pavlova, MD, Rheumatology, M&M Centers Ltd.; C.T. Ritchlin, MD, Immunology Department, University of Rochester; Y. Tanaka, MD, PhD, Internal Medicine, University of Occupational and Environmental Health; T. Takeuchi, MD, PhD, Rheumatology, Keio University Hospital; J.S. Smolen, MD, Rheumatology, Medical University of Vienna and Hietzing Hospital. Address correspondence to R.L. Thurmond, Janssen Research & Development, LLC, 3210 Merryfield Row, San Diego, California 92121, USA. E-mail: RThurmon@its.jnj.com. Accepted for publication May 20, 2016.
TingTing Ge
From the Immunology department, Janssen Research & Development, LLC, San Diego, California; the Medical Affairs department, Janssen Research & Development, LLC, Horsham, Pennsylvania; the Biostatistics department and the Immunology department, Janssen Research & Development, LLC, Spring House, Pennsylvania, USA; Early Development, Janssen China Research and Development, Shanghai, China; the Biostatistics department, Janssen Research & Development, LLC, Belmont, Massachusetts, USA; Rheumatology Department, M&M Centers LTD., Adazi, Latvia; Immunology Department, University of Rochester, Rochester, New York, USA; Internal Medicine, University of Occupational and Environmental Health, Kitakyushu; Rheumatology, Keio University Hospital, Tokyo, Japan; Rheumatology, Medical University of Vienna and Hietzing Hospital, Vienna, Austria. Sponsored by Janssen Research & Development, LLC. R. Thurmond, A. Greenspan, W. Radziszewski (previously employed by Janssen, currently employed by Sandoz Inc., Princeton, New Jersey, USA), X.L. Xu, Y. Miao, B. Chen, T. Ge, B. Zhou, and D.G. Baker are/were employees of Janssen, a Johnson and Johnson (J&J) Pharmaceutical Company, and own stock in J&J. D. Pavlova has received research grant support from Janssen. C.T. Ritchlin has received research grant support from AbbVie, Amgen, and UCB. He has received honoraria from AbbVie, Amgen, Janssen, Novartis, Sanofi, and UCB. Y. Tanaka has received consulting fees, speaking fees, and/or honoraria from AbbVie, Asahi Kasei Medical KK Pharma, Astellas Pharma, AstraZeneca, Bristol-Myers KK, Celltrion, Chugai, Daiichi-Sankyo, Eisai, Eli Lilly, Janssen Pharmaceutical, Mitsubishi-Tanabe, MSD, Novartis, Pfizer, Santen, and Takeda Pharmaceutical, and has received research grants from Asahi Kasei Pharma, AbbVie GK, Astellas Pharma, Bristol-Myers KK, Chugai, Daiichi, Eisai, Kyowa-Kirin, Mitsubishi-Tanabe, Nippon Kayaku, Pfizer Japan, Santen Pharmaceutical, Teijin, SymBio Pharmaceuticals, Takeda Pharmaceutical, and Taisho-Toyama Pharmaceutical. T. Takeuchi has received research grants, speaking fees, and/or consulting fees from AbbVie GK, Asahi Kasei Medical KK, Asahi Kasei Pharma, Astra Zeneca KK, Astellas Pharma, Bristol-Myers KK, Celtrion, Chugai Pharmaceutical, Daiichi-Sankyo, Eisai, Janssen Pharmaceutical, Eli Lilly Japan KK, Mitsubishi Tanabe Pharma, Nipponkayaku, Novartis Pharma KK, Pfizer Japan, Santen Pharmaceutical, SymBio Pharmaceuticals, Taisho Toyama Pharmaceutical, Takeda Pharmaceutical, and Teijin Pharma. J.S. Smolen has received research grant support from Abbott, BMS, MSD, Pfizer, Roche, and UCB and consultation and/or speaking honoraria from Abbott, Astra-Zeneca, BMS, Celgene, Glaxo, Janssen, MSD, Novo-Nordisk, Pfizer, Roche, Sanofi-Aventis, and UCB. R.L. Thurmond, PhD, Immunology Department, Janssen Research & Development, LLC; A. Greenspan, MD, Medical Affairs Department, Janssen Research & Development, LLC; W. Radziszewski, MD, PhD, Immunology Department, Janssen Research & Development, LLC; X.L. Xu, PhD, Immunology Department, Janssen Research & Development, LLC; Y. Miao, MS, Biostatistics Department, Janssen Research & Development, LLC; B. Chen, PhD, Early Development, Janssen China Research and Development; T. Ge, PhD, Biostatistics Department, Janssen Research & Development, LLC; B. Zhou, PhD, Biostatistics, Janssen Research & Development, LLC; D.G. Baker, MD, Immunology Department, Janssen Research & Development, LLC; D. Pavlova, MD, Rheumatology, M&M Centers Ltd.; C.T. Ritchlin, MD, Immunology Department, University of Rochester; Y. Tanaka, MD, PhD, Internal Medicine, University of Occupational and Environmental Health; T. Takeuchi, MD, PhD, Rheumatology, Keio University Hospital; J.S. Smolen, MD, Rheumatology, Medical University of Vienna and Hietzing Hospital. Address correspondence to R.L. Thurmond, Janssen Research & Development, LLC, 3210 Merryfield Row, San Diego, California 92121, USA. E-mail: RThurmon@its.jnj.com. Accepted for publication May 20, 2016.
Bei Zhou
From the Immunology department, Janssen Research & Development, LLC, San Diego, California; the Medical Affairs department, Janssen Research & Development, LLC, Horsham, Pennsylvania; the Biostatistics department and the Immunology department, Janssen Research & Development, LLC, Spring House, Pennsylvania, USA; Early Development, Janssen China Research and Development, Shanghai, China; the Biostatistics department, Janssen Research & Development, LLC, Belmont, Massachusetts, USA; Rheumatology Department, M&M Centers LTD., Adazi, Latvia; Immunology Department, University of Rochester, Rochester, New York, USA; Internal Medicine, University of Occupational and Environmental Health, Kitakyushu; Rheumatology, Keio University Hospital, Tokyo, Japan; Rheumatology, Medical University of Vienna and Hietzing Hospital, Vienna, Austria. Sponsored by Janssen Research & Development, LLC. R. Thurmond, A. Greenspan, W. Radziszewski (previously employed by Janssen, currently employed by Sandoz Inc., Princeton, New Jersey, USA), X.L. Xu, Y. Miao, B. Chen, T. Ge, B. Zhou, and D.G. Baker are/were employees of Janssen, a Johnson and Johnson (J&J) Pharmaceutical Company, and own stock in J&J. D. Pavlova has received research grant support from Janssen. C.T. Ritchlin has received research grant support from AbbVie, Amgen, and UCB. He has received honoraria from AbbVie, Amgen, Janssen, Novartis, Sanofi, and UCB. Y. Tanaka has received consulting fees, speaking fees, and/or honoraria from AbbVie, Asahi Kasei Medical KK Pharma, Astellas Pharma, AstraZeneca, Bristol-Myers KK, Celltrion, Chugai, Daiichi-Sankyo, Eisai, Eli Lilly, Janssen Pharmaceutical, Mitsubishi-Tanabe, MSD, Novartis, Pfizer, Santen, and Takeda Pharmaceutical, and has received research grants from Asahi Kasei Pharma, AbbVie GK, Astellas Pharma, Bristol-Myers KK, Chugai, Daiichi, Eisai, Kyowa-Kirin, Mitsubishi-Tanabe, Nippon Kayaku, Pfizer Japan, Santen Pharmaceutical, Teijin, SymBio Pharmaceuticals, Takeda Pharmaceutical, and Taisho-Toyama Pharmaceutical. T. Takeuchi has received research grants, speaking fees, and/or consulting fees from AbbVie GK, Asahi Kasei Medical KK, Asahi Kasei Pharma, Astra Zeneca KK, Astellas Pharma, Bristol-Myers KK, Celtrion, Chugai Pharmaceutical, Daiichi-Sankyo, Eisai, Janssen Pharmaceutical, Eli Lilly Japan KK, Mitsubishi Tanabe Pharma, Nipponkayaku, Novartis Pharma KK, Pfizer Japan, Santen Pharmaceutical, SymBio Pharmaceuticals, Taisho Toyama Pharmaceutical, Takeda Pharmaceutical, and Teijin Pharma. J.S. Smolen has received research grant support from Abbott, BMS, MSD, Pfizer, Roche, and UCB and consultation and/or speaking honoraria from Abbott, Astra-Zeneca, BMS, Celgene, Glaxo, Janssen, MSD, Novo-Nordisk, Pfizer, Roche, Sanofi-Aventis, and UCB. R.L. Thurmond, PhD, Immunology Department, Janssen Research & Development, LLC; A. Greenspan, MD, Medical Affairs Department, Janssen Research & Development, LLC; W. Radziszewski, MD, PhD, Immunology Department, Janssen Research & Development, LLC; X.L. Xu, PhD, Immunology Department, Janssen Research & Development, LLC; Y. Miao, MS, Biostatistics Department, Janssen Research & Development, LLC; B. Chen, PhD, Early Development, Janssen China Research and Development; T. Ge, PhD, Biostatistics Department, Janssen Research & Development, LLC; B. Zhou, PhD, Biostatistics, Janssen Research & Development, LLC; D.G. Baker, MD, Immunology Department, Janssen Research & Development, LLC; D. Pavlova, MD, Rheumatology, M&M Centers Ltd.; C.T. Ritchlin, MD, Immunology Department, University of Rochester; Y. Tanaka, MD, PhD, Internal Medicine, University of Occupational and Environmental Health; T. Takeuchi, MD, PhD, Rheumatology, Keio University Hospital; J.S. Smolen, MD, Rheumatology, Medical University of Vienna and Hietzing Hospital. Address correspondence to R.L. Thurmond, Janssen Research & Development, LLC, 3210 Merryfield Row, San Diego, California 92121, USA. E-mail: RThurmon@its.jnj.com. Accepted for publication May 20, 2016.
Daniel G. Baker
From the Immunology department, Janssen Research & Development, LLC, San Diego, California; the Medical Affairs department, Janssen Research & Development, LLC, Horsham, Pennsylvania; the Biostatistics department and the Immunology department, Janssen Research & Development, LLC, Spring House, Pennsylvania, USA; Early Development, Janssen China Research and Development, Shanghai, China; the Biostatistics department, Janssen Research & Development, LLC, Belmont, Massachusetts, USA; Rheumatology Department, M&M Centers LTD., Adazi, Latvia; Immunology Department, University of Rochester, Rochester, New York, USA; Internal Medicine, University of Occupational and Environmental Health, Kitakyushu; Rheumatology, Keio University Hospital, Tokyo, Japan; Rheumatology, Medical University of Vienna and Hietzing Hospital, Vienna, Austria. Sponsored by Janssen Research & Development, LLC. R. Thurmond, A. Greenspan, W. Radziszewski (previously employed by Janssen, currently employed by Sandoz Inc., Princeton, New Jersey, USA), X.L. Xu, Y. Miao, B. Chen, T. Ge, B. Zhou, and D.G. Baker are/were employees of Janssen, a Johnson and Johnson (J&J) Pharmaceutical Company, and own stock in J&J. D. Pavlova has received research grant support from Janssen. C.T. Ritchlin has received research grant support from AbbVie, Amgen, and UCB. He has received honoraria from AbbVie, Amgen, Janssen, Novartis, Sanofi, and UCB. Y. Tanaka has received consulting fees, speaking fees, and/or honoraria from AbbVie, Asahi Kasei Medical KK Pharma, Astellas Pharma, AstraZeneca, Bristol-Myers KK, Celltrion, Chugai, Daiichi-Sankyo, Eisai, Eli Lilly, Janssen Pharmaceutical, Mitsubishi-Tanabe, MSD, Novartis, Pfizer, Santen, and Takeda Pharmaceutical, and has received research grants from Asahi Kasei Pharma, AbbVie GK, Astellas Pharma, Bristol-Myers KK, Chugai, Daiichi, Eisai, Kyowa-Kirin, Mitsubishi-Tanabe, Nippon Kayaku, Pfizer Japan, Santen Pharmaceutical, Teijin, SymBio Pharmaceuticals, Takeda Pharmaceutical, and Taisho-Toyama Pharmaceutical. T. Takeuchi has received research grants, speaking fees, and/or consulting fees from AbbVie GK, Asahi Kasei Medical KK, Asahi Kasei Pharma, Astra Zeneca KK, Astellas Pharma, Bristol-Myers KK, Celtrion, Chugai Pharmaceutical, Daiichi-Sankyo, Eisai, Janssen Pharmaceutical, Eli Lilly Japan KK, Mitsubishi Tanabe Pharma, Nipponkayaku, Novartis Pharma KK, Pfizer Japan, Santen Pharmaceutical, SymBio Pharmaceuticals, Taisho Toyama Pharmaceutical, Takeda Pharmaceutical, and Teijin Pharma. J.S. Smolen has received research grant support from Abbott, BMS, MSD, Pfizer, Roche, and UCB and consultation and/or speaking honoraria from Abbott, Astra-Zeneca, BMS, Celgene, Glaxo, Janssen, MSD, Novo-Nordisk, Pfizer, Roche, Sanofi-Aventis, and UCB. R.L. Thurmond, PhD, Immunology Department, Janssen Research & Development, LLC; A. Greenspan, MD, Medical Affairs Department, Janssen Research & Development, LLC; W. Radziszewski, MD, PhD, Immunology Department, Janssen Research & Development, LLC; X.L. Xu, PhD, Immunology Department, Janssen Research & Development, LLC; Y. Miao, MS, Biostatistics Department, Janssen Research & Development, LLC; B. Chen, PhD, Early Development, Janssen China Research and Development; T. Ge, PhD, Biostatistics Department, Janssen Research & Development, LLC; B. Zhou, PhD, Biostatistics, Janssen Research & Development, LLC; D.G. Baker, MD, Immunology Department, Janssen Research & Development, LLC; D. Pavlova, MD, Rheumatology, M&M Centers Ltd.; C.T. Ritchlin, MD, Immunology Department, University of Rochester; Y. Tanaka, MD, PhD, Internal Medicine, University of Occupational and Environmental Health; T. Takeuchi, MD, PhD, Rheumatology, Keio University Hospital; J.S. Smolen, MD, Rheumatology, Medical University of Vienna and Hietzing Hospital. Address correspondence to R.L. Thurmond, Janssen Research & Development, LLC, 3210 Merryfield Row, San Diego, California 92121, USA. E-mail: RThurmon@its.jnj.com. Accepted for publication May 20, 2016.
Dace Pavlova
From the Immunology department, Janssen Research & Development, LLC, San Diego, California; the Medical Affairs department, Janssen Research & Development, LLC, Horsham, Pennsylvania; the Biostatistics department and the Immunology department, Janssen Research & Development, LLC, Spring House, Pennsylvania, USA; Early Development, Janssen China Research and Development, Shanghai, China; the Biostatistics department, Janssen Research & Development, LLC, Belmont, Massachusetts, USA; Rheumatology Department, M&M Centers LTD., Adazi, Latvia; Immunology Department, University of Rochester, Rochester, New York, USA; Internal Medicine, University of Occupational and Environmental Health, Kitakyushu; Rheumatology, Keio University Hospital, Tokyo, Japan; Rheumatology, Medical University of Vienna and Hietzing Hospital, Vienna, Austria. Sponsored by Janssen Research & Development, LLC. R. Thurmond, A. Greenspan, W. Radziszewski (previously employed by Janssen, currently employed by Sandoz Inc., Princeton, New Jersey, USA), X.L. Xu, Y. Miao, B. Chen, T. Ge, B. Zhou, and D.G. Baker are/were employees of Janssen, a Johnson and Johnson (J&J) Pharmaceutical Company, and own stock in J&J. D. Pavlova has received research grant support from Janssen. C.T. Ritchlin has received research grant support from AbbVie, Amgen, and UCB. He has received honoraria from AbbVie, Amgen, Janssen, Novartis, Sanofi, and UCB. Y. Tanaka has received consulting fees, speaking fees, and/or honoraria from AbbVie, Asahi Kasei Medical KK Pharma, Astellas Pharma, AstraZeneca, Bristol-Myers KK, Celltrion, Chugai, Daiichi-Sankyo, Eisai, Eli Lilly, Janssen Pharmaceutical, Mitsubishi-Tanabe, MSD, Novartis, Pfizer, Santen, and Takeda Pharmaceutical, and has received research grants from Asahi Kasei Pharma, AbbVie GK, Astellas Pharma, Bristol-Myers KK, Chugai, Daiichi, Eisai, Kyowa-Kirin, Mitsubishi-Tanabe, Nippon Kayaku, Pfizer Japan, Santen Pharmaceutical, Teijin, SymBio Pharmaceuticals, Takeda Pharmaceutical, and Taisho-Toyama Pharmaceutical. T. Takeuchi has received research grants, speaking fees, and/or consulting fees from AbbVie GK, Asahi Kasei Medical KK, Asahi Kasei Pharma, Astra Zeneca KK, Astellas Pharma, Bristol-Myers KK, Celtrion, Chugai Pharmaceutical, Daiichi-Sankyo, Eisai, Janssen Pharmaceutical, Eli Lilly Japan KK, Mitsubishi Tanabe Pharma, Nipponkayaku, Novartis Pharma KK, Pfizer Japan, Santen Pharmaceutical, SymBio Pharmaceuticals, Taisho Toyama Pharmaceutical, Takeda Pharmaceutical, and Teijin Pharma. J.S. Smolen has received research grant support from Abbott, BMS, MSD, Pfizer, Roche, and UCB and consultation and/or speaking honoraria from Abbott, Astra-Zeneca, BMS, Celgene, Glaxo, Janssen, MSD, Novo-Nordisk, Pfizer, Roche, Sanofi-Aventis, and UCB. R.L. Thurmond, PhD, Immunology Department, Janssen Research & Development, LLC; A. Greenspan, MD, Medical Affairs Department, Janssen Research & Development, LLC; W. Radziszewski, MD, PhD, Immunology Department, Janssen Research & Development, LLC; X.L. Xu, PhD, Immunology Department, Janssen Research & Development, LLC; Y. Miao, MS, Biostatistics Department, Janssen Research & Development, LLC; B. Chen, PhD, Early Development, Janssen China Research and Development; T. Ge, PhD, Biostatistics Department, Janssen Research & Development, LLC; B. Zhou, PhD, Biostatistics, Janssen Research & Development, LLC; D.G. Baker, MD, Immunology Department, Janssen Research & Development, LLC; D. Pavlova, MD, Rheumatology, M&M Centers Ltd.; C.T. Ritchlin, MD, Immunology Department, University of Rochester; Y. Tanaka, MD, PhD, Internal Medicine, University of Occupational and Environmental Health; T. Takeuchi, MD, PhD, Rheumatology, Keio University Hospital; J.S. Smolen, MD, Rheumatology, Medical University of Vienna and Hietzing Hospital. Address correspondence to R.L. Thurmond, Janssen Research & Development, LLC, 3210 Merryfield Row, San Diego, California 92121, USA. E-mail: RThurmon@its.jnj.com. Accepted for publication May 20, 2016.
Christopher T. Ritchlin
From the Immunology department, Janssen Research & Development, LLC, San Diego, California; the Medical Affairs department, Janssen Research & Development, LLC, Horsham, Pennsylvania; the Biostatistics department and the Immunology department, Janssen Research & Development, LLC, Spring House, Pennsylvania, USA; Early Development, Janssen China Research and Development, Shanghai, China; the Biostatistics department, Janssen Research & Development, LLC, Belmont, Massachusetts, USA; Rheumatology Department, M&M Centers LTD., Adazi, Latvia; Immunology Department, University of Rochester, Rochester, New York, USA; Internal Medicine, University of Occupational and Environmental Health, Kitakyushu; Rheumatology, Keio University Hospital, Tokyo, Japan; Rheumatology, Medical University of Vienna and Hietzing Hospital, Vienna, Austria. Sponsored by Janssen Research & Development, LLC. R. Thurmond, A. Greenspan, W. Radziszewski (previously employed by Janssen, currently employed by Sandoz Inc., Princeton, New Jersey, USA), X.L. Xu, Y. Miao, B. Chen, T. Ge, B. Zhou, and D.G. Baker are/were employees of Janssen, a Johnson and Johnson (J&J) Pharmaceutical Company, and own stock in J&J. D. Pavlova has received research grant support from Janssen. C.T. Ritchlin has received research grant support from AbbVie, Amgen, and UCB. He has received honoraria from AbbVie, Amgen, Janssen, Novartis, Sanofi, and UCB. Y. Tanaka has received consulting fees, speaking fees, and/or honoraria from AbbVie, Asahi Kasei Medical KK Pharma, Astellas Pharma, AstraZeneca, Bristol-Myers KK, Celltrion, Chugai, Daiichi-Sankyo, Eisai, Eli Lilly, Janssen Pharmaceutical, Mitsubishi-Tanabe, MSD, Novartis, Pfizer, Santen, and Takeda Pharmaceutical, and has received research grants from Asahi Kasei Pharma, AbbVie GK, Astellas Pharma, Bristol-Myers KK, Chugai, Daiichi, Eisai, Kyowa-Kirin, Mitsubishi-Tanabe, Nippon Kayaku, Pfizer Japan, Santen Pharmaceutical, Teijin, SymBio Pharmaceuticals, Takeda Pharmaceutical, and Taisho-Toyama Pharmaceutical. T. Takeuchi has received research grants, speaking fees, and/or consulting fees from AbbVie GK, Asahi Kasei Medical KK, Asahi Kasei Pharma, Astra Zeneca KK, Astellas Pharma, Bristol-Myers KK, Celtrion, Chugai Pharmaceutical, Daiichi-Sankyo, Eisai, Janssen Pharmaceutical, Eli Lilly Japan KK, Mitsubishi Tanabe Pharma, Nipponkayaku, Novartis Pharma KK, Pfizer Japan, Santen Pharmaceutical, SymBio Pharmaceuticals, Taisho Toyama Pharmaceutical, Takeda Pharmaceutical, and Teijin Pharma. J.S. Smolen has received research grant support from Abbott, BMS, MSD, Pfizer, Roche, and UCB and consultation and/or speaking honoraria from Abbott, Astra-Zeneca, BMS, Celgene, Glaxo, Janssen, MSD, Novo-Nordisk, Pfizer, Roche, Sanofi-Aventis, and UCB. R.L. Thurmond, PhD, Immunology Department, Janssen Research & Development, LLC; A. Greenspan, MD, Medical Affairs Department, Janssen Research & Development, LLC; W. Radziszewski, MD, PhD, Immunology Department, Janssen Research & Development, LLC; X.L. Xu, PhD, Immunology Department, Janssen Research & Development, LLC; Y. Miao, MS, Biostatistics Department, Janssen Research & Development, LLC; B. Chen, PhD, Early Development, Janssen China Research and Development; T. Ge, PhD, Biostatistics Department, Janssen Research & Development, LLC; B. Zhou, PhD, Biostatistics, Janssen Research & Development, LLC; D.G. Baker, MD, Immunology Department, Janssen Research & Development, LLC; D. Pavlova, MD, Rheumatology, M&M Centers Ltd.; C.T. Ritchlin, MD, Immunology Department, University of Rochester; Y. Tanaka, MD, PhD, Internal Medicine, University of Occupational and Environmental Health; T. Takeuchi, MD, PhD, Rheumatology, Keio University Hospital; J.S. Smolen, MD, Rheumatology, Medical University of Vienna and Hietzing Hospital. Address correspondence to R.L. Thurmond, Janssen Research & Development, LLC, 3210 Merryfield Row, San Diego, California 92121, USA. E-mail: RThurmon@its.jnj.com. Accepted for publication May 20, 2016.
Yoshiya Tanaka
From the Immunology department, Janssen Research & Development, LLC, San Diego, California; the Medical Affairs department, Janssen Research & Development, LLC, Horsham, Pennsylvania; the Biostatistics department and the Immunology department, Janssen Research & Development, LLC, Spring House, Pennsylvania, USA; Early Development, Janssen China Research and Development, Shanghai, China; the Biostatistics department, Janssen Research & Development, LLC, Belmont, Massachusetts, USA; Rheumatology Department, M&M Centers LTD., Adazi, Latvia; Immunology Department, University of Rochester, Rochester, New York, USA; Internal Medicine, University of Occupational and Environmental Health, Kitakyushu; Rheumatology, Keio University Hospital, Tokyo, Japan; Rheumatology, Medical University of Vienna and Hietzing Hospital, Vienna, Austria. Sponsored by Janssen Research & Development, LLC. R. Thurmond, A. Greenspan, W. Radziszewski (previously employed by Janssen, currently employed by Sandoz Inc., Princeton, New Jersey, USA), X.L. Xu, Y. Miao, B. Chen, T. Ge, B. Zhou, and D.G. Baker are/were employees of Janssen, a Johnson and Johnson (J&J) Pharmaceutical Company, and own stock in J&J. D. Pavlova has received research grant support from Janssen. C.T. Ritchlin has received research grant support from AbbVie, Amgen, and UCB. He has received honoraria from AbbVie, Amgen, Janssen, Novartis, Sanofi, and UCB. Y. Tanaka has received consulting fees, speaking fees, and/or honoraria from AbbVie, Asahi Kasei Medical KK Pharma, Astellas Pharma, AstraZeneca, Bristol-Myers KK, Celltrion, Chugai, Daiichi-Sankyo, Eisai, Eli Lilly, Janssen Pharmaceutical, Mitsubishi-Tanabe, MSD, Novartis, Pfizer, Santen, and Takeda Pharmaceutical, and has received research grants from Asahi Kasei Pharma, AbbVie GK, Astellas Pharma, Bristol-Myers KK, Chugai, Daiichi, Eisai, Kyowa-Kirin, Mitsubishi-Tanabe, Nippon Kayaku, Pfizer Japan, Santen Pharmaceutical, Teijin, SymBio Pharmaceuticals, Takeda Pharmaceutical, and Taisho-Toyama Pharmaceutical. T. Takeuchi has received research grants, speaking fees, and/or consulting fees from AbbVie GK, Asahi Kasei Medical KK, Asahi Kasei Pharma, Astra Zeneca KK, Astellas Pharma, Bristol-Myers KK, Celtrion, Chugai Pharmaceutical, Daiichi-Sankyo, Eisai, Janssen Pharmaceutical, Eli Lilly Japan KK, Mitsubishi Tanabe Pharma, Nipponkayaku, Novartis Pharma KK, Pfizer Japan, Santen Pharmaceutical, SymBio Pharmaceuticals, Taisho Toyama Pharmaceutical, Takeda Pharmaceutical, and Teijin Pharma. J.S. Smolen has received research grant support from Abbott, BMS, MSD, Pfizer, Roche, and UCB and consultation and/or speaking honoraria from Abbott, Astra-Zeneca, BMS, Celgene, Glaxo, Janssen, MSD, Novo-Nordisk, Pfizer, Roche, Sanofi-Aventis, and UCB. R.L. Thurmond, PhD, Immunology Department, Janssen Research & Development, LLC; A. Greenspan, MD, Medical Affairs Department, Janssen Research & Development, LLC; W. Radziszewski, MD, PhD, Immunology Department, Janssen Research & Development, LLC; X.L. Xu, PhD, Immunology Department, Janssen Research & Development, LLC; Y. Miao, MS, Biostatistics Department, Janssen Research & Development, LLC; B. Chen, PhD, Early Development, Janssen China Research and Development; T. Ge, PhD, Biostatistics Department, Janssen Research & Development, LLC; B. Zhou, PhD, Biostatistics, Janssen Research & Development, LLC; D.G. Baker, MD, Immunology Department, Janssen Research & Development, LLC; D. Pavlova, MD, Rheumatology, M&M Centers Ltd.; C.T. Ritchlin, MD, Immunology Department, University of Rochester; Y. Tanaka, MD, PhD, Internal Medicine, University of Occupational and Environmental Health; T. Takeuchi, MD, PhD, Rheumatology, Keio University Hospital; J.S. Smolen, MD, Rheumatology, Medical University of Vienna and Hietzing Hospital. Address correspondence to R.L. Thurmond, Janssen Research & Development, LLC, 3210 Merryfield Row, San Diego, California 92121, USA. E-mail: RThurmon@its.jnj.com. Accepted for publication May 20, 2016.
Tsutomu Takeuchi
From the Immunology department, Janssen Research & Development, LLC, San Diego, California; the Medical Affairs department, Janssen Research & Development, LLC, Horsham, Pennsylvania; the Biostatistics department and the Immunology department, Janssen Research & Development, LLC, Spring House, Pennsylvania, USA; Early Development, Janssen China Research and Development, Shanghai, China; the Biostatistics department, Janssen Research & Development, LLC, Belmont, Massachusetts, USA; Rheumatology Department, M&M Centers LTD., Adazi, Latvia; Immunology Department, University of Rochester, Rochester, New York, USA; Internal Medicine, University of Occupational and Environmental Health, Kitakyushu; Rheumatology, Keio University Hospital, Tokyo, Japan; Rheumatology, Medical University of Vienna and Hietzing Hospital, Vienna, Austria. Sponsored by Janssen Research & Development, LLC. R. Thurmond, A. Greenspan, W. Radziszewski (previously employed by Janssen, currently employed by Sandoz Inc., Princeton, New Jersey, USA), X.L. Xu, Y. Miao, B. Chen, T. Ge, B. Zhou, and D.G. Baker are/were employees of Janssen, a Johnson and Johnson (J&J) Pharmaceutical Company, and own stock in J&J. D. Pavlova has received research grant support from Janssen. C.T. Ritchlin has received research grant support from AbbVie, Amgen, and UCB. He has received honoraria from AbbVie, Amgen, Janssen, Novartis, Sanofi, and UCB. Y. Tanaka has received consulting fees, speaking fees, and/or honoraria from AbbVie, Asahi Kasei Medical KK Pharma, Astellas Pharma, AstraZeneca, Bristol-Myers KK, Celltrion, Chugai, Daiichi-Sankyo, Eisai, Eli Lilly, Janssen Pharmaceutical, Mitsubishi-Tanabe, MSD, Novartis, Pfizer, Santen, and Takeda Pharmaceutical, and has received research grants from Asahi Kasei Pharma, AbbVie GK, Astellas Pharma, Bristol-Myers KK, Chugai, Daiichi, Eisai, Kyowa-Kirin, Mitsubishi-Tanabe, Nippon Kayaku, Pfizer Japan, Santen Pharmaceutical, Teijin, SymBio Pharmaceuticals, Takeda Pharmaceutical, and Taisho-Toyama Pharmaceutical. T. Takeuchi has received research grants, speaking fees, and/or consulting fees from AbbVie GK, Asahi Kasei Medical KK, Asahi Kasei Pharma, Astra Zeneca KK, Astellas Pharma, Bristol-Myers KK, Celtrion, Chugai Pharmaceutical, Daiichi-Sankyo, Eisai, Janssen Pharmaceutical, Eli Lilly Japan KK, Mitsubishi Tanabe Pharma, Nipponkayaku, Novartis Pharma KK, Pfizer Japan, Santen Pharmaceutical, SymBio Pharmaceuticals, Taisho Toyama Pharmaceutical, Takeda Pharmaceutical, and Teijin Pharma. J.S. Smolen has received research grant support from Abbott, BMS, MSD, Pfizer, Roche, and UCB and consultation and/or speaking honoraria from Abbott, Astra-Zeneca, BMS, Celgene, Glaxo, Janssen, MSD, Novo-Nordisk, Pfizer, Roche, Sanofi-Aventis, and UCB. R.L. Thurmond, PhD, Immunology Department, Janssen Research & Development, LLC; A. Greenspan, MD, Medical Affairs Department, Janssen Research & Development, LLC; W. Radziszewski, MD, PhD, Immunology Department, Janssen Research & Development, LLC; X.L. Xu, PhD, Immunology Department, Janssen Research & Development, LLC; Y. Miao, MS, Biostatistics Department, Janssen Research & Development, LLC; B. Chen, PhD, Early Development, Janssen China Research and Development; T. Ge, PhD, Biostatistics Department, Janssen Research & Development, LLC; B. Zhou, PhD, Biostatistics, Janssen Research & Development, LLC; D.G. Baker, MD, Immunology Department, Janssen Research & Development, LLC; D. Pavlova, MD, Rheumatology, M&M Centers Ltd.; C.T. Ritchlin, MD, Immunology Department, University of Rochester; Y. Tanaka, MD, PhD, Internal Medicine, University of Occupational and Environmental Health; T. Takeuchi, MD, PhD, Rheumatology, Keio University Hospital; J.S. Smolen, MD, Rheumatology, Medical University of Vienna and Hietzing Hospital. Address correspondence to R.L. Thurmond, Janssen Research & Development, LLC, 3210 Merryfield Row, San Diego, California 92121, USA. E-mail: RThurmon@its.jnj.com. Accepted for publication May 20, 2016.
Josef S. Smolen
From the Immunology department, Janssen Research & Development, LLC, San Diego, California; the Medical Affairs department, Janssen Research & Development, LLC, Horsham, Pennsylvania; the Biostatistics department and the Immunology department, Janssen Research & Development, LLC, Spring House, Pennsylvania, USA; Early Development, Janssen China Research and Development, Shanghai, China; the Biostatistics department, Janssen Research & Development, LLC, Belmont, Massachusetts, USA; Rheumatology Department, M&M Centers LTD., Adazi, Latvia; Immunology Department, University of Rochester, Rochester, New York, USA; Internal Medicine, University of Occupational and Environmental Health, Kitakyushu; Rheumatology, Keio University Hospital, Tokyo, Japan; Rheumatology, Medical University of Vienna and Hietzing Hospital, Vienna, Austria. Sponsored by Janssen Research & Development, LLC. R. Thurmond, A. Greenspan, W. Radziszewski (previously employed by Janssen, currently employed by Sandoz Inc., Princeton, New Jersey, USA), X.L. Xu, Y. Miao, B. Chen, T. Ge, B. Zhou, and D.G. Baker are/were employees of Janssen, a Johnson and Johnson (J&J) Pharmaceutical Company, and own stock in J&J. D. Pavlova has received research grant support from Janssen. C.T. Ritchlin has received research grant support from AbbVie, Amgen, and UCB. He has received honoraria from AbbVie, Amgen, Janssen, Novartis, Sanofi, and UCB. Y. Tanaka has received consulting fees, speaking fees, and/or honoraria from AbbVie, Asahi Kasei Medical KK Pharma, Astellas Pharma, AstraZeneca, Bristol-Myers KK, Celltrion, Chugai, Daiichi-Sankyo, Eisai, Eli Lilly, Janssen Pharmaceutical, Mitsubishi-Tanabe, MSD, Novartis, Pfizer, Santen, and Takeda Pharmaceutical, and has received research grants from Asahi Kasei Pharma, AbbVie GK, Astellas Pharma, Bristol-Myers KK, Chugai, Daiichi, Eisai, Kyowa-Kirin, Mitsubishi-Tanabe, Nippon Kayaku, Pfizer Japan, Santen Pharmaceutical, Teijin, SymBio Pharmaceuticals, Takeda Pharmaceutical, and Taisho-Toyama Pharmaceutical. T. Takeuchi has received research grants, speaking fees, and/or consulting fees from AbbVie GK, Asahi Kasei Medical KK, Asahi Kasei Pharma, Astra Zeneca KK, Astellas Pharma, Bristol-Myers KK, Celtrion, Chugai Pharmaceutical, Daiichi-Sankyo, Eisai, Janssen Pharmaceutical, Eli Lilly Japan KK, Mitsubishi Tanabe Pharma, Nipponkayaku, Novartis Pharma KK, Pfizer Japan, Santen Pharmaceutical, SymBio Pharmaceuticals, Taisho Toyama Pharmaceutical, Takeda Pharmaceutical, and Teijin Pharma. J.S. Smolen has received research grant support from Abbott, BMS, MSD, Pfizer, Roche, and UCB and consultation and/or speaking honoraria from Abbott, Astra-Zeneca, BMS, Celgene, Glaxo, Janssen, MSD, Novo-Nordisk, Pfizer, Roche, Sanofi-Aventis, and UCB. R.L. Thurmond, PhD, Immunology Department, Janssen Research & Development, LLC; A. Greenspan, MD, Medical Affairs Department, Janssen Research & Development, LLC; W. Radziszewski, MD, PhD, Immunology Department, Janssen Research & Development, LLC; X.L. Xu, PhD, Immunology Department, Janssen Research & Development, LLC; Y. Miao, MS, Biostatistics Department, Janssen Research & Development, LLC; B. Chen, PhD, Early Development, Janssen China Research and Development; T. Ge, PhD, Biostatistics Department, Janssen Research & Development, LLC; B. Zhou, PhD, Biostatistics, Janssen Research & Development, LLC; D.G. Baker, MD, Immunology Department, Janssen Research & Development, LLC; D. Pavlova, MD, Rheumatology, M&M Centers Ltd.; C.T. Ritchlin, MD, Immunology Department, University of Rochester; Y. Tanaka, MD, PhD, Internal Medicine, University of Occupational and Environmental Health; T. Takeuchi, MD, PhD, Rheumatology, Keio University Hospital; J.S. Smolen, MD, Rheumatology, Medical University of Vienna and Hietzing Hospital. Address correspondence to R.L. Thurmond, Janssen Research & Development, LLC, 3210 Merryfield Row, San Diego, California 92121, USA. E-mail: RThurmon@its.jnj.com. Accepted for publication May 20, 2016.
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- Published online July 15, 2016.
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© 2016 The Journal of Rheumatology
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- Robin L. Thurmond,
- Andrew Greenspan,
- Waldemar Radziszewski,
- Xie L. Xu,
- Ye Miao,
- Bin Chen,
- TingTing Ge,
- Bei Zhou,
- Daniel G. Baker,
- Dace Pavlova,
- Christopher T. Ritchlin,
- Yoshiya Tanaka,
- Tsutomu Takeuchi and
- Josef S. Smolen
- From the Immunology department, Janssen Research & Development, LLC, San Diego, California; the Medical Affairs department, Janssen Research & Development, LLC, Horsham, Pennsylvania; the Biostatistics department and the Immunology department, Janssen Research & Development, LLC, Spring House, Pennsylvania, USA; Early Development, Janssen China Research and Development, Shanghai, China; the Biostatistics department, Janssen Research & Development, LLC, Belmont, Massachusetts, USA; Rheumatology Department, M&M Centers LTD., Adazi, Latvia; Immunology Department, University of Rochester, Rochester, New York, USA; Internal Medicine, University of Occupational and Environmental Health, Kitakyushu; Rheumatology, Keio University Hospital, Tokyo, Japan; Rheumatology, Medical University of Vienna and Hietzing Hospital, Vienna, Austria.
Sponsored by Janssen Research & Development, LLC. R. Thurmond, A. Greenspan, W. Radziszewski (previously employed by Janssen, currently employed by Sandoz Inc., Princeton, New Jersey, USA), X.L. Xu, Y. Miao, B. Chen, T. Ge, B. Zhou, and D.G. Baker are/were employees of Janssen, a Johnson and Johnson (J&J) Pharmaceutical Company, and own stock in J&J. D. Pavlova has received research grant support from Janssen.
C.T. Ritchlin has received research grant support from AbbVie, Amgen, and UCB. He has received honoraria from AbbVie, Amgen, Janssen, Novartis, Sanofi, and UCB. Y. Tanaka has received consulting fees, speaking fees, and/or honoraria from AbbVie, Asahi Kasei Medical KK Pharma, Astellas Pharma, AstraZeneca, Bristol-Myers KK, Celltrion, Chugai, Daiichi-Sankyo, Eisai, Eli Lilly, Janssen Pharmaceutical, Mitsubishi-Tanabe, MSD, Novartis, Pfizer, Santen, and Takeda Pharmaceutical, and has received research grants from Asahi Kasei Pharma, AbbVie GK, Astellas Pharma, Bristol-Myers KK, Chugai, Daiichi, Eisai, Kyowa-Kirin, Mitsubishi-Tanabe, Nippon Kayaku, Pfizer Japan, Santen Pharmaceutical, Teijin, SymBio Pharmaceuticals, Takeda Pharmaceutical, and Taisho-Toyama Pharmaceutical. T. Takeuchi has received research grants, speaking fees, and/or consulting fees from AbbVie GK, Asahi Kasei Medical KK, Asahi Kasei Pharma, Astra Zeneca KK, Astellas Pharma, Bristol-Myers KK, Celtrion, Chugai Pharmaceutical, Daiichi-Sankyo, Eisai, Janssen Pharmaceutical, Eli Lilly Japan KK, Mitsubishi Tanabe Pharma, Nipponkayaku, Novartis Pharma KK, Pfizer Japan, Santen Pharmaceutical, SymBio Pharmaceuticals, Taisho Toyama Pharmaceutical, Takeda Pharmaceutical, and Teijin Pharma. J.S. Smolen has received research grant support from Abbott, BMS, MSD, Pfizer, Roche, and UCB and consultation and/or speaking honoraria from Abbott, Astra-Zeneca, BMS, Celgene, Glaxo, Janssen, MSD, Novo-Nordisk, Pfizer, Roche, Sanofi-Aventis, and UCB.
R.L. Thurmond, PhD, Immunology Department, Janssen Research & Development, LLC; A. Greenspan, MD, Medical Affairs Department, Janssen Research & Development, LLC; W. Radziszewski, MD, PhD, Immunology Department, Janssen Research & Development, LLC; X.L. Xu, PhD, Immunology Department, Janssen Research & Development, LLC; Y. Miao, MS, Biostatistics Department, Janssen Research & Development, LLC; B. Chen, PhD, Early Development, Janssen China Research and Development; T. Ge, PhD, Biostatistics Department, Janssen Research & Development, LLC; B. Zhou, PhD, Biostatistics, Janssen Research & Development, LLC; D.G. Baker, MD, Immunology Department, Janssen Research & Development, LLC; D. Pavlova, MD, Rheumatology, M&M Centers Ltd.; C.T. Ritchlin, MD, Immunology Department, University of Rochester; Y. Tanaka, MD, PhD, Internal Medicine, University of Occupational and Environmental Health; T. Takeuchi, MD, PhD, Rheumatology, Keio University Hospital; J.S. Smolen, MD, Rheumatology, Medical University of Vienna and Hietzing Hospital.
Address correspondence to R.L. Thurmond, Janssen Research & Development, LLC, 3210 Merryfield Row, San Diego, California 92121, USA. E-mail: RThurmon@its.jnj.com.
Accepted for publication May 20, 2016.
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The Journal of Rheumatology
Vol. 51, Issue 3
1 Mar 2024
Toreforant, A Histamine H4 Receptor Antagonist, in Patients with Active Rheumatoid Arthritis Despite Methotrexate Therapy: Results of 2 Phase II Studies
Robin L. Thurmond, Andrew Greenspan, Waldemar Radziszewski, Xie L. Xu, Ye Miao, Bin Chen, TingTing Ge, Bei Zhou, Daniel G. Baker, Dace Pavlova, Christopher T. Ritchlin, Yoshiya Tanaka, Tsutomu Takeuchi, Josef S. Smolen
The Journal of Rheumatology Jul 2016, jrheum.160164; DOI: 10.3899/jrheum.160164
Toreforant, A Histamine H4 Receptor Antagonist, in Patients with Active Rheumatoid Arthritis Despite Methotrexate Therapy: Results of 2 Phase II Studies
Robin L. Thurmond, Andrew Greenspan, Waldemar Radziszewski, Xie L. Xu, Ye Miao, Bin Chen, TingTing Ge, Bei Zhou, Daniel G. Baker, Dace Pavlova, Christopher T. Ritchlin, Yoshiya Tanaka, Tsutomu Takeuchi, Josef S. Smolen
The Journal of Rheumatology Jul 2016, jrheum.160164; DOI: 10.3899/jrheum.160164