Research ArticleArticle
Open Access
Baseline Disease Activity Predicts Achievement of cDAPSA Treatment Targets With Apremilast: Phase III Results in DMARD-naïve Patients With Psoriatic Arthritis
Philip J. Mease, Arthur Kavanaugh, Alexis Ogdie, Alvin F. Wells, Martin Bergman, Dafna D. Gladman, Sven Richter, Lichen Teng, Shauna Jardon and Josef S. Smolen
The Journal of Rheumatology April 2022, jrheum.210906; DOI: https://doi.org/10.3899/jrheum.210906
Philip J. Mease
This study was sponsored by Amgen Inc. P.J. Mease, MD, Swedish Medical Center/Providence St. Joseph Health and University of Washington School of Medicine, Seattle, Washington, USA; A. Kavanaugh, MD, University of California, San Diego, School of Medicine, La Jolla, California, USA; A. Ogdie, MD, University of Pennsylvania, Philadelphia, Pennsylvania, USA; A.F. Wells, MD, PhD, Aurora Rheumatology and Immunotherapy Center, Franklin, Wisconsin, USA; M. Bergman, MD, Drexel University College of Medicine, Philadelphia, Pennsylvania, USA; D.D. Gladman, MD, Schroeder Arthritis Institute, Krembil Research Institute, Toronto Western Hospital, Toronto, Ontario, Canada; S. Richter, MD, L. Teng, PhD, S. Jardon, PharmD, Amgen Inc., Thousand Oaks, California, USA; J.S. Smolen, MD, Medical University of Vienna, Austria. PJM has received grant/research support from and served as a consultant for AbbVie, Amgen, Boehringer Ingelheim, BMS, Celgene, Eli Lilly, Galapagos, GSK, Novartis, Pfizer, Sun, and UCB, and has been a speaker for AbbVie, Amgen, Eli Lilly, Janssen, Novartis, Pfizer, and UCB. AK has received grant/research support from AbbVie, Amgen, AstraZeneca, BMS, Celgene, Centocor-Janssen, Pfizer, Roche, and UCB. AO has received grant/research support from AbbVie, Novartis, and Pfizer, and has served as a consultant to AbbVie, Amgen, BMS, Celgene, Corrona (now CorEvitas, LLC), Eli Lilly, Gilead, Novartis, Pfizer, and UCB. AFW has received grant/research support from AbbVie, Celgene, and Lilly, and has served as a consultant and speaker for AbbVie, Alexion, Amgen, BMS, Celgene, Horizon, Lilly, Novartis, and UCB. MB has served as a speaker for AbbVie, Amgen, Novartis, Pfizer, and Sanofi; has served as a consultant for AbbVie, BMS, Celgene, Genentech, Janssen, Merck, Novartis, Pfizer, and Sanofi; and is a stockholder in Johnson & Johnson. DDG has received grant/research support from and/or served as a consultant for AbbVie, Amgen, BMS, Celgene Corporation, Eli Lilly, Galapagos, Gilead, Janssen, Novartis, Pfizer, and UCB. SR, LT, and SJ are employees of and stockholders in Amgen Inc. JSS has received grant/ research support from AbbVie, AstraZeneca, Eli Lilly, Janssen, Merck Sharp & Dohme, Pfizer, and Roche, and has served as a consultant and speaker for AbbVie, Amgen, Astro, Celgene, Celltrion, Eli Lilly, Glaxo, ILTOO, Janssen, Merck Sharp & Dohme, Novartis-Sandoz, Pfizer, Roche-Chugai, Samsung, Sanofi, and UCB. Address correspondence to Dr. P.J. Mease, Seattle Rheumatology Associates, 601 Broadway, Suite 600, Seattle, WA 98122, USA. Email: pmease@philipmease.com. Accepted for publication March 29, 2022.
Arthur Kavanaugh
This study was sponsored by Amgen Inc. P.J. Mease, MD, Swedish Medical Center/Providence St. Joseph Health and University of Washington School of Medicine, Seattle, Washington, USA; A. Kavanaugh, MD, University of California, San Diego, School of Medicine, La Jolla, California, USA; A. Ogdie, MD, University of Pennsylvania, Philadelphia, Pennsylvania, USA; A.F. Wells, MD, PhD, Aurora Rheumatology and Immunotherapy Center, Franklin, Wisconsin, USA; M. Bergman, MD, Drexel University College of Medicine, Philadelphia, Pennsylvania, USA; D.D. Gladman, MD, Schroeder Arthritis Institute, Krembil Research Institute, Toronto Western Hospital, Toronto, Ontario, Canada; S. Richter, MD, L. Teng, PhD, S. Jardon, PharmD, Amgen Inc., Thousand Oaks, California, USA; J.S. Smolen, MD, Medical University of Vienna, Austria. PJM has received grant/research support from and served as a consultant for AbbVie, Amgen, Boehringer Ingelheim, BMS, Celgene, Eli Lilly, Galapagos, GSK, Novartis, Pfizer, Sun, and UCB, and has been a speaker for AbbVie, Amgen, Eli Lilly, Janssen, Novartis, Pfizer, and UCB. AK has received grant/research support from AbbVie, Amgen, AstraZeneca, BMS, Celgene, Centocor-Janssen, Pfizer, Roche, and UCB. AO has received grant/research support from AbbVie, Novartis, and Pfizer, and has served as a consultant to AbbVie, Amgen, BMS, Celgene, Corrona (now CorEvitas, LLC), Eli Lilly, Gilead, Novartis, Pfizer, and UCB. AFW has received grant/research support from AbbVie, Celgene, and Lilly, and has served as a consultant and speaker for AbbVie, Alexion, Amgen, BMS, Celgene, Horizon, Lilly, Novartis, and UCB. MB has served as a speaker for AbbVie, Amgen, Novartis, Pfizer, and Sanofi; has served as a consultant for AbbVie, BMS, Celgene, Genentech, Janssen, Merck, Novartis, Pfizer, and Sanofi; and is a stockholder in Johnson & Johnson. DDG has received grant/research support from and/or served as a consultant for AbbVie, Amgen, BMS, Celgene Corporation, Eli Lilly, Galapagos, Gilead, Janssen, Novartis, Pfizer, and UCB. SR, LT, and SJ are employees of and stockholders in Amgen Inc. JSS has received grant/ research support from AbbVie, AstraZeneca, Eli Lilly, Janssen, Merck Sharp & Dohme, Pfizer, and Roche, and has served as a consultant and speaker for AbbVie, Amgen, Astro, Celgene, Celltrion, Eli Lilly, Glaxo, ILTOO, Janssen, Merck Sharp & Dohme, Novartis-Sandoz, Pfizer, Roche-Chugai, Samsung, Sanofi, and UCB. Address correspondence to Dr. P.J. Mease, Seattle Rheumatology Associates, 601 Broadway, Suite 600, Seattle, WA 98122, USA. Email: pmease@philipmease.com. Accepted for publication March 29, 2022.
Alexis Ogdie
This study was sponsored by Amgen Inc. P.J. Mease, MD, Swedish Medical Center/Providence St. Joseph Health and University of Washington School of Medicine, Seattle, Washington, USA; A. Kavanaugh, MD, University of California, San Diego, School of Medicine, La Jolla, California, USA; A. Ogdie, MD, University of Pennsylvania, Philadelphia, Pennsylvania, USA; A.F. Wells, MD, PhD, Aurora Rheumatology and Immunotherapy Center, Franklin, Wisconsin, USA; M. Bergman, MD, Drexel University College of Medicine, Philadelphia, Pennsylvania, USA; D.D. Gladman, MD, Schroeder Arthritis Institute, Krembil Research Institute, Toronto Western Hospital, Toronto, Ontario, Canada; S. Richter, MD, L. Teng, PhD, S. Jardon, PharmD, Amgen Inc., Thousand Oaks, California, USA; J.S. Smolen, MD, Medical University of Vienna, Austria. PJM has received grant/research support from and served as a consultant for AbbVie, Amgen, Boehringer Ingelheim, BMS, Celgene, Eli Lilly, Galapagos, GSK, Novartis, Pfizer, Sun, and UCB, and has been a speaker for AbbVie, Amgen, Eli Lilly, Janssen, Novartis, Pfizer, and UCB. AK has received grant/research support from AbbVie, Amgen, AstraZeneca, BMS, Celgene, Centocor-Janssen, Pfizer, Roche, and UCB. AO has received grant/research support from AbbVie, Novartis, and Pfizer, and has served as a consultant to AbbVie, Amgen, BMS, Celgene, Corrona (now CorEvitas, LLC), Eli Lilly, Gilead, Novartis, Pfizer, and UCB. AFW has received grant/research support from AbbVie, Celgene, and Lilly, and has served as a consultant and speaker for AbbVie, Alexion, Amgen, BMS, Celgene, Horizon, Lilly, Novartis, and UCB. MB has served as a speaker for AbbVie, Amgen, Novartis, Pfizer, and Sanofi; has served as a consultant for AbbVie, BMS, Celgene, Genentech, Janssen, Merck, Novartis, Pfizer, and Sanofi; and is a stockholder in Johnson & Johnson. DDG has received grant/research support from and/or served as a consultant for AbbVie, Amgen, BMS, Celgene Corporation, Eli Lilly, Galapagos, Gilead, Janssen, Novartis, Pfizer, and UCB. SR, LT, and SJ are employees of and stockholders in Amgen Inc. JSS has received grant/ research support from AbbVie, AstraZeneca, Eli Lilly, Janssen, Merck Sharp & Dohme, Pfizer, and Roche, and has served as a consultant and speaker for AbbVie, Amgen, Astro, Celgene, Celltrion, Eli Lilly, Glaxo, ILTOO, Janssen, Merck Sharp & Dohme, Novartis-Sandoz, Pfizer, Roche-Chugai, Samsung, Sanofi, and UCB. Address correspondence to Dr. P.J. Mease, Seattle Rheumatology Associates, 601 Broadway, Suite 600, Seattle, WA 98122, USA. Email: pmease@philipmease.com. Accepted for publication March 29, 2022.
Alvin F. Wells
This study was sponsored by Amgen Inc. P.J. Mease, MD, Swedish Medical Center/Providence St. Joseph Health and University of Washington School of Medicine, Seattle, Washington, USA; A. Kavanaugh, MD, University of California, San Diego, School of Medicine, La Jolla, California, USA; A. Ogdie, MD, University of Pennsylvania, Philadelphia, Pennsylvania, USA; A.F. Wells, MD, PhD, Aurora Rheumatology and Immunotherapy Center, Franklin, Wisconsin, USA; M. Bergman, MD, Drexel University College of Medicine, Philadelphia, Pennsylvania, USA; D.D. Gladman, MD, Schroeder Arthritis Institute, Krembil Research Institute, Toronto Western Hospital, Toronto, Ontario, Canada; S. Richter, MD, L. Teng, PhD, S. Jardon, PharmD, Amgen Inc., Thousand Oaks, California, USA; J.S. Smolen, MD, Medical University of Vienna, Austria. PJM has received grant/research support from and served as a consultant for AbbVie, Amgen, Boehringer Ingelheim, BMS, Celgene, Eli Lilly, Galapagos, GSK, Novartis, Pfizer, Sun, and UCB, and has been a speaker for AbbVie, Amgen, Eli Lilly, Janssen, Novartis, Pfizer, and UCB. AK has received grant/research support from AbbVie, Amgen, AstraZeneca, BMS, Celgene, Centocor-Janssen, Pfizer, Roche, and UCB. AO has received grant/research support from AbbVie, Novartis, and Pfizer, and has served as a consultant to AbbVie, Amgen, BMS, Celgene, Corrona (now CorEvitas, LLC), Eli Lilly, Gilead, Novartis, Pfizer, and UCB. AFW has received grant/research support from AbbVie, Celgene, and Lilly, and has served as a consultant and speaker for AbbVie, Alexion, Amgen, BMS, Celgene, Horizon, Lilly, Novartis, and UCB. MB has served as a speaker for AbbVie, Amgen, Novartis, Pfizer, and Sanofi; has served as a consultant for AbbVie, BMS, Celgene, Genentech, Janssen, Merck, Novartis, Pfizer, and Sanofi; and is a stockholder in Johnson & Johnson. DDG has received grant/research support from and/or served as a consultant for AbbVie, Amgen, BMS, Celgene Corporation, Eli Lilly, Galapagos, Gilead, Janssen, Novartis, Pfizer, and UCB. SR, LT, and SJ are employees of and stockholders in Amgen Inc. JSS has received grant/ research support from AbbVie, AstraZeneca, Eli Lilly, Janssen, Merck Sharp & Dohme, Pfizer, and Roche, and has served as a consultant and speaker for AbbVie, Amgen, Astro, Celgene, Celltrion, Eli Lilly, Glaxo, ILTOO, Janssen, Merck Sharp & Dohme, Novartis-Sandoz, Pfizer, Roche-Chugai, Samsung, Sanofi, and UCB. Address correspondence to Dr. P.J. Mease, Seattle Rheumatology Associates, 601 Broadway, Suite 600, Seattle, WA 98122, USA. Email: pmease@philipmease.com. Accepted for publication March 29, 2022.
Martin Bergman
This study was sponsored by Amgen Inc. P.J. Mease, MD, Swedish Medical Center/Providence St. Joseph Health and University of Washington School of Medicine, Seattle, Washington, USA; A. Kavanaugh, MD, University of California, San Diego, School of Medicine, La Jolla, California, USA; A. Ogdie, MD, University of Pennsylvania, Philadelphia, Pennsylvania, USA; A.F. Wells, MD, PhD, Aurora Rheumatology and Immunotherapy Center, Franklin, Wisconsin, USA; M. Bergman, MD, Drexel University College of Medicine, Philadelphia, Pennsylvania, USA; D.D. Gladman, MD, Schroeder Arthritis Institute, Krembil Research Institute, Toronto Western Hospital, Toronto, Ontario, Canada; S. Richter, MD, L. Teng, PhD, S. Jardon, PharmD, Amgen Inc., Thousand Oaks, California, USA; J.S. Smolen, MD, Medical University of Vienna, Austria. PJM has received grant/research support from and served as a consultant for AbbVie, Amgen, Boehringer Ingelheim, BMS, Celgene, Eli Lilly, Galapagos, GSK, Novartis, Pfizer, Sun, and UCB, and has been a speaker for AbbVie, Amgen, Eli Lilly, Janssen, Novartis, Pfizer, and UCB. AK has received grant/research support from AbbVie, Amgen, AstraZeneca, BMS, Celgene, Centocor-Janssen, Pfizer, Roche, and UCB. AO has received grant/research support from AbbVie, Novartis, and Pfizer, and has served as a consultant to AbbVie, Amgen, BMS, Celgene, Corrona (now CorEvitas, LLC), Eli Lilly, Gilead, Novartis, Pfizer, and UCB. AFW has received grant/research support from AbbVie, Celgene, and Lilly, and has served as a consultant and speaker for AbbVie, Alexion, Amgen, BMS, Celgene, Horizon, Lilly, Novartis, and UCB. MB has served as a speaker for AbbVie, Amgen, Novartis, Pfizer, and Sanofi; has served as a consultant for AbbVie, BMS, Celgene, Genentech, Janssen, Merck, Novartis, Pfizer, and Sanofi; and is a stockholder in Johnson & Johnson. DDG has received grant/research support from and/or served as a consultant for AbbVie, Amgen, BMS, Celgene Corporation, Eli Lilly, Galapagos, Gilead, Janssen, Novartis, Pfizer, and UCB. SR, LT, and SJ are employees of and stockholders in Amgen Inc. JSS has received grant/ research support from AbbVie, AstraZeneca, Eli Lilly, Janssen, Merck Sharp & Dohme, Pfizer, and Roche, and has served as a consultant and speaker for AbbVie, Amgen, Astro, Celgene, Celltrion, Eli Lilly, Glaxo, ILTOO, Janssen, Merck Sharp & Dohme, Novartis-Sandoz, Pfizer, Roche-Chugai, Samsung, Sanofi, and UCB. Address correspondence to Dr. P.J. Mease, Seattle Rheumatology Associates, 601 Broadway, Suite 600, Seattle, WA 98122, USA. Email: pmease@philipmease.com. Accepted for publication March 29, 2022.
Dafna D. Gladman
This study was sponsored by Amgen Inc. P.J. Mease, MD, Swedish Medical Center/Providence St. Joseph Health and University of Washington School of Medicine, Seattle, Washington, USA; A. Kavanaugh, MD, University of California, San Diego, School of Medicine, La Jolla, California, USA; A. Ogdie, MD, University of Pennsylvania, Philadelphia, Pennsylvania, USA; A.F. Wells, MD, PhD, Aurora Rheumatology and Immunotherapy Center, Franklin, Wisconsin, USA; M. Bergman, MD, Drexel University College of Medicine, Philadelphia, Pennsylvania, USA; D.D. Gladman, MD, Schroeder Arthritis Institute, Krembil Research Institute, Toronto Western Hospital, Toronto, Ontario, Canada; S. Richter, MD, L. Teng, PhD, S. Jardon, PharmD, Amgen Inc., Thousand Oaks, California, USA; J.S. Smolen, MD, Medical University of Vienna, Austria. PJM has received grant/research support from and served as a consultant for AbbVie, Amgen, Boehringer Ingelheim, BMS, Celgene, Eli Lilly, Galapagos, GSK, Novartis, Pfizer, Sun, and UCB, and has been a speaker for AbbVie, Amgen, Eli Lilly, Janssen, Novartis, Pfizer, and UCB. AK has received grant/research support from AbbVie, Amgen, AstraZeneca, BMS, Celgene, Centocor-Janssen, Pfizer, Roche, and UCB. AO has received grant/research support from AbbVie, Novartis, and Pfizer, and has served as a consultant to AbbVie, Amgen, BMS, Celgene, Corrona (now CorEvitas, LLC), Eli Lilly, Gilead, Novartis, Pfizer, and UCB. AFW has received grant/research support from AbbVie, Celgene, and Lilly, and has served as a consultant and speaker for AbbVie, Alexion, Amgen, BMS, Celgene, Horizon, Lilly, Novartis, and UCB. MB has served as a speaker for AbbVie, Amgen, Novartis, Pfizer, and Sanofi; has served as a consultant for AbbVie, BMS, Celgene, Genentech, Janssen, Merck, Novartis, Pfizer, and Sanofi; and is a stockholder in Johnson & Johnson. DDG has received grant/research support from and/or served as a consultant for AbbVie, Amgen, BMS, Celgene Corporation, Eli Lilly, Galapagos, Gilead, Janssen, Novartis, Pfizer, and UCB. SR, LT, and SJ are employees of and stockholders in Amgen Inc. JSS has received grant/ research support from AbbVie, AstraZeneca, Eli Lilly, Janssen, Merck Sharp & Dohme, Pfizer, and Roche, and has served as a consultant and speaker for AbbVie, Amgen, Astro, Celgene, Celltrion, Eli Lilly, Glaxo, ILTOO, Janssen, Merck Sharp & Dohme, Novartis-Sandoz, Pfizer, Roche-Chugai, Samsung, Sanofi, and UCB. Address correspondence to Dr. P.J. Mease, Seattle Rheumatology Associates, 601 Broadway, Suite 600, Seattle, WA 98122, USA. Email: pmease@philipmease.com. Accepted for publication March 29, 2022.
Sven Richter
This study was sponsored by Amgen Inc. P.J. Mease, MD, Swedish Medical Center/Providence St. Joseph Health and University of Washington School of Medicine, Seattle, Washington, USA; A. Kavanaugh, MD, University of California, San Diego, School of Medicine, La Jolla, California, USA; A. Ogdie, MD, University of Pennsylvania, Philadelphia, Pennsylvania, USA; A.F. Wells, MD, PhD, Aurora Rheumatology and Immunotherapy Center, Franklin, Wisconsin, USA; M. Bergman, MD, Drexel University College of Medicine, Philadelphia, Pennsylvania, USA; D.D. Gladman, MD, Schroeder Arthritis Institute, Krembil Research Institute, Toronto Western Hospital, Toronto, Ontario, Canada; S. Richter, MD, L. Teng, PhD, S. Jardon, PharmD, Amgen Inc., Thousand Oaks, California, USA; J.S. Smolen, MD, Medical University of Vienna, Austria. PJM has received grant/research support from and served as a consultant for AbbVie, Amgen, Boehringer Ingelheim, BMS, Celgene, Eli Lilly, Galapagos, GSK, Novartis, Pfizer, Sun, and UCB, and has been a speaker for AbbVie, Amgen, Eli Lilly, Janssen, Novartis, Pfizer, and UCB. AK has received grant/research support from AbbVie, Amgen, AstraZeneca, BMS, Celgene, Centocor-Janssen, Pfizer, Roche, and UCB. AO has received grant/research support from AbbVie, Novartis, and Pfizer, and has served as a consultant to AbbVie, Amgen, BMS, Celgene, Corrona (now CorEvitas, LLC), Eli Lilly, Gilead, Novartis, Pfizer, and UCB. AFW has received grant/research support from AbbVie, Celgene, and Lilly, and has served as a consultant and speaker for AbbVie, Alexion, Amgen, BMS, Celgene, Horizon, Lilly, Novartis, and UCB. MB has served as a speaker for AbbVie, Amgen, Novartis, Pfizer, and Sanofi; has served as a consultant for AbbVie, BMS, Celgene, Genentech, Janssen, Merck, Novartis, Pfizer, and Sanofi; and is a stockholder in Johnson & Johnson. DDG has received grant/research support from and/or served as a consultant for AbbVie, Amgen, BMS, Celgene Corporation, Eli Lilly, Galapagos, Gilead, Janssen, Novartis, Pfizer, and UCB. SR, LT, and SJ are employees of and stockholders in Amgen Inc. JSS has received grant/ research support from AbbVie, AstraZeneca, Eli Lilly, Janssen, Merck Sharp & Dohme, Pfizer, and Roche, and has served as a consultant and speaker for AbbVie, Amgen, Astro, Celgene, Celltrion, Eli Lilly, Glaxo, ILTOO, Janssen, Merck Sharp & Dohme, Novartis-Sandoz, Pfizer, Roche-Chugai, Samsung, Sanofi, and UCB. Address correspondence to Dr. P.J. Mease, Seattle Rheumatology Associates, 601 Broadway, Suite 600, Seattle, WA 98122, USA. Email: pmease@philipmease.com. Accepted for publication March 29, 2022.
Lichen Teng
This study was sponsored by Amgen Inc. P.J. Mease, MD, Swedish Medical Center/Providence St. Joseph Health and University of Washington School of Medicine, Seattle, Washington, USA; A. Kavanaugh, MD, University of California, San Diego, School of Medicine, La Jolla, California, USA; A. Ogdie, MD, University of Pennsylvania, Philadelphia, Pennsylvania, USA; A.F. Wells, MD, PhD, Aurora Rheumatology and Immunotherapy Center, Franklin, Wisconsin, USA; M. Bergman, MD, Drexel University College of Medicine, Philadelphia, Pennsylvania, USA; D.D. Gladman, MD, Schroeder Arthritis Institute, Krembil Research Institute, Toronto Western Hospital, Toronto, Ontario, Canada; S. Richter, MD, L. Teng, PhD, S. Jardon, PharmD, Amgen Inc., Thousand Oaks, California, USA; J.S. Smolen, MD, Medical University of Vienna, Austria. PJM has received grant/research support from and served as a consultant for AbbVie, Amgen, Boehringer Ingelheim, BMS, Celgene, Eli Lilly, Galapagos, GSK, Novartis, Pfizer, Sun, and UCB, and has been a speaker for AbbVie, Amgen, Eli Lilly, Janssen, Novartis, Pfizer, and UCB. AK has received grant/research support from AbbVie, Amgen, AstraZeneca, BMS, Celgene, Centocor-Janssen, Pfizer, Roche, and UCB. AO has received grant/research support from AbbVie, Novartis, and Pfizer, and has served as a consultant to AbbVie, Amgen, BMS, Celgene, Corrona (now CorEvitas, LLC), Eli Lilly, Gilead, Novartis, Pfizer, and UCB. AFW has received grant/research support from AbbVie, Celgene, and Lilly, and has served as a consultant and speaker for AbbVie, Alexion, Amgen, BMS, Celgene, Horizon, Lilly, Novartis, and UCB. MB has served as a speaker for AbbVie, Amgen, Novartis, Pfizer, and Sanofi; has served as a consultant for AbbVie, BMS, Celgene, Genentech, Janssen, Merck, Novartis, Pfizer, and Sanofi; and is a stockholder in Johnson & Johnson. DDG has received grant/research support from and/or served as a consultant for AbbVie, Amgen, BMS, Celgene Corporation, Eli Lilly, Galapagos, Gilead, Janssen, Novartis, Pfizer, and UCB. SR, LT, and SJ are employees of and stockholders in Amgen Inc. JSS has received grant/ research support from AbbVie, AstraZeneca, Eli Lilly, Janssen, Merck Sharp & Dohme, Pfizer, and Roche, and has served as a consultant and speaker for AbbVie, Amgen, Astro, Celgene, Celltrion, Eli Lilly, Glaxo, ILTOO, Janssen, Merck Sharp & Dohme, Novartis-Sandoz, Pfizer, Roche-Chugai, Samsung, Sanofi, and UCB. Address correspondence to Dr. P.J. Mease, Seattle Rheumatology Associates, 601 Broadway, Suite 600, Seattle, WA 98122, USA. Email: pmease@philipmease.com. Accepted for publication March 29, 2022.
Shauna Jardon
This study was sponsored by Amgen Inc. P.J. Mease, MD, Swedish Medical Center/Providence St. Joseph Health and University of Washington School of Medicine, Seattle, Washington, USA; A. Kavanaugh, MD, University of California, San Diego, School of Medicine, La Jolla, California, USA; A. Ogdie, MD, University of Pennsylvania, Philadelphia, Pennsylvania, USA; A.F. Wells, MD, PhD, Aurora Rheumatology and Immunotherapy Center, Franklin, Wisconsin, USA; M. Bergman, MD, Drexel University College of Medicine, Philadelphia, Pennsylvania, USA; D.D. Gladman, MD, Schroeder Arthritis Institute, Krembil Research Institute, Toronto Western Hospital, Toronto, Ontario, Canada; S. Richter, MD, L. Teng, PhD, S. Jardon, PharmD, Amgen Inc., Thousand Oaks, California, USA; J.S. Smolen, MD, Medical University of Vienna, Austria. PJM has received grant/research support from and served as a consultant for AbbVie, Amgen, Boehringer Ingelheim, BMS, Celgene, Eli Lilly, Galapagos, GSK, Novartis, Pfizer, Sun, and UCB, and has been a speaker for AbbVie, Amgen, Eli Lilly, Janssen, Novartis, Pfizer, and UCB. AK has received grant/research support from AbbVie, Amgen, AstraZeneca, BMS, Celgene, Centocor-Janssen, Pfizer, Roche, and UCB. AO has received grant/research support from AbbVie, Novartis, and Pfizer, and has served as a consultant to AbbVie, Amgen, BMS, Celgene, Corrona (now CorEvitas, LLC), Eli Lilly, Gilead, Novartis, Pfizer, and UCB. AFW has received grant/research support from AbbVie, Celgene, and Lilly, and has served as a consultant and speaker for AbbVie, Alexion, Amgen, BMS, Celgene, Horizon, Lilly, Novartis, and UCB. MB has served as a speaker for AbbVie, Amgen, Novartis, Pfizer, and Sanofi; has served as a consultant for AbbVie, BMS, Celgene, Genentech, Janssen, Merck, Novartis, Pfizer, and Sanofi; and is a stockholder in Johnson & Johnson. DDG has received grant/research support from and/or served as a consultant for AbbVie, Amgen, BMS, Celgene Corporation, Eli Lilly, Galapagos, Gilead, Janssen, Novartis, Pfizer, and UCB. SR, LT, and SJ are employees of and stockholders in Amgen Inc. JSS has received grant/ research support from AbbVie, AstraZeneca, Eli Lilly, Janssen, Merck Sharp & Dohme, Pfizer, and Roche, and has served as a consultant and speaker for AbbVie, Amgen, Astro, Celgene, Celltrion, Eli Lilly, Glaxo, ILTOO, Janssen, Merck Sharp & Dohme, Novartis-Sandoz, Pfizer, Roche-Chugai, Samsung, Sanofi, and UCB. Address correspondence to Dr. P.J. Mease, Seattle Rheumatology Associates, 601 Broadway, Suite 600, Seattle, WA 98122, USA. Email: pmease@philipmease.com. Accepted for publication March 29, 2022.
Josef S. Smolen
This study was sponsored by Amgen Inc. P.J. Mease, MD, Swedish Medical Center/Providence St. Joseph Health and University of Washington School of Medicine, Seattle, Washington, USA; A. Kavanaugh, MD, University of California, San Diego, School of Medicine, La Jolla, California, USA; A. Ogdie, MD, University of Pennsylvania, Philadelphia, Pennsylvania, USA; A.F. Wells, MD, PhD, Aurora Rheumatology and Immunotherapy Center, Franklin, Wisconsin, USA; M. Bergman, MD, Drexel University College of Medicine, Philadelphia, Pennsylvania, USA; D.D. Gladman, MD, Schroeder Arthritis Institute, Krembil Research Institute, Toronto Western Hospital, Toronto, Ontario, Canada; S. Richter, MD, L. Teng, PhD, S. Jardon, PharmD, Amgen Inc., Thousand Oaks, California, USA; J.S. Smolen, MD, Medical University of Vienna, Austria. PJM has received grant/research support from and served as a consultant for AbbVie, Amgen, Boehringer Ingelheim, BMS, Celgene, Eli Lilly, Galapagos, GSK, Novartis, Pfizer, Sun, and UCB, and has been a speaker for AbbVie, Amgen, Eli Lilly, Janssen, Novartis, Pfizer, and UCB. AK has received grant/research support from AbbVie, Amgen, AstraZeneca, BMS, Celgene, Centocor-Janssen, Pfizer, Roche, and UCB. AO has received grant/research support from AbbVie, Novartis, and Pfizer, and has served as a consultant to AbbVie, Amgen, BMS, Celgene, Corrona (now CorEvitas, LLC), Eli Lilly, Gilead, Novartis, Pfizer, and UCB. AFW has received grant/research support from AbbVie, Celgene, and Lilly, and has served as a consultant and speaker for AbbVie, Alexion, Amgen, BMS, Celgene, Horizon, Lilly, Novartis, and UCB. MB has served as a speaker for AbbVie, Amgen, Novartis, Pfizer, and Sanofi; has served as a consultant for AbbVie, BMS, Celgene, Genentech, Janssen, Merck, Novartis, Pfizer, and Sanofi; and is a stockholder in Johnson & Johnson. DDG has received grant/research support from and/or served as a consultant for AbbVie, Amgen, BMS, Celgene Corporation, Eli Lilly, Galapagos, Gilead, Janssen, Novartis, Pfizer, and UCB. SR, LT, and SJ are employees of and stockholders in Amgen Inc. JSS has received grant/ research support from AbbVie, AstraZeneca, Eli Lilly, Janssen, Merck Sharp & Dohme, Pfizer, and Roche, and has served as a consultant and speaker for AbbVie, Amgen, Astro, Celgene, Celltrion, Eli Lilly, Glaxo, ILTOO, Janssen, Merck Sharp & Dohme, Novartis-Sandoz, Pfizer, Roche-Chugai, Samsung, Sanofi, and UCB. Address correspondence to Dr. P.J. Mease, Seattle Rheumatology Associates, 601 Broadway, Suite 600, Seattle, WA 98122, USA. Email: pmease@philipmease.com. Accepted for publication March 29, 2022.
Abstract
Objective The probability of achieving Clinical Disease Activity Index for Psoriatic Arthritis (cDAPSA) treatment targets (remission [REM], low disease activity [LDA]) was evaluated following apremilast monotherapy in disease-modifying antirheumatic drug (DMARD)-naïve patients with psoriatic arthritis (PsA) based on baseline disease activity.
Methods This post hoc probability analysis of PALACE 4, a phase III, multicenter, randomized, placebo-controlled study, evaluated shifting across cDAPSA categories from baseline to week 52 and included DMARD-naïve patients receiving apremilast 30 mg BID with available baseline cDAPSA data. Changes in articular/extraarticular manifestations were evaluated in patients with week 52 cDAPSA components. cDAPSA treatment target achievement was assessed in a subgroup with baseline extraarticular PsA manifestations (skin involvement, enthesitis, dactylitis).
Results Of 175 apremilast-treated patients in the probability analysis, 66.3% were in high disease activity (HDA) and 31.4% in moderate disease activity (ModDA) at baseline. Approximately twice as many patients in ModDA at baseline reached REM/LDA at week 52 vs those in HDA (61.7% vs 28.2%). Achieving cDAPSA treatment targets was associated with reductions in articular (swollen/tender joints) and extraarticular (skin involvement, enthesitis, dactylitis, functional disability) disease activity. Similar treatment target achievement rates were observed in the subgroup with ≥ 1 extraarticular PsA manifestation (n = 126; ModDA: 66.7%, HDA: 32.2%).
Conclusion Apremilast-treated patients with baseline ModDA had higher probability of achieving cDAPSA treatment targets than patients with HDA. Resolution and/or near resolution of articular and/or extraarticular PsA manifestations was achieved by patients in REM/LDA at week 52. Consistent treatment target achievement was observed in patients with 1 or multiple extraarticular manifestations of active PsA.
In this issue
The Journal of Rheumatology
Vol. 49, Issue 7
1 Jul 2022
Baseline Disease Activity Predicts Achievement of cDAPSA Treatment Targets With Apremilast: Phase III Results in DMARD-naïve Patients With Psoriatic Arthritis
Philip J. Mease, Arthur Kavanaugh, Alexis Ogdie, Alvin F. Wells, Martin Bergman, Dafna D. Gladman, Sven Richter, Lichen Teng, Shauna Jardon, Josef S. Smolen
The Journal of Rheumatology Apr 2022, jrheum.210906; DOI: 10.3899/jrheum.210906
Baseline Disease Activity Predicts Achievement of cDAPSA Treatment Targets With Apremilast: Phase III Results in DMARD-naïve Patients With Psoriatic Arthritis
Philip J. Mease, Arthur Kavanaugh, Alexis Ogdie, Alvin F. Wells, Martin Bergman, Dafna D. Gladman, Sven Richter, Lichen Teng, Shauna Jardon, Josef S. Smolen
The Journal of Rheumatology Apr 2022, jrheum.210906; DOI: 10.3899/jrheum.210906
