Research ArticleAccepted Articles
Open Access
Safety of guselkumab with and without prior TNF-α inhibitor treatment: Pooled results across four studies in patients with psoriatic arthritis
Proton Rahman, Wolf-Henning Boehncke, Philip J. Mease, Alice B. Gottlieb, Iain B. McInnes, May Shawi, Yanli Wang, Shihong Sheng, Alexa P. Kollmeier, Elke Theander, Jenny Yu, Evan Leibowitz, A. Marilise Marrache and Laura C. Coates
The Journal of Rheumatology January 2023, jrheum.220928; DOI: https://doi.org/10.3899/jrheum.220928
Proton Rahman
Craig L Dobbin Genetics Research Centre, Memorial University of Newfoundland, St. John's, NL, Canada. Geneva University Hospitals, Geneva, Switzerland. Rheumatology Research, Swedish Medical Center/Providence St. Joseph Health and University of Washington, Seattle, WA, USA. Icahn School of Medicine at Mount Sinai, New York, USA. University of Glasgow, Institute of Infection, Immunity and Inflammation, Glasgow, UK. Global Medical Affairs, Janssen Pharmaceutical Companies of Johnson & Johnson, Horsham, PA, USA. Janssen Research & Development, LLC, Spring House, PA, USA. Immunology, Janssen Research & Development, LLC, San Diego, CA, USA. Janssen Scientific Affairs, LLC, Solna, Sweden. Janssen Scientific Affairs, LLC, Horsham, PA, USA. Medical Affairs, Janssen Inc., Toronto, Canada. Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, Oxford, UK. Funding: The Phase 2 Guselkumab in Psoriatic Arthritis, DISCOVER-1, DISCOVER-2, and COSMOS studies were funded by Janssen Research & Development, LLC. Address correspondence to: Dr. Proton Rahman, 154 LeMarchant Road, St. Clare's Mercy Hospital, St. John's Newfoundland, Canada A1C 5B8. Email: prahman@mun.ca. Conflicts of Interest: PR: received consulting fees from AbbVie, Amgen, Bristol Myers Squibb, Celgene, Eli Lilly, Janssen, Merck, Novartis, Pfizer, and UCB; research grants from Janssen and Novartis. WHB: speaker for AbbVie, Almirall, Janssen, Leo and UCB; advisory board participation for AbbVie, Almirall, BMS, Janssen, Leo, Lilly, Novartis, and UCB. PJM: received research support, consulting fees, and/or speaker bureau support from AbbVie, Amgen, Bristol-Myers Squibb, Celgene, Eli Lilly, Galapagos, Gilead, GlaxoSmithKline, Inmagene, Janssen, Novartis, Pfizer, SUN Pharma, and UCB. ABG: Honoraria as an advisory board member, non-promotional speaker or consultant for: Amgen, AnaptysBio, Avotres Therapeutics, Boehringer Ingelheim, Bristol Myers Squibb, Dermavant, Eli Lilly, Janssen, Novartis, Pfizer, Sanofi, Sun Pharma, UCB Pharma, and Xbiotech (stock options for an RA project); research/educational grants from: AnaptysBio, Janssen, Novartis, Ortho Dermatologics, Sun Pharma, BMS, and UCB Pharma; all funds go to the Icahn School of Medicine at Mount Sinai. IBM: consultant fees from Astra Zeneca, AbbVie, Amgen, Bristol-Myers Squibb, Eli Lilly, Cabaletta, Compugen, GSK, Gilead, Janssen, Novartis, Pfizer, Sanofi, Roche, and UCB; grant/research support from Astra Zeneca, Bristol-Myers Squibb, Amgen, Eli Lilly, GSK, Janssen, Novartis, Roche, and UCB; shareholder of Causeway Therapeutics, Evelo Compugen.
Wolf-Henning Boehncke
Craig L Dobbin Genetics Research Centre, Memorial University of Newfoundland, St. John's, NL, Canada. Geneva University Hospitals, Geneva, Switzerland. Rheumatology Research, Swedish Medical Center/Providence St. Joseph Health and University of Washington, Seattle, WA, USA. Icahn School of Medicine at Mount Sinai, New York, USA. University of Glasgow, Institute of Infection, Immunity and Inflammation, Glasgow, UK. Global Medical Affairs, Janssen Pharmaceutical Companies of Johnson & Johnson, Horsham, PA, USA. Janssen Research & Development, LLC, Spring House, PA, USA. Immunology, Janssen Research & Development, LLC, San Diego, CA, USA. Janssen Scientific Affairs, LLC, Solna, Sweden. Janssen Scientific Affairs, LLC, Horsham, PA, USA. Medical Affairs, Janssen Inc., Toronto, Canada. Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, Oxford, UK. Funding: The Phase 2 Guselkumab in Psoriatic Arthritis, DISCOVER-1, DISCOVER-2, and COSMOS studies were funded by Janssen Research & Development, LLC. Address correspondence to: Dr. Proton Rahman, 154 LeMarchant Road, St. Clare's Mercy Hospital, St. John's Newfoundland, Canada A1C 5B8. Email: prahman@mun.ca. Conflicts of Interest: PR: received consulting fees from AbbVie, Amgen, Bristol Myers Squibb, Celgene, Eli Lilly, Janssen, Merck, Novartis, Pfizer, and UCB; research grants from Janssen and Novartis. WHB: speaker for AbbVie, Almirall, Janssen, Leo and UCB; advisory board participation for AbbVie, Almirall, BMS, Janssen, Leo, Lilly, Novartis, and UCB. PJM: received research support, consulting fees, and/or speaker bureau support from AbbVie, Amgen, Bristol-Myers Squibb, Celgene, Eli Lilly, Galapagos, Gilead, GlaxoSmithKline, Inmagene, Janssen, Novartis, Pfizer, SUN Pharma, and UCB. ABG: Honoraria as an advisory board member, non-promotional speaker or consultant for: Amgen, AnaptysBio, Avotres Therapeutics, Boehringer Ingelheim, Bristol Myers Squibb, Dermavant, Eli Lilly, Janssen, Novartis, Pfizer, Sanofi, Sun Pharma, UCB Pharma, and Xbiotech (stock options for an RA project); research/educational grants from: AnaptysBio, Janssen, Novartis, Ortho Dermatologics, Sun Pharma, BMS, and UCB Pharma; all funds go to the Icahn School of Medicine at Mount Sinai. IBM: consultant fees from Astra Zeneca, AbbVie, Amgen, Bristol-Myers Squibb, Eli Lilly, Cabaletta, Compugen, GSK, Gilead, Janssen, Novartis, Pfizer, Sanofi, Roche, and UCB; grant/research support from Astra Zeneca, Bristol-Myers Squibb, Amgen, Eli Lilly, GSK, Janssen, Novartis, Roche, and UCB; shareholder of Causeway Therapeutics, Evelo Compugen.
Philip J. Mease
Craig L Dobbin Genetics Research Centre, Memorial University of Newfoundland, St. John's, NL, Canada. Geneva University Hospitals, Geneva, Switzerland. Rheumatology Research, Swedish Medical Center/Providence St. Joseph Health and University of Washington, Seattle, WA, USA. Icahn School of Medicine at Mount Sinai, New York, USA. University of Glasgow, Institute of Infection, Immunity and Inflammation, Glasgow, UK. Global Medical Affairs, Janssen Pharmaceutical Companies of Johnson & Johnson, Horsham, PA, USA. Janssen Research & Development, LLC, Spring House, PA, USA. Immunology, Janssen Research & Development, LLC, San Diego, CA, USA. Janssen Scientific Affairs, LLC, Solna, Sweden. Janssen Scientific Affairs, LLC, Horsham, PA, USA. Medical Affairs, Janssen Inc., Toronto, Canada. Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, Oxford, UK. Funding: The Phase 2 Guselkumab in Psoriatic Arthritis, DISCOVER-1, DISCOVER-2, and COSMOS studies were funded by Janssen Research & Development, LLC. Address correspondence to: Dr. Proton Rahman, 154 LeMarchant Road, St. Clare's Mercy Hospital, St. John's Newfoundland, Canada A1C 5B8. Email: prahman@mun.ca. Conflicts of Interest: PR: received consulting fees from AbbVie, Amgen, Bristol Myers Squibb, Celgene, Eli Lilly, Janssen, Merck, Novartis, Pfizer, and UCB; research grants from Janssen and Novartis. WHB: speaker for AbbVie, Almirall, Janssen, Leo and UCB; advisory board participation for AbbVie, Almirall, BMS, Janssen, Leo, Lilly, Novartis, and UCB. PJM: received research support, consulting fees, and/or speaker bureau support from AbbVie, Amgen, Bristol-Myers Squibb, Celgene, Eli Lilly, Galapagos, Gilead, GlaxoSmithKline, Inmagene, Janssen, Novartis, Pfizer, SUN Pharma, and UCB. ABG: Honoraria as an advisory board member, non-promotional speaker or consultant for: Amgen, AnaptysBio, Avotres Therapeutics, Boehringer Ingelheim, Bristol Myers Squibb, Dermavant, Eli Lilly, Janssen, Novartis, Pfizer, Sanofi, Sun Pharma, UCB Pharma, and Xbiotech (stock options for an RA project); research/educational grants from: AnaptysBio, Janssen, Novartis, Ortho Dermatologics, Sun Pharma, BMS, and UCB Pharma; all funds go to the Icahn School of Medicine at Mount Sinai. IBM: consultant fees from Astra Zeneca, AbbVie, Amgen, Bristol-Myers Squibb, Eli Lilly, Cabaletta, Compugen, GSK, Gilead, Janssen, Novartis, Pfizer, Sanofi, Roche, and UCB; grant/research support from Astra Zeneca, Bristol-Myers Squibb, Amgen, Eli Lilly, GSK, Janssen, Novartis, Roche, and UCB; shareholder of Causeway Therapeutics, Evelo Compugen.
Alice B. Gottlieb
Craig L Dobbin Genetics Research Centre, Memorial University of Newfoundland, St. John's, NL, Canada. Geneva University Hospitals, Geneva, Switzerland. Rheumatology Research, Swedish Medical Center/Providence St. Joseph Health and University of Washington, Seattle, WA, USA. Icahn School of Medicine at Mount Sinai, New York, USA. University of Glasgow, Institute of Infection, Immunity and Inflammation, Glasgow, UK. Global Medical Affairs, Janssen Pharmaceutical Companies of Johnson & Johnson, Horsham, PA, USA. Janssen Research & Development, LLC, Spring House, PA, USA. Immunology, Janssen Research & Development, LLC, San Diego, CA, USA. Janssen Scientific Affairs, LLC, Solna, Sweden. Janssen Scientific Affairs, LLC, Horsham, PA, USA. Medical Affairs, Janssen Inc., Toronto, Canada. Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, Oxford, UK. Funding: The Phase 2 Guselkumab in Psoriatic Arthritis, DISCOVER-1, DISCOVER-2, and COSMOS studies were funded by Janssen Research & Development, LLC. Address correspondence to: Dr. Proton Rahman, 154 LeMarchant Road, St. Clare's Mercy Hospital, St. John's Newfoundland, Canada A1C 5B8. Email: prahman@mun.ca. Conflicts of Interest: PR: received consulting fees from AbbVie, Amgen, Bristol Myers Squibb, Celgene, Eli Lilly, Janssen, Merck, Novartis, Pfizer, and UCB; research grants from Janssen and Novartis. WHB: speaker for AbbVie, Almirall, Janssen, Leo and UCB; advisory board participation for AbbVie, Almirall, BMS, Janssen, Leo, Lilly, Novartis, and UCB. PJM: received research support, consulting fees, and/or speaker bureau support from AbbVie, Amgen, Bristol-Myers Squibb, Celgene, Eli Lilly, Galapagos, Gilead, GlaxoSmithKline, Inmagene, Janssen, Novartis, Pfizer, SUN Pharma, and UCB. ABG: Honoraria as an advisory board member, non-promotional speaker or consultant for: Amgen, AnaptysBio, Avotres Therapeutics, Boehringer Ingelheim, Bristol Myers Squibb, Dermavant, Eli Lilly, Janssen, Novartis, Pfizer, Sanofi, Sun Pharma, UCB Pharma, and Xbiotech (stock options for an RA project); research/educational grants from: AnaptysBio, Janssen, Novartis, Ortho Dermatologics, Sun Pharma, BMS, and UCB Pharma; all funds go to the Icahn School of Medicine at Mount Sinai. IBM: consultant fees from Astra Zeneca, AbbVie, Amgen, Bristol-Myers Squibb, Eli Lilly, Cabaletta, Compugen, GSK, Gilead, Janssen, Novartis, Pfizer, Sanofi, Roche, and UCB; grant/research support from Astra Zeneca, Bristol-Myers Squibb, Amgen, Eli Lilly, GSK, Janssen, Novartis, Roche, and UCB; shareholder of Causeway Therapeutics, Evelo Compugen.
Iain B. McInnes
Craig L Dobbin Genetics Research Centre, Memorial University of Newfoundland, St. John's, NL, Canada. Geneva University Hospitals, Geneva, Switzerland. Rheumatology Research, Swedish Medical Center/Providence St. Joseph Health and University of Washington, Seattle, WA, USA. Icahn School of Medicine at Mount Sinai, New York, USA. University of Glasgow, Institute of Infection, Immunity and Inflammation, Glasgow, UK. Global Medical Affairs, Janssen Pharmaceutical Companies of Johnson & Johnson, Horsham, PA, USA. Janssen Research & Development, LLC, Spring House, PA, USA. Immunology, Janssen Research & Development, LLC, San Diego, CA, USA. Janssen Scientific Affairs, LLC, Solna, Sweden. Janssen Scientific Affairs, LLC, Horsham, PA, USA. Medical Affairs, Janssen Inc., Toronto, Canada. Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, Oxford, UK. Funding: The Phase 2 Guselkumab in Psoriatic Arthritis, DISCOVER-1, DISCOVER-2, and COSMOS studies were funded by Janssen Research & Development, LLC. Address correspondence to: Dr. Proton Rahman, 154 LeMarchant Road, St. Clare's Mercy Hospital, St. John's Newfoundland, Canada A1C 5B8. Email: prahman@mun.ca. Conflicts of Interest: PR: received consulting fees from AbbVie, Amgen, Bristol Myers Squibb, Celgene, Eli Lilly, Janssen, Merck, Novartis, Pfizer, and UCB; research grants from Janssen and Novartis. WHB: speaker for AbbVie, Almirall, Janssen, Leo and UCB; advisory board participation for AbbVie, Almirall, BMS, Janssen, Leo, Lilly, Novartis, and UCB. PJM: received research support, consulting fees, and/or speaker bureau support from AbbVie, Amgen, Bristol-Myers Squibb, Celgene, Eli Lilly, Galapagos, Gilead, GlaxoSmithKline, Inmagene, Janssen, Novartis, Pfizer, SUN Pharma, and UCB. ABG: Honoraria as an advisory board member, non-promotional speaker or consultant for: Amgen, AnaptysBio, Avotres Therapeutics, Boehringer Ingelheim, Bristol Myers Squibb, Dermavant, Eli Lilly, Janssen, Novartis, Pfizer, Sanofi, Sun Pharma, UCB Pharma, and Xbiotech (stock options for an RA project); research/educational grants from: AnaptysBio, Janssen, Novartis, Ortho Dermatologics, Sun Pharma, BMS, and UCB Pharma; all funds go to the Icahn School of Medicine at Mount Sinai. IBM: consultant fees from Astra Zeneca, AbbVie, Amgen, Bristol-Myers Squibb, Eli Lilly, Cabaletta, Compugen, GSK, Gilead, Janssen, Novartis, Pfizer, Sanofi, Roche, and UCB; grant/research support from Astra Zeneca, Bristol-Myers Squibb, Amgen, Eli Lilly, GSK, Janssen, Novartis, Roche, and UCB; shareholder of Causeway Therapeutics, Evelo Compugen.
May Shawi
Craig L Dobbin Genetics Research Centre, Memorial University of Newfoundland, St. John's, NL, Canada. Geneva University Hospitals, Geneva, Switzerland. Rheumatology Research, Swedish Medical Center/Providence St. Joseph Health and University of Washington, Seattle, WA, USA. Icahn School of Medicine at Mount Sinai, New York, USA. University of Glasgow, Institute of Infection, Immunity and Inflammation, Glasgow, UK. Global Medical Affairs, Janssen Pharmaceutical Companies of Johnson & Johnson, Horsham, PA, USA. Janssen Research & Development, LLC, Spring House, PA, USA. Immunology, Janssen Research & Development, LLC, San Diego, CA, USA. Janssen Scientific Affairs, LLC, Solna, Sweden. Janssen Scientific Affairs, LLC, Horsham, PA, USA. Medical Affairs, Janssen Inc., Toronto, Canada. Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, Oxford, UK. Funding: The Phase 2 Guselkumab in Psoriatic Arthritis, DISCOVER-1, DISCOVER-2, and COSMOS studies were funded by Janssen Research & Development, LLC. Address correspondence to: Dr. Proton Rahman, 154 LeMarchant Road, St. Clare's Mercy Hospital, St. John's Newfoundland, Canada A1C 5B8. Email: prahman@mun.ca. Conflicts of Interest: PR: received consulting fees from AbbVie, Amgen, Bristol Myers Squibb, Celgene, Eli Lilly, Janssen, Merck, Novartis, Pfizer, and UCB; research grants from Janssen and Novartis. WHB: speaker for AbbVie, Almirall, Janssen, Leo and UCB; advisory board participation for AbbVie, Almirall, BMS, Janssen, Leo, Lilly, Novartis, and UCB. PJM: received research support, consulting fees, and/or speaker bureau support from AbbVie, Amgen, Bristol-Myers Squibb, Celgene, Eli Lilly, Galapagos, Gilead, GlaxoSmithKline, Inmagene, Janssen, Novartis, Pfizer, SUN Pharma, and UCB. ABG: Honoraria as an advisory board member, non-promotional speaker or consultant for: Amgen, AnaptysBio, Avotres Therapeutics, Boehringer Ingelheim, Bristol Myers Squibb, Dermavant, Eli Lilly, Janssen, Novartis, Pfizer, Sanofi, Sun Pharma, UCB Pharma, and Xbiotech (stock options for an RA project); research/educational grants from: AnaptysBio, Janssen, Novartis, Ortho Dermatologics, Sun Pharma, BMS, and UCB Pharma; all funds go to the Icahn School of Medicine at Mount Sinai. IBM: consultant fees from Astra Zeneca, AbbVie, Amgen, Bristol-Myers Squibb, Eli Lilly, Cabaletta, Compugen, GSK, Gilead, Janssen, Novartis, Pfizer, Sanofi, Roche, and UCB; grant/research support from Astra Zeneca, Bristol-Myers Squibb, Amgen, Eli Lilly, GSK, Janssen, Novartis, Roche, and UCB; shareholder of Causeway Therapeutics, Evelo Compugen.
Yanli Wang
Craig L Dobbin Genetics Research Centre, Memorial University of Newfoundland, St. John's, NL, Canada. Geneva University Hospitals, Geneva, Switzerland. Rheumatology Research, Swedish Medical Center/Providence St. Joseph Health and University of Washington, Seattle, WA, USA. Icahn School of Medicine at Mount Sinai, New York, USA. University of Glasgow, Institute of Infection, Immunity and Inflammation, Glasgow, UK. Global Medical Affairs, Janssen Pharmaceutical Companies of Johnson & Johnson, Horsham, PA, USA. Janssen Research & Development, LLC, Spring House, PA, USA. Immunology, Janssen Research & Development, LLC, San Diego, CA, USA. Janssen Scientific Affairs, LLC, Solna, Sweden. Janssen Scientific Affairs, LLC, Horsham, PA, USA. Medical Affairs, Janssen Inc., Toronto, Canada. Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, Oxford, UK. Funding: The Phase 2 Guselkumab in Psoriatic Arthritis, DISCOVER-1, DISCOVER-2, and COSMOS studies were funded by Janssen Research & Development, LLC. Address correspondence to: Dr. Proton Rahman, 154 LeMarchant Road, St. Clare's Mercy Hospital, St. John's Newfoundland, Canada A1C 5B8. Email: prahman@mun.ca. Conflicts of Interest: PR: received consulting fees from AbbVie, Amgen, Bristol Myers Squibb, Celgene, Eli Lilly, Janssen, Merck, Novartis, Pfizer, and UCB; research grants from Janssen and Novartis. WHB: speaker for AbbVie, Almirall, Janssen, Leo and UCB; advisory board participation for AbbVie, Almirall, BMS, Janssen, Leo, Lilly, Novartis, and UCB. PJM: received research support, consulting fees, and/or speaker bureau support from AbbVie, Amgen, Bristol-Myers Squibb, Celgene, Eli Lilly, Galapagos, Gilead, GlaxoSmithKline, Inmagene, Janssen, Novartis, Pfizer, SUN Pharma, and UCB. ABG: Honoraria as an advisory board member, non-promotional speaker or consultant for: Amgen, AnaptysBio, Avotres Therapeutics, Boehringer Ingelheim, Bristol Myers Squibb, Dermavant, Eli Lilly, Janssen, Novartis, Pfizer, Sanofi, Sun Pharma, UCB Pharma, and Xbiotech (stock options for an RA project); research/educational grants from: AnaptysBio, Janssen, Novartis, Ortho Dermatologics, Sun Pharma, BMS, and UCB Pharma; all funds go to the Icahn School of Medicine at Mount Sinai. IBM: consultant fees from Astra Zeneca, AbbVie, Amgen, Bristol-Myers Squibb, Eli Lilly, Cabaletta, Compugen, GSK, Gilead, Janssen, Novartis, Pfizer, Sanofi, Roche, and UCB; grant/research support from Astra Zeneca, Bristol-Myers Squibb, Amgen, Eli Lilly, GSK, Janssen, Novartis, Roche, and UCB; shareholder of Causeway Therapeutics, Evelo Compugen.
Shihong Sheng
Craig L Dobbin Genetics Research Centre, Memorial University of Newfoundland, St. John's, NL, Canada. Geneva University Hospitals, Geneva, Switzerland. Rheumatology Research, Swedish Medical Center/Providence St. Joseph Health and University of Washington, Seattle, WA, USA. Icahn School of Medicine at Mount Sinai, New York, USA. University of Glasgow, Institute of Infection, Immunity and Inflammation, Glasgow, UK. Global Medical Affairs, Janssen Pharmaceutical Companies of Johnson & Johnson, Horsham, PA, USA. Janssen Research & Development, LLC, Spring House, PA, USA. Immunology, Janssen Research & Development, LLC, San Diego, CA, USA. Janssen Scientific Affairs, LLC, Solna, Sweden. Janssen Scientific Affairs, LLC, Horsham, PA, USA. Medical Affairs, Janssen Inc., Toronto, Canada. Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, Oxford, UK. Funding: The Phase 2 Guselkumab in Psoriatic Arthritis, DISCOVER-1, DISCOVER-2, and COSMOS studies were funded by Janssen Research & Development, LLC. Address correspondence to: Dr. Proton Rahman, 154 LeMarchant Road, St. Clare's Mercy Hospital, St. John's Newfoundland, Canada A1C 5B8. Email: prahman@mun.ca. Conflicts of Interest: PR: received consulting fees from AbbVie, Amgen, Bristol Myers Squibb, Celgene, Eli Lilly, Janssen, Merck, Novartis, Pfizer, and UCB; research grants from Janssen and Novartis. WHB: speaker for AbbVie, Almirall, Janssen, Leo and UCB; advisory board participation for AbbVie, Almirall, BMS, Janssen, Leo, Lilly, Novartis, and UCB. PJM: received research support, consulting fees, and/or speaker bureau support from AbbVie, Amgen, Bristol-Myers Squibb, Celgene, Eli Lilly, Galapagos, Gilead, GlaxoSmithKline, Inmagene, Janssen, Novartis, Pfizer, SUN Pharma, and UCB. ABG: Honoraria as an advisory board member, non-promotional speaker or consultant for: Amgen, AnaptysBio, Avotres Therapeutics, Boehringer Ingelheim, Bristol Myers Squibb, Dermavant, Eli Lilly, Janssen, Novartis, Pfizer, Sanofi, Sun Pharma, UCB Pharma, and Xbiotech (stock options for an RA project); research/educational grants from: AnaptysBio, Janssen, Novartis, Ortho Dermatologics, Sun Pharma, BMS, and UCB Pharma; all funds go to the Icahn School of Medicine at Mount Sinai. IBM: consultant fees from Astra Zeneca, AbbVie, Amgen, Bristol-Myers Squibb, Eli Lilly, Cabaletta, Compugen, GSK, Gilead, Janssen, Novartis, Pfizer, Sanofi, Roche, and UCB; grant/research support from Astra Zeneca, Bristol-Myers Squibb, Amgen, Eli Lilly, GSK, Janssen, Novartis, Roche, and UCB; shareholder of Causeway Therapeutics, Evelo Compugen.
Alexa P. Kollmeier
Craig L Dobbin Genetics Research Centre, Memorial University of Newfoundland, St. John's, NL, Canada. Geneva University Hospitals, Geneva, Switzerland. Rheumatology Research, Swedish Medical Center/Providence St. Joseph Health and University of Washington, Seattle, WA, USA. Icahn School of Medicine at Mount Sinai, New York, USA. University of Glasgow, Institute of Infection, Immunity and Inflammation, Glasgow, UK. Global Medical Affairs, Janssen Pharmaceutical Companies of Johnson & Johnson, Horsham, PA, USA. Janssen Research & Development, LLC, Spring House, PA, USA. Immunology, Janssen Research & Development, LLC, San Diego, CA, USA. Janssen Scientific Affairs, LLC, Solna, Sweden. Janssen Scientific Affairs, LLC, Horsham, PA, USA. Medical Affairs, Janssen Inc., Toronto, Canada. Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, Oxford, UK. Funding: The Phase 2 Guselkumab in Psoriatic Arthritis, DISCOVER-1, DISCOVER-2, and COSMOS studies were funded by Janssen Research & Development, LLC. Address correspondence to: Dr. Proton Rahman, 154 LeMarchant Road, St. Clare's Mercy Hospital, St. John's Newfoundland, Canada A1C 5B8. Email: prahman@mun.ca. Conflicts of Interest: PR: received consulting fees from AbbVie, Amgen, Bristol Myers Squibb, Celgene, Eli Lilly, Janssen, Merck, Novartis, Pfizer, and UCB; research grants from Janssen and Novartis. WHB: speaker for AbbVie, Almirall, Janssen, Leo and UCB; advisory board participation for AbbVie, Almirall, BMS, Janssen, Leo, Lilly, Novartis, and UCB. PJM: received research support, consulting fees, and/or speaker bureau support from AbbVie, Amgen, Bristol-Myers Squibb, Celgene, Eli Lilly, Galapagos, Gilead, GlaxoSmithKline, Inmagene, Janssen, Novartis, Pfizer, SUN Pharma, and UCB. ABG: Honoraria as an advisory board member, non-promotional speaker or consultant for: Amgen, AnaptysBio, Avotres Therapeutics, Boehringer Ingelheim, Bristol Myers Squibb, Dermavant, Eli Lilly, Janssen, Novartis, Pfizer, Sanofi, Sun Pharma, UCB Pharma, and Xbiotech (stock options for an RA project); research/educational grants from: AnaptysBio, Janssen, Novartis, Ortho Dermatologics, Sun Pharma, BMS, and UCB Pharma; all funds go to the Icahn School of Medicine at Mount Sinai. IBM: consultant fees from Astra Zeneca, AbbVie, Amgen, Bristol-Myers Squibb, Eli Lilly, Cabaletta, Compugen, GSK, Gilead, Janssen, Novartis, Pfizer, Sanofi, Roche, and UCB; grant/research support from Astra Zeneca, Bristol-Myers Squibb, Amgen, Eli Lilly, GSK, Janssen, Novartis, Roche, and UCB; shareholder of Causeway Therapeutics, Evelo Compugen.
Elke Theander
Craig L Dobbin Genetics Research Centre, Memorial University of Newfoundland, St. John's, NL, Canada. Geneva University Hospitals, Geneva, Switzerland. Rheumatology Research, Swedish Medical Center/Providence St. Joseph Health and University of Washington, Seattle, WA, USA. Icahn School of Medicine at Mount Sinai, New York, USA. University of Glasgow, Institute of Infection, Immunity and Inflammation, Glasgow, UK. Global Medical Affairs, Janssen Pharmaceutical Companies of Johnson & Johnson, Horsham, PA, USA. Janssen Research & Development, LLC, Spring House, PA, USA. Immunology, Janssen Research & Development, LLC, San Diego, CA, USA. Janssen Scientific Affairs, LLC, Solna, Sweden. Janssen Scientific Affairs, LLC, Horsham, PA, USA. Medical Affairs, Janssen Inc., Toronto, Canada. Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, Oxford, UK. Funding: The Phase 2 Guselkumab in Psoriatic Arthritis, DISCOVER-1, DISCOVER-2, and COSMOS studies were funded by Janssen Research & Development, LLC. Address correspondence to: Dr. Proton Rahman, 154 LeMarchant Road, St. Clare's Mercy Hospital, St. John's Newfoundland, Canada A1C 5B8. Email: prahman@mun.ca. Conflicts of Interest: PR: received consulting fees from AbbVie, Amgen, Bristol Myers Squibb, Celgene, Eli Lilly, Janssen, Merck, Novartis, Pfizer, and UCB; research grants from Janssen and Novartis. WHB: speaker for AbbVie, Almirall, Janssen, Leo and UCB; advisory board participation for AbbVie, Almirall, BMS, Janssen, Leo, Lilly, Novartis, and UCB. PJM: received research support, consulting fees, and/or speaker bureau support from AbbVie, Amgen, Bristol-Myers Squibb, Celgene, Eli Lilly, Galapagos, Gilead, GlaxoSmithKline, Inmagene, Janssen, Novartis, Pfizer, SUN Pharma, and UCB. ABG: Honoraria as an advisory board member, non-promotional speaker or consultant for: Amgen, AnaptysBio, Avotres Therapeutics, Boehringer Ingelheim, Bristol Myers Squibb, Dermavant, Eli Lilly, Janssen, Novartis, Pfizer, Sanofi, Sun Pharma, UCB Pharma, and Xbiotech (stock options for an RA project); research/educational grants from: AnaptysBio, Janssen, Novartis, Ortho Dermatologics, Sun Pharma, BMS, and UCB Pharma; all funds go to the Icahn School of Medicine at Mount Sinai. IBM: consultant fees from Astra Zeneca, AbbVie, Amgen, Bristol-Myers Squibb, Eli Lilly, Cabaletta, Compugen, GSK, Gilead, Janssen, Novartis, Pfizer, Sanofi, Roche, and UCB; grant/research support from Astra Zeneca, Bristol-Myers Squibb, Amgen, Eli Lilly, GSK, Janssen, Novartis, Roche, and UCB; shareholder of Causeway Therapeutics, Evelo Compugen.
Jenny Yu
Craig L Dobbin Genetics Research Centre, Memorial University of Newfoundland, St. John's, NL, Canada. Geneva University Hospitals, Geneva, Switzerland. Rheumatology Research, Swedish Medical Center/Providence St. Joseph Health and University of Washington, Seattle, WA, USA. Icahn School of Medicine at Mount Sinai, New York, USA. University of Glasgow, Institute of Infection, Immunity and Inflammation, Glasgow, UK. Global Medical Affairs, Janssen Pharmaceutical Companies of Johnson & Johnson, Horsham, PA, USA. Janssen Research & Development, LLC, Spring House, PA, USA. Immunology, Janssen Research & Development, LLC, San Diego, CA, USA. Janssen Scientific Affairs, LLC, Solna, Sweden. Janssen Scientific Affairs, LLC, Horsham, PA, USA. Medical Affairs, Janssen Inc., Toronto, Canada. Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, Oxford, UK. Funding: The Phase 2 Guselkumab in Psoriatic Arthritis, DISCOVER-1, DISCOVER-2, and COSMOS studies were funded by Janssen Research & Development, LLC. Address correspondence to: Dr. Proton Rahman, 154 LeMarchant Road, St. Clare's Mercy Hospital, St. John's Newfoundland, Canada A1C 5B8. Email: prahman@mun.ca. Conflicts of Interest: PR: received consulting fees from AbbVie, Amgen, Bristol Myers Squibb, Celgene, Eli Lilly, Janssen, Merck, Novartis, Pfizer, and UCB; research grants from Janssen and Novartis. WHB: speaker for AbbVie, Almirall, Janssen, Leo and UCB; advisory board participation for AbbVie, Almirall, BMS, Janssen, Leo, Lilly, Novartis, and UCB. PJM: received research support, consulting fees, and/or speaker bureau support from AbbVie, Amgen, Bristol-Myers Squibb, Celgene, Eli Lilly, Galapagos, Gilead, GlaxoSmithKline, Inmagene, Janssen, Novartis, Pfizer, SUN Pharma, and UCB. ABG: Honoraria as an advisory board member, non-promotional speaker or consultant for: Amgen, AnaptysBio, Avotres Therapeutics, Boehringer Ingelheim, Bristol Myers Squibb, Dermavant, Eli Lilly, Janssen, Novartis, Pfizer, Sanofi, Sun Pharma, UCB Pharma, and Xbiotech (stock options for an RA project); research/educational grants from: AnaptysBio, Janssen, Novartis, Ortho Dermatologics, Sun Pharma, BMS, and UCB Pharma; all funds go to the Icahn School of Medicine at Mount Sinai. IBM: consultant fees from Astra Zeneca, AbbVie, Amgen, Bristol-Myers Squibb, Eli Lilly, Cabaletta, Compugen, GSK, Gilead, Janssen, Novartis, Pfizer, Sanofi, Roche, and UCB; grant/research support from Astra Zeneca, Bristol-Myers Squibb, Amgen, Eli Lilly, GSK, Janssen, Novartis, Roche, and UCB; shareholder of Causeway Therapeutics, Evelo Compugen.
Evan Leibowitz
Craig L Dobbin Genetics Research Centre, Memorial University of Newfoundland, St. John's, NL, Canada. Geneva University Hospitals, Geneva, Switzerland. Rheumatology Research, Swedish Medical Center/Providence St. Joseph Health and University of Washington, Seattle, WA, USA. Icahn School of Medicine at Mount Sinai, New York, USA. University of Glasgow, Institute of Infection, Immunity and Inflammation, Glasgow, UK. Global Medical Affairs, Janssen Pharmaceutical Companies of Johnson & Johnson, Horsham, PA, USA. Janssen Research & Development, LLC, Spring House, PA, USA. Immunology, Janssen Research & Development, LLC, San Diego, CA, USA. Janssen Scientific Affairs, LLC, Solna, Sweden. Janssen Scientific Affairs, LLC, Horsham, PA, USA. Medical Affairs, Janssen Inc., Toronto, Canada. Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, Oxford, UK. Funding: The Phase 2 Guselkumab in Psoriatic Arthritis, DISCOVER-1, DISCOVER-2, and COSMOS studies were funded by Janssen Research & Development, LLC. Address correspondence to: Dr. Proton Rahman, 154 LeMarchant Road, St. Clare's Mercy Hospital, St. John's Newfoundland, Canada A1C 5B8. Email: prahman@mun.ca. Conflicts of Interest: PR: received consulting fees from AbbVie, Amgen, Bristol Myers Squibb, Celgene, Eli Lilly, Janssen, Merck, Novartis, Pfizer, and UCB; research grants from Janssen and Novartis. WHB: speaker for AbbVie, Almirall, Janssen, Leo and UCB; advisory board participation for AbbVie, Almirall, BMS, Janssen, Leo, Lilly, Novartis, and UCB. PJM: received research support, consulting fees, and/or speaker bureau support from AbbVie, Amgen, Bristol-Myers Squibb, Celgene, Eli Lilly, Galapagos, Gilead, GlaxoSmithKline, Inmagene, Janssen, Novartis, Pfizer, SUN Pharma, and UCB. ABG: Honoraria as an advisory board member, non-promotional speaker or consultant for: Amgen, AnaptysBio, Avotres Therapeutics, Boehringer Ingelheim, Bristol Myers Squibb, Dermavant, Eli Lilly, Janssen, Novartis, Pfizer, Sanofi, Sun Pharma, UCB Pharma, and Xbiotech (stock options for an RA project); research/educational grants from: AnaptysBio, Janssen, Novartis, Ortho Dermatologics, Sun Pharma, BMS, and UCB Pharma; all funds go to the Icahn School of Medicine at Mount Sinai. IBM: consultant fees from Astra Zeneca, AbbVie, Amgen, Bristol-Myers Squibb, Eli Lilly, Cabaletta, Compugen, GSK, Gilead, Janssen, Novartis, Pfizer, Sanofi, Roche, and UCB; grant/research support from Astra Zeneca, Bristol-Myers Squibb, Amgen, Eli Lilly, GSK, Janssen, Novartis, Roche, and UCB; shareholder of Causeway Therapeutics, Evelo Compugen.
A. Marilise Marrache
Craig L Dobbin Genetics Research Centre, Memorial University of Newfoundland, St. John's, NL, Canada. Geneva University Hospitals, Geneva, Switzerland. Rheumatology Research, Swedish Medical Center/Providence St. Joseph Health and University of Washington, Seattle, WA, USA. Icahn School of Medicine at Mount Sinai, New York, USA. University of Glasgow, Institute of Infection, Immunity and Inflammation, Glasgow, UK. Global Medical Affairs, Janssen Pharmaceutical Companies of Johnson & Johnson, Horsham, PA, USA. Janssen Research & Development, LLC, Spring House, PA, USA. Immunology, Janssen Research & Development, LLC, San Diego, CA, USA. Janssen Scientific Affairs, LLC, Solna, Sweden. Janssen Scientific Affairs, LLC, Horsham, PA, USA. Medical Affairs, Janssen Inc., Toronto, Canada. Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, Oxford, UK. Funding: The Phase 2 Guselkumab in Psoriatic Arthritis, DISCOVER-1, DISCOVER-2, and COSMOS studies were funded by Janssen Research & Development, LLC. Address correspondence to: Dr. Proton Rahman, 154 LeMarchant Road, St. Clare's Mercy Hospital, St. John's Newfoundland, Canada A1C 5B8. Email: prahman@mun.ca. Conflicts of Interest: PR: received consulting fees from AbbVie, Amgen, Bristol Myers Squibb, Celgene, Eli Lilly, Janssen, Merck, Novartis, Pfizer, and UCB; research grants from Janssen and Novartis. WHB: speaker for AbbVie, Almirall, Janssen, Leo and UCB; advisory board participation for AbbVie, Almirall, BMS, Janssen, Leo, Lilly, Novartis, and UCB. PJM: received research support, consulting fees, and/or speaker bureau support from AbbVie, Amgen, Bristol-Myers Squibb, Celgene, Eli Lilly, Galapagos, Gilead, GlaxoSmithKline, Inmagene, Janssen, Novartis, Pfizer, SUN Pharma, and UCB. ABG: Honoraria as an advisory board member, non-promotional speaker or consultant for: Amgen, AnaptysBio, Avotres Therapeutics, Boehringer Ingelheim, Bristol Myers Squibb, Dermavant, Eli Lilly, Janssen, Novartis, Pfizer, Sanofi, Sun Pharma, UCB Pharma, and Xbiotech (stock options for an RA project); research/educational grants from: AnaptysBio, Janssen, Novartis, Ortho Dermatologics, Sun Pharma, BMS, and UCB Pharma; all funds go to the Icahn School of Medicine at Mount Sinai. IBM: consultant fees from Astra Zeneca, AbbVie, Amgen, Bristol-Myers Squibb, Eli Lilly, Cabaletta, Compugen, GSK, Gilead, Janssen, Novartis, Pfizer, Sanofi, Roche, and UCB; grant/research support from Astra Zeneca, Bristol-Myers Squibb, Amgen, Eli Lilly, GSK, Janssen, Novartis, Roche, and UCB; shareholder of Causeway Therapeutics, Evelo Compugen.
Laura C. Coates
Craig L Dobbin Genetics Research Centre, Memorial University of Newfoundland, St. John's, NL, Canada. Geneva University Hospitals, Geneva, Switzerland. Rheumatology Research, Swedish Medical Center/Providence St. Joseph Health and University of Washington, Seattle, WA, USA. Icahn School of Medicine at Mount Sinai, New York, USA. University of Glasgow, Institute of Infection, Immunity and Inflammation, Glasgow, UK. Global Medical Affairs, Janssen Pharmaceutical Companies of Johnson & Johnson, Horsham, PA, USA. Janssen Research & Development, LLC, Spring House, PA, USA. Immunology, Janssen Research & Development, LLC, San Diego, CA, USA. Janssen Scientific Affairs, LLC, Solna, Sweden. Janssen Scientific Affairs, LLC, Horsham, PA, USA. Medical Affairs, Janssen Inc., Toronto, Canada. Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, Oxford, UK. Funding: The Phase 2 Guselkumab in Psoriatic Arthritis, DISCOVER-1, DISCOVER-2, and COSMOS studies were funded by Janssen Research & Development, LLC. Address correspondence to: Dr. Proton Rahman, 154 LeMarchant Road, St. Clare's Mercy Hospital, St. John's Newfoundland, Canada A1C 5B8. Email: prahman@mun.ca. Conflicts of Interest: PR: received consulting fees from AbbVie, Amgen, Bristol Myers Squibb, Celgene, Eli Lilly, Janssen, Merck, Novartis, Pfizer, and UCB; research grants from Janssen and Novartis. WHB: speaker for AbbVie, Almirall, Janssen, Leo and UCB; advisory board participation for AbbVie, Almirall, BMS, Janssen, Leo, Lilly, Novartis, and UCB. PJM: received research support, consulting fees, and/or speaker bureau support from AbbVie, Amgen, Bristol-Myers Squibb, Celgene, Eli Lilly, Galapagos, Gilead, GlaxoSmithKline, Inmagene, Janssen, Novartis, Pfizer, SUN Pharma, and UCB. ABG: Honoraria as an advisory board member, non-promotional speaker or consultant for: Amgen, AnaptysBio, Avotres Therapeutics, Boehringer Ingelheim, Bristol Myers Squibb, Dermavant, Eli Lilly, Janssen, Novartis, Pfizer, Sanofi, Sun Pharma, UCB Pharma, and Xbiotech (stock options for an RA project); research/educational grants from: AnaptysBio, Janssen, Novartis, Ortho Dermatologics, Sun Pharma, BMS, and UCB Pharma; all funds go to the Icahn School of Medicine at Mount Sinai. IBM: consultant fees from Astra Zeneca, AbbVie, Amgen, Bristol-Myers Squibb, Eli Lilly, Cabaletta, Compugen, GSK, Gilead, Janssen, Novartis, Pfizer, Sanofi, Roche, and UCB; grant/research support from Astra Zeneca, Bristol-Myers Squibb, Amgen, Eli Lilly, GSK, Janssen, Novartis, Roche, and UCB; shareholder of Causeway Therapeutics, Evelo Compugen.
Abstract
Objective Assess pooled safety results through the end of the Phase 2/3 studies of guselkumab (≤2 years) in tumor necrosis factor-α inhibitor (TNFi) -naïve and -experienced patients with psoriatic arthritis (PsA).
Methods Data were pooled from the Phase 2 and DISCOVER-1 (TNFi-naïve/experienced), DISCOVER-2 (TNFi-naïve), and COSMOS (TNFi-experienced) studies. Patients with active PsA were randomized to guselkumab 100 mg every 4 or 8 weeks (Q4W+Q8W=Combined Guselkumab) or placebo with crossover to guselkumab Q4W or Q8W at Week 24. Timeadjusted adverse event (AE) rates (events/100 patient-years [PY]) and clinical laboratory findings were assessed during the placebo-controlled period and through end of study.
Results Of 1554 randomized patients (n=373 [guselkumab Q4W], 664 [guselkumab Q8W], and 517 [placebo]), 1138 (73.23%) were TNFi-naive and 416 (26.76%) were TNFi-experienced. Respective AE rates through Week 24 were 220.8/100PY (TNFi-naïve) and 251.6/100PY (TNFiexperienced) in the Combined Guselkumab group and 196.1/100PY (TNFi-naïve) and 303.0/100PY (TNFi-experienced) in the Placebo group. Among all guselkumab-treated patients (including those who crossed over from placebo), low AE rates were maintained during longterm evaluation in both TNFi-naïve (139.69/100PY) and TNFi-experienced (174.0/100PY) patients. Rates/100PY of AEs leading to treatment discontinuation, serious AEs, and other AEs of interest as well as occurrence of elevated hepatic transaminase levels and decreased neutrophil counts were consistent between placebo and guselkumab-treated patients through Week 24 treatment regardless of prior TNFi use and remained low through the end of the studies.
Conclusion The safety profile of guselkumab in TNFi-experienced patients was consistent with that in TNFi-naïve patients, which remained favorable for up to 2 years.
In this issue
The Journal of Rheumatology
Vol. 50, Issue 2
1 Feb 2023
Accepted manuscript
Safety of guselkumab with and without prior TNF-α inhibitor treatment: Pooled results across four studies in patients with psoriatic arthritis
Proton Rahman, Wolf-Henning Boehncke, Philip J. Mease, Alice B. Gottlieb, Iain B. McInnes, May Shawi, Yanli Wang, Shihong Sheng, Alexa P. Kollmeier, Elke Theander, Jenny Yu, Evan Leibowitz, A. Marilise Marrache, Laura C. Coates
The Journal of Rheumatology Jan 2023, jrheum.220928; DOI: 10.3899/jrheum.220928
Accepted manuscript
Safety of guselkumab with and without prior TNF-α inhibitor treatment: Pooled results across four studies in patients with psoriatic arthritis
Proton Rahman, Wolf-Henning Boehncke, Philip J. Mease, Alice B. Gottlieb, Iain B. McInnes, May Shawi, Yanli Wang, Shihong Sheng, Alexa P. Kollmeier, Elke Theander, Jenny Yu, Evan Leibowitz, A. Marilise Marrache, Laura C. Coates
The Journal of Rheumatology Jan 2023, jrheum.220928; DOI: 10.3899/jrheum.220928
