TY - JOUR
T1 - Potential Impact of Sex and BMI on Response to Therapy in Psoriatic Arthritis
T2 - Post Hoc Analysis of Results From the SEAM-PsA Trial
AU - Mease, Philip J.
AU - Gladman, Dafna D.
AU - Merola, Joseph F.
AU - Deodhar, Atul
AU - Ogdie, Alexis
AU - Collier, David H.
AU - Liu, Lyrica
AU - Kavanaugh, Arthur
N1 - Funding Information:
The study was funded by Immunex, a wholly owned subsidiary of Amgen Inc. 1P.J. Mease, MD, Director of Rheumatology Research, Swedish Medical Center/Providence St. Joseph Health, Seattle, Washington, and Clinical Professor, University of Washington, Seattle, Washington, USA; 2D.D. Gladman, MD, FRCPC, Professor of Medicine, Institute of Medical Science, University of Toronto, Toronto, Ontario, Canada; 3J.F. Merola, MD, Assistant Professor, Department of Dermatology and Medicine, Brigham and Women’s Hospital, Harvard Medical School, Boston, Massachusetts, USA; 4A. Deodhar, MD, MRCP, Professor of Medicine and Medical Director of Rheumatology Clinics, Division of Arthritis & Rheumatic Diseases, Oregon Health & Science University, Portland, Oregon, USA; 5A. Ogdie, MD, Associate Professor of Medicine, Department of Medicine, University of Pennsylvania, Philadelphia, Pennsylvania, USA; 6D.H. Collier, MD, Clinical Research Medical Director, Clinical Development, Amgen Inc., Thousand Oaks, California, USA; 7L. Liu, PhD, Biostatistician, Global Biostatistics, Amgen Inc., Thousand Oaks, California, USA; 8A. Kavanaugh, MD, Professor of Medicine, Division of Rheumatology, Allergy, and Immunology, University of California San Diego, La Jolla, California, USA. PJM has received research grants and has served as a consultant or has been a speaker for AbbVie, Amgen, Boehringer Ingelheim, BMS, Celgene, Galapagos, Gilead, GSK, Janssen, Novartis, Pfizer, SUN Pharma, and UCB. DDG has received research grants from Amgen, AbbVie, Celgene, Eli Lilly, Janssen, Novartis, Pfizer, and UCB; and has received consulting fees from Amgen, AbbVie, BMS, Celgene, Eli Lilly, Gilead, Galapagos, Janssen, Novartis, Pfizer, and UCB. JFM has received consulting fees from Merck, AbbVie, Dermavant, Eli Lilly, Novartis, Janssen, UCB, Celgene, Sanofi, Regeneron, Arena, SUN Pharma, Biogen, Pfizer, EMD Serono, Avotres, and Leo Pharma. AD has received research grants from AbbVie, GSK, Novartis, Pfizer, and UCB, and has received consulting fees from AbbVie, Amgen, Boehringer Ingelheim, BMS, Celgene, Gilead, GSK, Janssen, Novartis, Pfizer, and UCB. AO has received research grants from AbbVie, Novartis, and Pfizer to University of Pennsylvania and Amgen to FORWARD/NDB; has received consulting fees from AbbVie, Amgen, BMS, Celgene, CorEvitas, Gilead, Janssen, Eli Lilly, Novartis, Pfizer, and UCB; and reports receipt of royalties from Novartis (to spouse). DHC is an employee of and owns stock in Amgen. LL is an employee of and owns stock in Amgen. AK declares no conflicts of interest relevant to this work. Address correspondence to Dr. P.J. Mease, Rheumatology Research, Swedish Medical Center/Providence St. Joseph Health, 601 Broadway, Seattle, WA 98122, USA. Email: pmease@philipmease.com. Accepted for publication March 25, 2022.
Publisher Copyright:
© 2022 The Journal of Rheumatology.
PY - 2022/8/1
Y1 - 2022/8/1
N2 - Objective. In this post hoc analysis, we examined the potential impact of sex and BMI on response in the Study of Etanercept and Methotrexate in Combination or as Monotherapy in Subjects with Psoriatic Arthritis (SEAM-PsA) trial (NCT02376790), a 48-week, phase III, randomized controlled trial that compared outcomes with methotrexate (MTX) monotherapy, etanercept (ETN) monotherapy, and MTX+ETN combination therapy in patients with psoriatic arthritis (PsA) who were naïve to MTX and biologics. Methods. We evaluated key outcomes at week 24 stratified by sex (male vs female) and BMI (kg/m2; ≤ 30 vs > 30), including the American College of Rheumatology 20 (ACR20) criteria, minimal disease activity (MDA), very low disease activity (VLDA), and Psoriatic Arthritis Disease Activity Score (PASDAS). We analyzed data using descriptive statistics, normal approximation, logistic model, and analysis of covariance. Results. A total of 851 patients completed the SEAM-PsA trial. Higher proportions of men than women who received MTX+ETN combination therapy achieved ACR20 (71.5% vs 58.3%; P = 0.02), MDA (45.8% vs 25.2%; P = 0.0003), and VLDA (19.1% vs 9.5%; P = 0.03), and men achieved better PASDAS (-3.0 vs -2.3; P = 0.0004). Patients with BMI ≤ 30 generally had better outcomes than those with BMI > 30 in some treatment arms for ACR20, MDA, VLDA, and PASDAS; however, there was no consistent pattern regarding the treatment arm in which the difference occurred. Conclusion. Improved outcomes were observed more in men than in women for MDA and PASDAS with MTX+ETN combination therapy. Patients with BMI ≤ 30 had better outcomes than those with BMI > 30, with no clear pattern regarding treatment received. These findings suggest that contextual factors such as sex and BMI may affect response to PsA therapy.
AB - Objective. In this post hoc analysis, we examined the potential impact of sex and BMI on response in the Study of Etanercept and Methotrexate in Combination or as Monotherapy in Subjects with Psoriatic Arthritis (SEAM-PsA) trial (NCT02376790), a 48-week, phase III, randomized controlled trial that compared outcomes with methotrexate (MTX) monotherapy, etanercept (ETN) monotherapy, and MTX+ETN combination therapy in patients with psoriatic arthritis (PsA) who were naïve to MTX and biologics. Methods. We evaluated key outcomes at week 24 stratified by sex (male vs female) and BMI (kg/m2; ≤ 30 vs > 30), including the American College of Rheumatology 20 (ACR20) criteria, minimal disease activity (MDA), very low disease activity (VLDA), and Psoriatic Arthritis Disease Activity Score (PASDAS). We analyzed data using descriptive statistics, normal approximation, logistic model, and analysis of covariance. Results. A total of 851 patients completed the SEAM-PsA trial. Higher proportions of men than women who received MTX+ETN combination therapy achieved ACR20 (71.5% vs 58.3%; P = 0.02), MDA (45.8% vs 25.2%; P = 0.0003), and VLDA (19.1% vs 9.5%; P = 0.03), and men achieved better PASDAS (-3.0 vs -2.3; P = 0.0004). Patients with BMI ≤ 30 generally had better outcomes than those with BMI > 30 in some treatment arms for ACR20, MDA, VLDA, and PASDAS; however, there was no consistent pattern regarding the treatment arm in which the difference occurred. Conclusion. Improved outcomes were observed more in men than in women for MDA and PASDAS with MTX+ETN combination therapy. Patients with BMI ≤ 30 had better outcomes than those with BMI > 30, with no clear pattern regarding treatment received. These findings suggest that contextual factors such as sex and BMI may affect response to PsA therapy.
KW - body mass index
KW - etanercept
KW - methotrexate
KW - psoriatic arthritis
KW - sex
UR - http://www.scopus.com/inward/record.url?scp=85135288671&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=85135288671&partnerID=8YFLogxK
U2 - 10.3899/jrheum.211037
DO - 10.3899/jrheum.211037
M3 - Article
C2 - 35428718
AN - SCOPUS:85135288671
SN - 0315-162X
VL - 49
SP - 885
EP - 893
JO - Journal of Rheumatology
JF - Journal of Rheumatology
IS - 8
ER -