Comparative effectiveness of biologic agents for the treatment of psoriasis in a real-world setting: Results from a large, prospective, observational study (Psoriasis Longitudinal Assessment and Registry [PSOLAR]) - 14/04/16
, Robert Bissonnette, MD c, David Fiorentino, MD, PhD d, Alexa B. Kimball, MPH, MD e, Luigi Naldi, MD f, Neil H. Shear, MD g, Kavitha Goyal, MD h, Steven Fakharzadeh, MD, PhD h, Stephen Calabro, MS h, Wayne Langholff, PhD i, Yin You, MS i, Claudia Galindo, MD h, Seina Lee, MS, PharmD j, Mark G. Lebwohl, MD kAbstract |
Background |
Comparing effectiveness of biologics in real-world settings will help inform treatment decisions.
Objectives |
We sought to compare therapeutic responses among patients initiating infliximab, adalimumab, or etanercept versus ustekinumab during the Psoriasis Longitudinal Assessment and Registry (PSOLAR).
Methods |
Proportions of patients achieving a Physician Global Assessment score of clear (0)/minimal (1) and mean decrease in percentage of body surface area with psoriasis were evaluated at 6 and 12 months. Adjusted logistic regression (Physician Global Assessment score 0/1) and analysis of covariance (percentage of body surface area with psoriasis) were performed to determine treatment factors associated with effectiveness.
Results |
Of 2541 new users on registry, 2076 had efficacy data: ustekinumab (n = 1041), infliximab (n = 116), adalimumab (n = 662), and etanercept (n = 257). Patients receiving tumor necrosis factor-alpha(-α) inhibitors were significantly less likely to achieve Physician Global Assessment score 0/1 versus ustekinumab (infliximab [odds ratio {OR} 0.396, P < .0001], adalimumab [OR 0.686, P = .0012], etanercept [OR 0.554, P = .0003] at 6 months and infliximab [OR 0.449, P = .0040] at 12 months). Mean decrease in percentage of body surface area with psoriasis was significantly greater for ustekinumab versus adalimumab (point estimate 1.833, P = .0020) and etanercept (point estimate 3.419, P < .0001) at 6 months and versus infliximab (point estimate 3.945, P = .0005) and etanercept (point estimate 2.778, P = .0007) at 12 months.
Limitations |
Treatment selection bias and limited data for doing adjustments are limitations.
Conclusions |
In PSOLAR, effectiveness of ustekinumab was significantly better versus all 3 tumor necrosis factor-α inhibitors studied for the majority of comparisons at 6 and 12 months.
Le texte complet de cet article est disponible en PDF.Key words : adalimumab, biologic, BSA, DLQI, effectiveness, efficacy, etanercept, infliximab, PGA, PSOLAR, Psoriasis Longitudinal Assessment and Registry, ustekinumab
Abbreviations used : %BSA, CI, DLQI, HRQoL, OR, PGA, PSOLAR, SD, TNF
Plan
| This study was sponsored by Janssen Scientific Affairs, LLC (clincialtrials.gov: NCT00508547). |
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| Disclosure: Dr Strober received honoraria for serving as a consultant, advisory board member, and/or speaker for AbbVie, Amgen, Astra Zeneca, Boehringer Ingelheim, Celgene, Dermira, Eli Lilly, Forward Pharma, Janssen, Leo, Maruho, Medac, Novartis, Pfizer, Stiefel/GlaxoSmithKline, Sun, and UCB; received payments (to the University of Connecticut) as an investigator for AbbVie, Amgen, Celgene, Eli Lilly, Janssen, Merck, Novartis, Xenoport, and Xoma; received fees as a scientific director for the Consortium of Rheumatology Researchers of North America (CORRONA) Psoriasis Registry; and received grant support (to the University of Connecticut for Fellowship Program) from AbbVie and Janssen. Dr Bissonnette received honoraria and/or fees for serving as a consultant, advisory board member, and/or speaker for AbbVie, Amgen, Celgene, Eli Lilly, Galderma, Incyte, Janssen, Leo, Merck, and Novartis; and received grant support as an investigator for AbbVie, Amgen, Celgene, Eli Lilly, Galderma, Incyte, Janssen, Kineta, Leo, Merck, Novartis, and Pfizer. Dr Fiorentino received honoraria and fees for serving as an advisory board member and investigator for Janssen. Dr Kimball received honoraria for serving as a consultant for AbbVie, Dermira, Eli Lilly, Merck, Novartis, and Pfizer; received residency and fellowship program funding from Janssen; and received grant/research funding as an investigator for Abbott Laboratories, Amgen, Dermira, Janssen, Merck, and Novartis. Dr Naldi received honoraria for serving as a consultant, advisory board member, and/or speaker for AbbVie, Janssen, Menarini, Novartis, and Pfizer. Dr Shear received honoraria for serving as an advisory board member and/or speaker for AbbVie, Amgen, Celgene, Eli Lilly, Janssen, Leo, and Novartis. Drs Goyal, Fakharzadeh, Langholff, Galindo, and Lee; Mr Calabro; and Ms You are employees of, and own stock in, Johnson & Johnson. Dr Lebwohl is an employee of the Mount Sinai Medical Center, which receives research funds from Amgen, Anacor, Aqua, Canfite Biopharma, Celgene, Clinuvel, Coronado Biosciences, Eli Lilly, Ferndale, Janssen, Leo, Merck, Novartis, Pfizer, Sandoz, and Valeant. |
Vol 74 - N° 5
P. 851 - mai 2016 Retour au numéro
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