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Adalimumab therapy for psoriasis in real-world practice: efficacy, safety and results in biologic-naïve vs. non-naïve patients

Authors


  • Conflict of interests
    PPMvL carries out clinical trials for Abbott and Janssen-Cilag. She has received speaking and consulting fees from Wyeth and Schering-Plough and has received reimbursement for attending a symposium from Schering-Plough and Pfizer. RJBD has received funding from Merck Serono and carried out clinical trials for Wyeth, Schering-Plough, Centocor, Abbott, Merck Serono and Barrier Therapeutics. She has also received speaking and consulting fees from Wyeth and Schering-Plough and has received reimbursement for attending a symposium from Merck Serono, Wyeth and Janssen-Cilag. JBMB has no conflicts of interest to declare. PCMvdK serves as a consultant for Schering-Plough, Celgene, Centocor, Allmirall, UCB, Wyeth, Pfizer, Sofinnova, Abbott, Actelion, Galderma, Novartis, Janssen-Cilag and LEO Pharma. He receives research grants from Centocor, Wyeth, Schering-Plough, Merck Serono, Abbott and Philips Lighting. EMGJdJ served as a consultant for Biogen, Merck Serono, Wyeth and Abbott. She has received research grants from or was involved in clinical trials from Schering-Plough, Abbott, Merck Serono, Wyeth, Centocor and Janssen-Cilag.

  • Funding sources
    This was an investigator initiated study. The Radboud University Nijmegen Medical Centre was supported in part by UMC St Radboud Foundation, who received funding from Pfizer and Abbott for the project. Pfizer and Abbott played no role in the design and conduct of the study, data collection, data management, data analysis, interpretation of the data, manuscript preparation, manuscript review or manuscript approval.

P.P.M. van Lümig. E-mail: p.vanlumig@derma.umcn.nl

Abstract

Background  Patients and the course of treatment in daily practice are different from randomized controlled trials (RCTs).

Objectives  Primary objective: to analyse the percentage of patients achieving PASI 75. Secondary objectives: PASI 50, PASI 90, PASI 100 responses, the percentage of patients experiencing at least one serious adverse event (SAE) and the response in biologic-naïve vs. non-naïve patients.

Methods  Prospectively collected efficacy and safety data of a cohort of psoriasis patients treated with adalimumab in daily practice between May 2007 and July 2011 were analyzed. Efficacy was determined using an intention-to-treat analysis and an as treated analysis, in comparison with the course baseline PASI before the start of adalimumab and the original baseline PASI before the start of any biologic therapy.

Results  Eighty-five patients received adalimumab therapy with a mean treatment duration of 1.4 (range 0.02–3.1) years. Compared with the original baseline PASI, PASI 75 response rates at week 12 and 24 were 34% and 38% (ITT). PASI 75 responses were well maintained until week 132.

Only the PASI 75 response rate at week 12 differed significantly between biologic-naïve (56%) and non-naïve patients (29%). Sixteen patients (19%) experienced 28 SAEs. Seven patients (8%) experienced SAEs considered possibly or probably related to adalimumab.

Conclusions  In this cohort, PASI75 responses were substantial but lower than in RCTs and other daily practice studies. Efficacy was well maintained during more than 2 years of follow-up and differed only between biologic-naïve and non-naïve patients at week 12. The incidence of SAEs was low but seems higher than observed in RCTs.

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