Objectives: To evaluate the effectiveness of adalimumab in patients with psoriatic arthritis (PsA) and identify predictors of good clinical response for joint and skin lesions.
Methods: Patients received adalimumab 40 mg every other week in addition to standard therapy in this prospective, 12-week, open-label, uncontrolled study. Four definitions of good clinical response were used: ⩾50% improvement in American College of Rheumatology response criteria (ACR50), good response according to European League Against Rheumatism (EULAR) guidelines, a ⩾3-grade improvement in Physician Global Assessment of psoriasis (PGA) and a ⩾50% improvement in the Nail Psoriasis Severity Index (NAPSI). Response predictors were determined by logistic regression with backward elimination (selection level was 5%).
Results: Of 442 patients, 94% completed 12 weeks of treatment. At week 12, 74%, 51% and 32% of the patients had achieved ACR20, 50 and 70, respectively; 87% and 61% experienced moderate and good responses according to EULAR criteria, respectively. The percentage of patients with PGA results of “clear/almost clear” increased from 34% (baseline) to 68%. The mean NAPSI score was reduced by 44%. No new safety signals were detected. A lower Health Assessment Questionnaire Disability Index (HAQ-DI) score, greater pain assessment, male sex and absence of systemic glucocorticoid therapy were strongly associated with achievement of ACR50 and good response according to EULAR criteria. In addition, greater C-reactive protein concentration and polyarthritis predicted ACR50, and non-involvement of large joints predicted a good response according to EULAR criteria.
Conclusions: Adalimumab was effective in patients with PsA. Lower impairment of physical function, greater pain, male sex and no systemic treatment with glucocorticoids were factors that increased the chance of achieving a good clinical response.
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▸ Additional data (supplementary tables 1 and 2 and supplementary appendix) are published online only at http://ard.bmj.com/content/vol69/issue2
Funding The editing and publication management support in the development and revision of this manuscript was funded by Abbott Laboratories.
Competing interests FvdB has received speaker’s bureau honorarium and/or has served as a consultant for Abbott Laboratories, Schering-Plough, UCB and Wyeth. OF has given lectures at the request of Abbott and Wyeth, and has also received grant support from both companies. PH is a government employee. RvV has received research grants and consulting fees from Abbott, Bristol-Myers-Squibb, Centocor, Roche, Wyeth and Schering-Plough. ML-R has given lectures/organised education events at the request of Abbott, Roche, Wyeth, Schering-Plough and Bristol-Myers-Squibb, and has received research grants from Schering-Plough as well as consulting fees from Centocor, Bristol-Myers-Squibb, Roche and Novartis. ML-R has also served as advisory board members for Abbott, Schering-Plough, Roche and Bristol-Myers-Squibb. BM has received honoraria as speaker or consultant from the following companies: Abbott, Bristol-Myers-Squibb, Essex, Genzyme, Novartis, 4SC, Roche, UCB Pharma and Wyeth. PG has received research grants from Abbott and Wyeth; consulting fees from Abbott, Wyeth, Schering-Plough and Roche, and has been an advisory board member for Abbott, Wyeth, Schering-Plough, Roche and Bristol-Myers-Squibb. NM has received an unrestricted research grant from Abbott for a study of long-term outcomes in patients with psoriatic arthritis. ER has nothing to disclose. MK, MF and HK are full time employees of Abbott, an affiliate of Abbott Laboratories and hold shares of Abbott stock. SK is a contractor of Abbott GmbH.
Trial registration number: NCT00235885.
The STEREO Study Group included experts from academic institutions in Europe and members of Abbott Laboratories who designed the clinical trial. Clinical data were collected and analysed by Abbott Laboratories. All authors contributed to manuscript development and reviewed and approved the content of the submitted manuscript.
Provenance and Peer review Not commissioned; externally peer reviewed.