RT Journal Article SR Electronic T1 Adalimumab or Cyclosporine as Monotherapy and in Combination in Severe Psoriatic Arthritis: Results from a Prospective 12-month Nonrandomized Unblinded Clinical Trial JF The Journal of Rheumatology JO J Rheumatol FD The Journal of Rheumatology SP jrheum.110242 DO 10.3899/jrheum.110242 A1 George N. Karanikolas A1 Eftyhia-Maria Koukli A1 Aikaterini Katsalira A1 Aikaterini Arida A1 Dimitrios Petrou A1 Eleni Komninou A1 Kalliopi Fragiadaki A1 Anna Zacharioudaki A1 Ioannis Lasithiotakis A1 Eirini Giavri A1 George Vaiopoulos A1 Petros P. Sfikakis YR 2011 UL http://www.jrheum.org/content/early/2011/08/30/jrheum.110242.abstract AB Objective To assess the efficacy and safety of adalimumab or cyclosporine (CYC) as monotherapy or combination therapy for patients with active psoriatic arthritis (PsA), despite methotrexate (MTX) therapy. Methods A prospective 12-month, nonrandomized, unblinded clinical trial of 57, 58, and 55 patients who received CYC (2.5–3.75 mg/kg/day), adalimumab (40 mg every other week), or combination, respectively. Lowering of concomitant nonsteroidal antiinflammatory drugs (NSAID) and corticosteroids, and reductions of adalimumab and/or CYC doses in responding patients were not restricted. Results Mean numbers of tender/swollen joints at baseline were 9.7/6.7 in CYC-treated, 13.0/7.8 in adalimumab-treated, and 14.5/9.4 in combination-treated patients, indicating lesser disease severity of patients assigned to the first group. The Psoriatic Arthritis Response Criteria at 12 months were met by 65% of CYC-treated (p = 0.0003 in favor of combination treatment), 85% of adalimumabtreated (p = 0.15 vs combination treatment), and 95% of combination-treated patients, while the American College of Rheumatology-50 response rates were 36%, 69%, and 87%, respectively (p < 0.0001 and p = 0.03 in favor of combination treatment). A significantly greater mean improvement in Health Assessment Questionnaire Disability Index was achieved by combination treatment (–1.11) vs CYC (–0.41) or adalimumab alone (–0.85). Combination therapy significantly improved Psoriasis Area and Severity Index-50 response rates beyond adalimumab, but not beyond the effect of CYC monotherapy. Doses of NSAID and corticosteroids were reduced in combination-treated patients; CYC doses and frequency of adalimumab injections were also reduced in 51% and 10% of them, respectively. No new safety signals were observed. Conclusion The combination of adalimumab and CYC is safe and seemed to produce major improvement in both clinical and serological variables in patients with severely active PsA and inadequate response to MTX.