Abstract
Objective To evaluate the effect of baseline risk factors on radiographic progression in patients with active psoriatic arthritis (PsA) and an inadequate response to conventional synthetic disease-modifying antirheumatic drugs (csDMARDs) treated with tofacitinib or adalimumab.
Methods Tofacitinib is an oral Janus kinase inhibitor for the treatment of PsA. OPAL Broaden (NCT01877668) was a 12-month, double-blind phase III trial. Patients received tofacitinib 5 mg BID (N=107), tofacitinib 10 mg BID (N=104), or adalimumab 40 mg Q2W (N=106), all with 1 background csDMARD. Radiographs (baseline and Month 12) were scored using the van der Heijdemodified Total Sharp Score (mTSS) for PsA. Radiographic nonprogression was defined as an increase from baseline in mTSS ≤0.5, ≤0, or ≤0.66. Changes from baseline in mTSS and nonprogression (≤0.5 increase from baseline in mTSS) were analyzed by baseline C-reactive protein (CRP) >2.87 or ≤2.87 mg/L. Baseline predictors of radiographic progression were analyzed.
Results At Month 12, >90% of patients receiving tofacitinib or adalimumab met all radiographic nonprogression criteria. Mean changes from baseline through Month 12 in mTSS, erosion, and joint space narrowing scores were close to 0. Changes in radiographic outcomes were minimal, irrespective of baseline CRP levels >2.87 or ≤2.87 mg/L, with a small numerical difference observed for tofacitinib 5 mg BID. A significant relationship was observed between baseline CRP level and increases from baseline in mTSS >0.5 at Month 12.
Conclusion Elevated CRP levels at baseline were associated with greater structural progression. Changes in radiographic outcomes were minimal regardless of CRP levels.
