Background/Purpose: Tofacitinib is an oral Janus kinase inhibitor under investigation for the treatment of psoriatic arthritis (PsA). Here, we evaluate radiographic progression in PsA patients (pts) treated with tofacitinib, using data from a global, 12-month, placebo- and active-controlled, parallel-group Phase 3 study. Pts had an inadequate response to ≥1 conventional synthetic disease-modifying antirheumatic drug, and were tumor necrosis factor inhibitor‑naïve (OPAL Broaden; NCT01877668).

Methods: Pts were randomized to receive oral tofacitinib 5 mg twice daily (BID), tofacitinib 10 mg BID, adalimumab (ADA) 40 mg subcutaneous once every 2 weeks, or placebo (PBO). Pts who initially received PBO advanced to tofacitinib 5 or 10 mg BID at Month (M)3. Radiographs of the hands and feet at baseline (BL) and M12 were scored independently by 2 assessors using the van der Heijde-modified Total Sharp Score for PsA (mTSS; range 0–528);¹ average scores were used. For radiographs missing at M12, mTSS was calculated by linear extrapolation from an earlier mTSS. Change from BL in mTSS, erosion and joint space narrowing (JSN) was reported for all pts and pts grouped by BL C‑reactive protein (CRP) >2.87 mg/L or ≤2.87 mg/L. The proportion of pts with radiographic non-progression (defined as either an increase from BL in mTSS ≤0.5 or ≤0 and less than the smallest detectable change [SDC; ≤0.66 derived from this trial]) at M12 are reported for all pts.

Results: Treatment groups were comparable for demographics and BL characteristics (Table 1). Pts in all groups demonstrated minimal changes from BL in mTSS, erosion, and JSN at M12 (Table 2). Change from BL was similar in pts with CRP >2.87 mg/L or ≤2.87 mg/L. Radiographic non-progression at M12 using any threshold was observed in >90% of pts in all groups. At M12, 95.9%, 94.9%, and 97.9% of pts receiving tofacitinib 5 mg BID, tofacitinib 10 mg BID, and ADA, respectively, were non-progressors based on radiographic changes less than the SDC in mTSS.

Conclusion: Pts with PsA receiving tofacitinib showed minimal mean changes in mTSS at M12, regardless of whether BL CRP level was >2.87 mg/L or ≤2.87 mg/L. At M12, >90% of pts who received tofacitinib or ADA met all radiographic non-progression criteria.

1. van der Heijde et al. Ann Rheum Dis 2005;64 Suppl 2:ii61-4.