Background/Purpose: Tofacitinib is an oral Janus kinase inhibitor under investigation for the treatment of psoriatic arthritis (PsA). Up to 42% of patients (pts) with psoriasis also have PsA. We examined tofacitinib efficacy and patient-reported outcomes (PROs) in pts with psoriasis and concomitant PsA.

Methods: Data were pooled from identical 52-week, randomized, controlled studies: OPT Pivotal 1 (NCT01276639) and OPT Pivotal 2 (NCT01309737). Both studies enrolled pts with moderate to severe psoriasis. This analysis included only those with a medical history of PsA at baseline (prior diagnosis by a rheumatologist). Pts were randomized 2:2:1 to receive tofacitinib 5 or 10 mg twice daily (BID), or placebo (PBO). Pts receiving PBO advanced to tofacitinib at Week 16. The co-primary efficacy endpoints at Week 16 were the proportion of pts achieving a 75% improvement in the Psoriasis Area and Severity Index score (PASI75) and the proportion of pts achieving Physician’s Global Assessment (PGA) of “clear” or “almost clear”. Secondary endpoints included the proportion of pts achieving Patient’s Global Assessment (PtGA) of “clear” or “almost clear” and changes from baseline in Joint Pain Assessment (ΔJPA), Nail Psoriasis Severity Index (ΔNAPSI), and Short Form-36 Health Survey (ΔSF-36) physical component summary (PCS) score, mental component summary (MCS) score, and 8 domain scores.

Results: The analysis included 430 psoriasis pts with PsA at baseline; 172, 168, and 90 pts received tofacitinib 5 mg BID, tofacitinib 10 mg BID, and PBO, respectively. At Week 16 a greater proportion of pts achieved PASI75, PGA, and PtGA responses with tofacitinib 5 and 10 mg BID vs PBO (all p<0.0001 vs PBO; Table). Improvements were observed with tofacitinib 5 and 10 mg BID vs PBO in ΔJPA and ΔNAPSI (all p<0.0001 vs PBO; Table). Tofacitinib 5 mg BID significantly improved SF-36 PCS (p≤0.05) and 5 of 8 domain scores (physical functioning, role limitations: physical, bodily pain, vitality, social functioning [all p≤0.05]). Tofacitinib 10 mg BID significantly improved SF-36 PCS (p<0.001), MCS (p<0.001), and all 8 domain scores (all p≤0.05). A dose-response was observed across all endpoints following tofacitinib treatment (Table).

Conclusion: Tofacitinib significantly improved clinical endpoints and PROs vs PBO at Week 16 in pts who had concomitant psoriasis and PsA. Details of safety endpoints in pts with psoriasis and PsA in the OPT Pivotal studies will be included in the final presentation.