FRI0496 Comparing tofacitinib safety profile in patients with psoriatic arthritis in clinical studies with real-world data

Abstract

Background: Tofacitinib is an oral Janus kinase inhibitor under investigation for the treatment of psoriatic arthritis (PsA). Two Phase 3 studies have been completed (NCT01877668; NCT01882439) and a long-term extension (LTE) study is ongoing (database not locked; NCT01976364). Objectives: To compare incidence rates (IR) for adverse events (AEs) of special interest in a tofacitinib cohort from the Phase 3 PsA trials with real-world experience in a comparison cohort from the US Truven MarketScan database. Methods: The tofacitinib cohort included adult patients (pts) from 2 Phase 3 studies with ≥6 months PsA diagnosis who met ClASsification of Psoriatic ARthritis (CASPAR) criteria, had active plaque psoriasis, and active arthritis (≥3 swollen and ≥3 tender/painful joints) and who were treated with tofacitinib. Pts were grouped by those who received tofacitinib 5 (N=238) or 10 mg (N=236) twice daily (BID) in the 2 Phase 3 studies, and all pts who received ≥1 dose of tofacitinib in the 2 Phase 3 studies or the LTE (tofacitinib all doses, N=783). The comparison cohort (N=5799) comprised pts with moderate to severe PsA, defined by ≥1 inpatient or ≥2 outpatient 696.0 diagnosis codes on 2 unique calendar days (≥1 by a rheumatologist) between Oct 2010 and Sep 2015, initiating therapy with a systemic agent for PsA. Key Phase 3 study exclusion criteria were applied to the comparison cohort. IRs for serious infection events (SIEs), herpes zoster (HZ), malignancies (excluding non-melanoma skin cancer [NMSC]), NMSC and major adverse cardiovascular events (MACE) were compared. Results: Mean age, gender and diabetes history were generally similar between the tofacitinib and comparison cohorts (48.7-49.5 years, 42.4-49.2% male, 12.2- 15.7% with diabetes history). Overall more pts treated with tofacitinib had prior experience with corticosteroids (15.7-28.2%), conventional synthetic diseasemodifying antirheumatic drugs (100%) and tumour necrosis factor inhibitors (48.1-55.9%) vs the comparison cohort (11.9%, 46.6% and 36.6%, respectively). IRs for SIEs were lower for the tofacitinib vs the comparison cohort (Table 1). The tofacitinib cohort had a higher rate of HZ vs the comparison cohort (Table 1). IRs for malignancies and MACE were similar between cohorts (Table 1). Conclusions: IRs of AEs of special interest reported in tofacitinib PsA Phase 3 studies were generally comparable to those in a general PsA population comprising pts receiving a range of biologic agents, except HZ, which was higher for pts treated with tofacitinb but similar to the incidence observed with tofacitinib treatment in other indications. (Table Presented).