An Integrated Analysis of the Safety of Tofacitinib in Psoriatic Arthritis Across Phase III and Long Term Extension Studies with Comparison to Real World Observational Data
Drug Saf. 2020;43:379-392Patients with psoriatic arthritis (PsA) had similar safety profile with TOF to that of other systemic therapies in real-world settings, except for the known risk of HZ. Treatment recommendations from EULAR and GRAPPA for patients with PsA vary according to adverse prognostic risk factors, disease manifestations and responsiveness to prior treatment. Safety concerns for most PsA therapies include gastrointestinal AEs, hepatotoxicity, opportunistic infections (OIs) including TB, and SIEs. This study is a post-hoc analysis of two Phase 3 studies (OPAL Broaden and OPAL Beyond) and one long-term extension study (OPAL Balance) examining the safety profile of TOF, and comparing the incidence rate (IR) of AEs of special interest with observational data for other PsA treatments from the US Truven MarketScan database. The IR seen for SAEs and discontinuations due to SAEs in patients receiving TOF was similar to the rate seen in the RA clinical trial programme. For SIEs, defined as requiring parenteral antimicrobials in an emergency department or resulting in hospitalization, the IR of 1.3 and 2.0 for patients receiving TOF 5 mg or 10 mg BID was consistent with an IR of 2.7 for patients with RA, and 1.9 for patients with psoriasis. The IR of OI, major adverse cardiovascular events, malignancies and non-melanoma skin cancer in the TOF-treated patients was within the range of that seen in the observational comparison cohort. TOF was associated with a higher risk of HZ than most other PsA therapies, as is the case when used in RA.In patients with active PsA, TOF had a safety profile that was generally consistent with patients receiving other therapies in a real-world setting, and with its use in other indications.