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ABSTRACT: Introduction
Tofacitinib is an oral Janus kinase inhibitor for the treatment of psoriatic arthritis (PsA).Objective
Our objective was to compare the incidence rates (IRs) of adverse events in tofacitinib clinical trials and real-world observational data for alternative treatments.Methods
The tofacitinib "dose-comparison cohort" included months 0-12 of two phase III studies (tofacitinib 5 [n = 238] and 10 [n = 236] mg twice daily [BID]); the "all-tofacitinib comparison cohort" (n = 783) included two phase III and one ongoing long-term extension study (data cutoff May 2016). An "observational comparison cohort" (n = 5799) comprised patients initiating a conventional synthetic disease-modifying antirheumatic drug (DMARD), biologic DMARD, or apremilast in the US Truven MarketScan database from 2010 to 2015. IRs for serious infections (SIEs; requiring hospitalization), herpes zoster (HZ), malignancies (excluding non-melanoma skin cancer [NMSC]), NMSC, and major adverse cardiovascular events (MACE) across cohorts were qualitatively compared.Results
IRs (patients with events/100 patient-years) for SIEs were similar between the tofacitinib dose-comparison cohort (5 mg BID: 1.3; 10 mg BID: 2.0) and the observational comparison cohort (1.1-7.9; treatment dependent). The tofacitinib dose-comparison cohort had a higher rate of HZ (5 mg BID: 2.0; 10 mg BID: 2.7) than did the observational comparison cohort (0.8-2.0). IRs for NMSC were generally lower in the all-tofacitinib comparison cohort (0.5) than in the observational comparison cohort (0.4-6.0). IRs for MACE, malignancies excluding NMSC, and NMSC were similar between cohorts.Conclusion
In patients with PsA, tofacitinib had a safety profile similar to that of other systemic therapies in real-world settings, except for the risk of HZ, a known risk of tofacitinib.Trial registration
ClinicalTrials.gov: NCT01877668; NCT01882439; NCT01976364.
SUBMITTER: Burmester GR
PROVIDER: S-EPMC7105422 | biostudies-literature | 2020 Apr
REPOSITORIES: biostudies-literature
Burmester Gerd R GR Curtis Jeffrey R JR Yun Huifeng H FitzGerald Oliver O Winthrop Kevin L KL Azevedo Valderilio F VF Rigby William F C WFC Kanik Keith S KS Wang Cunshan C Biswas Pinaki P Jones Thomas T Palmetto Niki N Hendrikx Thijs T Menon Sujatha S Rojo Ricardo R
Drug safety 20200401 4
<h4>Introduction</h4>Tofacitinib is an oral Janus kinase inhibitor for the treatment of psoriatic arthritis (PsA).<h4>Objective</h4>Our objective was to compare the incidence rates (IRs) of adverse events in tofacitinib clinical trials and real-world observational data for alternative treatments.<h4>Methods</h4>The tofacitinib "dose-comparison cohort" included months 0-12 of two phase III studies (tofacitinib 5 [n = 238] and 10 [n = 236] mg twice daily [BID]); the "all-tofacitinib comparison coh ...[more]