Update on the Safety Profile of Tofacitinib in Rheumatoid Arthritis from Clinical Trials to Real-World Studies: A Narrat
- PDF / 485,059 Bytes
- 24 Pages / 595.276 x 790.866 pts Page_size
- 1 Downloads / 181 Views
REVIEW
Update on the Safety Profile of Tofacitinib in Rheumatoid Arthritis from Clinical Trials to RealWorld Studies: A Narrative Review ´ lvaro-Gracia Jose Marı´a A
. Jose Francisco Garcı´a-Llorente .
Mo´nica Valderrama . Susana Gomez . Maria Montoro
Received: October 13, 2020 / Accepted: November 11, 2020 Ó The Author(s) 2020
ABSTRACT Tofacitinib is approved for the treatment of moderate to severe active rheumatoid arthritis (RA) in adult patients who do not respond adequately or are intolerant to one or more disease-modifying anti-rheumatic drugs. The tofacitinib RA clinical development program included randomized controlled trials of 6–24month duration and long-term extension studies with [ 7061 patients and 22,875 patientyears of exposure. To date, there are no data from other randomized studies in patients with cardiovascular risk factors comparing the longterm safety of a JAK inhibitor versus an antiTNF. Real-world studies are necessary to complete the body of evidence supporting the effectiveness and safety of a therapeutic agent. In the case of tofacitinib, real-world data derive from health insurance claims databases, registries (US Corrona Registry, Swiss Registry, and ´ lvaro-Gracia J. M. A Rheumatology Department, Hospital General ˜o´n, Instituto de Universitario Gregorio Maran ˜o´n (IiSGM), Investigacio´n Sanitaria Gregorio Maran Madrid, Spain J. F. Garcı´a-Llorente Rheumatology Department, Hospital de Galdakao Usansolo, Bilbao, Spain M. Valderrama S. Gomez M. Montoro (&) Medical Department, Pfizer, Madrid, Spain e-mail: [email protected]
others), national pharmacovigilance programs, and hospital databases (case series). The present article provides complete and up-to-date information on the safety profile of tofacitinib in RA, from clinical trials to real-world studies. Tofacitinib has demonstrated a consistent safety profile during up to 9.5 years of experience in randomized controlled trials and long-term extension studies. Real-world evidence has not added new safety issues with respect to those found in the clinical program. In general, the safety profile of tofacitinib is consistent with that of biologic disease-modifying anti-rheumatic drugs, with an increased risk of herpes zoster that seems to be a class effect of Janus kinase inhibitors. The continuous follow-up of therapeutic agents to treat rheumatoid arthritis is needed to adequately establish the safety profile for new mechanisms of action and potential risks associated with their longer term use.
Keywords: Clinical trial; Real-world; Rheumatoid arthritis; Safety; Tofacitinib
Rheumatol Ther
Key Summary Points Why carry out this study? Although randomized controlled trials provide reliable evidence of the efficacy and safety of therapeutic agents, realworld studies are necessary to complete the body of evidence To provide the available information on the safety profile of tofacitinib during its clinical development program (including phase I, II, IIIB/IV, long-term extension studies and the integrated safety analyses)
Data Loading...
