Roberto Caporali1, Daniela Zavaglia2. 1. Division of Rheumatology, University of Pavia, IRCCS S. Matteo Foundation, Pavia, Italy. caporali@smatteo.pv.it. 2. Medical Department, Pfizer Italy, Rome, Italy.
Abstract
OBJECTIVES: Oral targeted synthetic disease-modifying anti-rheumatic drugs (DMARDs), including the Janus kinase inhibitors tofacitinib and baricitinib, are the latest addition to the therapeutic options for rheumatoid arthritis (RA). Tofacitinib 5 mg, twice daily, is approved for treatment, with or without methotrexate, of moderate to severe active RA in adults not adequately responding to, or not tolerating one or more DMARDs. In this narrative review we aimed to provide an overview of the real-world evidence for tofacitinib in RA. METHODS: The literature was reviewed up to March 2018 for studies regarding the efficacy and safety of tofacitinib for the treatment of RA. The focus was mainly on real-world studies with implications for every day clinical practice. RESULTS: The efficacy and safety of tofacitinib have been comprehensively assessed in a wide programme of randomised controlled trials. Extensive observational research on tofacitinib in RA is also ongoing worldwide and a substantial body of post-marketing real-world data from clinical practice is becoming available. There was a degree of consistency across the real-world studies reviewed. Tofacitinib tends to be used as monotherapy more frequently than bDMARDS and appears to be effective without background methotrexate. The data show a manageable safety profile, with no new safety signals and a discontinuation rate from safety issues <10%. Patients initiating tofacitinib usually have longer disease duration and have been exposed to longer bDMARDs than patients initiating a bDMARD. CONCLUSIONS: Real-world data are a key component of the evidence supporting the effectiveness of this novel drug and are of interest to all stakeholders. Treatment persistence and adherence to tofacitinib are good overall and similar to those seen for bDMARDs.
OBJECTIVES: Oral targeted synthetic disease-modifying anti-rheumatic drugs (DMARDs), including the Janus kinase inhibitors tofacitinib and baricitinib, are the latest addition to the therapeutic options for rheumatoid arthritis (RA). Tofacitinib 5 mg, twice daily, is approved for treatment, with or without methotrexate, of moderate to severe active RA in adults not adequately responding to, or not tolerating one or more DMARDs. In this narrative review we aimed to provide an overview of the real-world evidence for tofacitinib in RA. METHODS: The literature was reviewed up to March 2018 for studies regarding the efficacy and safety of tofacitinib for the treatment of RA. The focus was mainly on real-world studies with implications for every day clinical practice. RESULTS: The efficacy and safety of tofacitinib have been comprehensively assessed in a wide programme of randomised controlled trials. Extensive observational research on tofacitinib in RA is also ongoing worldwide and a substantial body of post-marketing real-world data from clinical practice is becoming available. There was a degree of consistency across the real-world studies reviewed. Tofacitinib tends to be used as monotherapy more frequently than bDMARDS and appears to be effective without background methotrexate. The data show a manageable safety profile, with no new safety signals and a discontinuation rate from safety issues <10%. Patients initiating tofacitinib usually have longer disease duration and have been exposed to longer bDMARDs than patients initiating a bDMARD. CONCLUSIONS: Real-world data are a key component of the evidence supporting the effectiveness of this novel drug and are of interest to all stakeholders. Treatment persistence and adherence to tofacitinib are good overall and similar to those seen for bDMARDs.
Authors: Pedro Santos-Moreno; Susan Martinez; Linda Ibata; Laura Villarreal; Fernando Rodríguez-Florido; Manuel Rivero; Adriana Rojas-Villarraga; Claudio Galarza-Maldonado Journal: Biologics Date: 2022-07-13