Exploration of Musculoskeletal Diseases
Safety and efficacy of non-medical switch from innovator to generic tofacitinib: a 3-month observational study in rheumatoid arthritis patients
By Ping Seung Ong, Manisha Chandran and Avreena Kaur Bhullar.
Abstract
Aim
Rheumatoid arthritis (RA) is a chronic autoimmune disease characterized by systemic inflammation. Following the expiry of the patent for innovator tofacitinib (Xeljanz), generic tofacitinib formulations such as Tozib have become available. This study evaluated the impact of a non-medical switch from innovator tofacitinib to generic tofacitinib on disease activity and flare rates over 3 months in patients with RA.
Methods
This retrospective multicenter observational study in Malaysia included 36 patients with RA in remission or low disease activity who underwent a non-medical switch from innovator to generic tofacitinib. Disease activity was assessed at baseline and 3 months using the Disease Activity Score-28 erythrocyte sedimentation rate (DAS28-ESR). Flare was defined as an increase in DAS28-ESR of ≥ 1.2, or ≥ 0.6 if the concurrent DAS28-ESR was ≥ 3.2.