To evaluate safety and efficacy of tocilizumab (TCZ) in a post-approval pilot study among selected Iranian patients with moderate to severe rheumatoid arthritis (RA) and inadequate responses to disease-modifying antirheumatic drugs (DMARDs).
Twenty-four weeks monitoring of adverse events and efficacy of TCZ plus previously used DMARD(s) and steroids, as well as investigating durability of TCZ effects within a year after the drug cessation. The efficacy end-points included 28-joint Disease Activity Score (DAS28) and an annual change in radiographic Sharp-van der Heijde score (SHS).
With no withdrawal from the study due to adverse events (AE) or unsatisfactory responses in the 21 treated patients, the most common drug-related AEs were dermatologic and the most common serious AEs were infectious in origin (all of the latter occurring after the last drug dose). The only case of TCZ dose alteration was due to increased transaminase levels. Changes in lipid and hemoglobin levels were within the expected ranges. At week 24, cumulative frequencies for significant clinical response, low disease activity and remission were 100%, 90.5% and 76.2%, respectively. The mean SHS in both hands showed no significant change a year after the first TCZ dose. Mean DAS28 levels gradually increased through 1 year post-cessation follow-up, with a somewhat slower rate compared to the initial mean DAS28 reduction.
In our DMARD-resistant RA patients, TCZ plus DMARD provided a predicted rapid clinical improvement and inhibited structural joint damage, but with some unexpected safety concerns and an expected vanishing of post-cessation efficacy.