In patients with rheumatoid arthritis (RA) who have experienced little benefit from disease-modifying antirheumatic drugs (DMARDs), subcutaneous tocilizumab (TCZ) appears to be well tolerated and associated with an American College of Rheumatology (ACR) response, according to a randomized study published in the Journal of Rheumatology.
Patients with RA were randomly assigned in a 2:1 ratio to receive either 162 mg subcutaneous TCZ every 2 weeks (n=437) or subcutaneous placebo every 2 weeks plus DMARDs (n=219) for a total of 2 years. Investigators performed a second randomization after a 24-week double-blind period in which patients received either open-label subcutaneous TCZ every 2 weeks (n=338) or placebo (n=119) groups. At 12 weeks after re-randomization, participants with inadequately controlled RA disease activity had the option to receive escape therapy with weekly subcutaneous TCZ.
At each point, there was a >70% ACR response in patients receiving TCZ subcutaneously, and the response was maintained beyond 24 weeks. There was a ≥0.30 decrease from baseline in the Health Assessment Questionnaire-Disability Index response rates after 24 weeks of subcutaneous TCZ treatment (>56%), and the 28-joint Disease Activity Score remission and ACR 50 and ACR 70 response rates were also maintained beyond 24 weeks (>32%, ≥50%, and >25%, respectively).
At 2 years, approximately 35% of patients from the subcutaneous TCZ group and 63% from the placebo group achieved an ACR 20 response after escape therapy. Investigators also observed a stable rate of serious adverse events through 96 weeks in the treatment group (11.20/100 patient-years).
This study also showed that escape therapy from subcutaneous TCZ every 2 weeks to subcutaneous TCZ every week had improved ACR responses, suggesting “that some patients who did not respond or only partially responded to TCZ-SC [every 2 weeks] may benefit from more frequent dosing.”
Kivitz A, Olech E, Borofsky MA, et al. Two-year efficacy and safety of subcutaneous tocilizumab in combination with disease-modifying antirheumatic drugs including escalation to weekly dosing in rheumatoid arthritis [published online December 15, 2017]. J Rheumatol. doi:10.3899/jrheum.161539