Patients with rheumatoid arthritis who inadequately responded to methotrexate monotherapy and were treated with tocilizumab plus methotrexate experienced subdued radiographic progression and maintained improvements in signs and symptoms over 5 years, according to data from Joel Kremer, MD, Albany Medical College, NY, and colleagues.1
Seeking to evaluate the 5-year efficacy and safety data of patients with active rheumatoid arthritis treated with tocilizumab, researchers conducted a randomized, 2-year, placebo-controlled study, and an open-label, 3-year extension of tocilizumab use in this patient population. Study participants received placebo or intravenous tocilizumab 4 mg/kg or 8 mg/kg every 4 weeks plus methotrexate; rescue with tocilizumab was receivable from week 16, and, after week 52, patients could switch to open-label tocilizumab 8 mg/kg.
Using the Genant-modified Total Sharp Score (GmTSS), Dr Kremer and colleagues analyzed radiographs of patients who had at least baseline, week 104, and post-week 104 radiographs by randomized treatment. The clinical and safety data was then combined for all patients who received ≥1 dose of tocilizumab, and presented results from the first tocilizumab dose.
Of the 1149 patients included in the study, 34% received 5 years of treatment. The mean 5-year GmTSS change demonstrated a greater inhibition of radiographic progression in tocilizumab patients compared with those who received placebo (1.34 vs. 3.02). In addition, the greatest annualized progression rate occurred in year 1. Overall, 53% and 35% of patients receiving tocilizumab and placebo experienced no progression (GmTSS ≤0), respectively.
Per the American College of Rheumatology improvement criteria response, Disease Activity Score 28-erythrocyte sedimentation rate, European League Against Rheumatism good/moderate response, and Boolean remission clinical benefit was maintained. Physical function was also maintained, and the 5-year safety profile was similar to that of 2 years.
“Over 5 years, tocilizumab [plus methotrexate] inhibited radiographic progression and maintained improvements in signs and symptoms and physical function in [methotrexate]-inadequate responders with active disease,” Dr Kremer and colleagues concluded. “No new safety signals occurred.”
- Kremer JM, Blanco R, Halland AM, et al. Clinical efficacy and safety maintained up to 5 years in patients with rheumatoid arthritis treated with tocilizumab in a randomised trial. Clin Exp Rheumatol. 2016 Apr 15. Epub ahead of print.