Clinical Efficacy, Safety Maintained for Up to 5 Years with Tocilizumab Use

In the News: Value-Based Care - May 2016

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.”


  1. 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.
Last modified: August 12, 2016
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