Sarilumab effective in broad range of RA patients: Study

November 16, 2015

Sarilumab, an investigational, human antibody against the IL-6 receptor, is highly effective in the difficult-to-treat TNF-IR population in rheumatoid arthritis (RA), according to data presented during the American College of Rheumatology (ACR) Annual Meeting in San Francisco, California.

Sarilumab, an investigational, human antibody against the IL-6 receptor, is highly effective in the difficult-to-treat TNF-IR population in rheumatoid arthritis (RA), according to data presented during the American College of Rheumatology (ACR) Annual Meeting in San Francisco, California.

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The SARIL-RA-TARGET, a pivotal, phase 3 study evaluated the efficacy and safety of the addition of sarilumab to non-biologic disease modifying anti-rheumatic drugs (DMARD) therapy in 546 patients with active RA who had an inadequate response or were intolerant to anti-TNF therapy. Patients were randomly assigned to 1 of 3 treatment groups self-administered subcutaneously (SC) every other week (Q2W): sarilumab 200 mg, sarilumab 150 mg, or placebo, in addition to non-biologic DMARD therapy.

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The study met both its coprimary end points of improvements in signs and symptoms of RA and improvements in physical function, improvement in physical function at week 12, as measured by mean change from baseline in the Health Assessment Questionnaire-Disability Index (HAQ-DI), and improvement in signs and symptoms of RA at week 24, as measured by the proportion of patients achieving an ACR20 response (ACR20).

The study met the following secondary efficacy end points:

  • The proportion of patients achieving an ACR50 and ACR70 response at week 24

  • The mean change from baseline to week 24 in disease activity score in 28 joints using C-reactive protein (DAS28-CRP), which evaluates the disease activity of RA

  • The proportion of patients achieving DAS28-CRP <2.6 at week 24

  • The change from baseline to week 24 in clinical disease activity index (CDAI), which also evaluates the disease activity of RA

  • The change from baseline to week 24 in HAQ-DI

Dr Cooper

“Despite the availability of a wide range of synthetic and biologic DMARDs for RA, not all drugs work in all patients making new treatment options important,” said Simon Cooper, MD, vice president, global project head at Sanofi. “Sarilumab targets IL-6 and we’ve seen improvements in the systemic symptoms of the disease, such as fatigue and anemia, not just improvements in the joints.”

Trends in RA treatment point to an expanded use of treatments – such as sarilumab – that work via new mechanisms of action, according to Janet van Adelsberg, MD, senior director, immunology and inflammation at Regeneron. “Results of the SARIL-RA-TARGET study suggest that sarilumab, if approved, may be a potential option for patients with moderately-to-severely active RA,” Dr van Adelsberg said.

Dr van Adelsberg

It is too early to speculate on the pricing of sub-cutaneous sarilumab at this time, according to Dr van Adelsberg.

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