Regeneron Pharmaceuticals and Sanofi, two leading biopharmaceutical companies focused on researching and developing innovative therapeutic solutions, recently announced that Sarilumab, a human IL-6 receptor antibody, when administered to rheumatoid arthritis (RA) patients significantly improves RA-associated symptoms.
The results were observed in a clinical trial — the SARIL-RA-TARGET trial — where 546 RA patients, previously identified as intolerant to TNF-alpha inhibitors, were randomly assigned to received one of three possible treatments (of note, TNF-alpha inhibitors are one of the most used drugs to treat inflammatory conditions such as RA, but also psoriatic arthritis, juvenile arthritis, Crohn’s colitis, ankylosing spondylitis and psoriasis; they work by reducing inflammation and slow-down/inhibit disease progression). These were self-administered subcutaneously to patients, every other week, in the following regimen: 200 or 150 milligrams (mg) of either sarilumab or placebo, together with non-biologic disease modifying anti-rheumatic drugs (DMARD).
The study primary endpoints were achieved and showed:
- At 24 weeks of treatment, RA patients treated with sarilumab exhibited improved signs and symptoms of RA, determined by the American College of Rheumatology guidelines. Specifically they registered that sarilumab in combination with DMARD therapy led to 61% and 56% when administered as 200 mg or 150 mg, respectively. The placebo in combination with DMARD therapy resulted in only 34%.
- At 12 weeks of treatment, there was a significant improvement in Ra patients’ physical function, determined by changes in the Health Assessment Question-Disability Index (HAQ-DI) from baseline to week 12.
The most common adverse effects registered included infections (notably, severe infections were rare) and reactions within the injection site, with sarilumab 200 mg registering 30%, sarilumab 150 mg 22%, and placebo 27%, for infections; for injection reaction, sarilumab 200 mg registered 8%, sarilumab 150 mg 7% and placebo 1%.
Two additional studies — the SARIL-RA-EASY and SARIL-RA-ASCERTAIN – were also successful in achieving their primary endpoints:
- – The SARIL-RA-EASY (with the participation of 217 patients) the primary endpoint was to evaluate both performance and outcome in using a sarilumab auto-injector device, which registered no malfunction.
- – The SARIL-RA-ASCERTAIN study (with the participation of 202 patients) determined the safety of combining DMARDs with two subcutaneous injections of sarilumab and tocilizumab in patients with intolerable for TNF-alpha inhibitors.
- The results for all trials will be presented in the future at appropriated medical conferences.
Regeneron is a leading science-based biopharmaceutical company based in Tarrytown, New York that discovers, invents, develops, manufactures, and commercializes medicines for the treatment of serious medical conditions. Regeneron commercializes medicines for eye diseases and a rare inflammatory condition and has product candidates in development in other areas of high unmet medical need, including hypercholesterolemia, oncology, rheumatoid arthritis, asthma, and atopic dermatitis.