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Sanofi and Lilly highlight rheumatoid arthritis hopefuls at ACR

Top-line results for sarilumab and baricitinib

Sanofi and Eli Lilly both reported pivotal phase III data on their rheumatoid arthritis candidates over the weekend, which back up their blockbuster potential.

Along with partner Regeneron, Sanofi presented top-line results from the SARIL-RA-TARGET study of sarilumab- an injectable interkeukin-6 (IL-6) inhibitor - while Lilly reported the RA-BEAM data on oral JAK1 and JAK2 inhibitor baricitinib.

Top-line results on both the sarilumab and baricitinib trials were reported earlier this year, but the presentation at the American College of Rheumatology (ACR) meeting in San Francisco gave the companies an opportunity to showcase the data to rheumatologists.

Baricitinib - originated by InCyte - was more effective than AbbVie's big-selling TNF inhibitor Humira (adalimumab), the most widely-used biologic therapy for RA, in patients with moderate-to-severe disease who were not responding to methotrexate.

Lilly's drug was significantly more effective than Humira after 12 weeks on a number of measures, including ACR20, ACR50 and ACR70 response rates - scores that represent at least a 20%, 50% and 70% symptom improvement, respectively.

The trial is the first to show that a once-daily, oral therapy can improve on $13bn-a-year Humira in this RA patient group, according to Lilly, which has four phase III trials in hand supporting the efficacy of its drug including a trial showing superiority to methotrexate in treatment-naïve patients.

The company has indicated it intends to file for approval of baricitinib in RA before the end of the year, with analysts predicting it could become a $1.5bn product in that indication despite Lilly's inexperience in rheumatology.

Meanwhile, treatment with sarilumab improved physical function in patients who did not respond to or were intolerant of TNF inhibitors, and successfully reduced symptoms compared to placebo.

Patients on sarilumab were able to carry out a range of daily activities more effectively, and more than half of the patients on the drug achieved a 20% improvement in RA symptom scores (an ACR20 response).

At a dose of 200mg self-administered every other week, 61% of patients achieved an ACR20, while for a lower 150mg dose of the antibody the proportion was 56%. Just over a third (35%) of subjects who were treated with placebo showed the same benefit.

After 24 weeks, the proportion of patients achieving a 70% improvement in symptoms (ACR70) was 16% and 20% respectively in the two sarilumab groups, compared to 7% for placebo.

Sanofi and Regeneron have high hopes for sarilumab - also predicting it could become a $1bn-plus product.

The two companies will be holding an investor conference call later today to emphasise the significance of the data in this hard-to-treat patent population, while Lilly and InCyte are scheduled to do likewise on Wednesday.

Article by
Phil Taylor

9th November 2015

From: Research



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