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Glaxo (GSK) Presents Phase III Data on Sirukumab & Benlysta

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GlaxoSmithKline plc (GSK - Free Report) reported results from two pivotal phase III studies – SIRROUND-T and SIRROUND-H – on subcutaneous sirukumab (anti-interleukin-6 monoclonal antibody) for the treatment of adults with moderate to severely active rheumatoid arthritis (RA).

SIRROUND-T evaluated sirukumab in adult patients with moderate to severely active RA who are refractory or intolerant to one or more anti-tumor necrosis factor (TNF) agents. Results demonstrated that a significantly higher proportion of patients treated with sirukumab witnessed an at least 20% improvement in signs and symptoms (ACR20) at week 16 in comparison to placebo, thereby meeting the primary endpoint of the study.

On the other hand, the SIRROUND-H study compared sirukumab monotherapy with Abbvie, Inc.’s (ABBV - Free Report) Humira (adalimumab) monotherapy in adult patients with moderate to severely active RA who were refractory to, intolerant to or inappropriate for methotrexate. Results showed that sirukumab monotherapy achieved the first two co-primary endpoints, having led to a significant improvement in disease activity compared with Humira monotherapy.

We note that regulatory applications seeking approval for sirukumab for RA have been filed in both the U.S. and the EU.

Glaxo is developing sirukumab under a licensing and co-development agreement with Johnson & Johnson’s (JNJ - Free Report) Janssen Biologics.

In a separate press release, Glaxo announced data from a seven-year safety and efficacy continuation phase III study on Benlysta for the treatment of patients with active, autoantibody-positive systemic lupus erythematosus (SLE). Data showed that long-term control of disease activity in patients receiving Benlysta plus standard of care led to meaningful benefits in their daily lives, including improvements in health-related quality of life and fatigue.

Data from the studies on sirukumab and Benlysta will be presented at the annual meeting of the American College of Rheumatology/Association for Rheumatology Health Professionals.

Glaxo currently carries a Zacks Rank #3 (Hold)


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