GSK, Janssen RA treatment meets co-primary endpoints in Phase III trial
pharmafile | June 9, 2016 | News story | Research and Development | GSK, Janssen, eular 2016, rheumatoid arthritis, sirukumab
GSK (LSE: GSK) and Janssen, a division of Johnson and Johnson, have announced data from a pivotal Phase III study investigating sirukumab in adult patients with moderate to severely active rheumatoid arthritis.
Sirukumab is an investigational human monoclonal IgG1 kappa antibody that selectively binds with high affinity to the IL-6 cytokine, which is a naturally occurring protein that plays a role in autoimmune conditins.
The study met both co-primary endpoints and all major secondary endpoints with statistical significance. The trial results were presented at the Annual European Congress of Rheumatology (EULAR 2016).
One of the primary endpoints used an X-ray measure of changes in joint destruction and damage, including joint erosion and joint space narrowing, called the van der Heijde-Sharp score. In this method, a higher score indicates greater structural damage. In the trial, significant inhibition of radiographic progression was demonstrated in both patients naïve to biologic therapy and those treated with biologics in the past, and were seen as early as 24.
Also, the other primary endpoint was at least a 20% improvement in rheumatoid arthritis signs and symptoms as measured by the American College of Rheumatology response criteria (ACR20) at week 16. This was observed in 54% of patients receiving sirukumab, compared with 26.4% of the placebo group.
Paul-Peter Tak, GSK’s chief immunology officer, says: “Many patients with rheumatoid arthritis continue to suffer with this debilitating and painful disease despite the availability of several treatment options. This study showed that sirukumab inhibited the progression of joint damage and improved the signs and symptoms of disease, disability and quality of life measures. These effects were seen with both the 100mg dose taken every two weeks and the 50mg dose taken every four weeks.”
Newman Yeilding, head of immunology development at Janssen, comments: “We believe sirukumab will represent an important option for the rheumatology community, and we look forward to presenting additional data from the comprehensive Phase 3 development program in the future as we work towards global regulatory submissions this year.”
Sean Murray
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