Rheumatoid Arthritis: Sirukumab Presents Safety Issues

An outside consultant, Sergio Schwartzman, M.D., Weill Cornell Medical College, Hospital for Special Surgery, New York Presbyterian Hospital, stated that RA is a disease that continues to leave patients with unmet alternatives when they fail to respond or show intolerance to currently available therapies. Schwartzman said that it is critically important that alternative treatments, including the function of sirukumab, continue to remain available to patients.

Schwartzman also said that he hopes the FDA will carefully consider the full benefits as revealed in the Phase 3 data and recommend, against the wishes of the committee, that sirukumab be used to treat patients with moderately to severely active RA. The development of alternative treatment options, including new molecular entities such as sirukumab are essential in helping RA doctors successfully treat their patients when those patients show little to no response to currently available treatment options or end up being intolerant of other treatment options.

References

Clarke, T. (2017, July 31). J&J arthritis drug sirukumab raises safety concerns: FDA staff. [Web]. In Reuters. Retrieved from: https://www.reuters.com/article/us-johnson-johnson-arthritis-fda-idUSKBN1AG1GD

FDA Advisory Committee Does Not Recommend Approval of Sirukumab for the Treatment of Moderately to Severely Active Rheumatoid Arthritis. (2017, August 2). [Web]. In Johnson & Johnson. Retrieved from: https://www.jnj.com/media-center/press-releases/fda-advisory-committee-does-not-recommend-approval-of-sirukumab-for-the-treatment-of-moderately-to-severely-active-rheumatoid-arthritis