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# Janssen Arthritis BLA has Safety Concern: FDA Reviewers
- URL: https://www.fdaweb.com/janssen-arthritis-bla-has-safety-concern-fda-reviewers/
- Published: 2017-07-31T12:00:00.000Z
- Updated: 2026-09-14T22:37:32.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5139262

FDA safety reviewers have raised some concern with a Janssen Biotech BLA for Plivensia (sirukumab) injection going before the agency’s Arthritis Advisory Committee 8/2\. The major safety findings with sirukumab were related to immunosuppression (XXX DELETE XXX)consistent with other disease-modifying anti-rheumatic drugs DMARDs, but the reviewers saw a trend of increased overall mortality with the therapy over placebo, according to a just-release FDA [briefing document](https://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/Drugs/ArthritisAdvisoryCommittee/UCM569150.pdf?ref=fdaweb.com). The common causes of mortality were major adverse cardiovascular events, infection and malignancy.

“The increased mortality was seen with both sirukumab doses at comparable rates. Sirukumab was associated with increased risk of serious infection, and there were reports of opportunistic infection and tuberculosis,” the document says. “Sirukumab treatment was associated with laboratory abnormalities including neutrophil count decrease, liver function test values increase, and increase in lipid parameters of LDL, HDL,and triglyceride. These changes were comparable for the sirukumab 100 mg q2w and 50 mg q4w doses. While these immunosuppression-related adverse events and laboratory parameter changes were in qualitative terms similar to other products targeting the IL-6 pathway, the observation of the trend of increased overall mortality seen within the controlledtime period of registration studies seems unique for the sirukumab program.”

Janssen Biotech is seeking approval for the therapy for treating adult patients with moderately to severely active rheumatoid arthritis who have had an inadequate response or are intolerant to one or more disease modifying anti-rheumatic drugs.