No new safety signals were identified. The most common adverse events in tocilizumab-treated patients were infections. At week 48, two patients in the placebo group had developed infections, while seven patients in the tocilizumab group had developed infections. This was not considered a statistically significant difference.
Michele B. Kaufman, PharmD, BCGP, is a freelance medical writer based in New York City and a pharmacist at New York Presbyterian Lower Manhattan Hospital.
ad goes here:advert-1
ADVERTISEMENT
SCROLL TO CONTINUE
References
- Scleroderma Foundation. Pulmonary fibrosis in systemic sclerosis: Diagnosis and management pamphlet. 2020 Jul.
- Jimenez SA, Mendoza FA. Scleroderma. Medscape. 2020 Jun 24.
- Genentech Inc. News release: Genentech’s Actemra becomes the first biologic therapy approved by the FDA for slowing the rate of decline in pulmonary function in adults with systemic sclerosis-associated interstitial lung disease, a rare, debilitating condition. 2021 Mar 4.
- U.S. Food & Drug Administration. FDA approval letter for Actemra subcutaneous. 2021 Mar 4.
- U.S. Food & Drug Administration. FDA approval letter for Actemra intravenous. 2021 Mar 4.
- Genentech Inc. News release: FDA grants breakthrough therapy designation for Actemra (tocilizumab) in systemic sclerosis. 2021 Jun 10.
- Roofeh D, Fin CJF, Goldin J, et al. Tocilizumab prevents progression of early systemic sclerosis associated interstitial lung disease. Arthritis Rheumatol. 2021 Feb 3. Online ahead of print.
- Khanna D, Denton CP, Jahries A, et al. Safety and efficacy of subcutaneous tocilizumab in adults with systemic sclerosis (faSScinate): A phase 2, randomized, controlled trial. Lancet. 2016 Jun 25; 387(10038): 2630–2640
