FDA Approves Sarilumab for Active Polyarticular Juvenile Idiopathic Arthritis

The FDA has approved sarilumab (Kevzara; Sanofi), an interleukin-6 receptor antagonist, for the treatment of individuals weighing 63 kg or greater with active polyarticular juvenile idiopathic arthritis (pJIA). pJIA is a form of arthritis that affects multiple joints at one time.¹

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“This latest approval for [sarilumab] brings a new treatment option with an established efficacy and safety profile to pediatric patients living with [pJIA]. This milestone highlights our ongoing commitment to bringing medicines to our younger patients living with this chronic condition that can cause debilitating joint pain and inflammation,” Brian Foard, executive vice president and head of specialty care at Sanofi, said in a press release.¹

The approval was supported by data from various well-controlled studies with pharmacokinetic findings from adults with rheumatoid arthritis. Data from a study evaluating the pharmacodynamics, dose findings, and safety for pediatric individuals with pJIA were also included in the approval.¹

In a multicenter, open-label, 2-phase study, investigators included individuals aged 2 to 17 years old with pJIA that was diagnosed according to the American College Rheumatology classification criteria and who had inadequate response to their current therapy, according to the prescribing information. The 2 phases consisted of a dose range finding part (part 1) and a confirmatory part (part 2). Part 1 included 3 doses in 12 weeks of the core treatment phase, followed by patients receiving the recommended dosage in part 2.²

A total of 101 individuals were treated, with 73 who received the recommended dose from baseline and 20 who switched dosages to the recommended dose during the study. In the patients starting on the recommended dose, the mean baseline mean disease duration was 2.48 years with a JADAS-27 score of 22.73.²

The efficacy of the drug was established in the trials in adults with RA, supporting the use of sarilumab in pediatric patients. In this study, the most common adverse reactions for the drug in this population was nasopharyngitis, neutropenia, upper respiratory tract infection, and injection site erythema.²

In 2017, sarilumab was approved for adults with RA, which was supported by the MOBILITY and TARGET trial. The MOBILITY trial showed that patients who received sarilumab with methotrexate experienced reduced signs and symptoms, improved physical functions, and less radiographic progression of structural damage compared to methotrexate with the placebo. In the TARGET study, the drug with a disease-modifying antirheumatic drug (DMARD) showed that individuals experienced reduced signs and symptoms and improved physical function when compared to DMARD and the placebo.³

These 2 trials were also used to support the efficacy and pharmacokinetics of the approval in this pediatric population.²

Furthermore, the drug was also approved for adults with polymyalgia rheumatic who had an inadequate response to corticosteroids or unable to tolerate corticosteroids taper in March 2023. This approval was based on data from the SAPHYR clinical trial, which showed that 28% of those who received sarilumab achieving sustained remission compared to 10% with the placebo.⁴

References

1. Kevzara approved by FDA for the treatment of active polyarticular juvenile idiopathic arthritis. News release. Sanofi. June 11, 2024. Accessed June 11, 2024. https://www.news.sanofi.us/2024-06-11-Kevzara-approved-by-FDA-for-the-treatment-of-active-polyarticular-juvenile-idiopathic-arthritis

2. Sarilumaab (Kevzara): prescribing information. Regeneron; Sanofi. June 2024. Accessed June 11, 2024. https://products.sanofi.us/Kevzara/Kevzara.pdf

3. Santye L. Sarilumab Receives FDA Approval for Rheumatoid Arthritis. Pharmacy Times. May 23, 2017. Accessed June 11, 2024. https://www.pharmacytimes.com/view/sarilumab-receives-fda-approval-for-rheumatoid-arthritis

4. Pharmacy Times. FDA Approves Sarilumab for Adults With Polymyalgia Rheumatica. March 1, 2023. Accessed June 11, 2024. https://www.pharmacytimes.com/view/fda-approves-sarilumab-for-adults-with-polymyalgia-rheumatica