Recently, researchers reported on 7-year interim results from the STRIVE registry and said that the results show that most children are able to tolerate adalimumab plus methotrexate well.
Children who have polyarticular juvenile idiopathic arthritis (JIA)—characterized by involvement of more than 4 joints within the first 6 months—tend to have more refractory disease and are at an increased risk for joint damage versus patients with other forms of JIA.
The emergence of biologics has improved the treatment of polyarticular JIA, though data are still accruing on the safety of these treatments in the pediatric population.
The STRIVE registry is assessing the long-term safety of adalimumab, with or without methotrexate, in patients with moderate to severe disease versus treatment with methotrexate alone. Patients enrolled in STIRVE will be followed for 10 years from enrollment into either the adalimumab or methotrexate arm. Recently, researchers reported on 7-year interim results from the registry, and said that the results show that most children are able to tolerate adalimumab plus methotrexate well.
Data from 838 patients were available at the cutoff date, with 301 patients in the methotrexate arm, and 537 patients in the methotrexate plus adalimumab arm. The most common adverse events (AEs) reported were nausea (10.3%), sinusitis (4.7%), and vomiting (4.3%) in the methotrexate-only arm, versus arthritis (3.9%), upper respiratory tract infection (3.5%), sinusitis (3.0%), tonsillitis (3.0%), and injection site pain (3.0%) in the adalimumab plus methotrexate arm.
Rates of serious infection were 1.5 events per 100 patient years in the methotrexate arm and 2.0 events per 100 patient years in the adalimumab plus methotrexate arm. Rates of AEs and serious AEs were similar between the 2 arms. No malignancies were reported, and no patients died.
According to the authors, these results demonstrate that most children can tolerate therapy with adalimumab and methotrexate up to 7 years, and no new safety signals were observed.
Reference
Brunner HI, Nanda K, Toth M, et al. Safety and effectiveness of adalimumab in patients with polyarticular course of juvenile idiopathic arthritis: STRIVE registry 7-year interim results [published online August 17, 2019]. Arthritis Care Res. doi: 10.1002/acr.24044.
AMCP Posters Tackle Interchangeability and Medicaid, Factors Driving Biosimilar Access
April 24th 2024Two posters from the Academy of Managed Care Pharmacy (AMCP) annual meeting explore how an interchangeable insulin glargine biosimilar plays into Medicaid budgets and the top factors driving access to biosimilars.
Decoding the Patent Puzzle: Navigating the Legal Landscape of Biosimilars
March 17th 2024On this episode of Not So Different, Ha Kung Wong, JD, an intellectual patent attorney and partner at Venable LLP, details the confusing landscape that is the US patent system and how it can be improved to help companies overcome barriers to biosimilar competition.
Julie Reed: Why 2024 Is Important for Biosimilars
April 17th 2024Julie Reed, executive director of the Biosimilars Forum, showcases how the biosimilar industry is expected to develop throughout 2024, including major policy changes and hope for continued improvement in market share for adalimumab biosimilars.
Biosimilars Rheumatology Roundup for February 2024—Podcast Edition
March 3rd 2024On this episode of Not So Different, The Center for Biosimilars® revisited all the major rheumatology biosimilar news from February 2024, including the FDA approval of the 10th adalimumab biosimilar, the promise for an oral delivery system for ustekinumab, and the impact of adalimumab products on COVID-19 antibodies.
Alvotech’s Stelara Biosimilar, Selarsdi, Receives FDA Approval
April 16th 2024Alvotech’s Selarsdi (ustekinumab-aekn), a biosimilar referencing Stelara (ustekinumab), gained FDA approval, making it the second ustekinumab biosimilar and second for the company to be given the green light for the American market.
What Clinicians Need to Know About Using Biosimilars to Treat IBD
April 13th 2024A review article, intended to act as a guide for clinicians, summarizes the available infliximab and adalimumab biosimilars for treating inflammatory bowel disease (IBD) as well as others that are coming down the pipeline.