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.
Physician and Patient Perspectives After Starting or Switching to Amgevita in IBD
March 23rd 2024A real-world study surveying physicians and patients on adalimumab biosimilar ABP 501 (Amgevita) in inflammatory bowel disease (IBD) found both patients initiating ABP 501 and those who had switched from the reference product had higher satisfaction levels.
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.
Webinar Addresses Solutions to Improve Adalimumab Biosimilar Uptake
March 18th 2024Government policies, including those related to prescribing incentives and interchangeability, need to be reworked to encourage biosimilar adoption and create meaningful savings for health systems, according to speakers at a recent webinar.
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.
The Role of Biosimilars: Advancing Access, Financial Health, and System Sustainability
March 11th 2024Kashyap Patel, MD, CEO of Carolina Blood and Cancer Care, a member of the Community Oncology Alliance, and member of The Center for Biosimilars® Advisory Board, glances back at the development of the biosimilar industry and the last 5 years of progress.