Most Children With Polyarticular JIA Can Tolerate Adalimumab Therapy

The Center for Biosimilars Staff

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.