medwireNews: Adalimumab, used with or without concurrent methotrexate, appears to be well tolerated among children with polyarticular‐course juvenile idiopathic arthritis (pcJIA), 7-year data from the STRIVE registry show.
In addition, new adalimumab users had a tendency for a lower mean JADAS-27-CRP score than new users of methotrexate (alone or in combination with other conventional DMARDs) during the first year of treatment, report Hermine Brunner (Cincinnati Children's Hospital Medical Center, Ohio, USA) and colleagues in Arthritis Care & Research.
The 7-year interim analysis included data for 838 patients aged 2–17 years with moderately to severely active JIA (ie, affecting ≥5 joints) who had recently begun treatment with adalimumab (n=537) or methotrexate (n=301) at the time of study entry.
During a median 3.5 years of observation, 45.4% of patients receiving adalimumab reported at least one adverse event, corresponding to 41.4 events per 100 person–years. By comparison, the adverse event rate was 52.2% during 4.5 years of follow-up among patients in the methotrexate group, corresponding to 43.2 events per 100 person–years.
Arthritis (3.9%), upper respiratory tract infection (3.5%), sinusitis (3.0%), tonsillitis (3.0%), and injection site pain (3.0%) were the most commonly reported adverse events in the adalimumab group, whereas nausea (10.3%), sinusitis (4.7%), and vomiting (4.3%) were the most common with methotrexate.
The researchers note that serious adverse event rates were low overall, but were numerically higher with adalimumab than with methotrexate, at 1.7 versus 0.5 events per 100 person–years.
In addition, no deaths, malignancies, active tuberculosis, oral candidiasis, demyelinating disorders, cerebrovascular events, or cases of congestive heart failure were reported in either arm.
Fewer patients discontinued adalimumab than methotrexate (57.7 vs 79.7%) during the study, with the difference particularly marked among those discontinuing due to a need for additional therapy (3.7 vs 32.6%).
In terms of effectiveness, patients in both groups achieved marked reductions in JADAS-27-CRP during the first year of treatment, which slowed thereafter. The improvement, however, occurred earlier among the patients in the adalimumab group, resulting in lower mean disease activity at 12 months compared with patients in the methotrexate group (JADAS-27-CRP of approximately 4 vs 5)
Brunner and co-authors conclude that “the 7-year interim results in this ongoing post-marketing registry show that [adalimumab] continues to be well tolerated in these patients with active pcJIA.”
By Laura Cowen
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