The results, “Leflunomide treatment in juvenile idiopathic arthritis,” were published in Rheumatology International.
Juvenile idiopathic arthritis (JIA) is characterized by joint swelling, stiffness, and pain. Over the past years, treatment with disease-modifying anti-rheumatic drugs (DMARDs) has become the standard first-line therapy for children with JIA.
Methotrexate (brand names Otrexup, Rasuvo, among others) is one of the most commonly prescribed DMARDs, and also one of the most studied in clinical trials. However, some patients are forced to stop treatment with the medication due to side effects, notably gastrointestinal problems.
Data on the safety and efficacy of other DMARDs that can be used as an alternative, such as Arava, meanwhile, is much more limited.
To learn more, researchers from Turkey reported the findings of a retrospective study designed to analyze the clinical effects of Arava in a group of children with JIA.
The team reviewed the medical records of 38 children who were monitored regularly while receiving treatment with Arava. Among them, 24 had oligoarticular JIA, 11 had polyarticular JIA, two had enthesitis-related juvenile arthritis (ERA), and one had psoriatic arthritis.
Most of the children — 36 out of 38 — had been initially treated with methotrexate, but were forced to stop treatment due to gastrointestinal (GI) intolerance. The remaining two children, who had been diagnosed with ERA, had started treatment with sulfasalazine. They switched to Arava when they started responding inadequately to sulfasalazine after three months.
Among the 36 children who had to stop treatment with methotrexate, 17 had moderate-or-high disease activity and required treatment with biologic agents, 13 had low disease activity, and six had entered into remission.
Arava was first administered to those who had low disease activity. Following that, it was given to those who relapsed after being in remission for two months. Finally, it was administered to those with moderate-or-high disease activity who had failed to respond adequately to treatment with three different biologic agents — Enbrel , Humira, and Actemra.
After three months of treatment with Arava, 15 out of the 19 children who had either low disease activity or had relapsed after being in remission for two months, entered into remission. The remaining four had an inadequate response to treatment and were started on one of two biologic agents — Enbrel or Humira — that were administered in combination with Arava.
The 17 children who had moderate-or-high disease activity and failed to respond to biologic agents were followed for a median period of 11 months after starting treatment with Arava.
At the last study visit, all 36 children achieved a state of inactive disease. During the whole study, only two adverse events — low white blood cell counts and high levels of liver enzymes — were reported. Both were easily solved within a period of two weeks.
“In conclusion, our findings support that [Arava] may be an effective treatment alternative in patients with [methotrexate] intolerance and in presence of low disease activity may diminish the requirement for biologic agents,” the researchers said.
“Even though, we did not observe any adverse effect among our patients, prospective trials with larger series are needed to show the safety of adding [Arava] to biologic agents in case of
inadequate response to biological drugs,” they added.