In patients aged 12 and over with a severe form of Behçet’s disease (vascular or neurological), receiving corticosteroids, induction treatment with infliximab, an anti-TNFα, is associated with a better remission rate. than induction treatment with cyclophosphamide, an alkylating agent. These are the conclusions of a study carried out by teams from the department of internal medicine and clinical immunology at Pitié-Salpêtrière hospital (AP-HP), Sorbonne University and Inserm. The results were published in the New England Journal of Medicine Evidence.
“Behçet syndrome is a chronic multisystem inflammatory disease that progresses in flares and can affect the skin, mucous membranes, joints, eyes, arteries, veins, central nervous system and gastrointestinal system,” recall the authors.
Cyclophosphamide and corticosteroids have long been the standard treatment for remission induction, but the combined adverse effects of these two treatments can increase therapy-related comorbidities. “These safety concerns highlight the need for safer and more effective remission induction strategies in severe cases of Behçet syndrome”estimate the authors, while data suggest that infliximab is promising in this indication.
Between May 2018 and April 2021, 52 patients with severe Behçet syndrome were included in the Itac trial involving 21 French centers; 71.1% had a vascular form and 28.9% had a neurological form. Patients were randomized into two groups in a 1:1 ratio, receiving intravenous infliximab (5 mg/kg at weeks 0, 2, 6, 12 and 18) or cyclophosphamide (0.7 g/m2 intravenously at weeks 0, 4, 8, 12, 16 and 20, with a maximum dose of 1.2 g/injection). All patients received corticosteroids.
Fewer relapses with infliximab
Of all patients, 69% achieved a complete response, defined by clinical, biological and radiological remission with a daily dose of prednisone ≤ 0.1 mg/kg at week 22, 73% among those with vascular involvement and 60% among those with central nervous system involvement.
The complete response rate was 81% in the infliximab group and 56% in the cyclophosphamide group. The authors also showed that the posterior probability that at least 70% of those treated had achieved a complete response at week 22 was 97.4% for infliximab and 6% for cyclophosphamide.
Furthermore, 71% of patients on infliximab and 57% of those on cyclophosphamide achieved a complete response in terms of central nervous system damage at week 22. Regarding other manifestations of Behçet’s disease, clinical improvements were noted. observed in both groups, with no significant difference. The relapse rate was 4% in the infliximab group and 16% in the cyclophosphamide group.
Treatment with infliximab was associated with fewer mild to moderate adverse effects than treatment with cyclophosphamide, with 29.6% of patients receiving infliximab affected compared to 64% of those receiving cyclophosphamide. The rate of severe adverse events reported was 15% and 12%, respectively.
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