Long‐Term Outcome of Ustekinumab Therapy for Behçet's Disease

Abstract

Objective. Oral ulcers, the hallmark lesion of Behçet's disease (BD), can be disabling and resistant to conventional treatment, and there is a need for safe and effective treatment. We undertook this study to investigate the long-term safety and efficacy of ustekinumab therapy for BD-related oral ulcers that are resistant to colchicine.Methods. This multicenter, prospective, open-label study included 30 patients who fulfilled the criteria of the International Study Group for BD and who were diagnosed as having active oral ulcers resistant to colchicine. Patients were treated subcutaneously with ustekinumab 90 mg at inclusion, at week 4, and then once every 12 weeks. Each patient was assessed longitudinally for the presence and number of oral ulcers, and median numbers of oral ulcers (with interquartile range [IQR]) were calculated. The primary efficacy end point was the proportion of patients at week 12 who experienced complete response, defined as having no oral ulcers.Results. The median number of oral ulcers per patient during ustekinumab therapy was significantly lower at week 12 compared to baseline (0 [IQR 0-1] versus 2 [IQR 2-3]; P < 0.0001). Complete response was achieved in 60.0% and 88.9% of patients at weeks 12 and 24, respectively. The median Behçet's Syndrome Activity Score (in which higher scores indicate more active disease) was significantly lower at weeks 12 and 24 (17.5 [IQR 10-42.5] and 10 [IQR 8-11], respectively) versus baseline (70 [IQR 50-70]; P < 0.0001). After a median follow-up of 12 months (IQR 6-16 months), 26 patients (86.7%) were still receiving ustekinumab treatment. Reasons for ustekinumab discontinuation included BD flare (n = 3) and side effects (n = 1). Seven patients (23.3%) experienced adverse events, including headaches (n = 4) and asthenia (n = 2), with no serious side effects.Conclusion. Ustekinumab seems to be effective in treating BD-related oral ulcers that are resistant to treatment with colchicine.

Long-term effectiveness and safety of secukinumab for treatment of refractory mucosal and articular Behçet’s phenotype: a multicentre study

“…17 24 Intriguingly, tackling the IL-17 axis with anti-IL-12/23 ustekinumab recently proved effective for the treatment of refractory oral ulcers in BS while also improving joint involvement. 13 In our study, we found evidence supporting the use of secukinumab as an effective and safe therapy for the long-term treatment of active mucosal and articular manifestations of BS.…”

“…6 The phosphodiesterase-4 inhibitor apremilast has been recently approved by the Food and Drug Administration for treatment of oral ulcers, [7][8][9][10] while the interleukin (IL)-1 inhibitors anakinra and canakinumab and the anti-IL-12/23 ustekinumab recently emerged as promising options for refractory oral ulcers in BS. [11][12][13] Articular involvement is common among patients with BS, with a prevalence of 11%-93% depending on the geographical region. 14 Joint involvement is typically a peripheral, non-deforming, non-erosive, asymmetric mono-oligoarthritis of the large and small joints.…”

Apremilast in Refractory Behçet’s Syndrome: A Multicenter Observational Study

“…With the increasing availability of bDMARDs, new targets have been assessed in BS recently. Ustekinumab – a monoclonal antibody targeting interleukin-12 and -23 – was evaluated in a prospective, open-label study, showing promising results in mucocutaneous and articular manifestations resistant to colchicine in BS ( 19 ). In a retrospective study, the anti-interleukin-17 secukinumab was evaluated in the mucocutaneous-articular cluster refractory to initial treatment, revealing itself as a potential alternative in this subgroup ( 20 ).…”

Терапевтические Возможности И Современные Подходы К Лечению Болезни Бехчета

“…The second study [16] involved 30 patients, observed for no less than 24 weeks. The authors obtained the results which were similar to the previously described: the mean number of mouth ulcers reduced significantly at the 12 th week of ustekinumab therapy against the initial level (0 vs. 2, р<0.0001).…”