Efficacy of adalimumab for Crohn’s disease in real clinical practice

Abstract

Aim. To evaluate the efficacy and safety of adalimumab (ADA) in patients with Crohn’s disease (CD) treated at the Department of Inflammatory Bowel Diseases, Moscow Clinical Research and Practical Center, and to determine the predictors of a therapy response. Subjects and methods. All the patients with CD treated with ADA were followed up for at least 6 months or until the drug was discontinued. Therapeutic effectiveness was evaluated at 4 weeks and 6 months after the initiation of treatment and at the end of a follow-up. Complete intestinal mucosal healing was assessed at 3 and 12 months following treatment initiation. Univariate and multivariate analyses were used to determine the predictors of treatment response. Results. A clinical analysis covered 70 patients (57.1% male); the follow-up period averaged 112 weeks. Perianal fistulas were at baseline established in 22 (31.4%) patients with CD. 12 (17.4%) patients had been previously treated with infliximab (INF), 7 of them discontinued the drug for secondary loss of response and 5 for adverse reactions. 68 (97.1%) patients responded to an induction course of ADA. At 4 weeks, 6 months, and at the end of the follow-up, clinical remission occurred in 66.7, 80.4 and 67.4 % of patients with luminal CD and in 45.4, 36.5, and 36.4% of those with perianal CD, respectively. At 3 and 12 months and at the end of the follow-up, there was complete healing of the intestinal mucosa in 23.5, and 41.2 and 29.5% of cases, respectively. Six (8.8%) patients responding to the induction course needed to be optimized with ADA to 40 mg weekly. The time interval between treatment initiation and dose optimization averaged 30 weeks (range 12-120 months). There were 15 (21,4%) adverse events that were responsible for ADA discontinuation in 3 (4,2%) patients. Conclusion. The findings demonstrate the efficacy and safety of ADA used in clinical practice.

Comparative Effectiveness of Ustekinumab Versus Adalimumab in Induction of Clinical Response and Remission in Crohn’s Disease: Experience of a Real-World Cohort at a Tertiary Care Inflammatory Bowel Disease Referral Center

“…In these studies, UST was successful in improving clinical, laboratory, radiologic and endoscopic markers of disease activity in patients with severe, refractory CD unresponsive to TNF inhibitors [13, 17-22]. While it is known that TNF blocker exposure appears to reduce the likelihood of response among patients receiving UST or ADA, the difference in incidence of response and remission between the two groups in this study was despite that, still especially stark [23, 24].…”

Clinical case of a new coronavirus infection in a patient with severe Crohn’s disease

“…К данному классу препаратов относится адалимумаб. В проведенных рандомизированных плацебо-контролируемых исследованиях CLASSIC-I, CLASSIC-II и CHARM была показана высокая эффективность адалимумаба как в достижении, так и поддержании ремиссии [10]. В исследовании CLASSIC-I ремиссия к 4 неделе наступала у 36% пациентов на фоне приема адалимумаба, в то время как на фоне приема плацебо -у 12%.…”

“…В исследовании CLASSIC-I ремиссия к 4 неделе наступала у 36% пациентов на фоне приема адалимумаба, в то время как на фоне приема плацебо -у 12%. В исследованиях CLASSIC II И CHARM была показана высокая эффективность адалимумаба в поддержании ремиссии в течение года лечения по сравнению с эффективностью плацебо (79-83% против 44% в исследовании CLASSIC-II и 36-41% против 12% в исследовании CHARM) [10].…”