Subcutaneous vedolizumab interval extension in inflammatory bowel disease patients: a case series.

Subcutaneous vedolizumab has demonstrated efficacy as a maintenance therapy in inflammatory bowel disease (IBD). However, data on the extension of subcutaneous vedolizumab injection intervals are lacking. Here, we present the first real-world data on subcutaneous vedolizumab interval extension in IBD patients. Nine patients (eight Crohn's disease patients and one ulcerative colitis patient) were included in the study. At interval extension (at baseline), all patients were in clinical and biochemical remission and requested an extension of their 2-weekly injection intervals due to side effects potentially related to subcutaneous vedolizumab. Patients increased their intervals to 3, 4, or 5 weeks. During a median follow-up of 10.0 months (IQR 6.5-19.5), no flare-ups were observed. After 6 months, median biochemical parameters remained stable compared to baseline levels (fecal calprotectin 24.0 µg/g [IQR 10.0-43.0] versus 28.0 µg/g [IQR 15.0-54.0], p = 0.553; C-reactive protein 3.4 mg/L [IQR 1.4-4.2] versus 3.1 mg/L [IQR 0.7-4.9], p = 0.172), while vedolizumab serum concentrations significantly decreased (22.0 µg/mL [IQR 20.0-33.0] versus 40.0 µg/mL [IQR 28.3-45.0], p = 0.018). After interval extension, almost all suspected vedolizumab-induced side effects disappeared within 6 months. Lengthening subcutaneous vedolizumab intervals in IBD patients in clinical and biochemical remission appears to be both effective and safe, potentially leading to substantial reductions in healthcare expenses.

Extending subcutaneous vedolizumab injection intervals in patients with inflammatory bowel disease: a case series We observed nine patients with inflammatory bowel disease who extended the time between injections of subcutaneous vedolizumab. All patients initially received subcutaneous vedolizumab every two weeks and were in clinical and biochemical remission. However, they wanted to extend the injection interval due to possible side effects. They gradually increased their injection intervals to 3, 4, or 5 weeks. Over a median follow-up of 10 months, none of the patients experienced a flare-up. After six months, clinical and biochemical parameters remained stable, while vedolizumab serum concentrations decreased. Side effects that may have been caused by vedolizumab mostly resolved within six months of extending the injection intervals. Lengthening the time between subcutaneous vedolizumab injections for patients in remission appears to be effective, safe, and may also reduce healthcare costs.

Symptomatic creatine phosphokinase elevation in a Crohn's disease patient caused by upadacitinib.

We present a Crohn's disease patient receiving high dose upadacitinib treatment with elevated CPK levels and myopathy, and provide the reader with practical tips on stopping and restarting upadacitinib, emphasizing the need for adequate monitoring.

Anti-drug antibodies against anti-TNF in patients with inflammatory bowel disease: an evaluation of possible strategies.

OBJECTIVE: Immunogenicity against anti-TNF antibodies usually leads to loss of response. We aimed to evaluate the efficacy of clinical strategies to improve clinical remission and pharmacokinetics upon detection of anti-drug antibodies (ADA). METHODS: Inflammatory bowel disease (IBD) patients with ADA against infliximab or adalimumab were identified through a single centre database search covering 2004-2022. Criteria for successful intervention upon ADA detection (baseline) were clinical remission after 1 year without further change in strategy. RESULTS: Two-hundred-and-fifty-five IBD patients (206 Crohn's disease) were identified. At baseline, median ADA level was 77 AU/ml; 50.2% of patients were in clinical remission. Implemented strategies were: (1) 81/255 (32%) conservative management, (2) 102/255 (40%) anti-TNF optimisation, (3) 72/255 (28%) switch within or out of class. Switching was the most successful strategy for clinical remission (from 19% at baseline to 69% at 1 year, p < 0.001). Patients that continued the same dose anti-TNF or discontinued biological therapy were often in clinical remission, but deteriorated significantly (-22.7%, p = 0.004). Anti-TNF dose intensification with immunomodulator optimisation was the fastest (median 3.0 months, p = 0.009) and most effective (65% ADA suppression, p < 0.001) strategy to suppress ADA compared to solely anti-TNF or immunomodulator optimisation. CONCLUSIONS: Switching therapy, within or out of class, is the most successful strategy to regain and maintain clinical remission upon immunogenicity. When switching to another anti-TNF, concomitant immunomodulatory therapy should be started or continued to prevent repeated immunogenic loss of response. Anti-TNF dose escalation with concomitant immunomodulator optimisation is the fastest and most effective strategy to suppress ADA.

Immunogenicity against anti-TNF antibodies is associated with loss of response in patients with inflammatory bowel diseases and remains a clinical challenge. We investigated potential therapeutic strategies in a retrospective patient cohort focusing on clinical efficacy and pharmacokinetics.

Efficacious dosing regimens for anti-TNF therapies in inflammatory bowel disease: where do we stand?

INTRODUCTION: During the last decades, biologics have revolutionized the treatment of Crohn's disease and ulcerative colitis. Even though the inflammatory bowel disease (IBD) armamentarium is rapidly expanding with novel biologics, anti-tumor necrosis factor (TNF) antibodies remain the first-line biologic therapy in most areas of the world. However, anti-TNF therapy is not effective in all patients (primary non-response) and patients can lose effect over time (secondary loss of response). AREAS COVERED: This review provides an overview of the current induction and maintenance dosing regimens of the available anti-TNF antibodies and associated challenges in adult patients with IBD. We outline different strategies to overcome these difficulties, including combination therapy, therapeutic drug monitoring (TDM), and dose escalation. Finally, we discuss expected future progress in anti-TNF management. EXPERT OPINION: Anti-TNF agents will remain a cornerstone of IBD treatment in the coming decade. Progress will be made in biomarkers for the prediction of response and individualized dosing regimens. The advent of subcutaneous infliximab challenges the need for concomitant immunosuppression.