anti-tumor necrosis factor in patients with ulcerative colitis in clinical remission: to continue or not?

Conditions: Colitis,Ulcerative

Summary: the primary objective is to assess if discontinuation of anti- tumor necrosis factor alpha (tnf) treatment in ulcerative colitis patients in sustained clinical remission, with the option to restart treatment in the case of relapse, is non-inferior to continued anti-tnf treatment. secondary objectives are to assess the efficacy and safety of restarting anti-tnf treatment after a relapse

the biostop study is a prospective, open randomized, multicenter, parallel-group study to compare clinical outcome of discontinuing (interventional group) compared to continuing (control group) biologic treatment with anti-tnf in ulcerative colitis patients in clinical remission. adult male and female patients with an established diagnosis of ulcerative colitis treated for minimum one year with anti-tnf maintenance therapy and being in clinical remission during the last 3 months are potential study patients. eligible patients who have given their informed written consent will be randomized 1:1 to either discontinue anti-tnf treatment or to continue anti-tnf treatment for another two years. patients in the control group who are still in clinical and endoscopic remission after two years on continued anti-tnf treatment, will then be switched to discontinue anti-tnf treatment. end of study/follow-up is after 4 years. in order to identify the primary endpoint (occurrence of disease relapse), each study center will have a phone number for patients to call in case of symptoms suspect of increased disease activity. if a patient is experiencing a potential disease flare (6-point mayo score \> 1) and/or 2 consecutive calprotectin tests are positive (\> 200 mg/kg), an unscheduled visit including recto sigmoidoscopy will be performed without delay to document disease status. 150 participants enrolled, september 2020 covid 19 - randomization period extended until 31.12.2020

Eligibility criteria:
inclusion criteria: * confirmed diagnosis of ulcerative colitis * treated for minimum 1 year with first-line anti-tumor necrosis factor (tnf) treatment * in sustained clinical remission during the last 3 months * capable of understanding and signing an informed consent form exclusion criteria: * discontinuation of systemic 5-aminosalicylic acid (asa) or immunomodulatory therapy or other medication that could affect disease activity during the last 3 months prior to randomization * any treatment of systemic corticosteroids due to disease exacerbation during the last 3 months (i.e. patients being in steroid free clinical remission) * patients on anti-tnf monotherapy with intolerance to both 5-asa and immunomodulatory therapy * change in the anti-tnf treatment during the last 3 months due to disease related factors, not including dose/frequency adjustments due to drug concentration measurements * use of any second-line anti-tnf medication irrespective of reason for stopping first-line anti-tnf * previous failed attempts of anti-tnf discontinuation of more than 4 months' duration, with the exception of discontinuation due to pregnancy * detection of anti-tnf antibodies in moderate-high titers prior to randomization * psychiatric or mental disorders * alcohol abuse or other substance abuse * language barriers or other factors which makes adherence to the study protocol impossible * participation in any other studies * pregnancy * breastfeeding

Keywords: tumor necrosis factor-alpha/antagonists & inhibitors infliximab adalimumab golimumab recurrence