Do cutaneous adverse events significantly affect monoclonal antibody based anti-TNF therapies in inflammatory bowel disease patients? A national experience throughout all care levels through the German Inflammatory Bowel Disease Study Group.

• Conditions: K50.9; K51.9; Crohn disease, unspecified; Ulcerative colitis, unspecified

• Registration Number: DRKS00004240
• Lead Sponsor: Charité Campus Virchow-Klinikum

Brief Summary

36% percent of all patients developed at least one skin reaction. - The chance of a change in therapy is increased by a factor of 1.33 with a skin reaction in the previous month, i.e. 33% higher compared to no skin reaction in the previous month. - However, based on the available results, there was no significant association between skin reaction in the previous month and change in therapy (p 0.2877), i.e. in most cases therapy was continued despite skin reaction. - Women are more likely to develop skin reactions under anti-TNF therapy than men. - Skin reactions occur approximately 2 to 3 months after initiation of therapy. - The three most common skin reactions are spots, nodules, and plaques. - There are no differences between the three anti-TNF biologics. - Demographic factors (age, gender, ethnic group, tobacco use, family history of IBD, bowel surgery), disease type, phenotype, activity, treatment response, comedication do not influence the occurrence of a skin reaction.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-07-09
• Study Completion: 2016-12-31
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 185

Inclusion Criteria

Valid informed consent. Patients who receive a monoclonal anti-TNF agent for Crohn's disease or ulcerative colitis for the first time.

Exclusion Criteria

Known skin disorder. Dermatological manifestation of the underlying disease.

Study & Design

• Study Type: observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Primary Endpoint: Impact of a skin reaction during the preceeding month on the anti-TNF therapy in the ongoing month. <br><br>Primary statistical analysis: comparison of the likelyhood of a therapy modification in a particular month if during the preceeding month <br><br>(a) no skin reaction occured versus<br>(b) a skin reaction occured

Secondary Outcome Measures

Name	Time	Method
•How common are skin reactions are anti-TNF related skin reactions in Crohn's disease and ulcerative colitis?<br>•which skin reactions do occur?<br>•When do they occur?<br>•Do skin reactions correlate with the disease phenotype?<br>•Does the inflammatory activity correlate with skin reactions?<br>•Do patient demographics correlate with skin reactions?? <br>•Do skin reactions correlate with concomitant mdeications?