IQWiG Assessment Finds No Added Benefit for Guselkumab Over Golimumab in Ulcerative Colitis Patients

A new IQWiG study compares guselkumab to golimumab for ulcerative colitis, finding no added clinical benefit over current standard treatments.

By: AXL Media

Published: Mar 28, 2026, 11:14 AM EDT

Source: Information for this report was sourced from Institute for Quality and Efficiency in Health Care

Rigorous Evaluation of a New Monoclonal Antibody

Guselkumab, a human monoclonal antibody, received approval in April 2025 for adult patients suffering from moderately to severely active ulcerative colitis. Following this regulatory milestone, the German Institute for Quality and Efficiency in Health Care (IQWiG) initiated a formal benefit assessment to determine if the drug provides a superior therapeutic outcome compared to established options. This evaluation is a mandatory step under the German Act on the Reform of the Market for Medicinal Products (AMNOG). The assessment focused on patients who have shown an inadequate response, a loss of response, or an intolerance to conventional therapies, a group that represents a significant portion of the chronic disease population.

Direct Comparative Trials Offer New Insights

For this specific patient group, IQWiG analyzed data from a randomized controlled trial (RCT) that directly compared guselkumab with golimumab. Daniela Preukschat, Head of the Chronic Diseases Division at IQWiG, noted that the institute has historically criticized the lack of direct head-to-head studies in the field of ulcerative colitis. The availability of this RCT marks a significant shift, providing physicians and patients with a clearer data set to evaluate treatment options from the outset. While previous assessments often relied on indirect comparisons, this direct study allows for a more precise measurement of how guselkumab performs against the current clinical standard.

Morbidity Gains vs Clinically Relevant Benefits

The trial results indicated that guselkumab might offer some minor improvements in specific areas such as general morbidity and health-related quality of life. However, IQWiG’s analysis found that these improvements did not reach the threshold of being "clinically relevant." In the context of German drug assessment, a benefit must be substantial enough to demonstrably improve patient outcomes beyond the fluctuations seen in standard care. Because the data did not show a clear superiority in total disease management or remission rates compared to golimumab, the institute concluded that there is no added benefit for this patient group.