The human monoclonal antibody guselkumab has been approved for certain adults with moderately to severely active ulcerative colitis since April 2025. In a benefit assessment, the German Institute for Quality and Efficiency in Health Care (IQWiG) has now examined whether guselkumab offers an added benefit to these patients.
Results from a randomized controlled trial (RCT) are available for patients who have had an inadequate response with, lost response to, or are intolerant to conventional therapy. This RCT includes a direct comparison of guselkumab with golimumab. The results suggest that guselkumab may offer benefits in terms of morbidity and health-related quality of life. Overall, however, there is no clinically relevant benefit of guselkumab and therefore no added benefit compared with the current standard treatment.
‘In the past, we have often criticised the lack of comparative studies on ulcerative colitis,’ says Daniela Preukschat, Head of the Chronic Diseases Division in IQWiG’s Drug Assessment Department. ‘This RCT, which is now available, provides important insights for patient care. Patients and their treating physicians can now assess the importance of guselkumab right from the start.‘
Since May 2025, guselkumab has also been approved for the treatment of certain adults with moderately to severely active Crohn’s disease. IQWiG has also conducted a benefit assessment for this chronic inflammatory bowel disease to determine whether guselkumab offers added benefit to patients, and here as well, direct comparative studies are available.
No added benefit of guselkumab was found for patients who have had an inadequate response with, lost response to, or were intolerant to conventional therapy. For patients who need a treatment switch following prior therapy with a biologic agent, guselkumab has a positive effect on health-related quality of life compared to ustekinumab. IQWiG therefore sees a hint of minor added benefit of guselkumab over the appropriate comparator therapy for this group.
The dossier assessments are part of the early benefit assessment according to the Act on the Reform of the Market for Medicinal Products (AMNOG) supervised by the Federal Joint Committee (G-BA). After publication of the dossier assessment, the G‑BA conducts a commenting procedure and makes a decision on the extent of the added benefit.