Ustekinumab approved in Switzerland for ulcerative colitis

Swissmedic approves the use of the monoclonal antibody for the treatment of moderate to severe active ulcerative colitis where treatment goals are not achieved with conventional therapy.

Thus, for adult patients with ulcerative colitis who have had an inadequate response to conventional therapies or who have an intolerance or contraindication, there is another treatment option [1]. Ustekinumab is the first biologic available for this indication that selectively inhibits IL12 and IL23 signaling pathways, which play an important role in the pathomechanism of CU [2]. The Swissmedic approval is based on data from the pivotal Phase III UNIFI study program, which consisted of an induction study of at least eight weeks followed by a maintenance study of 44 weeks. Both demonstrated the efficacy of ustekinumab in patients with moderate-to-severe active CU for whom corticosteroids or immunomodulators or other biologics (TNF-alpha inhibitors and/or vedolizumab) have not been adequately responded to or tolerated [3,4]. Ustekinumab has demonstrated a consistent safety profile for the indication of CU, and the studies show that the treatment is generally well tolerated.

Milestone for patients with ulcerative colitis

CU is a severe, chronic, immune-mediated inflammatory disease of the colon. Across Europe, there are approximately 2.6 million affected individuals [5]. Unpleasant symptoms range from abdominal cramps and fatigue to bloody diarrhea and are painful as well as debilitating [6,7]. There may be a significant “burden of disease” associated with CU. For up to two-thirds of patients, current treatment options do not result in symptom relief or complications may occur [8–11]. “Today marks a significant milestone in the treatment of ulcerative colitis,” said Jan Wehkamp, MD, Gastroenterology Disease Area Leader at Janssen R & D. “Approximately 32,000 people in Switzerland suffer from one of two types of inflammatory bowel disease – Crohn’s disease and ulcerative colitis – and are in urgent need of effective treatment options [12]. Ustekinumab has been available to people with Crohn’s disease since its approval in 2017. Thanks to the patients who enrolled and were willing to participate in the UNIFI clinical trial program, it is now available to patients with ulcerative colitis and can give them a chance at lasting remission and relief from often painful and debilitating symptoms.”

Source: Janssen

Literature:

^STELARA® Technical Information (January 2020), www.swissmedicinfo.ch
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