European Union approves Stelara for moderately to severely active ulcerative colitis

The Janssen Pharmaceutical Companies of Johnson & Johnson announced that the European Commission (EC) has approved the expanded use of Stelara (ustekinumab) for the treatment of adults with moderately to severely active ulcerative colitis (UC), who have had an inadequate response with, lost response to, or were intolerant to either conventional therapy or a biologic or have medical contraindications to such therapies.

The EC approval is based on data from the pivotal Phase III UNIFI trial programme – a programme that was split into an initial Induction study (UNIFI-I) of at least eight weeks, followed by a Maintenance study (UNIFI-M) of 44 weeks – both of which demonstrated ustekinumab’s efficacy as a treatment option for patients with moderately to severely active UC who demonstrated an inadequate response to or were unable to tolerate conventional (i.e. corticosteroids or immunomodulators) or biologic (i.e. one or more tumour necrosis factor [TNF]-alpha antagonists and/or vedolizumab) therapies.

Ustekinumab has demonstrated a consistent safety profile in UC where trials show the treatment is well tolerated. In the primary randomised population of the Induction and Maintenance studies, a similar proportion of patients in the ustekinumab and placebo groups experienced adverse events (AE), serious AEs, infections and serious infections through to week 44. During the Induction phase, one death from an oesophageal varices haemorrhage was reported, and no malignancies, opportunistic infections or tuberculosis were reported. During the Maintenance phase, no deaths and two malignancies other than non?melanoma skin cancer (NMSC) were reported (90 mg ustekinumab q8w: colon cancer [n=1]; 90 mg ustekinumab q12w: papillary renal cell carcinoma [n=1]). There was one patient-reported NMSC in the 90 mg ustekinumab q12w group (2 squamous cell carcinoma events).