The Janssen Pharmaceutical Companies of Johnson & Johnson welcomes the Scottish Medicines Consortium’s (SMC) decision to accept STELARA® (ustekinumab) for use within NHS Scotland for the treatment of adult patients 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.
UC is a chronic immune-mediated inflammatory disease of the rectum and large intestine, affecting approximately 23,500 people in Scotland, for which there is currently no cure.For up to one-third of people with UC, current treatments are not completely successful or complications may arise, where surgery may be considered.
“Crohn’s & Colitis UK are extremely pleased that people in Scotland living with ulcerative colitis may now benefit from this treatment option. The personal impact of uncontrolled symptoms of colitis can be devastating and debilitating and can severely affect a person’s daily living and activity. Having many treatment options available to doctors is hugely beneficial for patient outcomes,” commented Elaine Steven, Health Service Programme Manager, Crohn’s & Colitis UK. “This decision is particularly welcome during the COVID-19 crisis ensuring patients have access to a wide range of treatment options while supporting the NHS and IBD Services against further pressures on already stretched services. Our thanks go to the SMC for not delaying the publication of this decision at this critical time.”
Ustekinumab is the first biologic therapy for UC that targets interleukin (IL)-12 and IL-23 cytokines, known to play a key role in inflammatory and immune responses, offering clinicians and patients a new mechanism of action for treating UC.
“The approval of ustekinumab for ulcerative colitis by SMC is very welcome and timely news. This provides an effective and convenient new drug for clinicians to use in patients with UC, who are in need of new treatment options,” commented Professor Charlie Lees*, Consultant Gastroenterologist, Western General Hospital, Edinburgh. “It was only six years ago in Scotland that no biologics were approved for moderate to severely active ulcerative colitis. We now have an armamentarium of effective treatments that can get patients well, to a better quality of life and keep them off steroids and out of hospital.”
The SMC advice is based on data from the pivotal Phase 3 UNIFI trial programme which evaluated ustekinumab’s safety and efficacy as a treatment option for adult patients with moderately to severely active UC. The programme was split into an initial Induction study (UNIFI-I) of eight weeks, followed by a Maintenance study (UNIFI-M) of 44 weeks. All patients who were randomised into the 44-week Maintenance study were induction responders to IV ustekinumab. Among patients subsequently randomised to receive subcutaneous ustekinumab (q8w or q12w), a significantly greater percentage achieved clinical remission at week 44 vs initial responders randomised to placebo (44 percent and 38 percent, vs 24 percent, p<0.001 and p=0.002, respectively).
Jennifer Lee, EMEA Therapy Area Market Access Lead for Immunology, Janssen-Cilag Limited, commented “We are pleased with the SMC’s decision to accept ustekinumab for use within NHS Scotland for eligible patients living with ulcerative colitis. We have a long-standing commitment to developing innovative therapies to improve the lives of those living with immune-mediated inflammatory diseases. The advice from the SMC reflects the true need for new treatment options for patients living with moderately to severely active ulcerative colitis.”
Ustekinumab has demonstrated a safety profile in UC where trials show the treatment is generally well tolerated. Through to week 44, the proportions of patients receiving ustekinumab (q12w and q8w) were comparable to those receiving placebo in terms of the reporting of at least one adverse event (AE) (69.2%, 77.3% and 78.9%, respectively), serious AEs (7.6%, 8.5% and 9.7% respectively), infections (33.7%, 48.9% and 46.3%, respectively) and serious infections (3.5%, 1.7% and 2.3%, respectively). Overall, the safety for ustekinumab in UC patients was consistent with the known safety profile of ustekinumab in Crohn’s disease (CD).
Ustekinumab is already accepted by the SMC as a clinical and cost-effective option for the treatment of Crohn’s disease (CD) and for restricted use in plaque psoriasis and psoriatic arthritis.