Gastroenterologists welcome PBS listing of BMS and Janssen’s ulcerative colitis therapies

Pharma News: Professor Susan Connor, Head of the Inflammatory Bowel Disease Service at Liverpool Hospital and Professor Rupert Leong, Head of the Inflammatory Bowel Disease Services at Concord Hospital have welcomed 1st May PBS listings of two new therapies for patients with moderate to severe ulcerative colitis (UC).

BMS’ Zeposia (ozanimod) is the first and only oral S1PR (selective sphingosine-1-phosphate receptor) modulator indicated for patients with moderate to severe ulcerative colitis who have had an inadequate response, lost response or are intolerant to either conventional or biological therapies.

This announcement follows the successful results of the Phase 3 trial, True North, which demonstrated significant improvement in primary and secondary endpoints compared to placebo.

Professor Connor recognises the need for new treatment options to address the unmet clinical needs of UC patients.

In considering where this new UC therapy fits in the treatment paradigm, Professor Connor told Health Industry Hub in an interview. “What patients want is an effective therapy that is durable and tolerable. If these are all ticked, then their preference extends to an oral form of therapy that is easy to take.

“Ozanimod takes about two weeks to work, so it’s not going to be used in the acute severe UC group. It is a good option for moderate to severe UC patients and may end up earlier in the treatment paradigm after immunomodulator use because of its safety profile.”

She continued “There doesn’t seem to be any safety signals around malignancy, which is good. However, there are safety signals in terms of cardiac effects, which we can manage by sending the patient to a cardiologist, and for herpes zoster which we can vaccinate patients for.”

Janssen’s biologics therapy, Stelara (ustekinumab), is given via intravenous infusion (IV) for the initial dose while all maintenance doses are given by injection every 8 weeks with the option of self-injection. The therapy is also listed on the PBS for Crohn’s disease, plaque psoriasis and psoriatic arthritis.

“Many patients who live with ulcerative colitis experience ongoing disease that results in significant limitations to their ability to perform basic tasks such as going to school, showering or getting out of bed in the morning. The impact and severity of the condition is similar to Crohn’s disease, another form of IBD (inflammatory bowel disease). This PBS listing is the missing piece of the puzzle for IBD in Australia, which means clinicians now have access to a new treatment option through the PBS – with a different mode of action – to explore with eligible patients with ulcerative colitis,” explained Professor Leong.

Leanne Raven, CEO at Crohn’s & Colitis Australia, commented “IBD can have devastating impacts on individuals and their families. From maintaining work through to relationships – these are conditions which can interfere with all aspects of life. A variety of treatment options are needed to give all Australians with IBD hope for a fulfilling life. The reimbursement of Stelara for Australians living with ulcerative colitis is very welcomed.”

A recent study highlighted the current unmet needs in UC management. Survey of patients (n = 2100, mostly with moderate to severe UC) and clinicians (n = 1254) across 10 countries, including Australia, revealed that while 67% described their UC as controlled with few to no symptoms, patients experienced on average 4.3 flares in the past year. Diagnostic delay took an average of 2 years and 42% of patients waited ≥1 year. Most patients (65%) felt that UC controlled their life rather than them controlling their disease. Intriguingly, because of the fear of repercussions, many patients had not disclosed their UC to their employer.

At diagnosis, 78% of Aussie patients wished they had known where to find more information and support. The survey identified gaps in patient knowledge of UC, and for most aspects, clinicians recognised the knowledge gaps.

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