REMICADE® (infliximab) for acute and moderate-to-severe ulcerative colitis: A practical guide
Janssen conducted a series of dinner meetings on the practical use of REMICADE for acute and moderate-to-severe ulcerative colitis. To enable this important information to be available to those who could not attend one of these dinner meetings, the presentation on 5th February 2015 in Melbourne was filmed.
The views expressed in this video are those of the speakers or audience members, and do not necessarily reflect those of Janssen. Janssen cannot endorse the use of its products outside the approved Product Information.
Gastroenterologists met in Melbourne recently to discuss the role of REMICADE in the treatment of acute severe ulcerative colitis (UC) and moderate-to-severe UC. The meeting was chaired by Professor Peter Gibson, Director of Gastroenterology at the Alfred Hospital. He led a panel of Melbourne specialists in the discussion of two case studies. The panel consisted of:
- Dr William Connell, Head, IBD Service, St Vincent’s Hospital
- Dr Peter de Cruz, Head, IBD Service, Austin Health
- Dr Peter Prichard, Gastroenterologist, Epworth and Royal Melbourne Hospitals
- Dr Miles Sparrow, Head, IBD Service, Alfred Hospital.
REMICADE has been available through the Pharmaceutical Benefits Scheme (PBS) since 1 April 2014 for the treatment of acute severe UC, and since 1 December 2014 for initial and continuation therapy of moderate-to-severe UC. Ms Belinda Headon, IBD Nurse Consultant at the Alfred Hospital, discussed practical issues surrounding PBS prescribing for these indications.
Efficacy of infliximab in ulcerative colitis
The efficacy of infliximab in steroid-refractory UC was established in a study reported by Järnerot et al (2005).1 Seven of 24 of patients randomised to infliximab required a colectomy within 3 months, compared to 14 of 21 patients randomised to placebo (29% vs 67%, p=0.017). The benefit of infliximab rescue was sustained in the longer-term: after 3 years a total of 12 patients treated with infliximab and 16 randomised to placebo had required a colectomy (50% vs 76%, p=0.012).2
The ACT-1 and ACT-2 studies demonstrated the efficacy of infliximab in moderate-to-severely active UC.3 A three-dose induction regimen of 5 mg infliximab at weeks 0, 2, and 6, followed by maintenance infusions every 8 weeks, was superior to placebo in terms of the proportion of patients achieving clinical response, clinical remission, mucosal healing and reducing corticosteroid use through 30 weeks (ACT-2) and 54 weeks (ACT-1) of therapy and follow-up (p values at least <0.05). The rate of clinical response at week 8 is shown in Figure 1. A clinical response was defined as a decrease in the Mayo score of at least 3 points and at least 30%, with an accompanying decrease in the subscore for rectal bleeding of at least 1 point or an absolute rectal bleeding subscore of 0 or 1.
PBS information: This product is listed as a Section 100 item for Crohn’s disease and ulcerative colitis. Refer to PBS Schedule for full authority information.
Please refer to Product Information before prescribing. Full product Information is available here. Further information is available on request from Janssen.
- Järnerot G, Hertervig E, Friis-Liby I et al. Infliximab as rescue therapy in severe to moderately severe ulcerative colitis: a randomized, placebo-controlled study. Gastroenterology 2005; 128: 1805–1811.
- Gustavsson A, Järnerot G, Hertervig E et al. Clinical trial: colectomy after rescue therapy in ulcerative colitis - 3-year follow-up of the Swedish-Danish controlled infliximab study. Aliment Pharmacol Ther 2010; 32: 984–989.
- Rutgeerts P, Sandborn W, Feagan B et al. Infliximab for induction and maintenance therapy for ulcerative colitis. N Engl J Med 2005; 353: 2462–2476.
AU-REM0418. Date prepared: April 2015.