Long‐term efficacy and safety of ustekinumab in 122 refractory Crohn's disease patients: a multicentre experience

Abstract

In this cohort of refractory CD patients receiving long-term ustekinumab therapy, more than 50% of patients continued ustekinumab treatment with no loss of response, intolerance or surgery and with a good safety profile.

Subcutaneous rather than intravenous ustekinumab induction is associated with comparable circulating drug levels and early clinical response: a pilot study

“…Ustekinumab induction treatment using a subcutaneous preparation has already been approved for the treatment of moderate‐severe plaque psoriasis. Subcutaneous ustekinumab has been used off‐label in the treatment of Crohn's disease, with long‐term outcomes reported in various cohorts . We report outcomes with a subcutaneous induction regimen for Crohn's Disease with a cumulative dose of 360 mg ustekinumab, given in 3 divided subcutaneous doses, of 180 mg at Week 0 and 90 mg at Week 1 and Week 2.…”

Editorial: ustekinumab and Crohn's disease—what can we learn from long‐term extension studies?

“…1 Emergency surgery increased the risk of early post-operative complications, odds ratio 4.46 (95% confidence interval 1.75-11.36), and similar findings regarding emergency surgery has been shown previoulsy. [5][6][7] An English study on emergency colorectal surgery 5 found the 30-day mortality risk to be four-times greater compared with scheduled procedures. 8 Similar to Sacleux et al, 3 they found UC to be associated with more complications than CD.…”

“…Gastroenterologists and surgeons must work together to prevent unnecessarily high rates of emergency surgery, 43.9% in CD and 36.5% in UC. 6 Although I may be biased by being a surgeon, I am far from convinced that this should be interpreted as a factor against surgery among elderly IBD patients when needed. Rather, I think this shows even more firmly that we need to discuss these patients in multi-disciplinary team meetings INVITED EDITORIALS | 383…”

“…Extension studies usually include participants from a heterogeneous group of studies designed for drug registration with differing inclusion and exclusion criteria, in addition to different drug doses, dose intervals or allowable rescue therapies . On the other hand, single or multi‐centre studies of drug efficacy and safety are uncontrolled, and often reflect the practice of referral centres where the experience may not reflect that of most community IBD physicians . Nevertheless, both long‐term extension studies and single centre experience series are vital to our understanding of how a drug may perform over a longer period of time…”

“…5 On the other hand, single or multicentre studies of drug efficacy and safety are uncontrolled, and often reflect the practice of referral centres where the experience may not reflect that of most community IBD physicians. 6 Nevertheless, both long-term extension studies and single centre experience series are vital to our understanding of how a drug may perform over a longer period of time. 7 Ustekinumab, a fully humanised monoclonal antibody to the p40 subunit of both IL 12 and IL 23, is indicated for the treatments of moderate to severe Crohn's disease.…”