dm+d

Unassigned

New Medicines

Crohn's disease, moderate-to-severe - after steroids, immunosuppressants and anti-TNF therapy

Information

New molecular entity
Roche
Roche

Development and Regulatory status

Discontinued
Discontinued
Discontinued
Feb 22Roche has halted PIII trials for etrolizumab for Crohn´s disease. No specific details mentioned. Likely based on the results of the trial [11]

Category

A humanised monocloncal antibody against beta 7 integrin.
In 2010, there were around 79,115 adults in England with Crohn’s disease, of whom ~50% (39,557) are resistant or intolerant to conventional therapies.
Crohn's disease, moderate-to-severe - after steroids, immunosuppressants and anti-TNF therapy
Subcutaneous injection

Further information

Yes

Evidence based evaluations

Ulcerative colitis (UC) naive to TNF inhibitors and refractory to or intolerant of prior immunosuppressant and/or corticosteroid treatment

Information

New molecular entity
Roche
Roche

Development and Regulatory status

Discontinued
Discontinued
Discontinued
Oct 20Development discontinued [19].

Category

Humanized monoclonal antibody targeting the beta7 integrin subunit of the heterodimers alpha4beta7 (α4β7) and alphaEbeta7 (αEβ7)
Ulcerative colitis is the most common type of inflammatory disease of the bowel. It has an incidence in the UK of approximately 10 per 100,000 people annually and a prevalence of approximately 240 per 100,000 [11].
Ulcerative colitis (UC) naive to TNF inhibitors and refractory to or intolerant of prior immunosuppressant and/or corticosteroid treatment
Subcutaneous

Further information

Yes

Trial or other data

Aug 20Genentech announced mixed results from its late-stage study program. In the HIBISCUS II induction study, which included pts without prior anti-TNF treatment, etrolizumab did not meet its primary endpoint. In the HICKORY study, in pts with prior anti-TNF treatment, etrolizumab met the primary endpoint at induction but not at maintenance and in the LAUREL maintenance study in pts without prior anti-TNF treatment, etrolizumab failed to meet its primary endpoint. Genentech said etrolizumab demonstrated no significant difference in the proportion of pts achieving remission with s.c. etrolizumab vs. placebo. The safety profile of etrolizumab was consistent with previous studies and no major safety issues were identified. [18]