Vermeire 2014.

Methods	Randomized, double‐blind, placebo‐controlled, phase 2 study comparing SC etrolizumab to matched placebo (N = 124)
Participants	Adult patients (18‐75 years) with a diagnosis of UC for > 12 weeks and MCS > 5 points at screening (> 6 points at US sites) and a centrally read MCS > 2, a rectal bleeding subscore > 1, and disease extension > 25 cm from the anal verge Patients failed to respond to prior treatment with immunosuppressants and/or TNF‐α antagonists
Interventions	Etrolizumab 100 mg (n = 41): patients received 100 mg at weeks 0, 4 and 8, with placebo administered at week 2 Etrolizumab 300 mg (n = 40): patients received a 420 mg loading dose at week 0, followed by 300 mg at weeks 2, 4 and 8 Placebo (n = 43)
Outcomes	Primary outcome: clinical remission at week 10 Secondary outcomes: clinical remission at week 6; achievement of endoscopic subscore of 0 at weeks 6 and 10; achievement of rectal bleeding subscore of 0 at weeks 6 and 10; change from baseline in mucosal healing; histological active disease severity score; pharmacodymamic biomarkers in the peripheral blood and colonic tissue
Notes	124 patients were randomly assigned to placebo (n = 43), etrolizumab 100 mg (n = 41) or etrolizumab 300 mg (n = 40) 5 patients had an endoscopic subscore of 0 or 1, and were excluded from the modified intention‐to‐treat population (MITT = 119; 41 patients in the placebo group; 39 patients in the 100 mg group; 39 patients in the 300 mg group)
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Randomization was conducted with an interactive voice and web response system
Allocation concealment (selection bias)	Low risk	Randomization was conducted with an interactive voice and web response system
Blinding of participants and personnel (performance bias) All outcomes	Low risk	All patients, assessing physicians, the funder and its agents and study personnel were masked to treatment assignment, except for site pharmacists who prepared drugs but did not interact with patients
Blinding of outcome assessment (detection bias) All outcomes	Low risk	All patients, assessing physicians, the funder and its agents and study personnel were masked to treatment assignment, except for site pharmacists who prepared drugs but did not interact with patients
Incomplete outcome data (attrition bias) All outcomes	Low risk	Withdrawals were similar across groups
Selective reporting (reporting bias)	Low risk	All primary and secondary outcomes were reported
Other bias	Low risk	No other apparent sources of bias