Etrolizumab (etro), a humanised anti-β7 monoclonal antibody was evaluated in patients (pts) with moderate to severe Crohn’s Disease (CD) to determine safety and efficacy. Results of the Phase III BERGAMOT (NCT02394028) exploratory induction cohort are presented.Methods
Eligible pts with moderate to severe CD (refractory/intolerant to anti–TNFα agents, immunosuppressants, and/or corticosteroids) were assigned (2:2:1) etro 105 mg SC Q4W, etro 210 mg at wks 0, 2, 4, 8, and 12, or placebo (pbo) during a 14-wk induction period. Endpoints included CDAI remission (CDAI <150), CDAI-100 and −70 responses, PRO2 remission (weighted combined score ≤11, based on pt report of liquid/very soft stool frequency [SF] and abdominal pain [AP]), symptomatic remission (unweighted SF ≤3 and AP ≤1), and endoscopic improvement (≥50% reduction from baseline SES-CD) at wk 14.Results
300 pts (73% aTNF-experienced) with moderate to severe CD (mean CDAI [SD], 315.6 [60.0]; mean SES-CD [SD], 14.1 [7.3]; median faecal calprotectin [range] 918 [30–15 451] µg/g; median C-reactive protein [range], 9.75 [0.2–148.0] mg/L) received etro 105 mg (n=120), etro 210 mg (n=121), or pbo (n=59).Results
Symptomatic remission was seen in a greater proportion of pts receiving etro 105 mg and 210 mg compared with pbo at wks 6, 10, and 14. More pts achieved endoscopic improvement with etro 105 mg and 210 mg compared with pbo at wk 14 (table 1).Results
CDAI remission at wk 14 was greater with etro 105 mg and 210 mg compared with pbo: 23.3% (17.6, 30.2), 28.9% (22.7, 36.1) and 16.9% (10.4, 26.4) respectively. PRO2 remission was achieved at wk 14 in 28.3% (22.1, 35.5), 28.9% (22.7, 36.1), and 20.3% (13.1, 30.2) of pts, respectively.Results
The frequency of adverse events with etro was comparable with pbo; no deaths, anaphylaxis or progressive multifocal leucoencephalopathy occurred.Conclusion
Treatment with etro was well tolerated and resulted in clinically meaningful endoscopic improvement in pts with moderate to severe CD. Rapid symptomatic remission was observed as early as wk 6 and sustained through wk 14. Enrolment into induction cohorts and the maintenance phase is ongoing.