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Filgotinib Ph2/3 trial - SELECTION, 391 entered maintenance study, 273…
Filgotinib Ph2/3 trial - SELECTION
1,349 patient enrolled
Study A induction - 659 patients: Biologic naive
100mg - 277 patients - 19.1% NS
200mg - 245 patients - 26.1%
placebo - 137 patients 15.3%
34 patients discontinued
Study B induction - 689 patients: Biologic experienced
100mg - 285 patients - 9.5% NS
200mg - 262 patients - 11.5%
Placebo - 142 patients - 4.2%
54 patients Discontinued
Mucosal healing at week 10 200mg group defined as mayo score of 0 -1 and histological remission - Overall = 32.7% vs 10.2%
Biologic experienced Study B = 9.9% vs 4.2%
Biologic naïve study A = 23.3% vs 10.9%
391 entered maintenance study
273 entered maintenance study
664
patients in Maintenance study with
263
patients discontinuing before
week 58
100mg group
Placebo - 81 patients - 13.5%
100mg - 172 patients - 23.8% p=0.042
200mg group
200mg - 199 patients - 37.2% remission - p=0.0001
Placebo - 98 patients - 11.2%