Table 2:

Summary of Filgotinib (selective JAK-1 inhibitor) Trials

Trial	Type	Length	Number	Efficacy	Safety
DARWIN 1 Annals Rheum Disease, 2017 [26].	Phase IIb, multicenter, multinational, including US	24 weeks	594 received placebo vs drug at various doses and methotrexate	Drug met ACR endpoints at 12 weeks for doses 100 mg and 200 mg, but not for lower doses	No significant differences in adverse events between placebo and drug groups
DARWIN 2 Annals Rheum Disease, 2017 [27].	Phase IIb, multicenter, multinational including US	24 weeks	283 received placebo vs drug at various doses, no methotrexate	Drug met ACR endpoints starting at week 12 and persisted week 24	No significant difference in adverse events between placebo and drug group
Arthritis and Rheumatology, 2017 [24].	Phase IIa, proof of concept study done in Republic of Maldova	4 weeks	36 received placebo vs drug at 100 or 200 mg dose	Drug met ACR endpoints vs placebo	No major safety signals. Hemoglobin went up, decrease in neutrophils without neutropenia
Arthritis and Rheumatology, 2017 [24].	Phase IIa, dose ranging study in Republic of Maldova, Ukraine, Russia, and Hungary	4 weeks	91 received placebo various doses of drug	85% of 300 mg dose group had a ACR 20 response but this was not significantly better than placebo	No major safety signals. Hemoglobin went up, decrease in neutrophils without neutropenia.

Abbreviations: ACR – American College of Rheumatology