AbbVie has announced that FDA has approved Rinvoq (upadacitinib) for the treatment of moderate to severe rheumatoid arthritis who have inadequate or intolerant to methotrexate. Upadacitnib is oral JAK inhibitor.
The approval is based on the SELECT trial, the largest Phase 3 trial in the field of rheumatoid arthritis. Safety, efficacy, and tolerability were assessed in 4,400 across all treatment arms in five studies.
SELECT-EARLY
After 12 weeks, 52% patient on upadacitinib achieved ACR50 vs. 28% in patients on methotrexate
36% of patients achieved clinical remission compared to 14% in patients on methotrexate
SELECT-MONOTHERAPY
After 14 weeks, 65% of MTX-IR patients achieved ACR20 who are in upadacitinib vs 41% in patients who continued the treatment with methotrexate
30% of patients reported clinical remission
SELECT-COMPARE
After 12 weeks, 71% MTX-IR patients achieved ACR20 in Rinvoq + MTX arm vs 36% in patients on placebo + csDMARDs
30% of patients reported clinical remission
SELECT-NEXT
After 12 weeks, 64% of csDMARD-IR patients achieved ACR20 who were treated with Rinvoq vs. 36% in patients on placebo + csDMARD
SELECT-BEYOND
After 12 weeks, 65% of biologic-IR patients achieved ACR20 who were treated with Rinvoq + csDMARD vs. 28% in patients with placebo + csDMARD
The adverse effects reported were upper respiratory tract infections, nausea, cough, and pyrexia.