tofacitinib vs upadacitinib

NCT01262118 · Phase 1 · completed

This was a single-arm, open-label, unblinded study that tracked lipid biomarker levels before and after treatment in one group of patients, with no randomized or treated comparator arm and no statistical test of a treatment effect.

NCT02675426 · Phase 3 · completed

This was a randomized, quadruple-blind, placebo-controlled trial in 661 patients using two validated rheumatoid arthritis disease-activity measures as co-primary endpoints, and both upadacitinib doses produced significantly higher response rates than placebo on both measures (all comparisons p<0.001).

NCT01458951 · Phase 3 · completed

Design meets the 'strong' test: randomized, quadruple-blinded, placebo-controlled, adequately powered (429 vs 112), with a hard clinical/endoscopic composite primary endpoint (Mayo remission including endoscopic subscore) that was statistically significant in the favorable direction (p=0.0005, 13% absolute difference).

NCT02819635 · Phase 2/3 · completed

Randomized, quadruple-blinded, placebo-controlled, adequately powered (n=1302) trial with a hard clinical/endoscopic composite primary endpoint (Adapted Mayo Score remission, incorporating endoscopy); all primary comparisons across all three substudies and all active doses achieved statistical significance in the favorable direction (p<0.001 to 0.049), satisfying the 'strong' definition.