LSM change from baseline in CDAI, HAQ-DI, DAS28-4-ESR, and pain VAS at Month 3 in patients receiving MTX, tofacitinib 5 or 10 mg BID ± GC in ORAL Start (FAS). Values are LSM change (95% CI).
| Variables | MTX | Tofacitinib 5 mg BID | Tofacitinib 10 mg BID | |||
|---|---|---|---|---|---|---|
| + GC, n = 78a | − GC, n = 91a | + GC, n = 172a | − GC, n = 179a | + GC, n = 165a | − GC, n = 214a | |
| CDAI | −16.4 (−18.8 to −13.9) | −18.1 (−20.1 to −16.1) | −22.8*** (−24.5 to −21.1) | −24.7*** (−26.1 to −23.2) | −24.5*** (−26.2 to −22.7) | −26.1*** (−27.4 to −24.8) |
| HAQ–DI | −0.5 (−0.6 to −0.4) | −0.5 (−0.6 to −0.4) | −0.7* (−0.8 to −0.7) | −0.8** (−0.9 to −0.7) | −0.8*** (−0.9 to −0.7) | −0.9*** (−1.0 to −0.8) |
| DAS28-4-ESR | −1.5 (−1.8 to −1.2) | −1.6 (−1.9 to −1.4) | −2.3*** (−2.5 to −2.1) | −2.5*** (−2.6 to −2.3) | −2.5*** (−2.7 to −2.3) | −2.7*** (−2.9 to −2.5) |
| Pain VAS | −19.8 (−24.8 to −14.8) | −25.8 (−29.8 to −21.7) | −29.3* (−32.7 to −25.9) | −30.9* (−33.8 to −28.0) | −30.8** (−34.2 to −27.3) | −34.6** (−37.3 to −31.9) |
↵* p < 0.05;
↵** p < 0.001;
↵*** p < 0.0001 (without multiplicity adjustment for exploratory analysis) vs MTX within the respective subgroup.
↵a n based on HAQ-DI endpoint; however, patient numbers varied between outcome measures. BID: twice daily; CDAI: Clinical Disease Activity Index; DAS28-4-ESR: 28-joint Disease Activity Score using the erythrocyte sedimentation rate; FAS: full analysis set; GC: glucocorticoids; HAQ-DI: Health Assessment Questionnaire–Disability Index; LSM: least squares mean; MTX: methotrexate; VAS: visual analog scale.