Table 4.
Study | Outcome a | Week | Placebo | MTX | ABA | ADA | Upa 15 mg | Upa 30 mg |
---|---|---|---|---|---|---|---|---|
NEXT [21] | ΔVAS Pain | 12 | −10.3 | −29.9 ‡ | −31.7 ‡ | |||
ΔFACIT-F | 12 | 3.0 | 7.9 ‡ | 7.7 ‡ | ||||
ΔSF36-PCS | 12 | 3.0 | 7.6 ‡ | 8.0 ‡ | ||||
ΔHAQ-DI | 12 | −0.26 | −0.61 ‡ | −0.55 ‡ | ||||
BEYOND [22] | ΔSF36-PCS | 12 | 2.4 | 5.8 ‡ | 7.0 ‡ | |||
24 | NA | 7.2 | 8.0 | |||||
ΔHAQ-DI | 12 | −0.16 | −0.41 ‡ | −0.44 ‡ | ||||
COMPARE [23] | ΔVAS Pain | 12 | −15.7 | −25.6 | −32.1 †,¶ | |||
ΔFACIT-F | 12 | 4.8 | 7.4 | 9.0 †,ǀ | ||||
26 | 5.5 | 8.2 | 9.7 †,ǀ | |||||
ΔSF36-PCS | 12 | 3.6 | 6.3 | 7.9 †,ǁ | ||||
26 | 4.5 | 7.8 | 9.5 †,ǁ | |||||
ΔHAQ-DI | 12 | −0.28 | −0.49 | −0.60 †,ǁ | ||||
CHOICE [24] | ΔFACIT-F | 12 | 8.35 | 9.61 | ||||
24 | 10.32 | 10.73 | ||||||
ΔSF36-PCS | 12 | 7.03 | 9.62 | |||||
24 | 9.40 | 10.97 | ||||||
MONOTHERAPY [25] | ΔVAS Pain | 14 | −13.88 | −26.15 ¶¶ | −33.18 ¶¶ | |||
ΔSF36-PCS | 14 | 4.3 | 8.3 ¶ | 10.2 ¶ | ||||
ΔHAQ-DI | 14 | −0.32 | −0.65 ¶ | −0.73 ¶ | ||||
EARLY [26] | ΔVAS Pain | 12 | −25.36 | −36.28 ¶ | −39.67 ¶ | |||
24 | −28.40 | −39.84 ¶ | −44.67 ¶ | |||||
ΔFACIT-F | 12 | 6.80 | 10.01 ¶ | 9.57 ¶ | ||||
24 | 7.37 | 10.59 ¶ | 10.56 ¶ | |||||
ΔSF36-PCS | 12 | 5.77 | 10.09 ¶ | 10.11 ¶ | ||||
24 | 6.99 | 10.97 ¶ | 11.69 ¶ | |||||
ΔHAQ-DI | 12 | −0.49 | −0.83 ¶ | −0.86 ¶ | ||||
24 | −0.60 | −0.87 ¶ | −0.91 ¶ |
a Minimum clinically important differences: VAS pain, ≥10 mm; FACIT-T, ≥4 points; SF36-PCS, ≥2.5 points; HAD-DI, ≥0.22 units. ADA—adalimumab; ABA—abatacept; ∆—mean change from baseline; FACIT-F—functional assessment of chronic illness therapy fatigue scale; HAQ-DI—health assessment questionnaire disability index; MTX—methotrexate; SF-36 PCS—36-item short form health survey physical component summary score; VAS—visual analog scale. † 0.001 upadacitinib versus placebo. ‡ 0.0001 upadacitinib versus placebo. ǀ 0.05 upadacitinib versus active comparator (adalimumab, abatacept, methotrexate). ǁ 0.01 upadacitinib versus active comparator. ¶ 0.001 upadacitinib versus active comparator. ¶¶ 0.0001 upadacitinib versus active comparator.