*p≤0.001 RINVOQ + MTX vs placebo + MTX.
†p<0.01 RINVOQ + MTX vs adalimumab + MTX.
‡nominal p≤0.01 RINVOQ + MTX vs adalimumab + MTX.
§p≤0.001 RINVOQ + MTX vs adalimumab + MTX.
¶nominal p≤0.001 RINVOQ + MTX vs adalimumab + MTX.
HAQ-DI is rated on a 0–3 scale; patient’s assessment of pain is scored on a 0–100 mm scale.3
The primary endpoint of SELECT-COMPARE: Clinical remission (DAS28-CRP <2.6) RINVOQ + MTX vs placebo + MTX at Week 12, was met (p<0.001).2
Treatment groups are by initial randomisation. Per protocol, patients were rescued (RINVOQ to ADA, PBO to RINVOQ, and ADA to RINVOQ) at Weeks 14, 18, or 22 based on improvement in SJC+TJC, or Week 26 based on CDAI LDA. All PBO patients not previously rescued (at Weeks 14, 18, or 22) were switched to RINVOQ at Week 26. Patients rescued at Week 26 (due to not meeting CDAI LDA) were imputed as non-responder for each subsequent visit. For binary endpoints shown by randomised treatment group, NRI was applied for rescue, premature discontinuation of study drug, and missing data. For continuous endpoints by randomised treatment group, LOCF was applied for rescue; missing data were not imputed.3
Data analyses are in patients with moderate to severe RA across all studies of RINVOQ’s Phase III EMA registrational programme.1,3
ADA = adalimumab; CDAI = clinical disease activity index; CRP = C-reactive protein; DAS28 = disease activity score 28 joints; HAQ-DI = Health Assessment Questionnaire Disability Index; LS = least-squares; LDA = low disease activity; LOCF = last observation carried forward; MTX = methotrexate; NRI = non-responder imputation; RA = rheumatoid arthritis; SJC = swollen joint count; TJC = tender joint count.