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SELECT COMPARE - MTX inadequate responder patients2
A comparison of RINVOQ+MTX to adalimumab + MTX and Placebo + MTX2
RINVOQ + MTX demonstrated significantly greater DAS28 (CRP) remission rates and low disease activity rates than Placebo + MTX and adalimumab + MTX at 12 weeks2
Primary endpoint of DAS28-CRP < 2.6 RINVOQ + MTX vs Placebo + MTX at 12 weeks was met
Graph adapted from Fleischmann et al; 2019.
Remission is defined as DAS28-CRP <2.6 and LDA as DAS28-CRP ≤3.2.
*p≤0.001 vs placebo + MTX; †nominal p≤0.001 vs adalimumab + MTX. ‡p≤0.001vs adalimumab + MTX.
CRP, C-reactive protein; DAS28, Disease Activity Score 28 joints; LDA, low disease activity; MTX, methotrexate.
RINVOQ + MTX demonstrated significantly greater ACR response rates vs Placebo + MTX and Adalimumab + MTX at 12 weeks
Primary endpoint of DAS28-CRP < 2.6 RINVOQ + MTX vs Placebo + MTX at 12 weeks was met
Graph adapted from Fleischmann et al; 2019.
*p≤0.001 vs placebo + MTX; †nominal p≤0.05 vs adalimumab + MTX; ‡nominal p≤0.001 vs adalimumab + MTX; ¶nominal p≤0.001 vs placebo + MTX; #p≤0.001 vs adalimumab + MTX.
ACR20/50/70, American College of Rheumatology ≥20 %/50%/70% improvement; MTX, methotrexate.
RINVOQ + MTX inhibits radiographic progression over time
SELECT-COMPARE: Inhibition of structural joint damage progression at Week 267
SELECT-COMPARE: Inhibition of structural joint damage progression at Week 48 (linear extrapolation)7
Primary endpoint of DAS28-CRP < 2.6 RINVOQ + MTX vs Placebo + MTX at 12 weeks was met
Graph adapted from Fleischmann et al; 2019.
*nominal p<0.01 vs placebo + MTX
Results based on reading session 2
Treatment groups are by initial randomisation. For the placebo group, all data at Week 48 were imputed by linear extrapolation. X-ray data collected at treatment switching or at discontinuation of placebo (for patients who discontinued placebo) were used for extrapolation. Specifically, for placebo patients who switched to RINVOQ at Week 26, the Week 26 X-ray was used for extrapolation to impute the data at Week 48. For patients randomised to RINVOQ or adalimumab who were rescued, data at Week 48 were also imputed by linear extrapolation using X-ray data collected at treatment switching.
SELECT COMPARE Study design
A Phase 3 study investigating the efficacy and safety of RINVOQ + MTX compared with placebo + MTX and adalimumab + MTX for the treatment of moderate to severe RA in patients who had an inadequate response to MTX2,7
*Rescue criteria: At Weeks 14, 18, and 22, patients receiving adalimumab or placebo were switched to RINVOQ and patients receiving RINVOQ were switched to adalimumab if <20% improvement in tender joint count and swollen joint count vs baseline. At Week 26, all remaining placebo patients who were not rescued were switched to RINVOQ, and patients receiving RINVOQ or adalimumab were switched to adalimumab and RINVOQ, respectively, if CDAI >10.
Primary
RINVOQ+MTX vs PBO+MTX at 12 weeks: DAS28(CRP) < 2.6
Key secondary
RINVOQ+MTX vs PBO+MTX at 12 weeks: DAS28(CRP) ≤3.2, Change from baseline in DAS28(CRP), HAQ-DI, SF-36 PCS, CDAI≤10, Change in morning stiffness duration, Change in FACIT-F, ACR20
RINVOQ+MTX vs PBO+MTX at 26 weeks: Change in mTSS, % with mTSS≤0.
RINVOQ+MTX vs Adalimumab+MTX at 12 weeks: DAS28(CRP)≤ 3.2
- Patients ≥18 years of age were eligible to participate.
- Diagnosis of RA for ≥3 months fulfilling the 2010 ACR/EULAR classification for RA with active disease (≥6 swollen joints of 66, ≥6 tender joints of 68 examined, hsCRP ≥5 mg/L), and at least one of the following at screening: ≥3 erosions on x-rays of hands and feet, or ≥1 erosion and positivity for RF or anti-CCP antibodies.
- Patients must have had an inadequate response to MTX.
- Patients with prior exposure to at most 1 bDMARD (except adalimumab) were eligible (up to 20% of total study number of patients) if they had either limited exposure (<3 months) or had to discontinue the bDMARD due to intolerability.
- Patients with inadequate response to prior bDMARDs or prior exposure to a JAK inhibitor were excluded.
Anti-CCP antibodies: anti-cyclic citrullinated protein; ACR: American College of Rheumatology; ACR20: American College of Rheumatology >20% improvement; bDMARD: biological disease-modifying antirheumatic drug; CDAI: Clinical Disease Activity Index; DAS28 (CRP): disease activity score with 28 joint count (C-reactive protein); EOW: every other week; EULAR: European League Against Rheumatism; FACIT-F: Functional Assessment of Chronic Illness Therapy-Fatigue; HAQ-DI: Health Assessment Questionnaire without Didability Index; hsCRP: high-sensitivity C-reactive protein; mTSS: modified total sharp score; MTX: methotrexate; PBO: Placebo;QD: once daily; RF: rheumatoid factor; SF-36 PCS: PCS Short Form (36) Health Survey Physical Component Score.
Upadacitinib versus Placebo or Adalimumab in Patients with Rheumatoid Arthritis and an Inadequate Response to Methotrexate: Results of a Phase 3, Double Blind, Randomised Controlled Trails. Fleischman et al.
