Session Type: Poster Session (Sunday)
Session Time: 9:00AM-11:00AM
Background/Purpose: In Phase 3 trials, upadacitinib (UPA), an oral JAK1-selective inhibitor, has been assessed as monotherapy vs MTX (SELECT-EARLY1) and in combination with MTX vs adalimumab + MTX (ADA; SELECT-COMPARE2) in RA pts who were MTX naïve or with inadequate responses to MTX (MTX-IR), respectively. In this analysis we assessed individual and composite measures of disease activity in SELECT-EARLY and SELECT-COMPARE.
Methods: In SELECT-EARLY, MTX-naïve pts received UPA 15 mg or 30 mg monotherapy once daily (QD), or MTX monotherapy, for 12 wks. In SELECT-COMPARE, MTX-IR pts on stable background MTX received UPA 15 mg QD, PBO, or ADA 40 mg every 2 wks for 12 wks. For this analysis, responses at Wk 12 were defined as ≥50% improvement in the 7 components of the ACR response criteria. Among ACR50 responders, the proportions of pts with ≥50% improvement in all 7 components of the ACR criteria was assessed. The proportion of pts achieving TJC68=0 and SJC66=0 was also determined. All analyses were based on observed data without imputation.
Results: 947 pts were randomized in SELECT-EARLY, and 1629 pts in SELECT-COMPARE. Mean time since RA diagnosis was 2.7 years in SELECT-EARLY (median 6 months) and 8.2 years in SELECT-COMPARE; mean DAS28(CRP) was 5.9 and 5.8, respectively. In SELECT-EARLY, significantly more MTX-naïve pts receiving UPA 15 mg or 30 mg monotherapy achieved ≥50% improvements in all ACR components at Wk 12 compared with MTX (Table). In SELECT-COMPARE, significantly more MTX-IR pts on UPA 15 mg + MTX achieved ≥50% improvement in the ACR components vs PBO (all components) and ADA + MTX (all components except SJC and PhGA). Among pts with ACR50 responses at Wk 12, approximately half of the MTX-naïve pts on UPA 15 mg and 30 mg in SELECT-EARLY had ≥50% improvements in all 5 remaining ACR components (pain, PtGA, PhGA, HAQ-DI, hsCRP) compared with 28% with MTX. Corresponding proportions in MTX-IR pts in SELECT-COMPARE were 34% for UPA 15 mg + MTX, 28% for ADA + MTX, and 17% for PBO. UPA treatment also significantly increased the proportions of pts achieving both TJC68=0 and SJC66=0 vs PBO or MTX, and SJC66=0 vs ADA + MTX (Table).
Conclusion: In MTX-naïve and MTX-IR pts, treatment responses at 12 wks occurred in significantly higher proportions of pts receiving UPA monotherapy vs MTX and UPA + MTX vs PBO for all 7 components of the ACR response criteria, and for 5 of 7 ACR components for UPA + MTX vs ADA + MTX. Favorable outcomes with UPA treatment were evident both in composite and individual parameters.
- van Vollenhoven R, et al. Arthritis Rheumatol 2018;70(Suppl. 10): Abstract 891
- Fleischmann R, et al. Arthritis Rheumatol 2018;70(Suppl. 10): Abstract 890
To cite this abstract in AMA style:van Vollenhoven R, Östör A, Mysler E, Damjanov N, Song I, Song Y, Suboticki J, Strand V. The Impact of Upadacitinib versus Methotrexate or Adalimumab on Individual and Composite Disease Measures in Patients with Rheumatoid Arthritis [abstract]. Arthritis Rheumatol. 2019; 71 (suppl 10). https://acrabstracts.org/abstract/the-impact-of-upadacitinib-versus-methotrexate-or-adalimumab-on-individual-and-composite-disease-measures-in-patients-with-rheumatoid-arthritis/. Accessed July 2, 2020.
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ACR Meeting Abstracts - https://acrabstracts.org/abstract/the-impact-of-upadacitinib-versus-methotrexate-or-adalimumab-on-individual-and-composite-disease-measures-in-patients-with-rheumatoid-arthritis/