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Background The phase 3 SELECT-AXIS 2 trial (NCT04169373) assessed the efficacy and safety of upadacitinib (UPA) in patients with non-radiographic axial spondyloarthritis (nr-axSpA). This subgroup analysis investigated the efficacy of UPA in early versus established disease.
Objectives This post hoc analysis evaluated the rates of achievement of ≥40% improvement in ASAS score (ASAS40 response) and Ankylosing Spondylitis Disease Activity Score (ASDAS) low disease activity (LDA; <2.1) at week 14 in early versus established disease (defined as symptom duration <2 versus ≥2 years).
Methods In SELECT-AXIS 2[1], adult patients with or without prior biologic DMARD (bDMARD) exposure, with a clinical diagnosis of axSpA, fulfilling the Assessment of SpondyloArthritis international Society (ASAS) classification criteria for nr-axSpA, and with objective signs of active inflammation on MRI of SI joints and/or high-sensitivity (hs)-CRP exceeding the upper limit of normal (2.87 mg/L) at screening, were randomized 1:1 to UPA 15 mg once daily or placebo (PBO) for 52 weeks. Response rate, relative risk (RR; UPA versus PBO), and RR ratio (RRR; early versus established disease) are reported. When interpreting RRRs, a 95% confidence interval (CI) that crosses 1 indicates no statistically significant difference between the groups being compared.
Results Baseline characteristics were similar in patients with early versus established disease, although the proportion of females, mean age, and rates of prior bDMARD exposure were higher in established versus early disease (Table 1). Mean symptom duration was 1.0 versus 10.9 years in patients with early versus established disease. ASAS40 and ASDAS LDA response rates at week 14 were significantly increased with UPA versus PBO in both early and established disease (ASAS40: 61.3% versus 16.0% and 40.3% versus 24.0%; ASDAS LDA: 64.5% versus 16.0% and 37.1% versus 18.9%; respectively) (Figure 1). For ASAS40 and ASDAS LDA, the RR of response for UPA versus PBO was greater in early versus established disease (3.9 versus 1.7 and 4.4 versus 1.9, respectively). RRRs for ASAS40 and ASDAS LDA for early versus established disease were 2.3 (95% CI: 0.77, 6.95) and 2.3 (95% CI: 0.75, 6.81), respectively, reflecting no statistically significant difference in treatment response between early and established disease.
Conclusion UPA 15 mg is more efficacious than PBO in reducing signs and symptoms of nr-axSpA, regardless of symptom duration. Although treatment responses were numerically higher in early disease, the differences versus established disease were not statistically significant.
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Reference [1]Deodhar A, et al. Ann Rheum Dis 2022;81(Suppl 1):9. Abstract OP0016.
| Characteristic, mean (SD)a | Symptom duration | |
|---|---|---|
| Early diseaseb (N=56) | Established diseasec (N=255) | |
| Female, n (%) | 28 (50.0) | 153 (60.0) |
| Age, years | 35.7 (13.4) | 43.4 (11.4) |
| Duration since axSpA diagnosis, years | 0.7 (0.7) | 5.3 (6.0) |
| Median (range) duration since axSpA diagnosis, years | 0.5 (0.1, 4.8) | 3.4 (0.1, 32.4) |
| Duration of axSpA symptoms, years | 1.0 (0.4) | 10.9 (7.8) |
| Median (range) duration of axSpA symptoms, years | 1.0 (0.2, 2.0) | 8.7 (2.0, 41.1) |
| HLA-B27 positive, n (%) | 37 (66.1) | 146 (58.2)d |
| Concomitant csDMARD use, n (%) | 18 (32.1) | 72 (28.2) |
| Concomitant oral corticosteroid use, n (%) | 6 (10.7) | 29 (11.4) |
| Prior bDMARD exposure, n (%) | 7 (12.5) | 95 (37.3) |
| ASDAS-CRP | 3.7 (0.7) | 3.6 (0.7) |
| BASFI (0–10) | 5.5 (2.0) | 6.0 (2.1) |
| MRI SPARCC score (SI joints) | 4.8 (9.2)e | 3.8 (8.0)f |
| Patients’ assessment of total back pain (NRS 0–10) | 7.0 (1.3) | 7.3 (1.5) |
aAll data are mean (SD) unless otherwise stated. bDefined as symptom duration <2 years. cDefined as symptom duration ≥2 years. dN=251. eN=51. fN=237
axSpA, axial spondyloarthritis; ASDAS, Ankylosing Spondylitis Disease Activity Score; bDMARD, biologic DMARD; csDMARD, conventional synthetic DMARD; NRS, numeric rating scale; SD, standard deviation; SPARCC, Spondyloarthritis Research Consortium of Canada
Acknowledgements: NIL.
Disclosure of Interests Victoria Navarro-Compán Speakers bureau: AbbVie, BMS, Galapagos, Janssen, Lilly, MoonLake, MSD, Novartis, Pfizer, Roche, and UCB, Consultant of: AbbVie, BMS, Galapagos, Janssen, Lilly, MoonLake, MSD, Novartis, Pfizer, Roche, and UCB, Grant/research support from: AbbVie, BMS, Galapagos, Janssen, Lilly, MoonLake, MSD, Novartis, Pfizer, Roche, and UCB, Filip van den Bosch Speakers bureau: AbbVie, Amgen, Galapagos, Gilead, Janssen, Lilly, MoonLake, Novartis, Pfizer, and UCB., Consultant of: AbbVie, Amgen, Galapagos, Gilead, Janssen, Lilly, MoonLake, Novartis, Pfizer, and UCB., Percival D. Sampaio-Barros Speakers bureau: AbbVie, Janssen, Lilly, Novartis, Pfizer, and UCB., Consultant of: AbbVie, Janssen, Lilly, Novartis, Pfizer, and UCB., Fabiana Ganz Shareholder of: AbbVie, Employee of: AbbVie, Ana Biljan Shareholder of: AbbVie, Employee of: AbbVie, Yuanyuan Duan Shareholder of: AbbVie, Employee of: AbbVie, Kristin D’Silva Shareholder of: AbbVie, Employee of: AbbVie, Peter Wung Shareholder of: AbbVie, Employee of: AbbVie, Andrew Ostor Speakers bureau: AbbVie, BMS, Gilead, Janssen, Lilly, Novartis, Paradigm, Pfizer, Roche, and UCB., Consultant of: AbbVie, BMS, Gilead, Janssen, Lilly, Novartis, Paradigm, Pfizer, Roche, and UCB., Sofia Ramiro Speakers bureau: AbbVie, Lilly, MSD, Novartis, Pfizer, Sanofi, and UCB., Consultant of: AbbVie, Lilly, MSD, Novartis, Pfizer, Sanofi, and UCB., Grant/research support from: AbbVie, Galapagos, MSD, Novartis, Pfizer, and UCB.
Keywords: Spondyloarthritis
DOI: 10.1136/annrheumdis-2023-eular.2123