Upadacitinib improves patient-reported outcomes vs placebo or adalimumab in patients with rheumatoid arthritis: results from SELECT-COMPARE

Abstract

Objective: To evaluate the impact of upadacitinib vs placebo and adalimumab treatment, on patient-reported outcomes (PROs) in SELECT-COMPARE in an active RA population with inadequate responses to MTX (MTX-IR).

Methods: PROs in patients receiving upadacitinib (15 mg QD), placebo, or adalimumab (40 mg EOW) while on background MTX were evaluated over 48 weeks. PROs included Patient Global Assessment of Disease Activity (PtGA) and pain by visual analogue scale (VAS), the HAQ Disability Index (HAQ-DI), the 36-Item Short Form Survey (SF-36), morning (AM) stiffness duration and severity, the Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F), and work instability. Least squares mean (LSM) changes and proportions of patients reporting improvements ≥ minimal clinically important differences (MCIDs) and scores ≥ normative values were evaluated.

Results: Upadacitinib and adalimumab resulted in greater LSM changes from baseline vs placebo across all PROs (P < 0.05) at week 12, and pain and AM stiffness severity (P < 0.05) at week 2. More upadacitinib- vs placebo-treated (P < 0.05) and similar percentages of upadacitinib- vs adalimumab-treated patients reported improvements ≥ MCID across all PROs at week 12. Upadacitinib vs adalimumab resulted in greater LSM changes from baseline in PtGA, pain, HAQ-DI, stiffness severity, FACIT-F, and the SF-36 Physical Component Summary (PCS) (all P < 0.05) at week 12. More upadacitinib- vs adalimumab-treated patients reported scores ≥ normative values in HAQ-DI and SF-36 PCS (P < 0.05) at week 12. More upadacitinib- vs adalimumab-treated patients maintained clinically meaningful improvements in PtGA, pain, HAQ-DI, FACIT-F, and AM stiffness through 48 weeks.

Conclusion: In MTX-IR patients with RA, treatment with upadacitinib resulted in statistically significant and clinically meaningful improvements in PROs equivalent to or greater than with adalimumab.

Trial registration: ClinicalTrials.gov, http://clinicaltrials.gov, NCT02629159.

Keywords: DMARDs; inflammation; outcome measures; quality of life; rheumatoid arthritis.

Fig. 1

SF-36 domain scores at baseline and week 12 for all treatment groups relative to age- and gender-matched normative values ADA, adalimumab; A/G norms, age- and gender-matched normative values; BL, baseline; BP, bodily pain; GH, general health; MH, mental health; PBO, placebo; PF, physical functioning; RE, role-emotional; RP, role-physical; SF-36, 36-Item Short-Form Health Survey; SF, social functioning; UPA, upadacitinib; VT, vitality.

Fig. 2

Patients reporting PRO score improvements ≥ MCID at week 12 ^a P < 0.05 for UPA vs PBO; ^bP < 0.05 for UPA vs ADA. ADA, adalimumab; AM, morning; BP, bodily pain; FACIT-F, Functional Assessment of Chronic Illness Therapy–Fatigue; GH, general health; HAQ-DI, HAQ-Disability Index; MCID, minimal clinically important difference; MCS, Mental Component Summary; MH, mental health; NNT, number needed to treat; PBO, placebo; PCS, Physical Component Summary; PF, physical functioning; PRO, patient-reported outcome; PtGA, Patient’s Global Assessment of Disease Activity; RA-WIS; Work Instability Scale for RA; RE, role-emotional; RP, role-physical; SF, social functioning; SF-36, 36-Item Short-Form Health Survey; UPAD, upadacitinib; VAS, visual analog scale; VT, vitality.

Fig. 3

Patients reporting PRO scores ≥ normative values at baseline and week 12 ^a P < 0.01 for UPAD vs PBO; ^bP < 0.05 for UPA vs ADA. ADA, adalimumab; BL, baseline; BP, bodily pain; FACIT-F, Functional Assessment of Chronic Illness Therapy–Fatigue; GH, general health; HAQ-DI, HAQ-Disability Index; MCS, Mental Component Summary; MH, mental health; PBO, placebo; PCS, Physical Component Summary; PF, physical functioning; PRO, patient-reported outcome; RA-WIS, Work Instability Scale for RA; RE, role-emotional; RP, role-physical; SF, social functioning; SF-36, 36-Item Short-Form Health Survey; UPA, upadacitinib; VT, vitality.