SUPERIOR AND CONSISTENTLY PROVEN
RINVOQ + MTX demonstrated superiority vs ADA+MTX on ACR50, pain and HAQ-DI in MTX-IR patients at week 124
In RCTs RINVOQ demonstrated consistent rates of remission and significant inhibition of structural joint damage, with and without MTX4,6
Upadacitinib + MTX was statistically superior to adalimumab + MTX
at Week 12 on:1,2
ACR50 response rate
(NRI)
Pain (VAS)
(ANCOVA)
HAQ-DI
(ANCOVA)
Full analysis set. †p≤0.001 vs placebo + MTX. ‡p≤0.01 vs adalimumab + MTX. §p≤0.001 vs adalimumab + MTX. IIIndicates multiplicity-controlled comparison of upadacitinib + MTX vs placebo + MTX at Week 12. **Indicates multiplicity-controlled comparison of upadacitinib + MTX vs ADA + MTX at Week 12. Superiority for ACR50, Δpain (VAS) and ΔHAQ-DI for upadacitinib + MTX vs ADA + MTX at Week 12 were FDA ranked key secondary multiplicity-controlled endpoints. ΔHAQ-DI for UPA + MTX vs placebo + MTX at Week 12 was an EMA ranked key secondary multiplicity-controlled endpoint. All other data shown were prespecified non-ranked non-multiplicity-controlled endpoints. ACR, American College of Rheumatology; ADA, adalimumab; ANCOVA, analysis of covariance; EOW, every other week; HAQ-DI, Health Assessment Questionnaire – Disability Index; MTX, methotrexate; NRI, non-responder imputation; PBO, placebo; QD, once daily; UPA, upadacitinib; VAS, visual analog scale.
References
1. Fleischmann R et al. Arthritis Rheumatol 2019;71:1788–1800;
2. Fleischmann R et al. Arthritis Rheumatol 2018;70(10):890.
ACR50, pain (VAS) and physical function (HAQ-DI) at Week 1561
ACR50 response rate
(NRI)
Pain (VAS)
(ANCOVA)
HAQ-DI
(ANCOVA)
Nominal ##p<0.01, ###p<0.001 for UPA + MTX vs ADA + MTX. Treatment groups are by initial randomization. Observations after rescue were replaced with the last observation prior to rescue, and analysis was based on ANCOVA model with treatment and prior biologic-DMARD use as fixed factors and BL value as covariate.
HAQ-DI is rated on a 0–3 scale; patient’s assessment of pain is scored on a 0–100 mm scale.
ACR50, at least 50% improvement in American College of Rheumatology criteria; ADA, adalimumab; BL, baseline; DMARD, disease-modifying anti-rheumatic drug;EOW, every other week; HAQ-DI, Health Assessment Questionnaire-Disability Index; MTX, methotrexate; UPA, upadacitinib.
References
1. Fleischmann R et al. EULAR 2021. Poster POS0087.
Rinvoq Prescribing Information
For full information please see Rinvoq prescribing information Full prescribing information can be received from Abbvie Biopharmaceuticals Ltd. Israel at 4 Hacharash Street, Hod Hasharon 4524075. Tel: 09-7909600, Fax: 09-790960
3. RINVOQ Prescribing Information, March 2023.
4. Fleischmann, R, Panga , AL, Song, IH, et al. Upadacitinib versus placebo or adalimumab in patients with rheumatoid arthri is and an inadequate response to metotrexate: results of a phase 3, double-blind, randomized controlled trial. Arthritis Rheumatol. 2019 71: 1788-1800. doi:10.1002/art.41032
5. Smolen JS, Pangan AL Emery P, e al. Upadacitinib as monotherapy in patients with active rheumatoid arthritis a d inadequate response to methotrexate (SELECT MONOTHERAPY): a randomised, placebo-controlled, double-blind phase 3 study. Lancet. 2019; 393(10188): 2303 -2311. doi: 10.1016/S0140-6736(19)30419·2.
6. Van Vollenhoven, R, Takeuchi. T, Pangan, A.L. et al. Efficacy and safety of Upadacitinib monotherapy in methotrexate-naive patients with moderatelyto-severely active rheumatoid arthritis (SELECT-EARLY): a multicenter, multiCountry, randomized, double-blind, active comparator-controlled trial. Arthritis Rheumatol. 72: 1607-1620. doi:10.1002/art.41384