DURABLE GREATER REMISSION WITH OR WITHOUT MTX
RINVOQ achieved DAS28-CRP<2.6 and DAS28-CRP≤3.2 (ranked secondary endpoints) at Week 12 or 14, with durable remission and low disease activity rates from 60 to 84 weeks.4-6
DAS28-CRP <2.6 remission rates through 3 years (NRI)
DAS28-CRP <2.6 (NRI)
Full analysis set. *p≤0.01 vs placebo + MTX. †p≤0.001 vs placebo + MTX. ¶p≤0.01 vs adalimumab + MTX at Week 8. ‡p≤0.01 vs adalimumab + MTX. §p≤0.001 vs adalimumab + MTX. IIIndicates multiplicity-controlled comparison of upadacitinib + MTX vs placebo + MTX. **DAS28-CRP <2.6 for upadacitinib + MTX vs placebo + MTX at Week 12 was a primary multiplicity-controlled endpoint. All other p-values are nominal. ††Vertical line at Week 26 indicates the end of the placebo-controlled period. Treatment groups are by initial randomization. NRI was used for patients who were rescued or prematurely discontinued study drug, as well as for missing data. ADA, adalimumab; CRP, C-reactive protein; DAS28, Disease Activity Score for 28 joints; EMA, European Medicines Agency; EOW, every other week; MTX, methotrexate; NRI, non-responder imputation; PBO, placebo; QD, once daily; UPA, upadacitinib.
References
1. Fleischmann R et al. Arthritis Rheumatol 2019;71:1788–1800;
2. Fleischmann R et al. EULAR 2021. Poster POS0087.
Remission rates with or without concomitant MTX
These trials are not directly comparable
Full analysis set. aDAS28-CRP <2.6 for UPA 15 mg versus cMTX at Week 14 was an FDA and EMA ranked key secondary multiplicity-controlled endpoint for SELECT-MONOTHERAPY. bDAS28-CRP <2.6 for UPA 15 mg + MTX versus PBO + MTX at Week 12 was the EMA primary multiplicity controlled endpoint for SELECT-COMPARE. †p≤0.001 versus placebo + MTX (SELECT-COMPARE) or versus cMTX (SELECT-MONOTHERAPY). ψp≤0.01 versus ADA + MTX. ‡p≤0.01 versus ADA + MTX. §p≤0.001 versus ADA + MTX. IIIndicates multiplicity-controlled comparison of UPA + MTX versus PBO + MTX (SELECT-COMPARE) at Week 12 or UPA versus cMTX (SELECT-MONOTHERAPY) at Week 14. All other data shown were prespecified non-ranked non-multiplicity controlled endpoints; nominal p-values are provided. Boolean remission: TJC ≤1, SJC ≤1, CRP ≤1 mg/dL and patient global assessment ≤1 (on a 0–10 scale).
ADA, adalimumab; CDAI, Clinical Disease Activity Index; cMTX, continued MTX; CRP, C-reactive protein; DAS28, Disease Activity Score for 28 joints; EMA, European Medicines Agency; EOW, every other week; FDA, U.S. Food and Drug Administration; IR, inadequate response; MTX, methotrexate; NRI, non-responder imputation; PBO, placebo; QD, once daily; SDAI, Simplified Disease Activity Index; SJC, swollen joint count; TJC, tender joint count; UPA, upadacitinib.
References
1. Smolen J et al. Lancet 2019;393:2303 –2311;
2. Fleischmann R et al. Arthritis Rheumatol 2019;71(11):1788–1800;
3. Fleischmann R et al. Arthritis Rheumatol 2019;71(11):1788–1800 (Supplementary material).
DAS28-CRP remission rates through Week 841
SELECT-MONOTHERAPY
MTX-IR population
DAS28-CRP remission (<2.6)
Statistics were not reported for the data shown. DAS28-CRP <2.6 at Week 14 was a ranked secondary endpoint.2 All other timepoints for DAS28-CRP <2.6 were unranked. CDAI ≤2.8 and Boolean remission at all timepoints were unranked.
AO, as observed; CDAI, Clinical Disease Activity Index; cMTX, continued methotrexate; CRP, C-reactive protein; DAS28, Disease Activity Score for 28 joints; IR, inadequate response; MTX, methotrexate; NRI, non-responder imputation; UPA, upadacitinib.
References
1. Smolen JS et al. ACR 2020. Poster 0209;
2. Smolen J et al. Lancet 2019;393:2303 –2311.
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
CRP=C-reactive protein; DAS28-CRP=28 joint disease activity score using C-reactive protein; IR=intolerance or inadequate response; MTX=methotrexate; TNFi=tumor necrosis factor inhibitor
4. RINVOQ Prescribing Information, March 2023.
5. Smolen J, Emery P, Rigby W, et al. Upadacitinib as Monotherapy in Patients with Rheumatoid Arthritis and Prior Inadequate Response to Methotrexate: Results at 84 Weeks from the SELECT-MONOTHERAPY Study. Poster presented at: The European Congress of Rheumatology, 3-6 June 2020, E-Congress
6. Smolen JS, Pangan AL, Emery P, et al. Upadacitinib as monotherapy in patients with active rheumatoid arthritis and inadequate response to methotrexate (SELECT-MONOTHERAPY): a randomised, placebo-controlled, double-blind phase 3 study. Lancet. 2019;393(10188):2303 ‑2311.