[Affiliates to insert drivers to local asset]
RINVOQ SELECT-EARLY clinical trial results
Hear Dr. Stephen Hall discuss study results in MTX-naive patients with moderately to severely active RA.1
RINVOQ is not approved for the treatment of MTX-naive patients.
SELECT-EARLY: Study design
A Phase 3 study investigating the efficacy and safety of RINVOQ monotherapy compared with MTX in MTX-naive patients with moderately to severely active RA1,2
Rescue therapy from Weeks 12–24: In patients with <20% improvement in TJC and SJC at 2 consecutive visits, background medications were optimized.
*Rescue protocol from Week 26: group 1 if CDAI ≤2.8, patients continued their original study drug; group 2 if ≥20% improvement from baseline in tender joint count (TJC), and swollen joint count (SJC), but CDAI >2.8, background medications were optimized; group 3 if <20% improvement from baseline in TJC and SJC, and CDAI >2.8, RINVOQ 15 mg or upadacitinib 30 mg were added by rerandomization according to 1:1 ratio for those initially randomized to MTX, and MTX was added for those initially randomized to RINVOQ 15 mg or upadacitinib 30 mg.
†Study drug assignments remain the same in the blinded extension while allowing initiation of, or change in, background RA medication(s) as per local label.
Primary
RINVOQ 15 mg and upadacitinib 30 mg vs MTX for DAS28 (CRP) <2.6 at Week 24 (EMA) or ACR50 at Week 12 (FDA)
Safety
Adverse events, serious adverse events, adverse event of special interest (e.g., serious infections, opportunistic infections, MACEs, VTEs, malignancies)
- Patients ≥18 years of age were eligible to participate.
- Diagnosis of RA for ≥6 weeks fulfilling the 2010 ACR/EULAR classification for RA with active disease (at least 6 swollen joints out of 66, at least 6 tender joints out of 68, and hsCRP ≥5 mg/L) and ≥1 erosion on x-ray OR positive for both RF and ACCP.
- Patients were naive to MTX or received no more than 3 weekly MTX doses and completed a 4-week MTX washout.
- No prior intolerance to MTX, or no prior exposure to a JAK inhibitor or bDMARD.
RINVOQ is not indicated for MTX-naive patients.
The approved dose of RINVOQ is 15 mg once daily. Upadacitinib 30 mg is not an approved dose.
ACCP: anti-cyclic citrullinated protein; ACR: American College of Rheumatology; ACR50: improvement of at least 50% in the American College of Rheumatology core criteria; bDMARD: biological disease-modifying antirheumatic drug; CDAI: Clinical Disease Activity Index; DAS28 (CRP): disease activity score with 28-joint count (C-reactive protein); EMA: European Medicines Agency; EULAR: European League Against Rheumatism; FDA: Food and Drug Administration; hsCRP: high-sensitivity C-reactive protein; JAK: Janus kinase; MACE: major adverse cardiovascular events; MTX: methotrexate; QD: once daily; RF: rheumatoid factor; SJC: swollen joint count; TJC: tender joint count; VTE: venous thromboembolic event.
RINVOQ monotherapy data
SELECT-EARLY: Remission (primary endpoint) and low disease activity at Week 24 in MTX-naive patients1,3*
*RINVOQ is not indicated for MTX-naive patients.
†P≤0.001 vs MTX
‡P≤0.01 vs MTX
DAS28 (CRP): disease activity score with 28-joint counts (C-reactive protein); MTX: methotrexate.
Joint protection with RINVOQ monotherapy
SELECT-EARLY: Inhibition of structural joint damage progression as monotherapy in MTX-naive patients* at Week 241,3
Change in mTSS for RINVOQ vs MTX at Week 24 was a ranked secondary endpoint controlled for multiplicity. All other data shown for RINVOQ vs MTX were prespecified nonranked endpoints not controlled for multiplicity; nominal P-values are provided.
*RINVOQ is not indicated for MTX-naive patients.
†P≤0.01 vs MTX
‡P<0.001 vs MTX
§P<0.05 vs MTX
||Indicates multiplicity-controlled comparison of RINVOQ vs MTX.
LS: least squares; mTSS: modified total Sharp score; MTX: methotrexate.
SELECT-EARLY: Adverse events through 24 weeks of treatment1
*Deaths: In the methotrexate group, there was 1 sudden CV death. In the RINVOQ 15 mg group, there was 1 CV death, 1 death due to metastatic malignant melanoma.
†Herpes zoster: All nonserious, 12 were single dermatome.
‡Malignancies: In the methotrexate group, there was 1 case of ovarian cancer. In the RINVOQ 15-mg group, there was 1 metastatic malignant melanoma, 1 squamous cell carcinoma of the lung, 1 uterine carcinoma in situ.
§Major adverse cardiovascular events (adjudicated): In the methotrexate group, there was 1 CV death. In the RINVOQ 15-mg group, there was 1 nonfatal MI and 1 CV death due to other CV causes.
CV: cardiovascular; GI: gastrointestinal; MI: myocardial infarction; MTX: methotrexate.
Safety Information3
References
- van Vollenhoven R, Takeuchi T, Pangan AL, et al. Efficacy and safety of upadacitinib monotherapy in methotrexate-naïve patients with moderately to severely active rheumatoid arthritis (SELECT-EARLY): a randomized, double-blind, active-comparator, multi-center, multi-country trial. Arthritis Rheumatol. 2020;72(10):1607-1620. doi:10.1002/art.41384
- van Vollenhoven R, Takeuchi T, Pangan AL, et al. Monotherapy with upadacitinib in MTX-naive patients with rheumatoid arthritis: results at 48 weeks from the SELECT-EARLY study. Poster presented at: European Congress of Rheumatology (EULAR); June 12–15, 2019; Madrid, Spain.
- RINVOQ [Summary of Product Characteristics]. AbbVie Deutschland GmbH & Co. KG; May 2021.