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SELECT-CHOICE  - bDMARD inadequate responder patients2

A comparison of RINVOQ + csDMARD(s) to abatacept + csDMARD(s)2

RINVOQ + csDMARDs was superior to abatacept + csDMARDs in achievement of remission

(DAS28-CRP <2.6) at Week 122

 

SELECT-CHOICE: Remission rates at Week 122

Graph adapted from source material. The primary endpoint for SELECT-CHOICE of noninferiority (change in DAS28-CRP) at Week 12 was met.2

*p<0.001 RINVOQ + csDMARD(s) vs abatacept + csDMARD(s). 

bDMARD =  biological disease-modifying antirheumatic drug; CRP = C-reactive protein; csDMARD = conventional synthetic disease-modifying anti-rheumatic drug; DAS28 = disease activity score 28 joints; LDA = low disease activity; MTX = methotrexate; NRI = non-responder imputation; RA = rheumatoid arthritis; SJC = swollen joint count; TJC = tender joint count.

Study design

A Phase III study investigating the efficacy and safety of RINVOQ compared with abatacept for the treatment of moderate to severe active RA in patients who have had an inadequate response to at least one bDMARD.2

Primary endpoint
Week 12: non-inferiority vs abatacept (DAS28-CRP; change from baseline) was met.2

Patients in the RINVOQ group also received placebo IV infusions; patients in the abatacept group also received oral placebo. Patients were to continue protocol-specified stable background cDMARDs, NSAIDs, acetaminophen or oral/inhaled glucorticoids. Starting at Week 12, patients who did not have at least a 20% decrease in both TJC and SJC as compared with baseline at two consecutive visits were to have background medications adjusted/added. All patients who completed Week 24 were eligible to remain in an open-label long-term extension for up to 5 years, receiving RINVOQ 15 mg OD.

*Randomisation was stratified according to number of previous bDMARDs and geographic region.
IV abatacept administered at day 1 and Weeks 2, 4, 8, 12, 16 and 20; 500 mg in patients with a body weight of <60 kg, 750 mg in those with a weight of 60 to 100 kg and 1000 mg in those with a weight of >100kg.

Primary

RINVOQ + csDMARD(s) vs abatacept + csDMARD(s) at Week 12: Change from baseline in DAS28-CRP assessed for noninferiority

Key secondary

RINVOQ + csDMARD(s) vs abatacept + csDMARD(s) at Week 12: Superiority of RINVOQ over abatacept in change from baseline in DAS28-CRP and % of patients achieving DAS28-CRP (<2.6) remission.

  • Patients ≥18 years of age were eligible to participate
  • Diagnosis of RA for ≥3 months 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 of 3 mg/L or more)
  • Received csDMARDs for ≥3 months and on a stable dose for ≥4 weeks before study entry
  • Patients had to have been treated for >3 months prior to screening with at least 1 bDMARD but continued to exhibit active RA or had to discontinue bDMARD treatment due to intolerability or toxicity (irrespective of treatment duration)3
  • No prior exposure to a JAK inhibitor or abatacept
  • No prior history of inflammatory joint disease other than RA

 

bDMARD = biological disease-modifying antirheumatic drug; CRP = C-reactive protein; csDMARD = conventional synthetic disease-modifying anti-rheumatic drug; DAS28 = disease activity score 28 joints; EULAR = European League Against Rheumatism; hsCRP = high-sensitivity C-reactive protein; IV = intravenous; JAK = janus kinase;
MTX = methotrexate; NSAID = non-steroidal anti-inflammatory; OD = once daily; RA = rheumatoid arthritis; SJC = swollen joint count; TJC = tender joint count. 

SELECT-BEYOND  - bDMARD inadequate responder patients4

A comparison of RINVOQ + csDMARD(s) to placebo + csDMARD(s)4

RINVOQ + csDMARD(s) demonstrated a significantly greater DAS28-CRP remission rate and Lower Disease Activity rate than placebo + csDMARD(s) at Week 124,5

The primary endpoint of DAS28-CRP <3.2 RINVOQ + csDMARD(s) vs placebo + csDMARD(s) was met at Week 124

Graph adapted from source material.

*p≤0.0001 vs placebo + csDMARD(s), #nominal p<0.001 vs placebo + csDMARD(s). 

LDA is defined as DAS28-CRP ≤3.2 and remission as DAS28-CRP <2.6.

bDMARD = biological disease-modifying antirheumatic drug; CRP = C-reactive protein; csDMARD = conventional synthetic disease-modifying anti-rheumatic drug; DAS28 = disease activity score 28 joints; LDA = low disease activity.

RINVOQ + csDMARD(s) demonstrated significantly greater ACR20 and ACR50 response rates vs placebo + csDMARD(s) at Week 124

The primary endpoint of DAS28-CRP <3.2 RINVOQ + csDMARD(s) vs placebo + csDMARD(s) was met at Week 124

Graph adapted from source material.

*p<0.0001 vs placebo + csDMARD(s); ¶not significant vs placebo + csDMARD(s)

LDA is defined as DAS28-CRP ≤3.2 and remission as DAS28-CRP <2.6.

ACR20/50/70 = American College of Rheumatology ≥20 %/50%/70% improvement; bDMARD = biological disease-modifying antirheumatic drug; CRP = C-reactive protein; csDMARD = conventional synthetic disease-modifying anti-rheumatic drug; DAS28 = disease activity score 28 joints; LDA = low disease activity.

A Phase III study investigating the efficacy and safety of RINVOQ + csDMARDs compared to placebo + csDMARDs in patients with moderate to severe RA and an inadequate response to bDMARDs.4

Patients continued stable csDMARD therapy for the first 24 weeks of the study, restricted to oral or parenteral MTX, chloroquine, hydroxychloroquine, sulfasalazine, or leflunomide. Patients could be taking a maximum of 2 background csDMARDs, except the combination of MTX and leflunomide, which was not allowed.

*Randomisation was stratified by prior failed bDMARDs (1-2 with same mechanism of action vs ≥3 with the same mechanism of action or at least 2 biologics with different mechanisms of action).

Primary

RINVOQ + csDMARD(s) vs PBO + csDMARD(s) at Week 12: DAS28(CRP) ≤3.2

Key secondary

RINVOQ + csDMARD(s) vs PBO + csDMARD(s) at Week 12: % pts achieving; Change from baseline in DAS28-CRP, HAQ-DI, SF-36 PCS

  • Patients ≥18 years of age were eligible to participate
  • Diagnosis of RA for ≥3 months 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 of 3 mg/L or more)
  • Patients must have had an inadequate response for at least 3 months with at least one bDMARD or an intolerance or toxicity to bDMARDs
  • Patients were on csDMARD therapy for at least 3 months and on stable doses for at least 4 weeks before study entry
  • No prior exposure to a JAK inhibitor

 

The approved dose of RINVOQ is 15 mg once daily. Upadacitinib 30 mg OD is not an approved dose in RA.

ACR = American College of Rheumatology; bDMARD = biological disease-modifying anti-rheumatic drug; CRP = C-reactive protein; csDMARD = conventional synthetic disease-modifying anti-rheumatic drug; DAS28 = disease activity score 28 joints; EULAR = European League Against Rheumatism; HAQ-DI = Health Assessment Questionnaire Disability Index; hsCRP = high-sensitivity C-reactive protein; IV = intravenous; JAK = janus kinase; MTX = methotrexate; PBO = placebo; OD = once daily; RA = rheumatoid arthritis; SF-36 PCS = Short Form (36) Health Survey Physical Component Score; SJC = swollen joint count; TJC = tender joint count. 

Safety and Efficacy of Upadacitinib in Patients with Active Rheumatoid Arthritis Refractory to Biologic Disease-Modifying Anti-Rheumatic Drugs: A Double-Blind, Randomised Controlled Phase III Trial. Genovese et al., 2018.

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References

  1. RINVOQ (Upadactinib) SmPC.
  2. Rubbert-Roth A, Enejosa J, Pangan AL, et al. Trial of upadacitinib or abatacept in rheumatoid arthritis. N Engl J Med 2020;383(16):1511-1521.
  3. Clinicaltrials.gov A Phase 3 Study to Compare Upadacitinib to Abatacept in Subjects With Rheumatoid Arthritis on Stable Dose of Conventional Synthetic Disease-Modifying Antirheumatic Drugs (csDMARDs) Who Have an Inadequate Response or Intolerance to Biologic DMARDs (SELECT-CHOICE) Available at: https://clinicaltrials.gov/ct2/show/NCT03086343 Last accessed February 2022
  4. Genovese MC, Fleischmann R, Combe B, et al. Safety and efficacy of upadacitinib in patients with active rheumatoid arthritis refractory to biologic disease-modifying antirheumatic drugs (SELECT-BEYOND) a double-blind, randomised controlled phase 3 trial. Lancet. 2018;391(10139):2513–2524.
  5. Genovese CM, Fleischmann R, Combe B, et al. Upadacitinib (ABT-494) in Patients With Active Rheumatoid Arthritis and Inadequate Response or Intolerance to Biological DMARDs: A Phase 3 Randomized, Placebo-Controlled, Double-Blind Study of a Selective JAK-1 Inhibitor. 2017. Poster presented at the ACR Annual Meeting, November 3–8, 2017, San Diego, California, United States.

UK-UPAD-210319. Date of preparation: February 2022.

Adverse events should be reported. Reporting forms and information can be found at yellowcard.mhra.gov.uk.
Adverse events should also be reported to AbbVie on GBPV@abbvie.com