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SELECT-MONOTHERAPY - MTX inadequate responder patients2

A comparison of RINVOQ to cMTX2

RINVOQ monotherapy provides significant improvements in clinical and functional outcomes vs cMTX2

SELECT-MONOTHERAPY: Remission rates at Week 14 (NRI)2

SELECT-MONOTHERAPY: Remission rates at Week 84 (NRI)3†

Graph adapted from source material. The primary endpoint of SELECT-MONOTHERAPY was low disease activity (DAS28-CRP ≤3.2) at Week 14: 45% of patients on RINVOQ 15 mg OD met LDA, compared with 19% of cMTX-treated patients (p≤0.0001). The primary endpoint was met.2

DAS28-CRP <2.6 at Week 14 was a secondary endpoint.

From Week 14, patients initially randomised to cMTX at baseline were switched to RINVOQ 15 mg per prespecified randomisation assignment. Patients who switched from MTX to RINVOQ were included in the RINVOQ analysis set from the start of RINVOQ treatment.3 Response rates at Week 84 were consistent using NRI analyses.

*p≤0.0001 RINVOQ 15 mg OD vs cMTX.2
nominal p=NS RINVOQ 15 mg OD vs cMTX to RINVOQ 15 mg OD.

ACR/EULAR definition of remission. At any timepoint, a patient must satisfy all of the following: TJC ≤1, SJC ≤1, CRP ≤1 mg/dL and PGA ≤1 (on a 0 to 10 scale).

CDAI = clinical disease activity index; cMTX = continued methotrexate; CRP = C-reactive protein; DAS28 = disease activity score 28 joints; LDA = low disease activity; MTX = methotrexate; NRI = non-responder imputation; NS = not significant; PGA = patient global assessment; OD = once daily; RA = rheumatoid arthritis; SDAI = simplified disease activity index; SJC = swollen joint count; TJC = tender joint count.

RINVOQ monotherapy demonstrated improvements in HAQ-DI vs cMTX at Week 142

SELECT-MONOTHERAPY: HAQ-DI LS mean change from baseline at Week 142

Improvement in HAQ-DI is a reduction in score.

Graphs adapted from source material. The primary endpoint of SELECT-MONOTHERAPY was low disease activity (DAS28-CRP ≤3.2) at Week 14: 45% of patients on RINVOQ 15 mg OD met LDA, compared with 19% of cMTX-treated patients (p≤0.0001). The primary endpoint was met.2

HAQ-DI is a secondary endpoint.

*p<0.001 RINVOQ 15 mg OD vs cMTX.2

cMTX = continued methotrexate; CRP = C-reactive protein; DAS28 = disease activity score 28 joints; HAQ-DI = health assessment questionnaire disability index; LDA = low disease activity; MTX = methotrexate; OD = once daily; RA = rheumatoid arthritis.

SELECT-MONOTHERAPY: SF-36 domain scores at Week 144

p<0.001 RINVOQ vs MTX all domains

The 36-Item Short Form Health Survey (SF-36) consists of two aggregate [Physical (PCS) and Mental Component Summary (MCS)] scores based on eight domains, measured on a scale of 0-100 where a higher score indicates better health.4

For SF-36(PCF) RINVOQ showed statistically significant improvements from baseline vs MTX at Week 14 (8.3 vs 4.3, p<0.01).

Individual SF-36 scores were not prespecified endpoints, so the p values are descriptive only.

Domains include:

  • PF, physical functioning
  • RP, role-physical
  • BP,  bodily pain
  • GH, general health
  • VT, vitality
  • SF, social functioning
  • RE, role-emotional
  • MH, mental health

The primary endpoint of SELECT-MONOTHERAPY was low disease activity (DAS28-CRP ≤3.2) at Week 14: 45% of patients on RINVOQ 15 mg OD met LDA, compared with 19% of cMTX-treated patients (p≤0.0001). The primary endpoint was met.2

cMTX = continued methotrexate; CRP = C-reactive protein; DAS28 = disease activity score 28 joints; LDA = low disease activity; MTX = methotrexate.

A Phase III study investigating the efficacy and safety of RINVOQ monotherapy after switching from MTX compared with cMTX for the treatment of moderate to severe RA in patients who had an inadequate response to MTX 2

Upadacitinib 30 mg OD is not an approved dose in RA.

*For the primary analysis at Week 14, comparisons of RINVOQ 15 mg and upadacitinib 30 mg vs cMTX were done by combining data from the two cMTX groups. 
From Week 14, patients initially randomized to cMTX at baseline were switched to RINVOQ 15 mg or upadacitinib 30 mg per prespecified randomisation assignment.

Primary

RINVOQ vs cMTX at Week 14: DAS28-CRP ≤3.2

Key secondary

RINVOQ vs cMTX at Week 14: % of pts achieving DAS28-CRP <2.6; Changes from baseline in DAS28-CRP, HAQ-DI, SF-36 PCS, morning stiffness duration

  • 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 more than 3 mg/L hsCRP)
  • Patients must have had an inadequate response to MTX
  • No prior exposure to a JAK inhibitor or bDMARD

ACR = American College of Rheumatology; bDMARD = biological disease-modifying antirheumatic drug; CRP = C-reactive protein; DAS28 = disease activity score 28 joints; EULAR = European League Against Rheumatism; HAQ-DI = Health Assessment Questionnaire Disability Index; hsCRP = high-sensitivity C-reactive protein; JAK = janus kinase; MTX = methotrexate; PBO = placebo; OD = once daily; SF-36 PCS = Short Form (36) Health Survey Physical Component Score.

Upadacitinib as Monotherapy in Patients with Active Rheumatoid Arthritis and Inadequate Response to Methotrexate: a Randomized, Placebo-Controlled, Double-Blind Phase III Study. Smolen et al., 2019.

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References

  1. RINVOQ (Upadactinib) SmPC.
  2. 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 (and supplementary appendix). Lancet. 2019;393(10188):2303–2311.
  3. Smolen JS, 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. Presented at the European Congress of Rheumatology, 3-6 June, 2020.
  4. Strand V, Tundia N, Wells A, et al. Upadacitinib monotherapy improves patient-reported outcomes in rheumatoid arthritis: results from SELECT-EARLY and SELECT-MONOTHERAPY. Rheumatology, Volume 60, Issue 7, July 2021, Pages 3209–3221,
    https://doi.org/10.1093/rheumatology/keaa770.

UK-UPAD-210318. Date of preparation: January 2022.

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Adverse events should also be reported to AbbVie on GBPV@abbvie.com