RINVOQ® (upadacitinib) Demonstrated Superiority Versus HUMIRA® (adalimumab) for Primary Endpoint in a Head-to-Head Study in Rheumatoid Arthritis Patients Who Have Failed First TNF inhibitor Français
- Upadacitinib demonstrated superiority versus adalimumab for primary endpoint of achieving low disease activity (DAS28-CRP ≤3.2) and ranked secondary endpoint of remission (DAS28-CRP <2.6) at week 121
- SELECT-SWITCH is the first Phase 3b/4 head-to-head trial comparing TNF inhibitor cycling with switching to upadacitinib in adults with moderate to severe rheumatoid arthritis and inadequate response or intolerance to a TNF inhibitor1
- The safety profile for upadacitinib was consistent with previously reported studies, with no new safety risks identified in the 12-week period1,2
- The SELECT-SWITCH study results were recently published in Annals of the Rheumatic Diseases1.
MONTREAL, April 28, 2026 /CNW/ - Today, AbbVie (NYSE: ABBV) announced positive topline results from the Phase 3b/4 head-to-head SELECT-SWITCH study evaluating the efficacy and safety of upadacitinib (RINVOQ®) 15 mg, once daily, compared to adalimumab (HUMIRA®) 40 mg, every other week, in adult patients with moderate to severe rheumatoid arthritis (RA) on a stable background of methotrexate (MTX) who had an inadequate response or intolerance to a TNF inhibitor (TNFi) other than adalimumab.1 This study achieved the primary endpoint and the majority of ranked secondary endpoints at week 12 with no new safety risks identified.1 The manuscript of the study is available on Annals of the Rheumatic Diseases.
"SELECT-SWITCH is the first head-to-head trial comparing TNF inhibitor cycling with switching to the JAK inhibitor upadacitinib," said lead study investigator Eduardo Mysler, M.D., rheumatologist and executive medical director, Organización Medica de Investigación, Argentina. "Upadacitinib demonstrated superiority in achieving low disease activity and remission at week 12 in nearly twice as many patients compared to adalimumab, providing clinicians with evidence-based guidance for those who need an alternative approach after failure or intolerance of initial TNF inhibitor therapy."
"The SELECT-SWITCH study contributes meaningful head-to-head evidence that is highly relevant to the Canadian rheumatology community" said Dr. Louis Bessette, MD, FRCP(C), MSc. "These findings help inform treatment strategies following TNF inhibitor failure and reinforce the need for individualized approaches to improve outcomes for patients across Canada".
A significantly higher proportion of patients who received upadacitinib achieved low disease activity (defined as Disease Activity Score 28 C-reactive Protein [DAS28-CRP] ≤3.2; primary endpoint) and remission (defined as DAS28-CRP <2.6; ranked secondary endpoint) compared to adalimumab at week 12. Upadacitinib also demonstrated superiority versus adalimumab for additional ranked secondary endpoints measured at week 12.1
- 43.3% of patients receiving upadacitinib achieved DAS28-CRP≤3.2 compared to 22.4% of patients on adalimumab (p<0.001)
- 28.4% of patients receiving upadacitinib achieved DAS28-CRP<2.6 compared to 14.5% of patients on adalimumab (p<0.001)
Treatment guidelines establish remission as the optimal treatment goal in RA, yet more than half of patients fail to achieve remission, even on advanced therapies.3-5 As longer disease duration is associated with a reduced likelihood of achieving remission, it is important to optimize treatment strategies as early as possible in the disease course.6 TNFis are the most common first-line targeted therapy in RA, and switching to a second TNFi is highly prevalent in clinical practice, despite limited evidence on the efficacy of TNFi cycling compared to switching to a different mode of action after the first TNFi failure.7-15
"These positive findings add to the expanding body of evidence supporting the switch to a new mechanism of action for patients who experience an inadequate response or intolerance to a first TNF inhibitor," said Stephanie Sauvageau, Head of Medical Affairs, AbbVie Canada. "For individuals living with RA, the primary treatment goal is to achieve remission or maintain low disease activity, and this study shows that there are options that can deliver these outcomes for many patients."
The safety profile for upadacitinib and adalimumab in this study were consistent with previously reported studies; with no new safety risks identified in the 12-week period.1,2,16 The most frequently reported treatment emergent AEs (≥ 3%) in any treatment group were urinary tract infection, nasopharyngitis and RA (worsening).1 Rates of serious adverse events were generally balanced across the treatment groups, occurring in 2.4% of patients treated with adalimumab and 2.0% of patients treated with upadacitinib. One malignancy was reported in each group. No adjudicated venous thromboembolism, major adverse cardiovascular event or deaths were observed.1
About Rheumatoid Arthritis
Affecting more than 17 million people worldwide, rheumatoid arthritis is a complex, systemic autoimmune disease that occurs when the immune system mistakenly attacks joints, creating inflammation that causes the tissue inside of joints to thicken, damaging the bones and associated connective tissue.17-19 Pain, fatigue and stiffness are among the signs and symptoms of rheumatoid arthritis that can have an impact on daily living.20 If not properly treated, rheumatoid arthritis can lead to permanent, debilitating bone and cartilage damage.
About SELECT - SWITCH (M23-700)
SELECT-SWITCH is a Phase 3b/4 multicenter, randomized, double-blind, double-dummy, active comparator-controlled study, comparing the efficacy and safety of upadacitinib versus adalimumab in 492 adult patients with moderate to severe rheumatoid arthritis on a stable background of methotrexate (MTX) and who had an inadequate response or intolerance to a single TNF inhibitor (TNFi) other than adalimumab. The study comprises a 35-day screening period, a 12-week randomized, double-blind, double-dummy, active comparator-controlled (Period 1), followed by a 36-week blinded extension period (Period 2). Participants were randomized 1:1 to receive upadacitinib (15 mg once daily orally) + MTX versus adalimumab (40 mg subcutaneously every other week) + MTX. Eligible patients continue to receive the same study treatment in Period 2 as assigned in Period 1, up to 48 weeks. The primary endpoint of the study is the percentage of participants achieving low disease activity, defined as Disease Activity Score 28 C-reactive protein [DAS28-CRP]) ≤3.2 at the end of Period 1 (Week 12). More information on this trial can be found at https://clinicaltrials.gov/study/NCT05814627.
About the SELECT Study Program
The robust SELECT Phase 3 rheumatoid arthritis program has evaluated more than 4,900 patients with moderate to severe rheumatoid arthritis in six studies. The studies include assessments of efficacy, safety and tolerability across multiple rheumatoid arthritis patient populations, including in patients with prior non-response to advanced therapies.21-23 Key measures of efficacy evaluated include ACR responses, Disease Activity Score (DAS28-CRP), patient-reported outcomes and inhibition of radiographic progression. More information on these trials can be found at www.clinicaltrials.gov (NCT02675426, NCT02706873, NCT02629159, NCT03086343, NCT02706847, NCT02706951).
About RINVOQ® (upadacitinib)
Discovered and developed by AbbVie scientists, RINVOQ is a once-daily oral medication in an extended-release tablet. It is a Janus kinase (JAK) inhibitor that interferes with the JAK-STAT signaling pathway, which is thought to play a role in inflammatory response.
RINVOQ is approved in Canada for the following indications:
- For adults with moderately to severely active rheumatoid arthritis (RA);
- For adults with active psoriatic arthritis (PsA);
- For adults and adolescents 12 years of age and older with refractory moderate to severe atopic dermatitis (AD);
- For adults with active ankylosing spondylitis (AS);
- For adults with active non-radiographic axial spondyloarthritis (nr-axSpA);
- For adults with moderately to severely active ulcerative colitis (UC);
- For adults with moderately to severely active Crohn's disease (CD); and
- For adults with giant cell arteritis (GCA).
For important safety information, please consult the RINVOQ Product Monograph at www.abbvie.ca.
About AbbVie in Rheumatology
For more than 20 years, AbbVie has been dedicated to improving care for people living with rheumatic diseases. Anchored by a longstanding commitment to discovering and delivering transformative therapies, we pursue cutting-edge science that improves our understanding of promising new pathways and targets, ultimately helping more people living with rheumatic diseases reach their treatment goals.
About AbbVie
AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas – immunology, oncology, neuroscience, and eye care – and products and services in our Allergan Aesthetics portfolio.
For more information about AbbVie, please visit us at www.abbvie.ca. Follow AbbVie Canada on Instagram or find us on LinkedIn.
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SOURCE AbbVie Canada
Media Inquiries: Hind Mahreche, AbbVie Canada, 514-348-8175, [email protected]
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