RINVOQ® (upadacitinib) Approved by European Commission as an Oral Treatment for Adults with Active Non-Radiographic Axial Spondyloarthritis

  • With this approval, RINVOQ® (upadacitinib 15 mg, once daily) is the first and only Janus Kinase (JAK) inhibitor approved to treat patients across the spectrum of axial spondyloarthritis (nr-axSpA and ankylosing spondylitis) in the European Union (EU)1
  • Approval is supported by data from the Phase 3 SELECT-AXIS 2 pivotal clinical trial in which RINVOQ delivered meaningful disease control with nearly half of nr-axSpA patients achieving ASAS40 at week 14 (45 percent versus 23 percent; p<0.0001) compared to placebo2

NORTH CHICAGO, IL, USA I July 29, 2022 I AbbVie (NYSE: ABBV) today announced that the European Commission (EC) has approved RINVOQ® (upadacitinib 15 mg, once daily), an oral therapy, for the treatment of active non-radiographic axial spondyloarthritis (nr-axSpA) in adult patients with objective signs of inflammation, as indicated by elevated C-reactive protein (CRP) and/or magnetic resonance imaging (MRI), who have responded inadequately to nonsteroidal anti-inflammatory drugs (NSAIDs).*1 

"For years, healthcare providers and patients have had limited treatment options to manage axial spondyloarthritis, which can cause back pain, stiffness, and irreversible damage to the spine," said Thomas Hudson, M.D., senior vice president of research and development, chief scientific officer, AbbVie. "AbbVie is proud to offer RINVOQ as a first-in-class treatment option now approved in the European Union for adults living with nr-axSpA with objective signs of inflammation and inadequate response to NSAIDs. RINVOQ is the first and only JAK inhibitor approved to treat patients across the spectrum of axial spondyloarthritis, which includes nr-axSpA and ankylosing spondylitis."

Axial spondyloarthritis (axSpA) is a chronic, progressive and disabling inflammatory rheumatic disease that causes joint inflammation, leading to back pain and stiffness.3,4,5 AxSpA consists of two subsets that have been clinically defined as ankylosing spondylitis (AS), also known as radiographic axial spondyloarthritis (r-axSpA), and non-radiographic axial spondyloarthritis (nr-axSpA).6 Approximately 10-40 percent of patients eventually progress from nr-axSpA to r-axSpA over a 2- to 10-year period.7

"The European Commission's approval of RINVOQ for the treatment of nr-axSpA offers physicians in the European Union an important new therapeutic option with proven efficacy in both nr-axSpA and AS patient populations," said Filip Van den Bosch, M.D.,** SELECT-AXIS 2 investigator and professor in the Department of Rheumatology at the University Hospital of Ghent University. "Living with nr-axSpA can pose many challenges and significantly impact a patient's quality of life. Early and effective disease management of patients with active nr-axSpA is key to improving health outcomes."

AbbVie previously disclosed topline results from the Phase 3 SELECT-AXIS 2 nr-axSpA clinical trial and the full results have been published in The Lancet. Study results show a significantly greater proportion of patients receiving RINVOQ 15 mg achieved an Assessment of SpondyloArthritis international Society 40 percent (ASAS40) response at week 14 (45 percent versus 23 percent; p<0.0001) compared to placebo.2 Statistical significance was also achieved in 12 of the 14 multiplicity-controlled secondary endpoints compared to placebo at week 14.2 Safety data were previously reported with no new risks identified compared to the known safety profile of RINVOQ.2 Through week 14, the proportion of patients who experienced an adverse event (AE) was similar between treatment groups (RINVOQ at 48 percent and placebo at 46 percent).2

The EC Marketing Authorization for nr-axSpA means that RINVOQ is approved in all member states of the European Union, as well as Iceland, Liechtenstein, Northern Ireland and Norway.

RINVOQ also recently received a label enhancement in the EU for the already approved indication of AS to include data on patients with active AS who had an inadequate response to biologic disease-modifying anti-rheumatic drugs (bDMARDs) based on the results of the Phase 3 SELECT-AXIS 2 clinical trial in this population, as well as two-year results of the Phase 2/3 SELECT-AXIS 1 clinical trial that evaluated AS bDMARD-naïve patients.8,9 

AbbVie previously disclosed topline results from the Phase 3 SELECT-AXIS 2 AS bDMARD-IR study, in which a significantly greater proportion of patients receiving RINVOQ 15 mg achieved an ASAS40 response at week 14 (45 percent versus 18 percent) compared to placebo.8 All 14 ranked secondary endpoints were met including those evaluating improvements from baseline in disease activity, pain (total and nocturnal back pain), function, MRI SPARCC score (spine), spinal mobility, enthesitis, and health-related quality of life.8  Safety data were previously reported with no new risks identified compared to the known safety profile of RINVOQ.8 Through week 14, the proportion of patients who experienced an AE was similar between treatment groups (RINVOQ at 41 percent and placebo at 37 percent).8

About the SELECT-AXIS 1 and SELECT-AXIS 2 trial programs2,8,9

SELECT-AXIS 1 is a Phase 2/3, multicenter, randomized, double-blind, parallel-group, placebo-controlled study designed to evaluate the safety and efficacy of RINVOQ in adult patients with active AS who are bDMARD-naïve and had inadequate response to at least two NSAIDs or intolerance to/contraindication for NSAIDs. Period 2 is an open-label extension period to evaluate the long-term safety and efficacy of RINVOQ in subjects who completed Period 1. More information on this trial can be found at www.clinicaltrialsregister.eu/ (2017-000431-14) in the EU, and at www.clinicaltrials.gov  (NCT03178487) in the U.S.

SELECT-AXIS 2 (NCT04169373) was conducted under a master protocol and includes two separate studies (SELECT-AXIS 2 AS (bDMARD-IR) study, or Study 1 and SELECT-AXIS 2 nr-axSpA study, or Study 2).

Study 1: SELECT-AXIS 2 AS (bDMARD-IR) study8

A randomized, double-blind, placebo-controlled Phase 3 trial, which evaluated the efficacy and safety of RINVOQ compared with placebo, in 420 patients with a clinical diagnosis of AS who fulfilled the modified New York criteria, had BASDAI score ≥4 and total back pain score ≥4 (based on a numerical scale of 0-10), and had an inadequate response to bDMARD therapy.

Study 2: SELECT-AXIS 2 nr-axSpA study2

A randomized, double-blind, placebo-controlled, Phase 3 trial which evaluated the efficacy and safety of RINVOQ compared with placebo, in 314 patients with a clinical diagnosis of nr-axSpA. Patients enrolled in the study had active signs of inflammation as indicated by MRI + sacroiliac joint inflammation, and/or high sensitivity C-reactive protein (hs-CRP) >upper limit of normal (2.87 mg/L) at screening, and who had BASDAI score ≥4 and a total back pain score ≥4 (based on a numerical scale of 0-10).

More information on the SELECT-AXIS 2 program is available at https://www.clinicaltrialsregister.eu/ (2019-003229-12) in the EU, and at www.clinicaltrials.gov (NCT04169373) in the U.S.

About Axial Spondyloarthritis (axSpA)

Axial spondyloarthritis is a chronic inflammatory disease that affects the spine, causing back pain, limited mobility, and structural damage.6 It consists of two subsets that have been clinically defined as radiographic axial SpA (ankylosing spondylitis) and non-radiographic axial spondyloarthritis (nr-axSpA).6 In ankylosing spondylitis, patients have definitive structural damage of the sacroiliac joints visible on X-rays. Non-radiographic axial spondyloarthritis is clinically defined by the absence of definitive X-ray evidence of structural damage to the sacroiliac (SI) joint by plain X-ray.6 

About RINVOQ® (upadacitinib)1  
Discovered and developed by AbbVie scientists, RINVOQ is a selective JAK inhibitor that is being studied in several immune-mediated inflammatory diseases. In human cellular assays, RINVOQ preferentially inhibits signaling by JAK1 or JAK1/3 with functional selectivity over cytokine receptors that signal via pairs of JAK2. 

In the EU, RINVOQ is approved for the treatment of adults with moderate to severe active rheumatoid arthritis who have responded inadequately to, or who are intolerant to one or more disease-modifying anti-rheumatic drugs; for the treatment of active psoriatic arthritis (PsA) in adult patients who have responded inadequately to, or who are intolerant to one or more DMARDs; for the treatment of active non-radiographic axial spondyloarthritis in adult patients with objective signs of inflammation as indicated by elevated CRP and/or MRI, who have responded inadequately to NSAIDs; for the treatment of active ankylosing spondylitis (AS) in adult patients who have responded inadequately to conventional therapy; for adults (15 mg and 30 mg) and adolescents (15 mg) with moderate to severe atopic dermatitis; and for the treatment of adult patients with moderately to severely active ulcerative colitis (UC) who have had an inadequate response, lost response or were intolerant to either conventional therapy or a biologic agent.1

Phase 3 trials of RINVOQ in atopic dermatitis, axial spondyloarthritis, Crohn's disease, giant cell arteritis and Takayasu arteritis are ongoing.10,11,12,13,14,15

EU Indications and Important Safety Information about RINVOQ® (upadacitinib)1

Indications

Ulcerative colitis

RINVOQ is indicated for the treatment of adult patients with moderately to severely active ulcerative colitis (UC) who have had an inadequate response, lost response or were intolerant to either conventional therapy or a biologic agent.

Rheumatoid arthritis

RINVOQ is indicated for the treatment of moderate to severe active rheumatoid arthritis (RA) in adult patients who have responded inadequately to, or who are intolerant to one or more disease-modifying anti-rheumatic drugs (DMARDs). RINVOQ may be used as monotherapy or in combination with methotrexate.

Psoriatic arthritis

RINVOQ is indicated for the treatment of active psoriatic arthritis (PsA) in adult patients who have responded inadequately to, or who are intolerant to one or more DMARDs. RINVOQ may be used as monotherapy or in combination with methotrexate.

Axial spondyloarthritis

Non-radiographic axial spondyloarthritis (nr-axSpA) 
RINVOQ is indicated for the treatment of active non-radiographic axial spondyloarthritis in adult patients with objective signs of inflammation as indicated by elevated C-reactive protein (CRP) and/or magnetic resonance imaging (MRI), who have responded inadequately to nonsteroidal anti-inflammatory drugs (NSAIDs). 

Ankylosing spondylitis (AS, radiographic axial spondyloarthritis) 
RINVOQ is indicated for the treatment of active ankylosing spondylitis in adult patients who have responded inadequately to conventional therapy. 

Atopic dermatitis

RINVOQ is indicated for the treatment of moderate to severe atopic dermatitis (AD) in adults and adolescents 12 years and older who are candidates for systemic therapy.

See RINVOQ full summary of product characteristics (SmPC) atwww.ema.europa.eu/en.

Globally, prescribing information varies; refer to the individual country product label for complete information.

About AbbVie in Rheumatology
For more than 20 years, AbbVie has been dedicated to improving care for people living with rheumatic diseases. Our longstanding commitment to discovering and delivering transformative therapies is underscored by our pursuit of cutting-edge science that improves our understanding of promising new pathways and targets in order to help more people living with rheumatic diseases reach their treatment goals. For more information on AbbVie in rheumatology, visit https://www.abbvie.com/our-science/therapeutic-focus-areas/immunology/immunology-focus-areas/rheumatology.html.

About AbbVie
AbbVie's mission is to discover and deliver innovative medicines 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, eye care, virology, women's health and gastroenterology, in addition to products and services across its Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on Twitter, Facebook, Instagram, YouTube and LinkedIn.

*This recommendation is without prejudice to the final conclusions of the ongoing referral procedure under Article 20 of Regulation (EC) No 726/2004 resulting from pharmacovigilance data.

**Dr. Van den Bosch is a consultant and advisor for AbbVie.

References:

1 AbbVie, Ltd. RINVOQ (upadacitinib) [summary of product characteristics]. https://www.ema.europa.eu/en/documents/product-information/rinvoq-epar-product-information_en.pdf. Accessed July 28, 2022.

2 Deodhar, A, et al. Efficacy and Safety of Upadacitinib in Patients with Active Non-Radiographic Axial Spondyloarthritis: a Double-Blind, Randomized, Placebo-Controlled Phase 3 Trial. EULAR 2022 Congress; 2534.

3 Crossfield SSR, Marzo-Ortega H, Kingsbury SR, et al. Changes in ankylosing spondylitis incidence, prevalence and time to diagnosis over two decades.  RMD Open 2021;7:e001888. doi: 10.1136/rmdopen-2021-001888.

4 Mayo Clinic. Ankylosing Spondylitis. 2019. Available at: https://www.mayoclinic.org/diseases-conditions/ankylosing-spondylitis/symptoms-causes/syc-20354808. Accessed June 2022.

5 Dean, LE, et al. Global prevalence of ankylosing spondylitis. Rheumatology (Oxford). 2014 Apr;53(4):650-7. doi: 10.1093/rheumatology/ket387. Epub 2013

6 Deodhar AA, Understanding Axial Spondyloarthritis: A Primer for Managed Care. Am J Manag Care. 2019;25:S319-S330.

7 Protopopov M, Poddubnyy D. Radiographic progression in non-radiographic axial spondyloarthritis. Expert Rev Clin Immunol. 2018;14(6):525-533.

8 Van der Heijde, D, et al. Efficacy and Safety of Upadacitinib in Patients With Active Ankylosing Spondylitis Refractory to Biologic Therapy: a Double-Blind, Randomized, Placebo-Controlled Phase 3 Trial. EULAR 2022 Congress; 2518.

9 Van der Heijde D, et al. Efficacy and Safety of Upadacitinib in Patients with Active Ankylosing Spondylitis: 2-Year Results from a Randomized, Double-Blind, Placebo-Controlled Study with Open-Label Extension [abstract]. Arthritis Rheumatol. 2021; 73 (suppl 10).

10 Evaluation of Upadacitinib in Adolescent and Adult Patients With Moderate to Severe Atopic Dermatitis (Eczema) (Measure Up 1). ClinicalTrials.gov. 2021. Available at: https://clinicaltrials.gov/ct2/show/NCT03569293. Accessed June 2022.

11 A Study to Evaluate Efficacy and Safety of Upadacitinib in Adult Participants With Axial Spondyloarthritis (SELECT-AXIS 2). ClinicalTrials.gov. 2021. Available at: https://clinicaltrials.gov/ct2/show/NCT04169373. Accessed June 2022.

12 A Study of the Efficacy and Safety of Upadacitinib (ABT-494) in Participants With Moderately to Severely Active Crohn's Disease Who Have Inadequately Responded to or Are Intolerant to Biologic Therapy. ClinicalTrials.gov. 2021. Available at: https://clinicaltrials.gov/ct2/show/NCT03345836. Accessed June 2022.

13 A Study to Evaluate the Safety and Efficacy of Upadacitinib (ABT-494) for Induction and Maintenance Therapy in Participants With Moderately to Severely Active Ulcerative Colitis (UC). ClinicalTrials.gov. 2021. Available at: https://clinicaltrials.gov/ct2/show/NCT02819635. Accessed June 2022.

14 A Study to Evaluate the Safety and Efficacy of Upadacitinib in Participants With Giant Cell Arteritis (SELECT-GCA). ClinicalTrials.gov. 2021. Available at: https://clinicaltrials.gov/ct2/show/NCT03725202. Accessed June 2022.

15 A Study to Evaluate the Efficacy and Safety of Upadacitinib in Subjects With Takayasu Arteritis (TAK) (SELECT-TAK). ClinicalTrials.gov. 2021. Available at: https://clinicaltrials.gov/ct2/show/NCT04161898. Accessed June 2022.

SOURCE: AbbVie

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