NICE Recommends RINVOQ®▼(upadacitinib) As A Treatment Option For Active Ankylosing Spondylitis (AS) In Adults

NICE Recommends RINVOQ^®▼(upadacitinib) As A Treatment Option For Active Ankylosing Spondylitis (AS) In Adults

• Publication of a positive Final Appraisal Document (FAD) means RINVOQ^®▼(upadacitinib) will be available in England and Wales as a treatment option for active ankylosing spondylitis in adults that is not controlled well enough with conventional therapy, only if tumour necrosis factor (TNF)-alpha inhibitors are not suitable or do not control the condition well enough^[i]
• AS is a chronic, inflammatory musculoskeletal disease primarily affecting the spine and characterised by debilitating symptoms of pain, limited mobility, structural damage and fatigue^[ii]
• There is a high un-met medical need in AS, particularly in patients who have an inadequate response to bDMARDs. Effective oral treatment options other than non-steroidal anti-inflammatory drug (NSAIDs) are scarce.

MAIDENHEAD, UK, 17 AUGUST 2022 – The National Institute for Health and Care Excellence (NICE) has issued a positive Final Appraisal Document (FAD) recommending upadacitinib 15 mg prolonged release tablet, a once-daily oral therapy, as an option for treating active ankylosing spondylitis in adults, which is not controlled well enough with conventional therapy.¹

In AS, changes to the sacroiliac joints or the spine can be seen on X-ray. AS is a painful, progressive form of inflammatory arthritis mainly affecting the spine, but which can also affect other joints, tendons and ligaments.²  Typical symptoms include slow or gradual onset of back pain and stiffness over weeks or months. The current average delay to diagnosis from when symptoms start is 8.5 years, by which time irreversible damage to the spine may have occurred.² AS or radiological axial SpA (axSpA) is more frequently diagnosed in men compared with women (3:1).^[iii]

This NICE recommendation is based on data from the pivotal SELECT-AXIS 1^[iv] and 2 clinical trials.^[v] There are an estimated 33,000 – 154,000 adults with AS in the UK.²  NICE’s recommendation follows the granting of Marketing Authorisation for upadacitinib in AS in January 2021.^[vi]

Professor Raj Sengupta, Consultant Rheumatologist and Clinical Lead for Axial Spondyloarthritis, from Royal United Hospitals, Bath commented, “AS is a progressive disease and without effective treatment can lead to increasing pain and loss of function. Treating AS as early as possible is key to maintaining a good quality of life. This recommendation from NICE is welcome news which will provide an additional treatment option to help people gain control of their AS.”

Dale Webb, Chief Executive, the National Axial Spondyloarthritis Society (NASS) said, "We see the impact that this disease and delays in receiving appropriate care can have every day. We welcome this decision by NICE. The availability of more treatment options for AS has the potential to change the lives of people with AS and their families.”

Commenting on the recommendation, Belinda Byrne, Medical Director at AbbVie UK, said, “We are pleased that by working closely with NICE, we have been able to demonstrate the value that upadacitinib can bring to patients with AS. For over 20 years, we have been dedicated to improving the outcomes of people with AS and other immune-mediated diseases.” 

The decision expands access to upadacitinib for people living with inflammatory musculoskeletal conditions in England and Wales: NICE previously granted a positive recommendation as a treatment option for upadacitinib in severe active rheumatoid arthritis (RA) in 2020^[vii], moderate RA in 2021^[viii] and Psoriatic arthritis (PsA) in 2022.^[ix]

The publication of this guidance as a Fast Track Appraisal comes after AbbVie engaged with NICE and the clinical and patient communities to demonstrate the clinical benefit and value of upadacitinib in AS.

[i] NICE Rinvoq AS FAD – Upadacitinib for treating active ankylosing spondylitis [ID3848]

[ii] NASS. What is AS? Available from: https://nass.co.uk/about-as/what-is-as/ [Last accessed: August 2022]

[iii] Rusman T, Bentum RE, van der Horst-Bruinsma I. Sex and gender differences in axial spondyloarthritis: myths and truths. Rheumatology, Volume 59, Issue Supplement_4, October 2020, Pages iv38–iv46

[iv] Van der Heijde D, et al. Efficacy and safety of upadacitinib in patients with active ankylosing spondylitis (SELECT-AXIS 1): a multicentre, randomised, double-blind, placebo-controlled, phase 2/3 trial. Lancet. 2019 Dec 7;394(10214):2108-2117. doi: 10.1016/S0140-6736(19)32534-6. Epub 2019 Nov 12.

[v] Deodhar A, et al.  Upadacitinib for the treatment of active non-radiographic axial spondyloarthritis (SELECT-AXIS 2): a randomised, double-blind, placebo-controlled, phase 3 trial. Lancet 2022; 400: 369–79

[vi] RINVOQ (upadacitinib) Summary of Product Characteristics. Available at: https://www.medicines.org.uk/emc/product/10972 [Last Accessed: August 2022]

[vii] Upadacitinib for treating severe rheumatoid arthritis. Technology appraisal guidance [TA665] Published: 09 December 2020 https://www.nice.org.uk/guidance/ta665/ [Last Accessed: August 2022]

[viii] Upadacitinib for treating moderate rheumatoid arthritis. Technology appraisal guidance [TA744] Published: 10 November 2021.  https://www.nice.org.uk/guidance/ta744 / [Last Accessed: August 2022]

[ix] NICE. Upadacitinib for treating active psoriatic arthritis after inadequate response to DMARDs. Available from: https://www.nice.org.uk/guidance/ta768 [Last Accessed: August 2022]