NICE recommends upadacitinib as treatment for severe rheumatoid arthritis

NICE recommends upadacitinib as treatment for severe rheumatoid arthritis

The National Institute for Health and Care Excellence (NICE) has issued a positive Final Appraisal Determination (FAD) recommending upadacitinib, a once-daily oral therapy, for people with previously treated severe active rheumatoid arthritis (RA).1 The decision means that people with severe RA may now benefit from upadacitinib, which is the only treatment to have demonstrated improved rates of clinical remission* versus the current standard of care in the treatment of the disease (adalimumab + MTX).2

In its guidance, NICE recommends upadacitinib, in combination with methotrexate for people with severe active RA, where their disease has responded inadequately to, or they are intolerant to at least two conventional disease-modifying anti-rheumatic drugs (DMARDs). Where methotrexate cannot be tolerated or is contraindicated, upadacitinib is recommended as monotherapy.*1 The publication of this guidance ensures these patients are able to access upadacitinib without delay, whilst NICE continues its evaluation of upadacitinib for the treatment of moderate active RA as a separate Single Technology Appraisal (STA).

As a once daily tablet, upadacitinib works inside cells to block certain signals that cause an overreaction of the immune system and the inflammation which causes damage to the joints in RA.[x] Its recommendation by NICE is based on data from the global Phase 3 SELECT rheumatoid arthritis clinical trial programme which evaluated the efficacy, safety and tolerability  of upadacitinib in patients with moderate to severe active rheumatoid arthritis in five pivotal studies.2-6

Professor Chris Edwards, Consultant Rheumatologist and Honorary Chair of Clinical Rheumatology, University Hospital Southampton NHS Foundation Trust said: “This recommendation from NICE is very welcome news and means that eligible patients with severe disease now have another treatment option. In clinical trials upadacitinib appears able to induce disease remission in some patients, even when their RA has not responded adequately to previous treatments like methotrexate or anti-TNF therapy”.

Clare Jacklin, Chief Executive of the National Rheumatoid Arthritis Society (NRAS), said: “NRAS welcomes the news that upadacitinib has been approved for treating people living with severe RA. Rheumatoid arthritis is a complex auto-immune condition which can affect people in different ways. Therefore, treatment cannot be a one size fits all approach. It is essential that physicians have an array of medications available to enable them to tailor treatment to an individual patient’s disease type and that there is continued investment in research and innovative medicines for RA.”

Commenting on the recommendation, Belinda Byrne, Medical Director at AbbVie UK, said “We are pleased that the Committee has recognised the value that upadacitinib can bring to those with severe RA. We remain committed to working with NICE through what it has explained will now be a separate STA for upadacitinib in the treatment of moderate RA. We are optimistic that we can also reach a positive reimbursement decision for these patients, who have significant burden of disease but limited treatment options currently.”


[i] NICE. Final Appraisal Document. Upadacitinib for treating severe rheumatoid arthritis . Available at

[ii] Fleischmann R, et al. Upadacitinib versus Placebo or Adalimumab in Rheumatoid Arthritis: Results of a Phase 3, Double-Blind, Randomized Controlled Trial. Arthritis Rheumatol. 2019 Nov;71(11):1788-1800. doi: 10.1002/art.41032. Epub 2019 Aug 2

[iii] Burmester GR, et al; Safety and efficacy of upadacitinib in patients with rheumatoid arthritis and inadequate response to conventional synthetic disease-modifying anti-rheumatic drugs (SELECT-NEXT): a randomised, double-blind, placebo-controlled phase 3 trial. Lancet. 2018 Jun 23;391(10139):2503-2512. doi: 10.1016/S0140-6736(18)31115-2. Epub 2018 Jun 18

[iv] Smolen JS, et al. A Phase 3 Randomised, Placebo-controlled, Double-Blind Study of Upadacitinib as Monotherapy in Patients with Active Rheumatoid Arthritis and Inadequate Response to Methotrexate: SELECT-MONOTHERAPY. Lancet. 2019 Jun 29;393(10191):2590. doi: 10.1016/S0140-6736(19)31474-6. Epub 2019 Jun 27.

[v] van Vollenhoven R. Efficacy and Safety of Upadacitinib Monotherapy in Methotrexate-naïve Patients with Moderately to Severely Active Rheumatoid Arthritis (SELECT-EARLY): A Randomized, Double-blind, Active-comparator, Multi-center, Multi-country Trial. Arthritis & Rheumatology. 2020. doi: 10.1002/art.41384

[vi] Genovese MC, et al. Safety and efficacy of upadacitinib in patients with active rheumatoid arthritis refractory to biologic disease-modifying anti-rheumatic drugs (SELECT-BEYOND): a double-blind, randomised controlled phase 3 trial. Lancet. 2018 Jun 23;391(10139):2513-2524. doi: 10.1016/S0140-6736(18)31116-4. Epub 2018 Jun 13

[vii] NICE. Adalimumab, etanercept, infliximab, certolizumab pegol, golimumab, tocilizumab and abatacept for rheumatoid arthritis not previously treated with DMARDs or after conventional DMARDs only have failed (TA375). January 2016

[viii] Bergstra SA et al. Inequity in access to bDMARD care and how it influences disease outcomes across countries worldwide: results from the METEOR-registry Ann Rheum Dis. 2018; 77:1413-1420

[ix] Monti S, et al. Rheumatoid arthritis treatment: the earlier the better to prevent joint damage. RMD Open. 2015;1(Suppl1):e000057.

[x] RINVOQ 15 mg prolonged-release tablets SMPC,

[xi] Committee for Medicinal Products for Human Use (CHMP). 17 October 2019. EMA/CHMP/521394/2019

[xii] Taylor P, et al. A structured literature review of the burden of illness and unmet needs in patients with rheumatoid arthritis: A  current perspective. Rheum Int. 2016;36:685-95

[xiii] The State of Musculoskeletal Health. Versus Arthritis. 2019. Available at:

[xiv]. Mayo Clinic. Rheumatoid arthritis Patient Factsheet. Available at: Last accessed 20.10.20

[x] RINVOQ 15 mg prolonged-release tablets SMPC,