- Positive indication means upadacitinib will be available to those with previously treated severe active RA[i]*
- SMC approval is based on data from pivotal Phase 3 SELECT clinical trial programme, in which upadacitinib demonstrated improved rates of clinical remission** compared to treatment with placebo; methotrexate (MTX) monotherapy; and adalimumab (TNF antagonist) plus MTX in patients with severe RA [ii][iii],[iv],[v],-[vi]
- For the majority of people living with RA, remission is not currently achieved.[vii]An estimated 44,000 people in the Scotland live with RA[viii].
The Scottish Medicines Consortium (SMC) has issued a positive decision recommending treatment by NHS Scotland with upadacitinib. Upadacitinib is a janus kinase inhibitor (JAKi) which is a once-daily oral therapy, for people with previously treated severe active RA. The decision means people in Scotland with severe RA may now benefit from upadacitinib with or without MTX.1 Upadacitinib combined with MTX is the only JAKi to consistently demonstrate improved rates of remission** compared to the current standard of care (adalimumab + MTX) across multiple remission measures with significance maintained over time (up to 72 weeks).1,2
In its guidance, the SMC recommends upadacitinib as monotherapy or in combination with MTX, for people with severe active RA, where their disease has not responded to intensive therapy with a combination of conventional disease-modifying anti-rheumatic drugs (DMARDs) and in patients with severe disease inadequately controlled by a TNF antagonist in whom rituximab is not appropriate.1* The publication of this guidance ensures these patients are able to access upadacitinib without delay via NHS Scotland.
There are around 44,000 people in Scotland living with RA.8 RA is a progressive autoimmune disease in which the immune system attacks the lining of the joints, causing inflammation and symptoms such as pain, fatigue, and stiffness.[ix] Although there is no cure for RA, advances in treatment have made clinical remission possible for more people living with the disease.[x] Being in remission reduces disability and improves quality of life but is only achieved for an estimated 26% of patients in the UK currently.10,7
Dr Martin Perry, Consultant Rheumatologist, Royal Alexandra Hospital Glasgow commented:
“This is a welcome decision from the SMC which means another treatment option will be available for those with severe active RA in Scotland. Clinical studies have shown that upadacitinib can achieve increased rates of disease remission in patients compared to the current standard of care in Scotland. This is great news for patients, bringing the possibility of remission within reach”.
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 in Scotland. RA is a complex auto-immune condition which can affect people in different ways. It is important that physicians have an array of medications available to enable them to tailor treatment to an individual patient’s disease type and needs to ensure the best care possible is being delivered. Given this, it is essential for continued investment in research and innovative medicines for RA”.
Commenting on the recommendation, Belinda Byrne, Medical Director at AbbVie UK, said:
“AbbVie is pleased by the positive decision given by the SMC for treatment with upadacitinib for people living with severe active RA in Scotland. AbbVie is committed to improving treatment options for those living with RA. The recommendation means those with severe active RA in Scotland who have already tried multiple treatment options which have failed will have a new option, which can be taken both in combination with other drugs and as a monotherapy”.
[i] SMC medicines advice for upadacitnib treatment of rheumatoid arthritis. Available at https://www.scottishmedicines.org.uk/medicines-advice/upadacitinib-rinvoq/
[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] 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
[viii] Arthritis Research UK. Arthritis Research UK response to Health and Sport Committee draft Budget 2018-19 Call for Views. Available at: http://www.parliament.scot/S5_HealthandSportCommittee/Inquiries/DRB026_Arthritis_Research_UK.pdf [Accessed: September 2019]
[ix] 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
[x] Monti S, et al. Rheumatoid arthritis treatment: the earlier the better to prevent joint damage. RMD Open. 2015;1(Suppl