NICE Issues Positive Final Appraisal Determination for AbbVie’s RINVOQ®▼(upadacitinib) in Severe Active Rheumatoid Arthritis (RA)

NICE Issues Positive Final Appraisal Determination for AbbVie’s RINVOQ^®▼(upadacitinib) in Severe Active Rheumatoid Arthritis (RA)

-       Positive recommendation means upadacitinib will be available to those with previously treated severe active RA^[i]*

-       NICE 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 plus MTX in patients with moderate to severe RA ^{[ii][iii],[iv],[v],-[vi]}  

-       An estimated 400,000 people in the UK live with rheumatoid arthritis^[vii] and for the majority remission is not achieved currently^[viii]

Maidenhead, UK, Nov. 6^th, 2020 – 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 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).

There are around 400,000 people in the UK living with RA.⁷ It 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.⁷ Although there is no cure for RA, advances in treatment have made clinical remission possible for more people living with the disease^[ix]. Being in remission reduces disability and improves quality of life but is only achieved for an estimated 26% of patients in the UK currently.^8,9

Professor Chris Edwards, Consultant Rheumatologist and Honorary Chair of Clinical Rheumatology, University Hospital Southampton NHS Foundation Trust commented: “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.”

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