Scottish Medicines Consortium (SMC) Extends Advice Accepting RINVOQ®▼(upadacitinib) For Treatment of Adults with Moderate Rheumatoid Arthritis

PRESS RELEASE

Scottish Medicines Consortium (SMC) Extends Advice Accepting RINVOQ®▼(upadacitinib) For Treatment of Adults with Moderate Rheumatoid Arthritis

• Upadacitinib, a once daily pill, which was previously accepted by the SMC for restricted use for the treatment of severe rheumatoid arthritis (RA) is now available for people with moderate RA in adult patients who have responded inadequately to, or who are intolerant to one or more disease-modifying anti-rheumatic drugs (DMARDs). It has been recommended for restricted use in adults with moderate disease (a disease activity score [DAS28] of 3.2 to 5.1) when intensive therapy with 2 or more conventional DMARDs has not controlled the disease well enough. Upadacitinib may be used as monotherapy or in combination with methotrexate.[1]
• An estimated 44,000 people in Scotland live with RA[2], the majority of whom have not achieved remission.[3]
• Scottish Medicines Consortium (SMC) approval is based on data from the 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 moderate to severe RA.[4]^{,[5],[6],[7],[8]}

MAIDENHEAD, UK, 12 DECEMBER 2022: AbbVie (NYSE: ABBV) today announced that the Scottish Medicines Consortium (SMC) has accepted RINVOQ^® (upadacitinib) 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). It has been recommended for restricted use in adults with moderate disease (a disease activity score [DAS28] of 3.2 to 5.1) when intensive therapy with 2 or more conventional DMARDs has not controlled the disease well enough. Upadacitinib may be used as monotherapy or in combination with methotrexate.¹

Upadacitinib is a janus kinase inhibitor (JAKi) which is a once-daily oral therapy, which was previously reimbursed by the SMC for people with severe RA.1This has now been extended to moderate RA, meaning more people in Scotland with RA may now benefit from upadacitinib.

Martin Perry, Rheumatology Specialty Advisor Greater Glasgow and Clyde, said: “This is a welcome decision from the Scottish Medicines Consortium which means another treatment option will be available for those with moderate RA in Scotland, where there is currently a treatment gap, and should produce increased rates of disease remission for RA patients in Scotland.”

There are around 44,000 people in Scotland living with RA.² Most people develop RA between the age of 40 and 60, but it can affect people of any age.[9] 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.[10] Although there is no cure for RA, advances in treatment have made clinical remission possible for more people living with the disease.[11] Being in remission reduces disability and improves quality of life but is only achieved for an estimated 26% of patients in the UK currently.11^,3

Clare Jacklin, Chief Executive of the National Rheumatoid Arthritis Society (NRAS), said: “Today’s decision from the SMC is welcome news for many people living with moderate RA in Scotland. This recommendation could enable more people to get their disease under better control at an earlier stage which has major implications for reducing damage caused by uncontrolled disease. For many, having an effective treatment earlier in their disease progression could mean getting their life back, going back to or remaining in work and enjoying time with family and friends.”

“Thousands of people are still significantly impacted by RA despite currently available treatments,” said Belinda Byrne, Medical Director at AbbVie UK. “We very much welcome this decision from the SMC, which has enabled us to make upadacitinib available in Scotland as an additional option for people with moderate RA and continue our dedication to improving the lives of patients.”

-ENDS-

For more information about upadacitinib please follow this link: https://www.medicines.org.uk/emc/product/10972/smpc

▼ Adverse events should be reported. Reporting forms and information can be found at www.mhra.gov.uk/yellowcard. Adverse events should also be reported to AbbVie UK Ltd. Please contact GBPV@abbvie.com.

AbbVie UK Media:                                          Four Health Communications:

Laura Wetherly                                               Natalie Adams

+44 (0) 7500881257                                       +44(0) 7384 918 025

laura.wetherly@abbvie.com                          natalie.adams@four.health

NOTES TO EDITORS:

About upadacitinib[12]

Upadacitinib is a once-daily, oral, selective, and reversible Janus Kinase (JAK) inhibitor. It received marketing authorisation in December 2019 for the treatment of adult patients with moderate to severe active RA, who have had an inadequate response or are intolerant to one or more DMARDs and it may be used as monotherapy or in combination with the DMARD methotrexate. Upadacitinib’s Summary of Product Characteristics can be found at: https://www.medicines.org.uk/emc/product/10972/smpc

About the SELECT Clinical Trial Programme

The global Phase 3 SELECT rheumatoid arthritis programme evaluated nearly 4,400 patients with moderate to severe active rheumatoid arthritis in five pivotal studies: SELECT-NEXT, SELECT-BEYOND, SELECT-MONOTHERAPY, SELECT-COMPARE and SELECT-EARLY.[13]^,4^,5^,6^,7^,8

The studies include assessments of efficacy, safety and tolerability across a variety of patients, including those for whom biologic disease-modifying anti-rheumatic drugs failed or those who were unable to tolerate them, and those who were naïve or inadequate responders to MTX.4^,5^,6^,7^,8

Across the SELECT Phase 3 studies, upadacitinib met all primary and ranked secondary endpoints. Notably, upadacitinib demonstrated consistent efficacy with or without methotrexate and achieved consistent remission* rates across patient populations studied.4^,5^,6^,7

• In SELECT-COMPARE, upadacitinib plus MTX (n=651) demonstrated significantly higher remission rates* versus placebo plus MTX (n=651) (29 percent vs. 6 percent at week 12; p≤0.001) and HUMIRA^® (adalimumab) plus MTX (n=327) (29 percent vs 18 percent at week 12; nominal p≤0.001).4
• More patients treated with upadacitinib alone (n=217) achieved remission* than MTX (n=216) in SELECT-MONOTHERAPY (28 percent vs 8 percent at week 14; p≤0.0001) and in SELECT-EARLY (48 percent vs 19 percent at week 24; p≤0.001) (n=317 and 314 respectively).6^,7
• In SELECT-EARLY upadacitinib monotherapy (n=317) demonstrated significant inhibition of structural damage** compared to methotrexate (n=314) (0.1 vs 0.7 at week 24; p≤0.01). Upadacitinib +MTX (n=651) also demonstrated significant inhibition of joint damage** when compared to placebo + MTX (n=651) in SELECT-COMPARE (0.2 vs 0.9 at week 26; p≤0.001).7^,4

The most commonly reported adverse drug reactions were upper respiratory tract infections (13.5 percent), nausea (3.5 percent), increased blood creatine phosphokinase (2.5 percent) and cough (2.2 percent). The most common serious adverse reactions were serious infections.12

About Rheumatoid Arthritis

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.10 Over time uncontrolled disease can cause irreversible joint damage, disability and increases the risk of developing other conditions.[14]^,[15] Due to its systemic nature, around 40% of people with RA will experience signs and symptoms beyond their joints and other organs such as the eyes, lungs and heart can be affected.[16] Although there is no cure for RA, advances in treatment have made it possible to put the disease into remission, where disease activity falls below a certain level and symptoms may not impact daily activities.¹¹ Prompt treatment and achievement of remission, are key to achieving the best long-term outcomes for people with the disease.11

About AbbVie in Rheumatology

For more than 20 years, AbbVie has been dedicated to improving care for people living with rheumatic diseases. Our long-standing 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.

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.co.uk. Follow @abbvieuk on Twitter. 

* assessed by DAS28-CRP <2.6 and CDAI≤2.8                                                      

**as measured by modified Total Sharp Score (mTSS), from baseline

[1] SMC medicines advice for upadacitnib treatment of rheumatoid arthritis. Available at  https://www.scottishmedicines.org.uk/medicines-advice/upadacitinib-rinvoq-ra-resub-smc2495/ [Accessed December 2022]

[2] 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: November 2022]

[3] 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

[4] 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

[5] 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

[6] 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.

[7] 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

[8] 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

[9] NRAS, What is RA,  https://nras.org.uk/resource/what-is-ra/, [Accessed December 2022]

[10] 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

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

  1):e000057.

[12] RINVOQ 15 mg prolonged-release tablets SMPC, https://www.medicines.org.uk/emc/product/10972/smpc

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

[14] 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

[15] The State of Musculoskeletal Health. Versus Arthritis. 2019. Available at: https://www.versusarthritis.org/about-arthritis/data-and-statistics/state-of-musculoskeletal-health-2019/

[16] Mayo Clinic. Rheumatoid arthritis Patient Factsheet. Available at: https://www.mayoclinic.org/diseases-conditions/rheumatoid-arthritis/symptoms-causes/syc-20353648. Last accessed November 2022