NICE recommends AbbVie’s RINVOQ® ▼ (upadacitinib) for use in adults and adolescents 12 years and older with moderate to severe atopic dermatitis (eczema)

Press release key messages:

• Adults and young people 12 years and over with moderate to severe atopic dermatitis (AD) that are suitable for systemic treatment where the disease has not responded to at least 1 systemic immunosuppressant, or these are not suitable, in England and Wales will now have access to upadacitinib (1)
• The decision from NICE follows the Scottish Medicines Consortium (SMC) acceptance in April 2022 (1)
• Upadacitinib has demonstrated clinically meaningful skin clearance (EASI 75 and vIGA-AD score clear/almost clear) at week 16 vs placebo in phase 3 clinical trials (1)
• Upadacitinib has been recommended alongside two other atopic dermatitis treatments (1)

MAIDENHEAD, UK, 29 June 2022 – AbbVie (NYSE: ABBV) today announced that the National Institute for Health and Care Excellence (NICE) has issued a Final Appraisal Document recommending RINVOQ^® (upadacitinib) as a treatment of moderate to severe atopic dermatitis (AD) for adults and young people aged 12 and over, if the disease has not responded to at least 1 systemic immunosuppressant, or these are not suitable. (1) Upadacitinib has been recommended alongside two other AD treatments.(1)

AD is a chronic inflammatory skin condition and is the most common form of eczema. (4) AD incidence has increased 2-3 times in the past 3 decades in industrialised countries. (5,6) In the UK, 5% of adults aged 18 and over, and 6% of adolescents aged 13-17 years have eczema. (7)

“Every day I see the profound impact eczema can have on people and their families. Atopic dermatitis can affect more than people’s skin, it impacts their social life, work and education, mental health and relationships.” said Andrew Proctor, Chief Executive at the National Eczema Society, adding: “Although several treatments are available, more options are needed to treat this complex heterogeneous condition. We welcome today's announcement that provides access to another medication for people 12 years and older in England and Wales with moderate to severe atopic dermatitis.”

The decision from NICE follows the SMC’s positive advice in April 2022 (8 and is supported by data from three Phase 3  and a Phase 3b clinical trials with 3,276 patients diagnosed with moderate to severe eczema. (9,10) Upadacitinib has demonstrated clinically meaningful skin clearance (EASI 75 and vIGA-AD score clear/almost clear) at week 16 vs placebo in phase 3 clinical trials n=1,683 p<0.0001.3 It has also shown clinically meaningful itch reduction (improvement in Worst Pruritus NRS>4) and skin clearance (EASI 75) as early as week 1 and 2, respectively, compared to placebo p≤0.0001.3 In the phase 3b head-to-head study in adults, upadacitinib (30 mg, once daily) monotherapy demonstrated superiority compared to dupilumab (300 mg, every other week) monotherapy for the primary endpoint, (EASI 75) at week 16. (11)

Dr Andrew Pink, Consultant Dermatologist and Director of the Adult Clinical Trials Unit at St. John’s Institute of Dermatology, Guy’s and St. Thomas’ NHS Foundation, said: “The relentless daily itching caused by atopic dermatitis can be debilitating. Upadacitinib represents a new treatment option for people with moderate to severe atopic dermatitis which could alleviate itch and improve skin appearance.”

Belinda Byrne, Medical Director, AbbVie UK, said: “Following the recent SMC acceptance, this decision from NICE paves the way for patients in England and Wales to benefit from this new treatment option. We constantly aim to bring our treatments to as many people as appropriate and are pleased to add another medicine to the pathway for people with moderate to severe atopic dermatitis across the UK.”

Upadacitinib is now recommended by NICE and accepted by SMC to treat atopic dermatitis, psoriatic arthritis, and rheumatoid arthritis, subject to eligibility criteria.(1,2,9,10)

-Ends-

▼This medicine is subject to additional monitoring. This will allow quick identification of new safety information. You can report side effects directly via the Yellow Card Scheme at https://yellowcard.mhra.gov.uk/ or via the Medicines and Healthcare products Regulatory Agency (MHRA) Yellow Card app, available in the Google Play or Apple App Stores. Adverse events should also be reported to AbbVie at GBPV@abbvie.com.  By reporting side effects, you can help provide more information on the safety of this medicine.

AbbVie UK media:

Laura Wetherly                                                                       Elspeth Cuerden

AbbVie UK                                                                              Health Unlimited

T: +44 (0)7500 881 257                                                        

E: Laura.Wetherly@abbvie.com                                            E: Elspeth.Cuerden@unlimitedgroup.com

NOTES TO EDITORS:

About upadacitinib (10)

RINVOQ^® (upadacitinib) is a once-daily, oral janus kinase (JAK) inhibitor. (1,2) It received marketing authorisation in the UK in 2021 for the treatment of moderate to severe atopic dermatitis in adults and adolescents aged 12 years and older, with inadequate response to at least one conventional systemic immunosuppressant, or for whom such treatment is considered unsuitable. (9,10)

The recommended dose of upadacitinib to treat atopic dermatitis in adults is 15 mg or 30 mg once daily oral tablet based on individual patient presentation, and 15 mg once daily for adolescents (12-17 years of age) and adults aged 65 years and older. (10) Upadacitinib can be used with or without topical corticosteroids. (3,10)

About the Phase 3 Atopic Dermatitis Clinical Trial Programme (9)

AbbVie has conducted four clinical trials with upadacitinib; Measure Up 1, Measure Up 2, AD Up and Heads Up.

Across the Phase 3 studies Measure Up 1, Measure Up 2 and AD Up, all primary and secondary endpoints were met with 15 mg and 30 mg doses of upadacitinib compared to placebo. (3) A significantly greater proportion of patients treated with upadacitinib 15 mg or 30 mg achieved vIGA-AD 0 or 1, EASI 75, or a ≥ 4-point improvement on the Worst Pruritus NRS compared to placebo at week 16. Rapid improvements in skin clearance (EASI 75 at week 2) and itch (WP-NRS response at week 1) were also achieved. (10)

Results at week 16 were maintained through week 52 in patients treated with either dose of upadacitinib in Measure Up 1 and 2 Phase 3 trials.(10,12)

In the placebo-controlled atopic dermatitis clinical trials, the most commonly reported adverse reactions (≥2% of patients) with upadacitinib 15 mg or 30 mg were upper respiratory tract infection (25.4%), acne (15.1%), herpes simplex (8.4%), headache (6.3%), CPK increased (5.5%), cough (3.2%), folliculitis (3.2%), abdominal pain (2.9%), nausea (2.7%), neutropenia (2.3%), pyrexia (2.1%), and influenza (2.1%). The most common serious adverse reactions were serious infections.(9)

The efficacy and safety of upadacitinib 30 mg was also assessed in Heads Up: Phase 3b multicentre, randomized, double-blind, double-dummy, active comparator-controlled study in adults with moderate to severe atopic dermatitis. Patients were randomized to receive upadacitinib (30 mg, once daily, orally administered) or dupilumab (300 mg, every other week, subcutaneous injection) for 24 weeks. Patients who received dupilumab received an initial dose of 600 mg at the baseline visit followed by 300 mg every other week.11 In adults, upadacitinib (30 mg, once daily) monotherapy demonstrated superiority compared to dupilumab for the primary endpoint, (EASI 75) at week 16 compared to dupilumab (300 mg, every other week) monotherapy. (11) Adverse events were reported in 62.8% of upadacitinib and 71.6% of dupilumab patients. The safety profile of upadacitinib in the Heads up study was consistent with that observed in pivotal phase 3 AD clinical trials.(11,12)

About AbbVie in Dermatology

Our deep expertise in immunology is rooted in more than two decades of world-class science and an unwavering commitment to innovation. Patients inspire our every step. Their needs fuel our passion. As we advance research, we aim to bring to life our vision of reducing the burden for all those touched by immune-mediated diseases.

For nearly quarter of a century, AbbVie has been helping to raise the bar in chronic inflammatory skin diseases. We work tirelessly to advance standards of care for the patients who need it most. We boldly forge breakthroughs that are beyond "slightly better" - they can be life-changing. Our pursuit has led to exciting discoveries and the opportunity to deliver treatments in areas of high unmet medical need for patients. With recent launches and a rich pipeline AbbVie continues to propel the science harnessing our deep knowledge, resources and insights to go beyond managing symptoms to changing the course of diseases with medicines that can profoundly change lives.  ​

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 or YouTube.

References

1. National Institute for Health and Care Excellence. Upadacitinib for treating moderate to severe atopic dermatitis in people aged 12 and over. Available from: https://www.nice.org.uk/guidance/indevelopment/gid-ta10597. [Last accessed: June 2022]
2. Scottish Medicines Consortium Medicines Advice for Upadacitinib. Available from: https://www.scottishmedicines.org.uk/medicines-advice/upadacitinib-rinvoq-full-smc2417/. [Last accessed: June 2022]
3. Guttman-Yassky E et al. Once-daily upadacitinib versus placebo in adolescents and adults with moderate-to-severe atopic dermatitis (Measure Up 1 and Measure Up 2): results from two replicate double-blind, randomised controlled phase 3 trials. The Lancet, 397(10290), pp.2151-2168.
4. NHS Atopic eczema. Available from: https://www.nhs.uk/conditions/atopic-eczema/. [Last accessed: June 2022]
5. Bieber T. Atopic Dermatitis. Ann Dermatol 2010;22(2):125.
6. Nutten S. Atopic Dermatitis: Global Epidemiology and Risk Factors. Ann Nutr Metab 2015;66(Suppl. 1):8-16
7. de Lusignan S et al. The epidemiology of eczema in children and adults in England: A population-based study using primary care data. Clin Exp Allergy. 2021;51(3):471-482. doi:10.1111/cea.13784
8. Scottish Medicines Consortium Medicines Advice for Upadacitinib. Available from: https://www.scottishmedicines.org.uk/medicines-advice/upadacitinib-rinvoq-full-smc2417/. [Last accessed: June 2022]
9. RINVOQ (upadacitinib) 30 mg prolonged-release tablets. Summary of Product Characteristics. Available from: https://www.medicines.org.uk/emc/product/12830/smpc. [Last accessed: June 2022]
10. RINVOQ (upadacitinib) 15 mg prolonged-release tablets. Summary of Product Characteristics. Available from: https://www.medicines.org.uk/emc/product/10972/smpc. [Last accessed: June 2022]
11. Blauvelt, A et. al. A Phase 3 Trial of Upadacitinib Versus Dupilumab in Atopic Dermatitis. JAMA Dermatology doi: 10.1001/jamadermatol.2021.3023
12. Simpson EL et al. Efficacy and safety of upadacitinib in patients with atopic dermatitis: Results through week 52 from replicate, Phase 3, randomized, double-blind, placebo-controlled studies: Measure Up1 and Measure Up 2. JAMA Dermatology 2022;158(4):404-413