Scottish Medicines Consortium accepts AbbVie’s RINVOQ® ▼ (upadacitinib) for Use in Adolescents and Adults with Active Atopic Dermatitis (eczema)

Scottish Medicines Consortium accepts AbbVie’s RINVOQ^® ▼ (upadacitinib) for Use in Adolescents and Adults with Active Atopic Dermatitis (eczema)

• Scotland the first nation in the UK to provide access via the NHS to upadacitinib for people with moderate to severe eczema over 12 years of age, with inadequate response to at least one conventional systemic immunosuppressant, or to whom such treatment is considered unsuitable¹
• Upadacitinib demonstrated clinically meaningful itch reduction and skin clearance within 2 weeks across four clinical trial programmes²
• The SMC advice will provide access to the first advanced treatment in pill form for adolescents with AD in Scotland
• Upadacitinib is now available across three indications (atopic dermatitis, rheumatoid arthritis and psoriatic arthritis)in Scotland^1,3,4

 

MAIDENHEAD, UK, 11 April 2022 – AbbVie (NYSE: ABBV) announced today the Scottish Medicines Consortium (SMC) has issued a positive decision accepting RINVOQ^® (upadacitinib) as a treatment of atopic dermatitis (eczema) for people over 12 years, with inadequate response to at least one conventional systemic immunosuppressant, or for whom such treatment is considered unsuitable.¹

Atopic dermatitis is a chronic inflammatory skin condition and is the most common form of eczema,⁵ affecting up to 1 in 5 children and 5-10% of UK adults.⁶ AD incidence has increased 2-3 times in the past 3 decades in industrialised countries.^7,8

“People with severe eczema often suffer from extremely itchy, cracked, and dry skin over much of their body. Working with adolescents who have severe eczema we see the impact it has on a daily basis for them and their family. It can affect their education and work opportunities, their daily activities, sleep, self-esteem and mental health. Despite the availability of several treatments, there is still a large unmet need, especially for adolescent patients,” said Christine Roxburgh, Chief Executive at Eczema Outreach Support, adding: “Today’s approval will provide another option for people in Scotland who most urgently need it.”

The SMC’s advice follows the MHRA approval in August 2021 and is supported by data from four Phase 3 clinical trials with 2584 patients diagnosed with moderate to severe eczema.⁴ Upadacitinib (15 mg or 30 mg) has shown to produce 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.² 15 mg once daily is the recommended dose for adolescents (12-17 years of age) and adults 65 years and older.³

Dr Richard Weller, Reader and Honorary Consultant Dermatologist at the University of Edinburgh, said: “Eczema can be debilitating for a lot of patients, especially those with the most severe form of the condition. Upadacitinib has shown potential to clear skin and reduce itch quickly and could make a real difference for patients in Scotland, who have bad eczema which is uncontrolled by existing drugs. This positive decision from the SMC will increase the choice of effective treatments available for people with bad eczema.”   

Belinda Byrne, Medical Director, AbbVie UK, said: “We are delighted that the SMC has led the way with this advice and as a result, people with atopic dermatitis in Scotland are now the first in the UK to have access to this innovative treatment.  We know that despite treatment advances for many patients, the unbearable impact of their eczema has continued to go far beyond their skin. Availability of this treatment in Scotland may help them to lead as normal a life as possible.”

Upadacitinib is now approved by the SMC to treat psoriatic arthritis, atopic dermatitis and rheumatoid arthritis for people in Scotland.^1,3,4

- Ends -

 

Notes to Editors

 

▼This medicine is subject to additional monitoring. This will allow quick identification of new safety information. If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this booklet or the Patient Information Leaflet. You can help by reporting side effects directly via the Yellow Card Scheme at https://yellowcard.mhra.gov.uk/ or via the 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.

 

About upadacitinib³

RINVOQ^® (upadacitinib) is a once-daily, oral, selective, and reversible janus kinase (JAK) inhibitor.^3,4 It received MHRA approval for the treatment of adult and adolescents for the Treatment of Both Adults and Adolescents with Moderate to Severe Atopic Dermatitis in 2021.^3,4

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

 

About the Phase 3 Atopic Dermatitis Clinical Trial Programme⁴

Across the Phase 3 studies, all primary and secondary endpoints were met with 15 mg and 30 mg doses of upadacitinib compared to placebo. 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 and itch were also achieved.⁴

Results at week 16 continued to be maintained through week 52 in patients treated with either dose of upadacitinib.^3,9

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.⁴

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. And 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 of new, potentially ground-breaking medicines, 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 changes lives.  ​

 

About AbbVie UK
AbbVie's mission is to discover and deliver innovative medicines that solve serious health issues today and address the medical challenges of tomorrow. The company strive to have a remarkable impact on people's lives across several key therapeutic areas: immunology, oncology, neuroscience, eye care, virology, 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 us @abbvieuk on Twitter, YouTube.

 

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AbbVie UK Media: Laura Wetherly +44 (0)75 0088 1257 Laura.wetherly@abbvie.com

Anastasios Koutsos +44 (0)79 6254 2569 Anastasios.koutsos@unlimitedgroup.com

 

 

 

 

 

 

References

1. Scottish Medicines Consortium Medicines Advice for Upadacitinib. Available at: https://www.scottishmedicines.org.uk/medicines-advice/upadacitinib-rinvoq-full-smc2417/. Accessed April 2022.
2. Paller AS, et al. Efficacy and Safety of Upadacitinib in Adult and Adolescent Subgroups With Moderate-to-Severe Atopic Dermatitis: An Analysis of the Measure Up 1, Measure Up 2, and AD Up Phase 3 Clinical Trials. Presented at the 2021 Revolutionizing Atopic Dermatitis (RAD) Virtual Conference, June 13, 2021; 2021; Virtual Conference.
3. RINVOQ (upadacitinib) 15 mg prolonged-release tablets Summary of Product Characteristics. Available at: https://www.medicines.org.uk/emc/product/10972/smpc. Accessed April 2022.
4. RINVOQ (upadacitinib) 30 mg prolonged-release tablets Summary of Product Characteristics. Available at: https://www.medicines.org.uk/emc/product/12830/smpc. Accessed April 2022.
5. NHS Atopic eczema. Available at: https://www.nhs.uk/conditions/atopic-eczema/. Accessed April 2022
6. Cork et al., Atopic dermatitis epidemiology and unmet need in the United Kingdom, J Dermatolog Treat. 2020 Dec;31(8):801-809.
7. Bieber T. Atopic dermatitis. Ann Dermatol. 2010 May;22(2):125-37.
8. Nutten S. Atopic dermatitis: global epidemiology and risk factors. Ann Nutr Metab. 2015;66 Suppl 1:8-16.
9. 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. Poster presentation at the 2021 Dermatology Education Foundation (DEF) Essential Resource Meeting (DERM2021), August 5-8, 2021, Las Vegas NV, USA.