AbbVie Advances Immunology Pipeline with First Patient Dosed in Global Phase 3 Trial of Upadacitinib (RINVOQ®) in Hidradenitis Suppurativa

–  First registered, randomized Phase 3 trial in hidradenitis suppurativa (HS) evaluating the efficacy and safety of upadacitinib (RINVOQ^®) in adults and adolescents with moderate to severe HS¹

–  HS is a difficult-to-treat chronic, inflammatory disease with few therapeutic options available^2,3

–  AbbVie applies proven expertise in immunology and HS in continued efforts to bring new treatment options to patients living with this underserved condition⁴

NORTH CHICAGO, IL, USA I July 24, 2023 I AbbVie (NYSE: ABBV) today announced that the first patient has been dosed in the Phase 3 Step-Up HS study evaluating upadacitinib (RINVOQ^®) in adults and adolescents with moderate to severe hidradenitis suppurativa (HS) who have failed anti-tumor necrosis factor (TNF) therapy and/or one approved non-anti-TNF inhibitor therapy for HS.¹

“Hidradenitis suppurativa is a chronic, inflammatory disease that often leads to irreversible skin damage and extreme pain for patients,” said Roopal Thakkar, M.D., senior vice president, development and regulatory affairs and chief medical officer, AbbVie. “Leveraging our proven expertise in immunology and experience in HS, we continue to drive innovation and pursue advancement of care in patient populations with difficult-to-treat immune-mediated diseases that have limited therapeutic options.”

HS can appear on the skin as painful bumps, nodules or abscesses that leak fluid, lead to scarring and even connect under the skin as tunnels.⁵ Nodules generally develop in areas of the body where hair grows or skin rubs against skin, such as the underarms, groin or back of the neck.⁵

While HS is estimated to affect up to one percent of the global population, patients can experience increasing disease severity and symptoms for as long as seven to 10 years before receiving an accurate diagnosis.^6,7 There is no cure for HS, and there are limited treatment options, making further study of this disease critical to better understand its impact and help meet patients’ unmet needs.^3,8

About Step-Up HS¹
Step-Up HS is the first Phase 3, randomized, placebo-controlled, double-blind, multicenter study to evaluate the efficacy and safety of upadacitinib compared to placebo in adults and adolescents (12 to less than 18 years old) with moderate to severe HS who have failed anti-TNF therapy and/or one approved non-anti-TNF inhibitor therapy for HS. Aiming to enroll approximately 1,300 participants across 275 sites worldwide, the study consists of three periods. In Period 1 (0 to 16 weeks), the safety and efficacy of upadacitinib 30 mg will be evaluated versus placebo, which is the primary analysis of the study. In Period 2 (16 to 20 weeks), based on clinical response, patients will be re-randomized to upadacitinib 30 mg, upadacitinib 15 mg or placebo, followed by a long-term extension Period 3 (20 to 68 weeks).

The study’s primary endpoint will measure the percentage of participants achieving HS clinical response (HiSCR) 50, defined as at least a 50 percent reduction in the total abscess and inflammatory nodule (AN) count with no increase in abscess count and no increase in draining fistula count relative to baseline at week 16.

The Phase 2 study was completed and study results were presented at the American Academy of Dermatology (AAD) Annual Meeting in March 2023 and are planned for publication in a scientific journal. Additional results from the Phase 2 study will be presented at a future medical congress.

Additional information about the study can be found at https://clinicaltrials.gov/ under the identifier NCT05889182.

About RINVOQ^® (upadacitinib)
Discovered and developed by AbbVie scientists, RINVOQ is a selective JAK inhibitor that is being studied in several immune-mediated inflammatory diseases.⁴ Based on enzymatic and cellular assays, RINVOQ demonstrated greater inhibitory potency for JAK-1 vs JAK-2, JAK-3, and TYK-2.⁹ The relevance of inhibition of specific JAK enzymes to therapeutic effectiveness and safety is not currently known.

Phase 3 trials of RINVOQ in rheumatoid arthritis, atopic dermatitis, psoriatic arthritis, axial spondyloarthritis, Crohn’s disease, ulcerative colitis, giant cell arteritis, Takayasu arteritis, and systemic juvenile idiopathic arthritis are ongoing.^10-18 Use of upadacitinib in HS is not approved and its safety and efficacy have not been evaluated by regulatory authorities.

RINVOQ (upadacitinib) U.S. Uses and Important Safety Information⁹

RINVOQ is a prescription medicine used to treat:

• Adults with moderate to severe rheumatoid arthritis (RA) when 1 or more medicines called tumor necrosis factor (TNF) blockers have been used, and did not work well or could not be tolerated.
• Adults with active psoriatic arthritis (PsA) when 1 or more medicines called TNF blockers have been used, and did not work well or could not be tolerated.
• Adults with active ankylosing spondylitis (AS) when 1 or more medicines called TNF blockers have been used, and did not work well or could not be tolerated.
• Adults with active non-radiographic axial spondyloarthritis (nr-axSpA) with objective signs of inflammation when a TNF blocker medicine has been used, and did not work well or could not be tolerated.
• Adults with moderate to severe ulcerative colitis (UC) when 1 or more medicines called TNF blockers have been used, and did not work well or could not be tolerated.
• Adults with moderate to severe Crohn’s disease (CD) when 1 or more medicines called TNF blockers have been used, and did not work well or could not be tolerated.

It is not known if RINVOQ is safe and effective in children with juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, non-radiographic axial spondyloarthritis, ulcerative colitis, or Crohn’s disease.

• Adults and children 12 years of age and older with moderate to severe eczema (atopic dermatitis [AD]) that did not respond to previous treatment and their eczema is not well controlled with other pills or injections, including biologic medicines, or the use of other pills or injections is not recommended.

RINVOQ is safe and effective in children 12 years of age and older weighing at least 88 pounds (40 kg) with atopic dermatitis.

It is not known if RINVOQ is safe and effective in children under 12 years of age with atopic dermatitis.

Please click here for the Full Prescribing Information and Medication Guide.

Globally, prescribing information varies; refer to the individual country product label for complete information.

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 and gastroenterology, in addition to products and services across our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on Twitter, Facebook, Instagram, YouTube and LinkedIn.

References

1. A Study to Assess Change in Disease Activity and Adverse Events of Oral Upadacitinib in Adult and Adolescent Participants With Moderate to Severe Hidradenitis Suppurativa Who Have Failed Anti-TNF Therapy (Step-Up HS). ClinicalTrials.gov. 2023. Available at: https://clinicaltrials.gov/study/NCT05889182?cond=Hidradenitis%20Suppurativa&intr=Upadacitinib&rank=1. Accessed July 2023.
2. Lee E, Alhusayen R, et al. What is hidradenitis suppurativa?; Canadian Family Physician. 2017.
3. Fragoso NM, Masson R, Gillenwater TJ, Shi VY, Hsiao JL. Emerging Treatments and the Clinical Trial Landscape for Hidradenitis Suppurativa Part I: Topical and Systemic Medical Therapies. Dermatol Ther (Heidelb). 2023 Jul 4. doi: 10.1007/s13555-023-00956-6. Epub ahead of print. PMID: 37402031.
4. Pipeline – Our Science | AbbVie. 2023. Available at: https://www.abbvie.com/our-science/pipeline.html.Accessed on July 13, 2023.
5. AbbVie. No BS About HS. What is HS? 2022. Available at: https://www.nobsabouths.com/what-is-hidradenitis-suppurativa#WhoIsAffected. Accessed on July 13, 2023.
6. Jfri A, Nassim D, O’Brien E, Gulliver W, Nikolakis G, Zouboulis CC. Prevalence of Hidradenitis Suppurativa: A Systematic Review and Meta-regression Analysis. JAMA Dermatol. 2021 Aug 1;157(8):924-931. doi: 10.1001/jamadermatol.2021.1677. PMID: 34037678; PMCID: PMC8156162.
7. Kimball A, et al. N Engl J Med. 375.5; 2016: 422-34. Available at: https://pubmed.ncbi.nlm.nih.gov/27518661/.
8. AbbVie. No BS About HS. HS Treatment Options. 2022. Available at: https://www.nobsabouths.com/treat-hidradenitis-suppurativa/treatment-options. Accessed on July 13, 2023.
9. RINVOQ [Package Insert]. North Chicago, IL: AbbVie Inc.; 2023.
10. A Study Comparing Upadacitinib (ABT-494) to Placebo in Adults With Rheumatoid Arthritis on a Stable Dose of Conventional Synthetic Disease-Modifying Antirheumatic Drugs (csDMARDs) Who Have an Inadequate Response to csDMARDs Alone (SELECT-NEXT). ClinicalTrials.gov. 2021. Available at: https://clinicaltrials.gov/ct2/show/NCT02675426. Accessed on July 13, 2023.
11. Evaluation of Upadacitinib in Adolescent and Adult Patients With Moderate to Severe Atopic Dermatitis (Eczema) (Measure Up 1). ClinicalTrials.gov. 2021. Available at: https://clinicaltrials.gov/ct2/show/NCT03569293. Accessed on July 13, 2023.
12. A Study Comparing Upadacitinib (ABT-494) to Placebo and to Adalimumab in Participants With Psoriatic Arthritis Who Have an Inadequate Response to at Least One Non-Biologic Disease Modifying Anti-Rheumatic Drug (SELECT – PsA 1). ClinicalTrials.gov. 2021. Available at: https://clinicaltrials.gov/ct2/show/NCT03104400. Accessed on July 13, 2023.
13. A Study to Evaluate Efficacy and Safety of Upadacitinib in Adult Participants With Axial Spondyloarthritis (SELECT AXIS 2). ClinicalTrials.gov. 2021. Available at: https://clinicaltrials.gov/ct2/show/NCT04169373. Accessed on July 13, 2023.
14. A Study of the Efficacy and Safety of Upadacitinib (ABT-494) in Participants With Moderately to Severely Active Crohn’s Disease Who Have Inadequately Responded to or Are Intolerant to Biologic Therapy. ClinicalTrials.gov. 2021. Available at: https://clinicaltrials.gov/ct2/show/NCT03345836. Accessed on July 13, 2023.
15. A Study to Evaluate the Safety and Efficacy of Upadacitinib (ABT-494) for Induction and Maintenance Therapy in Participants With Moderately to Severely Active Ulcerative Colitis (UC). ClinicalTrials.gov. 2021. Available at: https://clinicaltrials.gov/ct2/show/NCT02819635. Accessed on July 13, 2023.
16. A Study to Evaluate the Safety and Efficacy of Upadacitinib in Participants With Giant Cell Arteritis (SELECT-GCA). ClinicalTrials.gov. 2021. Available at: https://clinicaltrials.gov/ct2/show/NCT03725202. Accessed on July 13, 2023.
17. A Study to Evaluate the Efficacy and Safety of Upadacitinib in Subjects With Takayasu
    Arteritis (TAK) (SELECT-TAK). ClinicalTrials.gov. 2021. Available at: https://clinicaltrials.gov/ct2/show/NCT04161898. Accessed on July 13, 2023.
18. A Multicenter, Randomized Open-Label Study to Assess the Efficacy, Safety, and Pharmacokinetics of Upadacitinib With a Tocilizumab Reference Arm in Subjects From 1 Year to Less Than 18 Years Old With Active Systemic Juvenile Idiopathic Arthritis. ClinicalTrials.gov. Available at: https://clinicaltrials.gov/study/NCT05609630?cond=Systemic%20Juvenile%20Idiopathic%20Arthritis&intr=Upadacitinib&rank=1. Accessed on July 13, 2023.

SOURCE: AbbVie