Breaking News
December 17, 2018 - Stealth BioTherapeutics Granted Fast Track Designation for Elamipretide for the Treatment of Dry Age-Related Macular Degeneration with Geographic Atrophy
December 17, 2018 - Studies reveal role of red meat in gut bacteria, heart disease development
December 17, 2018 - Eisai enters into agreement with Eurofarma for its anti-obesity agent lorcaserin
December 17, 2018 - Researchers use brain connectome to reassess neuroimaging findings of Alzheimer’s disease
December 17, 2018 - “Miracle” baby survives Ebola in Congo and rapid a new Ebola detection device
December 17, 2018 - Study finds misuse of benzodiazepines to be highest among young adults
December 17, 2018 - TGen receives PayPal grant to underwrite costs of genetic tests for children with rare disorders
December 17, 2018 - New research highlights why HIV-infected patients suffer higher rates of cancer
December 17, 2018 - Antibiotic-resistant bacteria could soon be targeted with Alzheimer’s drug
December 17, 2018 - Rutgers scientists take an important step in making diseased hearts heal themselves
December 17, 2018 - Tailored Feedback at CRC Screen Improves Lifestyle Behaviors
December 17, 2018 - Loss of two genes drives a deadly form of colorectal cancer, reveals a potential treatment
December 17, 2018 - How the Mediterranean Diet Can Help Women’s Hearts
December 17, 2018 - Sustained connections associated with symptoms of autism
December 17, 2018 - Concussion rates among young football players were higher than previously reported
December 17, 2018 - Cresco Labs granted approval to operate marijuana dispensary in Ohio
December 17, 2018 - Study provides insight into health risks facing new mothers
December 17, 2018 - AMSBIO expands Wnt signaling pathway product range to aid research
December 16, 2018 - Surgical treatment unnecessary for many prostate cancer patients
December 16, 2018 - Excess weight responsible for cancers globally finds report
December 16, 2018 - Regular sex associated with greater enjoyment of life in seniors
December 16, 2018 - Social stigma contributes to poor mental health in the autistic community
December 16, 2018 - Multidisciplinary team successfully performs complex surgery on patient suffering from enlarged skull
December 16, 2018 - Experts analyze data that can guide antidepressant discontinuation
December 16, 2018 - Menlo Therapeutics’ Successful Phase 2 Clinical Trial of Serlopitant Demonstrates Reduction of Pruritus Associated with Psoriasis
December 16, 2018 - Siblings of children with autism or ADHD are at elevated risk for both disorders
December 16, 2018 - New project aims to understand why and how metabolic disorders develop in patients
December 16, 2018 - Diets containing GM maize have no harmful effects on health or metabolism of rats
December 16, 2018 - Are doctors and teachers confusing immaturity and attention deficit?
December 16, 2018 - Hearing loss linked with increased risk for premature death
December 16, 2018 - Chromatrap buffer reagents for lysing cells offer many benefits
December 16, 2018 - Young Breast Cancer Patients Face Higher Risk for Osteoporosis
December 16, 2018 - 3-D printing offers helping hand to people with arthritis
December 16, 2018 - Community Health Choice helps manage complex and chronic care conditions
December 16, 2018 - Regular trips out could dramatically reduce depression in older age
December 16, 2018 - CWRU to use VivaLNK’s Vital Scout device for stress study in student athletes
December 16, 2018 - ‘Easy Way Out’? Stigma May Keep Many From Weight Loss Surgery
December 16, 2018 - Gout drug may protect against chronic kidney disease
December 16, 2018 - Talking about memories enhances the wellbeing of older and younger people
December 16, 2018 - Occupational exposure to pesticides increases risk for cardiovascular disease among Latinos
December 16, 2018 - A biomarker in the brain’s circulation system may be Alzheimer’s earliest warning
December 16, 2018 - Magnesium may play important role in optimizing vitamin D levels, study shows
December 16, 2018 - The effect of probiotics on intestinal flora of premature babies
December 16, 2018 - Parents spend more time talking with kids about mechanics of using mobile devices
December 16, 2018 - Biohaven Announces Positive Results from Ongoing Rimegepant Long-Term Safety Study
December 16, 2018 - Arterial stiffness may predict dementia risk
December 16, 2018 - Study explores link between work stress and increased cancer risk
December 16, 2018 - Sex work criminalization linked to incidences of violence finds study
December 16, 2018 - Johns Hopkins researchers discover swarming behavior in fish-dwelling parasite
December 16, 2018 - Schistosomiasis prevention and treatment could help control HIV
December 16, 2018 - Early postpartum opioids linked with persistent usage
December 16, 2018 - Johns Hopkins researchers identify molecular causes of necrotizing enterocolitis in preemies
December 16, 2018 - Advanced illumination expands capabilities of light-sheet microscopy
December 16, 2018 - Alzheimer’s could possibly be spread via contaminated neurosurgery
December 16, 2018 - Unraveling the complexity of cancer biology can prompt new avenues for drug development
December 16, 2018 - Inflammatory Bowel Disease, Prostate Cancer Linked
December 16, 2018 - Cannabis youth prevention strategy should target mental wellbeing
December 15, 2018 - Recent developments and challenges in hMAT inhibitors
December 15, 2018 - Sewage bacteria found lurking in Hudson River sediments
December 15, 2018 - CDC selects UMass Amherst biostatistician model that helps predict influenza outbreaks
December 15, 2018 - Researchers reveal brain mechanism that drives itch-evoked scratching behavior
December 15, 2018 - New computer model helps predict course of the disease in prostate cancer patients
December 15, 2018 - Obesity to Blame for Almost 1 in 25 Cancers Worldwide
December 15, 2018 - How the brain tells you to scratch that itch
December 15, 2018 - New findings could help develop new immunotherapies against cancer
December 15, 2018 - World’s largest AI-powered medical research network launched by OWKIN
December 15, 2018 - Young people suffering chronic pain battle isolation and stigma as they struggle to forge their identities
December 15, 2018 - Lifespan extension at low temperatures depends on individual’s genes, study shows
December 15, 2018 - New ingestible capsule can be controlled using Bluetooth wireless technology
December 15, 2018 - Researchers uncover microRNAs involved in the control of social behavior
December 15, 2018 - Research offers hope for patients with serious bone marrow cancer
December 15, 2018 - Link between poverty and obesity is only about 30 years old, study shows
December 15, 2018 - Mass spectrometry throws light on old case of intentional heavy metal poisoning
December 15, 2018 - BeyondSpring Announces Phase 3 Study 105 of its Lead Asset Plinabulin for Chemotherapy-Induced Neutropenia Meets Primary Endpoint at Interim Analysis
December 15, 2018 - Study finds that in treating obesity, one size does not fit all
December 15, 2018 - Tenacity and flexibility help maintain psychological well-being, mobility in older people
December 15, 2018 - Study reveals role of brain mechanism in memory recall
December 15, 2018 - High levels of oxygen encourage the brain to remain in deep, restorative sleep
December 15, 2018 - Experimental HIV vaccine strategy works in non-human primates, research shows
December 15, 2018 - Genetically modified pigs could limit replication of classical swine fever virus, study shows
AbbVie Presents Upadacitinib Longer-Term (32-Week) and Patient-Reported Outcomes Data from Phase 2b Atopic Dermatitis Study at 27th European Academy of Dermatology and Venereology (EADV) Congress

AbbVie Presents Upadacitinib Longer-Term (32-Week) and Patient-Reported Outcomes Data from Phase 2b Atopic Dermatitis Study at 27th European Academy of Dermatology and Venereology (EADV) Congress

image_pdfDownload PDFimage_print

NORTH CHICAGO, Ill., Sept. 13, 2018 /PRNewswire/ — AbbVie (NYSE: ABBV), a research-based global biopharmaceutical company, today announced new results from the ongoing Phase 2b study including longer-term (32-week) efficacy and safety data and patient-reported outcomes data evaluating upadacitinib, an investigational, once-daily oral JAK1-selective inhibitor, in adult patients with moderate to severe atopic dermatitis.1,2 Results from a pre-specified, interim analysis from the Phase 2b dose-ranging study showed that treatment with upadacitinib 7.5 mg, 15 mg or 30 mg resulted in greater improvements in itch and skin lesions, with statistically significant differences observed versus placebo at week 32.1 Additionally, results from a further analysis of a subset of patients showed that upadacitinib improved patient-reported itch and impact on sleep due to atopic dermatitis in patients receiving upadacitinib (30 mg, once-daily) compared to placebo at week 16.2 Data from these two analyses will be presented today at the 27th European Academy of Dermatology and Venereology (EADV) Congress in Paris. Upadacitinib is not approved by regulatory authorities and its safety and efficacy have not been established.

“Results from this study increase our understanding of upadacitinib’s potential to be an important treatment option for patients living with atopic dermatitis,” said Marek Honczarenko, M.D., Ph.D., vice president, global immunology development, AbbVie. “At AbbVie, we continuously strive to discover and develop innovative medicines for patients who are in need of more treatment options that advance standards of care and improve quality of life. Data from the mid-stage clinical study support the recent advancement of upadacitinib into Phase 3 clinical studies and underscore our commitment to patients with atopic dermatitis.”

Atopic dermatitis is a common chronic, relapsing, inflammatory skin disease with associated comorbidities.5 One-third of atopic dermatitis patients have moderate to severe disease, which manifests as a debilitating, itchy rash with significant physical, psychological and economic burden.5,6 There is a large unmet need for therapies that are effective to manage the signs and symptoms of moderate to severe atopic dermatitis.

“The symptoms associated with atopic dermatitis can have a profound impact on patients’ quality of life, causing serious discomfort and pain, and impacting their ability to sleep,” said Jonathan Silverberg, M.D., Ph.D., M.P.H., Associate Professor of Dermatology, Medical Social Sciences and Preventive Medicine, Northwestern University Feinberg School of Medicine and lead study investigator. “The patient-reported outcome results presented at EADV are encouraging, and provide further insight into the improvement provided by upadacitinib in patients with moderate to severe atopic dermatitis.”

Longer-Term Results at Week 321

These results are from an interim analysis at week 32 of an ongoing Phase 2b study entitled, “Efficacy and Safety of Upadacitinib Treatment Over 32 Weeks for Patients with Atopic Dermatitis from a Phase 2b, Randomized, Placebo-Controlled Trial” (P0236).1 At week 16, patients in each upadacitinib group were re-randomized in a 1:1 ratio to continue on the Period 1 dose (7.5/15/30 mg, once-daily) or to placebo (withdrawal), while the Period 1 placebo group was re-randomized to receive upadacitinib (30 mg, once-daily) or placebo.1 Four weeks following re-randomization (week 20), blinded rescue therapy with upadacitinib (30 mg, once-daily) was provided after the first instance of a less than EASI 50 response.1

Results showed that patients treated with upadacitinib across all dose groups (7.5/15/30 mg, once-daily) achieved significant improvement in extent and severity of atopic dermatitis, as measured by the mean percent improvement from baseline in the Eczema Area and Severity Index (EASI) score.1 For patients receiving upadacitinib, the mean percent improvement from baseline in the EASI score was 48/44/69 percent for the 7.5/15/30 mg doses, respectively, compared to 34 percent for patients receiving placebo.1 Among patients receiving placebo in Period 1 and re-randomized to receive the upadacitinib 30 mg dose in Period 2, the mean percent improvement from baseline in the EASI score was 97 percent at week 32.1

Additionally, significant improvement in pruritus (itch) from baseline was observed across all upadacitinib treatment groups at week 32.1 Patients re-randomized to upadacitinib achieved a 53/44/61 percent improvement in itch across the 7.5/15/30 mg doses, respectively, compared to 6 percent worsening in itch for patients receiving placebo, as measured by the pruritus numerical rating scale (NRS).1

Efficacy Results at Week 321

Period 1 Dose

PBO

UPA 7.5 mg

UPA 15 mg

UPA 30 mg

Period 2 Dose

PBO

(n=10)

UPA

30 mg (n=10)

PBO

(n=15)

UPA

7.5 mg (n=16)

PBO

(n=19)

UPA

15 mg (n=18)

PBO

 (n=19)

UPA

30 mg (n=19)

Mean Percent Improvement from Baseline in EASI Scorea

34%

97%***

9%

48%*

12%

44%*

22%

69%**

Mean Percent Improvement from Baseline in Pruritus/Itch Numerical Rating Scaleb

 

 

 

-6%

94%***

-6%

53%**

3%

44%**

-13%

61%***

 

*p<0.05, **p<0.01, ***p<0.001

aEczema Area and Severity Index (EASI) score is a tool used to measure the extent (area) and severity of atopic dermatitis

bItch was rated from 0 (no itch) to 10 (worst imaginable itch)

In this study, no new safety signals were detected.1 There were two serious adverse events in the placebo group re-randomized to receive upadacitinib 30 mg, including one serious infection and one case of non-melanoma skin cancer.1 No cardiovascular events (adjudicated), malignancies other than non-melanoma skin cancer, deep vein thrombosis (DVT) or pulmonary embolism (PE) occurred through week 32 in the Phase 2b study.1

AbbVie has previously announced positive results from the Phase 2b study in February 2018 and September 2017.

Patient-Reported Outcomes at Week 16: Itch, Skin Pain and Impact on Sleep Due to Atopic Dermatitis

Results from an additional analysis in a subset of patients through week 162 showed that patients treated with upadacitinib had improvements on patient-reported outcomes covering itch and the impact of atopic dermatitis on sleep.2 In the study, patients completed a symptom and impact questionnaire daily, which included three items to assess itch and skin pain (itch during sleep, itch while awake, skin pain) and three items to assess impact on sleep (difficulty falling asleep, sleep impact, bother from waking up at night).2

Improvements on all measures were observed as early as week 2 for all upadacitinib dose groups compared to placebo.2 At week 16, only the upadacitinib 30 mg group showed improvements on all measures except skin pain.2

Patient-reported outcomes are an important component of understanding how patients perceive the physical, psychological and social burden of their disease.7 Using patient-reported outcomes data to assess the impact of the disease allows patients to take an active role in their treatment journey, providing valuable insight to their healthcare teams.

About the Phase 2b Upadacitinib Study

Interim results were reported from an ongoing, 88 week dose-ranging, randomized, double-blind, parallel-group, placebo-controlled multicenter Phase 2b study1 designed to evaluate the safety and efficacy of upadacitinib in adult patients with moderate to severe atopic dermatitis not adequately controlled by topical treatments, or for whom topical treatments were not medically advisable. In Period 1 (16 weeks), subjects were randomized in a 1:1:1:1 ratio to one of four treatment groups (three upadacitinib dosing groups, 7.5/15/30 mg, once-daily, and one placebo group). In Period 2 (72 weeks), each upadacitinib group was re-randomized in a 1:1 ratio to continue the Period 1 dose or placebo (withdrawal). Patients randomized to placebo in Period 1 were re-randomized at week 16 to either upadacitinib 30 mg once-daily or placebo. After four weeks of re-randomization (week 20), rescue therapy with upadacitinib 30 mg once-daily was provided after the first instance of a less than EASI 50 response. The primary endpoint of the study was the mean percentage change from baseline in Eczema Area and Severity Index (EASI) score at 16 weeks. Secondary endpoints included the proportion of patients achieving EASI 90, EASI 75, Investigator Global Assessment (IGA) of 0 or 1 and percent change in pruritus/itch numerical rating scale (NRS). More information on this trial can be found at www.clinicaltrials.gov (NCT02925117).

About Upadacitinib

Discovered and developed by AbbVie, upadacitinib is a once-daily oral, small molecule JAK1-selective inhibitor being developed for moderate to severe atopic dermatitis and other immune-mediated diseases.3,4 Phase 3 trials of upadacitinib in rheumatoid arthritis, psoriatic arthritis and Crohn’s disease are ongoing and it is also being investigated to treat ulcerative colitis, ankylosing spondylitis and atopic dermatitis.8-13

Upadacitinib is an investigational oral agent and is not approved by regulatory authorities. Safety and efficacy have not been established.

About AbbVie

AbbVie is a global, research and development-based biopharmaceutical company committed to developing innovative advanced therapies for some of the world’s most complex and critical conditions. The company’s mission is to use its expertise, dedicated people and unique approach to innovation to markedly improve treatments across four primary therapeutic areas: immunology, oncology, virology and neuroscience. In more than 75 countries, AbbVie employees are working every day to advance health solutions for people around the world. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on Twitter, Facebook or LinkedIn.

Forward-Looking Statements

Some statements in this news release are, or may be considered, forward-looking statements for purposes of the Private Securities Litigation Reform Act of 1995. The words “believe,” “expect,” “anticipate,” “project” and similar expressions, among others, generally identify forward-looking statements. AbbVie cautions that these forward-looking statements are subject to risks and uncertainties that may cause actual results to differ materially from those indicated in the forward-looking statements. Such risks and uncertainties include, but are not limited to, challenges to intellectual property, competition from other products, difficulties inherent in the research and development process, adverse litigation or government action, and changes to laws and regulations applicable to our industry. Additional information about the economic, competitive, governmental, technological and other factors that may affect AbbVie’s operations is set forth in Item 1A, “Risk Factors,” of AbbVie’s 2017 Annual Report on Form 10-K, which has been filed with the Securities and Exchange Commission. AbbVie undertakes no obligation to release publicly any revisions to forward-looking statements as a result of subsequent events or developments, except as required by law.

References

  1. Guttman-Yassky, E et al. ePoster #P0236. 27th European Academy of Dermatology and Venerology (EADV) Congress. September 2018.
  2. Silverberg, J et al. Presentation #FC04.03. 27th European Academy of Dermatology and Venerology (EADV) Congress. September 2018.
  3. Voss, J, et al. Pharmacodynamics Of a Novel Jak1 Selective Inhibitor In Rat Arthritis and Anemia Models and In Healthy Human Subjects. [abstract]. Arthritis Rheum 2013;65 Suppl 10 :2374. DOI: 10.1002/art.2013.65.issue-s10.
  4. Pipeline – Our Science | AbbVie. AbbVie. 2018. Available at: https://www.abbvie.com/our-science/pipeline.html. Accessed on September 6, 2018.
  5. Nutten S, Atopic Dermatitis: Global Epidemiology and Risk Factors. Ann Nutr Metab 2015;66(suppl 1):8-16 2. Accessed on September 6, 2018.
  6. Wei, W, et al. Discordance Between Physician- and Patient-Reported Disease Severity in Adults with Atopic Dermatitis: A US Cross-Sectional Survey. Am J Clin Dermatol. 2017; 18(6): 825–835.
  7. Deshpande, PR et al. Patient-reported outcomes: A new era in clinical research. Perspect Clin Res. 2011 Oct-Dec; 2(4): 137–144.
  8. A Study Comparing ABT494 to Placebo in Subjects 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. 2018. Available at: https://clinicaltrials.gov/ct2/show/NCT02675426. Accessed on September 6, 2018.
  9. 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. 2018. Available at: https://clinicaltrials.gov/ct2/show/NCT03104400. Accessed on September 6, 2018.
  10. A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of ABT-494 for the Induction of Symptomatic and Endoscopic Remission in Subjects With Moderately to Severely Active Crohn’s Disease Who Have Inadequately Responded to or Are Intolerant to Immunomodulators or Anti-TNF Therapy. ClinicalTrials.gov. 2018. Available at: https://clinicaltrials.gov/ct2/show/NCT02365649. Accessed on September 6, 2018.
  11. A Study Evaluating the Safety and Efficacy of Upadacitinib in Subjects With Active Ankylosing Spondylitis (SELECT Axis 1). ClinicalTrials.gov. 2018. Available at: https://clinicaltrials.gov/ct2/show/study/NCT03178487. Accessed on September 6, 2018.
  12. A Study to Evaluate the Safety and Efficacy of ABT-494 for Induction and Maintenance Therapy in Subjects With Moderately to Severely Active Ulcerative Colitis. ClinicalTrials.gov. 2018. Available at: https://clinicaltrials.gov/ct2/show/NCT02819635. Accessed on September 6, 2018.
  13. Phase 2b AD Dose Ranging Study (40wk) N=160. ClinicalTrials.gov. 2018. Available at: https://clinicaltrials.gov/ct2/show/NCT02925117. Accessed on September 6, 2018.

SOURCE AbbVie

Posted: September 2018

About author

Related Articles