Breaking News
December 13, 2018 - Paternal grandfather’s access to food associated with grandson’s mortality risk
December 13, 2018 - Our brain senses angry voices in a flash, study shows
December 13, 2018 - PM2.5 Exposure Linked to Asthma Rescue Medication Use
December 13, 2018 - Can’t exercise? A hot bath may help improve inflammation, metabolism, study suggests
December 13, 2018 - Can artificial intelligence help doctors with the human side of medicine?
December 13, 2018 - Virginia Tech and UC San Diego researchers team up to develop nonopioid drug for chronic pain
December 13, 2018 - NIH offers support for HIV care and prevention research in the southern United States
December 12, 2018 - Activating brain region could revive the urge to socialize among opioid addicts
December 12, 2018 - Relationship impairment appears to interfere with seeking mental health treatment in men
December 12, 2018 - Sleep, Don’t Cram, Before Finals for Better Grades
December 12, 2018 - Effective treatments for urticarial vasculitis
December 12, 2018 - Gun violence is a public health issue: One physician’s story
December 12, 2018 - The Science of Healthy Aging
December 12, 2018 - Yes to yoghurt and cheese: New improved Mediterranean diet
December 12, 2018 - Researchers uncover a number of previously unknown insecticide resistance mechanisms
December 12, 2018 - Regulating the immune system’s ‘regulator’
December 12, 2018 - In breaking bad news, the comfort of silence
December 12, 2018 - Study finds upward link between alcohol consumption and physical activity in college students
December 12, 2018 - FDA issues warning letter to Zhejiang Huahai Pharmaceutical involved in valsartan recall
December 12, 2018 - Presence of antiphospholipid antibodies tied to first-time MI
December 12, 2018 - DNA analysis finds that stethoscopes are teaming with bacteria
December 12, 2018 - New study could help inform research on preventing falls
December 12, 2018 - Women and men with heart attack symptoms receive different care from EMS
December 12, 2018 - Disrupted biological clock can contribute to onset of diseases, USC study shows
December 12, 2018 - New publications generate controversy over the value of reducing salt consumption in populations
December 12, 2018 - New data from TAILORx trial confirms lack of chemo benefit regardless of race or ethnicity
December 12, 2018 - Specific class of biomarkers can accurately indicate the severity of cancer
December 12, 2018 - Meds Taken Do Not Vary With ADL Impairment in Heart Failure
December 12, 2018 - Long-term study shows that HIV-2 is deadlier than previously thought
December 12, 2018 - People living near oil and gas wells show early signs of cardiovascular disease
December 12, 2018 - IONTAS founder and pioneer in phage display technology attends Nobel Prize Award Ceremony
December 12, 2018 - People who eat red meat have high levels of chemical associated with heart disease, study finds
December 12, 2018 - New method uses water molecules to unlock neurons’ secrets
December 12, 2018 - Genetics study offers hope for new acne treatment
December 12, 2018 - New computer model predicts prostate cancer progression
December 12, 2018 - Nobel Laureates lecture about immune checkpoint therapy for cancer treatment
December 12, 2018 - More Illnesses From Tainted Romaine Lettuce Reported
December 12, 2018 - Aspirin could reduce HIV infections in women
December 12, 2018 - The EORTC Brain Tumor Group and Protagen AG collaborate to study immuno-competence of long-term glioblastoma survivors
December 12, 2018 - Insights into magnetotactic bacteria could guide development of biological nanorobots
December 12, 2018 - Sacrificial immune cells alert body to infection
December 12, 2018 - Low-salt diet may be more beneficial for females than males
December 12, 2018 - Major soil organic matter compound battles chronic wasting disease
December 12, 2018 - Findings may open up new ways to treat dwarfism and other ER-stress-related conditions
December 12, 2018 - New computational model provides clearer picture of shape-changing cells’ structure and mechanics
December 12, 2018 - 10 Facts on Patient Safety
December 12, 2018 - Poorest dying nearly 10 years younger than the rich in ‘deeply worrying’ trend for UK
December 12, 2018 - Innovative care model for children with ASD reduces use of behavioral drugs in ED
December 12, 2018 - Spending time in and around Hong Kong’s waters linked to better health and wellbeing
December 12, 2018 - Simple measures to prevent weight gain over Christmas
December 12, 2018 - Research advances offer hope for patient-tailored AML treatment
December 12, 2018 - Researchers discover a ‘blind spot’ in atomic force microscopy
December 12, 2018 - Sprayable gel could help prevent recurrences of cancer after surgery
December 12, 2018 - SLU researchers explore how fetal exposure to inflammation can alter immunity in newborns
December 12, 2018 - How do patients want to discuss symptoms with clinicians?
December 12, 2018 - Zinc chelation may be able to deliver drug to insulin-producing cells
December 12, 2018 - Brigham researchers develop automated, low-cost tool to predict a woman’s ovulation
December 12, 2018 - Some people with Type 2 diabetes may be testing their blood sugar more often than needed
December 12, 2018 - Slow-growing type of glioma may be vulnerable to immunotherapy, suggests study
December 12, 2018 - Study provides new information regarding microRNA function in cellular homeostasis of zebrafish
December 12, 2018 - Study provides new understanding of mysterious ‘hereditary swelling’
December 12, 2018 - Researchers shed new light on how to combat Shiga and ricin toxins
December 12, 2018 - Pregnant Women Commonly Refuse Vaccines
December 12, 2018 - Drug treatment could offer new hope for some patients with brain bleeding
December 12, 2018 - Health care financial burden of animal-related injuries is growing, study says
December 12, 2018 - Macrophage cells could help repair the heart following a heart attack, study finds
December 12, 2018 - Researchers develop new system for efficiently producing human norovirus
December 12, 2018 - New artificial intelligence-based system to differentiate between different types of cancer cells
December 11, 2018 - Brazilian professors propose guidelines for therapeutic use of melatonin
December 11, 2018 - Healthy Lifestyle Lowers Odds of Breast Cancer’s Return
December 11, 2018 - New research identifies two genes linked to serious congenital heart condition
December 11, 2018 - NIH Director talks science, STEM careers with preteens
December 11, 2018 - Disabling a Cellular Antivirus System Could Improve Gene Therapy
December 11, 2018 - New tool swiftly provides accurate measure of patients’ cognitive difficulties
December 11, 2018 - NICE releases new guidelines for diagnosis and management of COPD
December 11, 2018 - Without Obamacare penalty, think it’ll be nice to drop your plan? Better think twice
December 11, 2018 - Researchers capture high-resolution X-ray and NMR image of key immune regulator
December 11, 2018 - Natural flavonoid is effective at treating leishmanisis infections, study shows
December 11, 2018 - Avoidant grievers unconsciously monitor and block mind-wandering contents, study shows
December 11, 2018 - Study identifies how hantaviruses infect lung cells
AbbVie Announces Patient-Reported Outcomes Data from Three Pivotal Phase 3 Studies of Risankizumab, Showing Significant Improvements in Health-Related Quality of Life for Patients with Psoriasis

AbbVie Announces Patient-Reported Outcomes Data from Three Pivotal Phase 3 Studies of Risankizumab, Showing Significant Improvements in Health-Related Quality of Life for Patients with Psoriasis

image_pdfDownload PDFimage_print

NORTH CHICAGO, Ill., Sept. 13, 2018 /PRNewswire/ — AbbVie (NYSE: ABBV), a research-based global biopharmaceutical company, today announced new patient-reported outcomes data from three pivotal Phase 3 trials evaluating risankizumab, an investigational interleukin-23 (IL-23) inhibitor, in adult patients with moderate to severe plaque psoriasis. Across all three trials, patients reported significant improvements in health-related quality of life, mental health and work productivity measures when treated with risankizumab.1,2 Data from these studies will be presented at the 27th European Academy of Dermatology and Venerology (EADV) Congress in Paris. Risankizumab is not approved by regulatory authorities and its safety and efficacy have not been established.

At week 16, significantly more risankizumab-treated patients reported a psoriasis symptom scale (PSS) score of 0, indicating they were symptom-free based on a score assessing pain, redness and itchiness, compared with STELARA® (ustekinumab) and placebo in ultIMMa-1 and ultIMMa-2.1 Significantly more patients treated with risankizumab continued to report a PSS score of 0 at one year (52 weeks) compared to ustekinumab.1 In IMMvent, significantly more patients treated with risankizumab achieved a Dermatology Life Quality Index (DLQI) score of 0 or 1, indicating psoriasis no longer had impact on their life quality, compared to HUMIRA® (adalimumab) at week 16.2 Risankizumab-treated patients maintained reported outcomes at week 44 in IMMvent.2 Improvements in hospital anxiety and depression scales (HADS) and work limitation questionnaire (WLQ), a measure of work productivity, were also reported.1,2

AbbVie has previously announced positive top-line results from ultIMMa-1, ultIMMa-2 and IMMvent in a press release found here. Efficacy and safety results from the ultIMMa-1 and ultIMMa-2 studies were recently published in The Lancet.4

Safety results from all three Phase 3 trials have been previously reported.4,5

“Patients treated with risankizumab reported significant improvements in severity of psoriasis symptoms and measures of quality of life compared to current standards of care, as consistently demonstrated by the results of all three Phase 3 pivotal trials,” said Marek Honczarenko, M.D., Ph.D., vice president, global immunology development, AbbVie. “Patients with psoriasis are seeking new treatment options that help them not only to achieve and maintain clear skin, but may also improve their quality of life. These results add to the growing body of evidence demonstrating that risankizumab has the potential to be an important additional treatment option for patients with plaque psoriasis.”

Patient-reported outcomes are an important component of understanding how patients perceive the physical, psychological and social impact of their disease.6 Using patient-reported outcomes to assess disease activity helps patients to take an active role in their treatment journey, providing valuable insights to their healthcare team.6

“Psoriasis can impact many aspects of a person’s life, both physically and psychologically,” said Prof. Matthias Augustin, Director, Institute and German Center for Health Services Research in Dermatology and Nursing IVDP, University Medical Center Hamburg. “Improvements in quality of life reported by patients as early as week 16 and up to one year show risankizumab’s potential to significantly reduce the burden of psoriasis on daily life and adds to our knowledge about its clinical efficacy in psoriasis patients.”

Psoriasis Symptom Scale (PSS)

In pooled analyses from ultIMMa-1 and ultIMMa-2, significantly more patients treated with risankizumab (n=598) reported a PSS of 0 compared to placebo (n=200) and ustekinumab (n=199), indicating they were symptom-free based on pain, redness, itchiness and burning. At week 16, 30 percent of patients receiving risankizumab had a PSS score of 0, compared with 15 and 1 percent of patients receiving ustekinumab and placebo, respectively (p

Dermatology Life Quality Index (DLQI)

Dermatology Life Quality Index2 is a measure of a patient’s health-related quality of life, ranging from 0 to 30, with lower scores indicating the disease has less impact on life quality. In IMMvent, risankizumab (n=301) was associated with significantly greater improvement in DLQI score from baseline than adalimumab (n=304) at week 16 (with an 11.5 point reduction in DLQI score versus 9.7 points, p

Hospital Anxiety and Depression Scale (HADS)

Hospital Anxiety and Depression Scale1 is a self-assessment scale designed to measure depression, anxiety and emotional distress, with scores ranging from 0 to 21 (increasing in severity). In pooled analyses from ultIMMa-1 and ultIMMa-2, risankizumab-treated patients reported significantly greater improvements from baseline on the HADS anxiety and depression scales (scores reduced by 3 points for anxiety and 2.7 points for depression, respectively) compared to ustekinumab (scores reduced by 2.2 points for anxiety and 2 points for depression, respectively) at week 16 (p

Work Limitation Questionnaire (WLQ)

The Work Limitation Questionnaire2 measures the degree to which health problems interfere with aspects of job performance and the productivity impact of these work limitations. Work Limitation Questionnaire scores range from 0 to 100, with lower scores indicating less amount of time that health interferes with job demands and productivity. In IMMvent, patients receiving risankizumab showed a significantly larger improvement in WLQ total productivity loss from baseline compared to those receiving adalimumab at week 16 (score reduced by 2.8 percent versus 1.9 percent, p

About the Phase 3 ultIMMa-1 and ultIMMa-2 Studies

ultIMMa-1 and ultIMMa-24 are replicate Phase 3, randomized, double-blind, double-dummy, placebo- and active-controlled studies designed to evaluate the safety and efficacy of risankizumab compared to placebo or ustekinumab in adult patients with moderate to severe chronic plaque psoriasis. Risankizumab (150 mg) was given as a subcutaneous injection at week 0, 4, 16, 28, 40. Ustekinumab 45 mg or 90 mg, based on screening weight, was delivered as a subcutaneous injection at week 0, 4, 16, 28, 40. The active comparator used for these studies was sourced from the European Union. The co-primary endpoints were achievement of at least a 90 percent improvement in the PASI score (PASI 90) at week 16 and achievement of a sPGA score of clear or almost clear (0/1) at week 16 compared to placebo. Key secondary endpoints included PASI 90 and sPGA score of clear or almost clear (0/1) compared to ustekinumab at week 16 and achievement of PASI 90 and PASI 100 at week 52 compared to ustekinumab. These Phase 3 studies have been conducted in cooperation between AbbVie and Boehringer Ingelheim. More information on these trials can be found at www.clinicaltrials.gov (ultIMMa-1: NCT02684370; ultIMMa-2: NCT02684357).

About the Phase 3 IMMvent Study

The IMMvent study5 is a Phase 3 randomized, double-blind, double-dummy, active-controlled study designed to evaluate the safety and efficacy of risankizumab compared to adalimumab in adult patients with moderate to severe chronic plaque psoriasis. In the first phase patients were randomized 1:1 to either risankizumab (150 mg), given as a subcutaneous injection at baseline, 4 weeks later and every 12 weeks thereafter or adalimumab, given as a subcutaneous injection, with an initial dose of 80 mg followed by 40 mg every other week starting one week after the initial dose. The co-primary endpoints were achievement of at least a 90 percent improvement in the PASI score (PASI 90) at week 16 and achievement of a sPGA score of clear or almost clear (0/1) at week 16.

Patients originally randomized to risankizumab received it throughout the study. Those originally randomized to adalimumab followed a treatment course based on week 16 response: those with less than PASI 50 at week 16 switched to risankizumab; those with PASI 90 continued adalimumab; and those with a PASI 50 but less than PASI 90 response were re-randomized to switch to risankizumab or continue adalimumab. For this phase, PASI 90 at week 44 was the primary endpoint for those patients re-randomized at week 16. PASI 100 at week 44 was the ranked secondary endpoint. This Phase 3 study has been conducted in cooperation between AbbVie and Boehringer Ingelheim. More information on this trial can be found at www.clinicaltrials.gov (NCT02694523).

About the Risankizumab Phase 3 Psoriasis Program

The global risankizumab Phase 3 psoriasis program4,5,7 evaluates more than 2,000 patients with moderate to severe plaque psoriasis in four pivotal studies. The studies include assessments of efficacy, safety and tolerability of risankizumab. Key measures of efficacy include measures of disease activity and skin clearance, including PASI 90, PASI 100 and sPGA 0/1, as well as long-term clinical outcomes. More information on this program can be found at www.clinicaltrials.gov (NCT02672852, NCT02694523, NCT02684370, NCT02684357).

About Risankizumab

Risankizumab is an investigational compound that is designed to selectively block IL-23 by binding to its p19 subunit.3 IL-23, a key cytokine involved in inflammatory processes, is thought to be linked to a number of chronic immune-mediated diseases.8 Phase 3 trials of risankizumab in psoriasis and Crohn’s disease are ongoing, and it is also being investigated to treat psoriatic arthritis and ulcerative colitis.1-3,9,10,11,12

Risankizumab is part of a collaboration between Boehringer Ingelheim and AbbVie, with AbbVie leading future development and commercialization of risankizumab globally. Risankizumab 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.

1 Augustin, M., et al. ePoster #1996. 27th European Academy of Dermatology and Venereology (EADV) Congress. September 2018.
2 Crowley, J., et al. ePoster #P1947. 27th European Academy of Dermatology and Venereology (EADV) Congress. September 2018.
3 Papp K.A., et al. Risankizumab versus Ustekinumab for Moderate-to-Severe Plaque Psoriasis. N Engl J Med. 2017 Apr 20; 376:1551-1560.
4 Gordon K, et al. Efficacy and safety of risankizumab in moderate-to-severe plaque psoriasis (UltIMMa-1 and UltIMMa-2): results from two double-blind, randomised, placebo-controlled and ustekinumab-controlled phase 3 trials. The Lancet. 2018 Aug 25;392(10148):650-661.
5 Reich, K., et al. ePoster #P1813. 27th European Academy of Dermatology and Venereology (EADV) Congress. September 2018.
6 Deshpande, P.R. et al. Patient-reported outcomes: A new era in clinical research. Perspect Clin Res. 2011 Oct-Dec; 2(4): 137–144.
7 Blauvet, A., et al. Presentation # FC29. Psoriasis Gene to Clinic – 8th International Congress. October 2017.
8 Duvallet E, Sererano L, Assier E, et. al. Interleukin-23: a key cytokine in inflammatory diseases. Ann Med. 2011 Nov;43(7):503-11.
9 A Study of the Efficacy and Safety of Risankizumab in Subjects With Moderately to Severely Active Crohn’s Disease. ClinicalTrials.gov. 2018. Available at: https://clinicaltrials.gov/ct2/show/NCT03105128. Accessed on September 5, 2018.
10 BI 655066/ABBV-066/Risankizumab Compared to Placebo in Patients With Active Psoriatic Arthritis. ClinicalTrials.gov. 2018. Available at: https://clinicaltrials.gov/ct2/show/NCT02719171. Accessed on September 5, 2018.
11 A Study to Assess the Efficacy and Safety of Risankizumab in Subjects With Ulcerative Colitis Who Responded to Induction Treatment in M16-067 or M16-065. ClinicalTrials.gov. 2018. https://www.clinicaltrials.gov/ct2/show/NCT03398135. Accessed on September 5, 2018.
12 A Study to Evaluate the Efficacy and Safety of Risankizumab in Subjects With Moderately to Severely Active Ulcerative Colitis Who Have Failed Prior Biologic Therapy. ClinicalTrials.gov. 2018. https://www.clinicaltrials.gov/ct2/show/NCT03398148. Accessed on September 5, 2018.
13 HUMIRA [Summary of Product Characteristics]. AbbVie Ltd.; Available at: http://www.ema.europa.eu/docs/en_GB/document_library/EPAR__Product_Information/human/000481/WC500050870.pdf. Last updated August 2018. Accessed on September 5, 2018.

SOURCE AbbVie

Posted: September 2018

About author

Related Articles