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

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)¹

• 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<0.001). At one year, 56 percent of risankizumab-treated patients reported being symptom free (PSS=0), compared with 30 percent of patients receiving ustekinumab (p<0.001).

Dermatology Life Quality Index (DLQI)²

• Dermatology Life Quality Index 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<0.001). Significantly more patients treated with risankizumab achieved a DLQI score of 0 or 1 (66 percent) compared to adalimumab (49 percent) at week 16 (p<0.001). At week 44, patients maintained benefits achieved with risankizumab.

Hospital Anxiety and Depression Scale (HADS)¹

• Hospital Anxiety and Depression Scale 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<0.01). At one year, patients maintained benefits achieved with risankizumab.

Work Limitation Questionnaire (WLQ)²

• The Work Limitation Questionnaire 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<0.05). The benefits gained were maintained at week 44, with risankizumab-treated patients WLQ productivity loss score reduced by 3.3 percent and adalimumab-treated patients score reduced by 2.6 percent, based on a mean reduction from baseline. Work Limitation Questionnaire subscales were also presented.

About the Phase 3 ultIMMa-1 and ultIMMa-2 studies⁴

ultIMMa-1 and ultIMMa-2 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 study⁵

The IMMvent study 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^4,5,7

The global risankizumab Phase 3 psoriasis program 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 HUMIRA in the European Union¹³

HUMIRA is indicated for the treatment of moderate to severe chronic plaque psoriasis in adult patients who are candidates for systemic therapy.

Important EU Safety Information¹³

HUMIRA is contraindicated in patients with active tuberculosis or other severe infections such as sepsis, and opportunistic infections and in patients with moderate to severe heart failure (NYHA class III/IV). It is also contraindicated in patients hypersensitive to the active substance or to any of the excipients; serious allergic reactions including anaphylaxis have been reported. The use of HUMIRA increases the risk of developing serious infections, including hepatitis B reactivation, which may, in rare cases, be life-threatening. Rare cases of lymphoma and leukemia have been reported in patients treated with HUMIRA. On rare occasions, a severe type of cancer called hepatosplenic T-cell lymphoma has been observed and often results in death. A risk for the development of malignancies in patients treated with TNF-antagonists cannot be excluded. Rare cases of pancytopenia, aplastic anaemia, demyelinating disease, lupus, lupus-related conditions and Stevens-Johnson syndrome have been reported in patients treated with HUMIRA. The most frequently reported adverse events across all indications included respiratory infections, injection site reactions, headache and musculoskeletal pain.

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

Full summary of product characteristics is available at: www.ema.europa.eu

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 – 8^th 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.

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