AbbVie Presents New Positive Late-Breaking Data from Two Phase 3 Psoriasis Trials of Risankizumab at the 2018 American Academy of Dermatology Annual Meeting

NORTH CHICAGO, Ill., Feb. 17, 2018 /PRNewswire/ -- AbbVie (NYSE: ABBV), a global research and development-based biopharmaceutical company, today presented new positive results from the pivotal Phase 3 ultIMMa-1 and ultIMMa-2 replicate clinical trials that evaluated the safety and efficacy of risankizumab (150 mg) compared to placebo or ustekinumab (45 or 90 mg, based on patient weight). These results were featured during the "Late-breaking Research: Clinical Trials" session at the 2018 American Academy of Dermatology Annual Meeting in San Diego.

Risankizumab is an investigational interleukin-23 (IL-23) inhibitor being evaluated for the treatment of patients with moderate to severe plaque psoriasis.¹ Risankizumab is not approved by regulatory authorities and its safety and efficacy have not been established.

In October of 2017, AbbVie announced positive top-line results from these two pivotal trials, an evaluation of the primary and ranked secondary endpoints, including the Psoriasis Area and Severity Index (PASI 90 and PASI 100) at 16 weeks and one year and clear or almost clear skin (sPGA 0/1) at 16 weeks. The press release is available here. Risankizumab is part of a collaboration with Boehringer Ingelheim, with AbbVie leading future development and commercialization of risankizumab globally.

In today's presentation, additional ranked secondary endpoints showed significantly higher rates of skin clearance at week 16 and at one year of treatment, compared with ustekinumab, as measured by static Physician Global Assessment (sPGA 0).¹ The skin clearance rates (sPGA 0) presented today are consistent with the previously reported PASI 100 rates at one year.¹

In addition, through one year of treatment, significantly more patients receiving risankizumab self-reported a Dermatology Life Quality Index (DLQI) score of 0 or 1 compared with ustekinumab.¹ DLQI 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.³

"Not only do these data show significant rates of clear skin, but because we know the burden of psoriasis extends beyond the skin, we are encouraged by the patient-reported improvement in quality of life after one year of treatment," said Kenneth B. Gordon, M.D., professor and chair of the Department of Dermatology at the Medical College of Wisconsin, dermatologist at the Froedtert & the Medical College of Wisconsin Froedtert Hospital and principal investigator of the ultIMMa-1 study. "Given the significant impact of psoriasis, it is important to continue to investigate additional treatment options."

Evaluation of Clear Skin (sPGA 0) at 16 Weeks and One Year

• Results at week 16 and one year (52 weeks) demonstrated significantly higher rates of clear skin (sPGA 0), both ranked secondary endpoints, in patients treated with risankizumab, compared to ustekinumab patients in ultIMMa-1 and ultIMMa-2.¹

        ultIMMa-1 and ultIMMa-2 sPGA 0 Results at Week 16 and One Year*
         --------------------------------------------------------------

                                       ultIMMa-1                           ultIMMa-2
                                       ---------                           ---------

        Risankizumab         Ustekinumab      Risankizumab      Ustekinumab
           150 mg              45/90 mg          150 mg           45/90 mg
          (n=304)              (n=100)           (n=294)           (n=99)
           ------               ------           ------            -----

    sPGA 0 at Week 16*                 37%              14%               51%        25%
    -----------------                  ---               ---                ---         ---

    sPGA 0 at Week 52*                 58%              21%               60%        30%
    -----------------                  ---               ---                ---         ---

    *P<0.001. Not all secondary
     endpoints for the trials
     are shown.

Evaluation of Clear or Almost Clear Skin (sPGA 0/1) at One Year

• In an exploratory analysis at one year (52 weeks), more risankizumab patients also demonstrated clear or almost clear skin (sPGA 0/1), compared to ustekinumab patients in ultIMMa-1 and ultIMMa-2.¹

             ultIMMa-1 and ultIMMa-2 sPGA 0/1 Results at One Year*
             -----------------------------------------------------

                                       ultIMMa-1                           ultIMMa-2
                                       ---------                           ---------

        Risankizumab         Ustekinumab      Risankizumab      Ustekinumab
           150 mg              45/90 mg          150 mg           45/90 mg
          (n=304)              (n=100)           (n=294)           (n=99)
           ------               ------           ------            -----

    sPGA 0/1 at Week
     52*                               86%              54%               83%        55%
    ----------------                   ---               ---                ---         ---

    *P <0.001. Not all
     secondary endpoints for
     the trials are shown.

Evaluation of Quality of Life (DLQI) at 16 Weeks and One Year

• More patients treated with risankizumab reported a DLQI score of 0 or 1 versus ustekinumab at 16 weeks, a ranked secondary endpoint, and one year (52 weeks), an exploratory analysis.¹

       ultIMMa-1 and ultIMMa-2 DLQI 0/1 Results at Week 16 and One Year*
       -----------------------------------------------------------------

                                       ultIMMa-1                           ultIMMa-2
                                       ---------                           ---------

        Risankizumab         Ustekinumab      Risankizumab      Ustekinumab
           150 mg              45/90 mg          150 mg           45/90 mg
          (n=304)              (n=100)           (n=294)           (n=99)
           ------               ------           ------            -----

    DLQI 0/1 at Week
     16*                               66%              43%               67%        47%
    ----------------                   ---               ---                ---         ---

    DLQI 0/1 at Week
     52*                               75%              47%               71%        44%
    ----------------                   ---               ---                ---         ---

    *P <0.001. Not all
     secondary endpoints for
     the trials are shown.

In both the ultIMMa-1 and ultIMMa-2 trials, the most frequently reported treatment-emergent adverse events in the risankizumab arms were upper respiratory tract infection.⁴ In ultIMMa-1, one patient receiving risankizumab presented with latent tuberculosis and was treated with rifampicin.¹ Safety findings were previously reported here.

"AbbVie's enduring commitment to dermatology is grounded in more than 20 years of expertise in immunology," said Marek Honczarenko, M.D., Ph.D., vice president, immunology development, AbbVie. "Risankizumab treatment resulted in significant rates of complete skin clearance which further supports its potential to be an important treatment option. We look forward to submitting our regulatory application for risankizumab in moderate to severe chronic plaque psoriasis the first half of this year."

About the Phase 3 ultIMMa-1 and ultIMMa-2 studies¹
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 at week 16 included PASI 90, sPGA score of clear (sPGA 0), sPGA score of clear or almost clear (0/1) and DLQI score of 0/1, compared to ustekinumab. Key secondary endpoints at week 52 included PASI 90, PASI 100 and sPGA 0 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 Risankizumab
Risankizumab is an investigational compound that is designed to selectively block IL-23 by binding to its p19 subunit.² IL-23, a key cytokine involved in inflammatory processes, is thought to be linked to a number of chronic immune-mediated diseases.⁵ Phase 3 trials of risankizumab in psoriasis and Crohn's disease are ongoing, and it is also being investigated to treat psoriatic arthritis.^6,7 Future trials are planned to investigate risankizumab in ulcerative colitis.^8,9

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 Gordon K, et al. Efficacy and Safety of Risankizumab: Results from Two Double-Blind, Placebo- and Ustekinumab-Controlled, Phase 3 Trials in Moderate-to-Severe Plaque Psoriasis. American Academy of Dermatology. February 2018.
² Papp K.A., et al. Risankizumab versus Ustekinumab for Moderate-to-Severe Plaque Psoriasis. NEJM. 2017.
³ Hongbo Y, et al. Translating the science of quality of life into practice: What do dermatology life quality index scores mean? J Invest Dermatol. 2005 Oct;125(4):659-64.
⁴ Gordon K, et al. Efficacy and Safety of Risankizumab: Results from Two Double-blind, Placebo- and Ustekinumab-controlled, Phase 3 Trials in Moderate-to-severe Plaque Psoriasis. [Abstract F061]. AAD 2018. Available at: https://www.aad.org/File Library/Top navigation/Media/AM18-F061-Clinical-Trials-Book.pdf. Accessed February 16, 2018.
⁵ Duvallet E, Sererano L, Assier E, et. al. Interleukin-23: a key cytokine in inflammatory diseases. Ann Med. 2011 Nov;43(7):503-11.
⁶ 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 February 2, 2018.
⁷ 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 February 2, 2018.
⁸ 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 February 2, 2018.
⁹ 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 February 2, 2018.

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