ABBVIE INC. Based on these data, AbbVie will advance its clinical program of lutikizumab in HS to Phase 3.1,2
Lutikizumab is AbbVie's investigational, dual-variable-domain interleukin (IL) 1/1 antagonist. Studies have shown IL 1 and 1 are elevated in HS lesions.8
'AbbVie continues to pioneer research in the pursuit of new treatment options for patients with hidradenitis suppurativa, a frequently overlooked, underserved, and often suffering patient population,' said
This study was a 16-week, Phase 2, randomized, double-blind, parallel group, placebo controlled, dose-ranging, multicenter study that evaluated the safety and efficacy of lutikizumab in 153 adult patients with moderate to severe HS who had previously failed anti-TNF therapy. Most patients (70.6 percent) had severe baseline Hurley Stage 3 disease - the most extensive form of HS - characterized by scarring, lesions and sinus tracts. Patients were randomized at baseline to receive one of three subcutaneous doses of lutikizumab (100 mg every other week, 300 mg every other week, or 300 mg every week) or placebo. The study's primary endpoint was an achievement of HiSCR 50 at week 16, and the secondary endpoint was skin pain NRS30 at week 16 among subjects with baseline NRS3.1
In addition to achieving higher response rates in the primary endpoint and despite most patients having severe disease, the trial also showed patients receiving lutikizumab 300 mg weekly and 300 mg every other week achieved higher rates of improved skin pain via NRS30 and HiSCR75, a higher threshold of HS clinical response, compared to placebo. Lutikizumab 100 mg every other week did not show greater efficacy compared to placebo.1
About Hidradenitis Suppurativa
Hidradenitis Suppurativa, sometimes referred to as 'acne inversa' by dermatologists, is an inflammatory, chronic, recurrent, progressive disease that causes irreversible skin damage and disability due to the formation of painful cysts, abscesses and draining fistula.3,4,5,6,7 While advances in treatment have been made, limited treatment options are available. Globally, HS affects up to 1 percent of the population14 and can take on average 7-10 years for a person to be diagnosed.15,16
About Lutikizumab (ABT-981)
Lutikizumab (ABT-981) is a dual-variable-domain interleukin (IL) 1/1 antagonist being investigated in several immune-mediated diseases, including HS and ulcerative colitis. Studies have shown IL 1 and 1 are elevated in HS lesions.8 Lutikizumab is an investigational agent and is not approved by regulatory authorities. Safety and efficacy have not been established.
About AbbVie in Dermatology
For more than a decade, AbbVie has worked to uncover new solutions and improve care for people with serious skin diseases, including psoriasis, psoriatic arthritis, hidradenitis suppurativa and atopic dermatitis. With a broad clinical trial program, we continue to actively research and adapt to the evolving needs of the dermatology community and advance our pipeline to help people achieve their treatment goals and live beyond their skin disease.
About AbbVie
AbbVie's mission is to discover and deliver innovative medicines and solutions 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, and eye care in addition to products and services in our Allergan Aesthetics portfolio.
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 and uses of future or conditional verbs, 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 expressed or implied 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 2022 Annual Report on Form 10-K, which has been filed with the
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