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Randomized Controlled Trial
. 2023 Jul;24(4):595-607.
doi: 10.1007/s40257-023-00792-6. Epub 2023 May 17.

Safety of Lebrikizumab in Adults and Adolescents with Moderate-to-Severe Atopic Dermatitis: An Integrated Analysis of Eight Clinical Trials

Linda Stein Gold  1 , Diamant Thaçi  2 , Jacob P Thyssen  3 , Melinda Gooderham  4   5 , Vivian Laquer  6 , Angela Moore  7   8   9 , Chitra R Natalie  10 , Fangyi Zhao  10 , Eric Meskimen  10 , Hany Elmaraghy  10 , Sonia Montmayeur  10 , Gaia Gallo  10 , Gemma Jimenez  11 , Marjolein de Bruin-Weller  12
Affiliations
Randomized Controlled Trial

Safety of Lebrikizumab in Adults and Adolescents with Moderate-to-Severe Atopic Dermatitis: An Integrated Analysis of Eight Clinical Trials

Linda Stein Gold et al. Am J Clin Dermatol. 2023 Jul.

Abstract

Background: Lebrikizumab is a monoclonal antibody that binds with high affinity to interleukin (IL)-13, thereby blocking the downstream effects of IL-13 with high potency.

Objectives: To report integrated safety of lebrikizumab in adults and adolescents with moderate-to-severe atopic dermatitis from phase 2 and 3 studies.

Methods: Five double-blind, randomized placebo-controlled studies; one randomized open-label study; one adolescent open-label, single-arm study; and one long-term safety study were summarized in two datasets: (1) placebo-controlled week 0-16 (All-PC Week 0-16) in patients who received lebrikizumab 250 mg every 2 weeks (LEBQ2W) versus placebo and (2) patients who received any dose of lebrikizumab at any time during the studies (All-LEB). Exposure-adjusted incidence rates (IR)/100 patient-years (PY) are provided.

Results: A total of 1720 patients received lebrikizumab (1637.0 PY exposure). In All-PC Week 0-16, the frequency of treatment-emergent adverse events (TEAEs) was similar between treatment groups; most events were nonserious and mild or moderate in severity. The most frequently reported TEAEs were atopic dermatitis (placebo) and conjunctivitis (LEBQ2W). Frequencies of conjunctivitis cluster were 2.5% (placebo) and 8.5% (LEBQ2W), and all events were mild or moderate (All-LEB 10.6%, IR, 12.2). Frequencies of injection site reactions were 1.5% (placebo) and 2.6% (LEBQ2W; All-LEB 3.1%, IR, 3.3). Frequencies of adverse events leading to treatment discontinuation were 1.4% (placebo) and 2.3% (LEBQ2W; All-LEB 4.2%, IR, 4.5).

Conclusion: The safety profile for lebrikizumab consisted of TEAEs that were mostly nonserious, mild or moderate in severity, and did not lead to treatment discontinuation. The safety profile was similar in both adults and adolescents.

Clinicaltrials: GOV: NCT02465606, NCT02340234, NCT03443024, NCT04146363, NCT04178967, NCT04250337, NCT04250350, NCT04392154 Safety of lebrikizumab in adults and adolescents with moderate-to-severe atopic dermatitis: an integrated analysis of eight clinical trials (MP4 34165 KB).

Plain language summary

Atopic dermatitis (AD) is a common chronic (persistent) skin disease that occurs in up to 7% of adults and approximately 20% of children. Lebrikizumab is a monoclonal antibody that goes against interleukin-13, which is overexpressed in patients with AD. Lebrikizumab is given by injection and is being studied to treat AD. It has been tested in several studies in both adults and adolescents (patients age ≥ 12 – < 18 years). In some of those studies, patients used lebrikizumab by itself, and in other studies patients used lebrikizumab in combination with low-to-moderate strength topical (rubbed on the skin) corticosteroid medicines. We examined the safety of lebrikizumab by combining the data from eight of those studies and analyzing the data in two datasets. The first dataset compared the safety of lebrikizumab 250 mg injected every 2 weeks with placebo (no drug in the injection) in four 16-week studies in which neither patient nor physician knew whether lebrikizumab or placebo was being injected. The second dataset included four additional studies and examined the safety of lebrikizumab in all patients receiving at least 1 injection of lebrikizumab at any dose. A total of 1720 patients took lebrikizumab. In the first dataset the frequency of adverse events was similar between lebrikizumab and placebo, and most events that did occur were mild or moderate in severity and were not serious. The most common adverse event in patients treated with placebo was atopic dermatitis, and in patients treated with lebrikizumab it was conjunctivitis. Frequencies of adverse events in the conjunctivitis cluster, which included a search for the terms of conjunctivitis, allergic conjunctivitis, bacterial conjunctivitis, viral conjunctivitis, and giant papillary conjunctivitis, were 2.5% in placebo and 8.5% in lebrikizumab, and all events were mild or moderate. Frequencies of injection site reactions were 1.5% in placebo and 2.6% in lebrikizumab, and frequencies of adverse events that led to patients stopping treatment were 1.4% in placebo and 2.3% in lebrikizumab. In the second dataset, the rate of these adverse events did not increase with longer duration of lebrikizumab. The safety profile for lebrikizumab consisted of adverse events that were mostly nonserious, mild or moderate in severity, and did not lead to stopping treatment. The safety profile was similar in both adults and adolescents.

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Conflict of interest statement

Linda Stein Gold has been an investigator, speaker, and/or advisory board member for: AbbVie, Amgen, AnaptysBio, Arcutis, Arena, Aslan, Bausch Health, Boehringer Ingelheim, BMS, Celgene, Coherus, Dermira, Dermavant, Eli Lilly, Galderma, Incyte, Janssen, LEO Pharma, Novartis, Pfizer, Regeneron, Sanofi Genzyme, Sun Pharmaceuticals, and UCB. Diamant Thaçi has been a consultant, investigator, speaker, and participant in scientific advisory boards for AbbVie, Almirall, Amgen, Bristol Myers Squibb, BMS, Janssen-Cilag, Galderma, Galapagos, LEO Pharma, Eli Lilly and Company, New-Bridge, Novartis, Pfizer, Regeneron, Samsung, Sanofi, Sun-Pharma, and UCB. Jacob P Thyssen has been a consultant for and/or has received grant/research/honorarium support from: Regeneron, Sanofi-Genzyme, LEO Pharma, AbbVie, Eli Lilly and Company, and Pfizer. Melinda Gooderham has been a speaker, investigator, or advisory board member for: AbbVie, Amgen, Akros, AnaptysBio, Arcutis, Arena, Aslan, Bausch Health, Boehringer Ingelheim, BMS, Celgene, Coherus, Dermira, Dermavant, Eli Lilly and Company, Galderma, GSK, Incyte, Janssen, Kyowa Kirin, LEO Pharma, Medimmune, Merck, Moonlake, Nimbus, Novartis, Pfizer, Regeneron, Reistone, Sanofi Genzyme, Sun Pharmaceuticals, Tarsus, UCB, and Ventyx. Vivian Laquer conducts research for Abbvie, Acelyrin, Acrotech, Biofrontera, Amgen, Argenx, Arcutis, Aslan, Bristol Meyers Squibb, Cara, Dermavant, Eli Lilly, Galderma, Horizon Therapeutics, Incyte, Janssen, Leo, Novartis, Padagis, Pfizer, Q32, Rapt, Sun, UCB, and Ventyx. Angela Moore has received study funds or honoraria from Abbvie, Aclaris, Acrotech, Almirall, Arcutis, Bayer, Bristol Myer Squibb, Cara Therapeutics, Dermavant, Eli Lilly and Company, Galderma, Incyte, Janssen, Pfizer, Regeneron, and UCB. Chitra R. Natalie, Fangyi Zhao, Eric Meskimen, Hany Elmaraghy, Sonia Montmayeur, and Gaia Gallo are employees and stockholders of Eli Lilly and Company. Gemma Jimenez is an employee of Almirall. M. De Bruin-Weller has been a consultant, advisory board member, and/or speaker for AbbVie, Almirall, Amgen, Aslan, Eli Lilly and Company, Galderma, Janssen, Leo Pharma, Pfizer, Regeneron, and Sanofi-Genzyme.

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