Anti-OX40 antibody(Gan&Lee Pharmaceuticals)

Plain Language SummaryWhat is this summary about?This is a plain language summary of an article published in the Journal of Allergy and Clinical Immunology on November 8, 2024. The article described the results of the clinical study STREAM-AD. This study tested a medicine called amlitelimab in people with moderate-to-severe atopic dermatitis (AD, also called atopic eczema).AD is a common chronic skin disease that leads to severely itchy and dry skin. In AD, the immune system is overactive leading to chronic inflammation and damage to the skin. For some people with AD, medicated creams and ointments given by doctors do not work in reducing AD signs and symptoms.Amlitelimab is a new medicine given by injection under the skin that is being investigated and is not yet approved for use by the US Food and Drug Administration. Amlitelimab is an 'anti-OX40 ligand antibody', which means it is a medication that targets the OX40 ligand. This is a distinct part of the immune system not addressed by current therapies. The STREAM-AD clinical study looked at how well amlitelimab treatment worked in improving the signs and symptoms of AD. It also assessed how safe it was. All assessments involved comparing amlitelimab to placebo (dummy treatment) in people with AD for whom medicated creams and ointments did not work. The study also looked at how long relief from these signs and symptoms lasted after stopping treatment.What were the results?The study had two parts. Results from Part 1 showed that amlitelimab, given every 4 weeks, helped improve AD signs (e.g., extent and severity of red and dry skin) and symptoms (e.g., severity of itch) compared to placebo after 24 weeks.Participants who had skin that was clear or almost clear and/or experienced a 75% improvement in their Eczema Area and Severity Index (EASI) score after 24 weeks could begin Part 2 of the study. In Part 2, participants continued amlitelimab or stopped amlitelimab treatment for 28 weeks. Results from Part 2 showed that improvements seen in Part 1 were maintained regardless of whether participants continued taking amlitelimab or stopped. Amlitelimab was well tolerated, and the most commonly reported side effects were the common cold (known in the study as nasopharyngitis and upper respiratory tract infection), COVID-19 infection, and headache.What do the results mean?Amlitelimab, given every 4 weeks, improved AD signs and symptoms. Additionally, these effects of amlitelimab were maintained by most participants for 28 weeks after they stopped taking the medicine. This suggests the possibility of long-term relief. Amlitelimab was also shown to be well tolerated over 52 weeks.This is an abstract of the Plain Language Summary of Publication article.View the full Plain Language Summary PDF of this article to read the full-text Disclosure statementS Weidinger has received institutional research grants from LEO Pharma, Pfizer Inc., and Sanofi Deutschland GmbH; has performed consultancies for AbbVie, Almirall, Boehringer Ingelheim, Eli Lilly and Company, Galderma, Kymab (a Sanofi company), LEO Pharma, Novartis, Pfizer Inc., Regeneron Pharmaceuticals, and Sanofi Genzyme; has lectured at educational events sponsored by AbbVie, Almirall, Galderma, LEO Pharma, Novartis, Pfizer Inc., Regeneron Pharmaceuticals, and Sanofi Genzyme; and is involved in performing clinical trials with many pharmaceutical companies that manufacture drugs used for the treatment of psoriasis and atopic dermatitis. A Blauvelt has served as a speaker (received honoraria) for Almirall, Eli Lilly and Company, and UCB; has served as a scientific adviser (received honoraria) for AbbVie, Almirall, Alumis, Amgen, Anaptysbio, Apogee, Arcutis, Astria, Boehringer Ingelheim, Bristol Myers Squibb, Celltrion, Corvus, Dermavant, Eli Lilly and Company, Galderma, GlaxoSmithKline, Immunovant, Incyte, IQVIA, Janssen, LEO, Lipidio, Merck, Novartis, Oruka, Paragon, Pfizer, Regeneron, Sanofi, Spherix Global Insights, Sun Pharma, Syncona, Takeda, UCB, Union, and Zai Lab; has acted as a clinical study investigator (institution has received clinical study funds) for AbbVie, Acelyrin, Almirall, Alumis, Amgen, Arcutis, Boehringer Ingelheim, Bristol Myers Squibb, Dermavant, Eli Lilly and Company, Galderma, Incyte, Janssen, LEO, Merck, Novartis, Pfizer, Regeneron, Sanofi, Sun Pharma, Takeda, and UCB; and owns stock in Lipidio and Oruka. KA Papp has received honoraria and/or grants from, and is a consultant, investigator, or a scientific officer for AbbVie, Acelyrin, Akros, Alumis, Amgen, Arcutis, Bausch Health/Valeant, Boehringer Ingelheim, Bristol Myers Squibb, Can-Fite Biopharma, Celltrion, Concert Pharmaceuticals, Dermavant, Dermira, DiCE Pharmaceuticals, DiCE Therapeutics, Eli Lilly and Company, Evelo Biosciences, Forbion, Galderma, Horizon Therapeutics, Incyte Corporation, Janssen, Kymab, Kyowa Hakko Kirin, LEO Pharma, Meiji Seika Pharma, Mitsubishi Pharma, Nimbus Therapeutics, Novartis, Pfizer, Reistone, Sanofi-Aventis/Genzyme, Sandoz, Sun Pharma, Takeda, Tarsus Pharmaceuticals, UCB Pharma, and Zai Lab. A Reich serves as consultant or speaker for AbbVie, Bioderma, Bristol Myers Squibb, Celgene, Chema Elektromet, Eli Lilly, Galderma, Janssen, LEO Pharma, Medac, Menlo Therapeutics, Novartis, Pierre-Fabre, Sandoz, and Trevi; and is principal investigator or sub-investigator in clinical trials sponsored by AbbVie, Argenx, Corbus, Drug Delivery Solutions Ltd., Eli Lilly, Galderma, Genentech, Janssen, Kymab Ltd (a Sanofi company), LEO Pharma, Menlo Therapeutics, MetrioPharm, MSD, Novartis, Pfizer, Trevi, and Viela Bio. CH Lee AbbVie, Eli Lilly, Janssen, Kyowa Kirin, LEO Pharma, Novartis, Pfizer, Sanofi, and Tanabe. M Worm reports consultancy for AbbVie, Actelion Pharmaceuticals Deutschland, Aimmune Therapeutics, Alergopharma ALK-Abelló, Amgen, AstraZeneca, Biotest, Boehringer Ingelheim, DBV Technologies, GSK, Kymab Ltd (a Sanofi company), LEO Pharma, Lilly, Mylan, Novartis, Pfizer, Regeneron Pharmaceuticals Inc., Sanofi-Aventis, and Viatris. C Lynde serves as a principal investigator and/consultant for AbbVie, Acelyrin, Actelion, Akros, Amgen, Anacor, Aralez Pharmaceuticals, Arcutis, Astellas, Avillion, Bausch Health (Valeant), Boehringer Ingelheim, Bristol Myers Squibb, Celgene, Celltrion, Coherus, Dermavant, Dermira, Eli Lilly, Galderma, Gilead, GSK, Incyte, Janssen, Kyowa Kirin, LEO Pharma, MedImmune, Meiji Seika Pharma, Merck, Novartis, Pfizer, Regeneron, Roche, Sandoz, Sanofi Genzyme, Sun Pharma, Takeda, and UCB. Y Kataoka has received honoraria from AbbVie, Maruho, Pfizer, and Sanofi; and has served as a clinical investigator for AbbVie, Eli Lilly, LEO Pharma, Maruho, Novartis, Otsuka, Pfizer, Sanofi, and Taiho Pharmaceutical. P Foley has received grant/research support (paid to institution) from AbbVie, Amgen, Bristol Myers Squibb, Celgene, Galderma, Janssen, LEO Pharma, Lilly, Merck, Novartis, Pfizer, Sanofi, Sun Pharma, and UCB; has served as an investigator for AbbVie, Akaal, Alumis, Amgen, Apogee, Arcutis, Argenx, Aslan, AstraZeneca, Avalo, Boehringer Ingelheim, Botanix, Bristol Myers Squibb, Celgene, Celtaxsys, Claruvis, CSL, Cutanea, Dermira, Evelo Biosciences, Galderma, Genentech, Geneseq, GenesisCare, GSK, Hexima, Incyte, Janssen, Kymab, LEO Pharma, Lilly, MedImmune, Merck, Novartis, Pfizer, Regeneron, Reistone, Roche, Sanofi, Sun Pharma, Takeda, Teva, UCB, and Valeant; has served on advisory boards for AbbVie, Amgen, Arrotex, Aslan, Boehringer Ingelheim, Bristol Myers Squibb, Celgene, CSL, Galderma, GSK, Hexima, Janssen, LEO Pharma, Lilly, Mayne Pharma, Merck, Novartis, Pfizer, Sanofi, Sun Pharma, UCB, and Valeant; has served as a consultant for Apogee, Aslan, Bristol Myers Squibb, Galderma, GenesisCare, Hexima, Janssen, LEO Pharma, Lilly, Mayne Pharma, MedImmune, Novartis, Oruka, Pfizer, Roche, and UCB; has received travel grants from AbbVie, Galderma, Janssen, LEO Pharma, Lilly, Merck, Novartis, Pfizer, Roche, Sanofi, and Sun Pharma; and has served as a speaker or received honoraria from AbbVie, Amgen, Boehringer Ingelheim, Bristol Myers Squibb, Celgene, CSL, Galderma, GSK, Janssen, LEO Pharma, Lilly, Merck, Novartis, Pfizer, Roche, Sanofi, Sun Pharma, UCB, and Valeant. X Wei is a former employee of Sanofi. W Wong, AC Solente, C Weber, S Adelman, S Davey, F Hurbin, N Rynkiewicz, K Yen, JT O'Malley, and C Bernigaud are employees of Sanofi and may hold stock and/or stock options in the company. The authors have no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript apart from those disclosed.Medical writing support was provided by Yohana Ghebrechristos, PhD, of IMPRINT Science, New York, NY, USA, and was funded by Sanofi.Patient reviewers on this PLSP have received honorarium from Immunotherapy for their review work but have no other relevant financial relationships to disclose.Peer reviewers on this manuscript have no relevant financial or other relationships to disclose.FundingThe trial was designed and sponsored by Kymab Ltd, a Sanofi company. The analysis and financial support for STREAM-AD were provided by Sanofi. Sanofi participated in the interpretation of data and the review and approval of the manuscript. All authors had full access to all the data in the study and had final responsibility for the decision to submit the manuscript for publication.