Latest news with #dupilumab
Medscape
2 days ago
- Health
- Medscape
Dupilumab Treatment May Raise Weight in Patients With AD
TOPLINE: Patients with atopic dermatitis (AD) who underwent treatment with dupilumab showed a mean weight gain of 3.6 kg, with 67% of patients experienced an average increase of 5.9 kg. The findings suggested that dupilumab treatment may be associated with weight changes, potentially due to its effect on interleukin-4 signalling and metabolic regulation. METHODOLOGY: Researchers conducted a retrospective chart review of 30 patients with moderate-to-severe AD (mean age, 40.1 years; 30% women) who were prescribed dupilumab between April 2018 and December 2023. Inclusion criteria required dupilumab treatment for more than 6 months with documented weight measurements within 3 months before initiation and at 3-6 months post-initiation. The analysis included demographic data, prior treatments, disease severity, and weight changes. The mean weight before the commencement of dupilumab was 81.5 kg. Prior systemic treatments included methotrexate (n = 17), ciclosporin (n = 11), azathioprine (n = 7), and mycophenolate mofetil (n = 3). TAKEAWAY: Overall, 67% of patients experienced weight gain, with a mean increase of 5.9 kg. Additionally, 23% of patients showed no weight loss, and 10% of patients lost weight, with a mean loss of 3.7 kg. The overall mean weight gain was 3.6 kg (median, 4 kg; range, -8 to 13 kg). IN PRACTICE: "The blockade of IL-4 [interleukin-4], a cytokine involved in inflammatory responses and metabolic regulation, might contribute to changes in appetite and energy balance," the authors wrote. "While there is evidence suggesting a possible association between dupilumab and weight gain, it is essential to approach this issue with a nuanced perspective. Future studies should aim to disentangle these complex interactions, considering both the biological mechanisms at play and the broader psychosocial factors that impact weight in patients with AD," they added. SOURCE: This study was led by Darren Roche, Department of Dermatology, Tallaght University Hospital, Dublin, Ireland. It was published online on June 30, 2025, in Clinical and Experimental Dermatology. LIMITATIONS: Multiple factors including disease severity, inflammation, lifestyle choices, and psychological stressors could have influenced patient weight. This study was limited by its retrospective design, a small sample size, and a short follow-up period. DISCLOSURES: This research did not receive any specific grant from any funding agency in the public, commercial, or not-for-profit sectors. The authors reported having no conflicts of interest. This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication.
Medscape
24-06-2025
- Health
- Medscape
Head-to-Head Trial Finds Winner for CRSwNP With Asthma
Dupilumab significantly outperformed omalizumab in reducing the size of nasal polyps and improving sense of smell in adults with severe chronic rhinosinusitis with nasal polyps (CRSwNP) and coexisting asthma, according to the head-to-head EVEREST phase 4 biologics trial . The study is the first to demonstrate the superiority of dupilumab over omalizumab across both upper and lower airway disease outcomes — resulting in a significant reduction in nasal polyp score and a greater improvement in pre-bronchodilator forced expiratory volume 1. The two therapies had generally similar safety profiles, according to the researchers. "The data provide important insights that can help guide patients and physicians through the treatment decision-making process,' said Eugenio De Corso, MD, ENT specialist at the A. Gemelli University Hospital Foundation, Rome, Italy, who presented the findings at the 2025 annual congress of the European Academy of Allergy and Clinical Immunology. 'Dupilumab also demonstrated nominally greater improvements in asthma-related endpoints, including lung function and asthma control, compared to omalizumab.' De Corso said that the results do not change the approved indications for dupilumab and do not support starting treatment with the drug earlier in the course of care. But 'they do provide important insight into how two long-standing biologics in the treatment landscape compare to each other in patients with CRSwNP and coexisting asthma, which could support treatment decision-making for physicians,' he said. Tackling a Dual Burden CRSwNP is often marked by persistent nasal congestion, facial pain, and anosmia, and when asthma coexists, as it frequently does in this patient population, disease burden increases and managing symptoms becomes even more complex. Existing treatments have limited long-term benefit. Type 2 inflammation, driven largely by the interleukin-4 and interleukin-13 pathways, plays a central role in the pathophysiology of both CRSwNP and asthma. Dupilumab targets signalling of both molecules, whereas omalizumab primarily targets immunoglobulin E (IgE), a different antibody involved in allergic responses, and this mechanistic difference underpinned the rationale for the EVEREST trial. The EVEREST randomized, double-blind, active-controlled phase 4 trial enrolled 360 adults with severe, uncontrolled CRSwNP and coexisting asthma. Participants received either 300 mg of dupilumab subcutaneously every 2 weeks (n = 181) or omalizumab (n = 179) dosed based on body weight and baseline serum IgE levels every 2 or 4 weeks. All patients continued to receive mometasone furoate nasal spray as background therapy. Participants had a mean age 51.5 years, were 55% men, 42.5% had respiratory symptoms worsened by their use of nonsteroidal anti-inflammatory drugs, and roughly half had used systemic corticosteroids in the 2 years prior to the start of the study. Primary endpoints were nasal polyp score (range, 0-8) and University of Pennsylvania Smell Identification Test (range, 0-40). Greater improvement with dupilumab compared with omalizumab was evident by week 4 and continued through week 24, De Corso and his colleagues reported. At 24 weeks, dupilumab demonstrated statistically and clinically significant superiority over omalizumab in both primary endpoints with a 1.6-point greater reduction in nasal polyp score ( P < .001); and an eight-point greater improvement in smell identification ( P < .001). Secondary endpoints also favored dupilumab with a 0.58-point greater reduction in nasal congestion score; a 0.81-point greater improvement in loss of smell ( P < .001); a 1.74-point greater reduction in overall severity of symptoms; and a 12.7-point greater improvement in patient-reported quality of life ( P < .0001), the researchers reported. Use of dupilumab was also associated with small but statistically significant improvements in expiratory volumes and control of asthma, the study found. Safety profiles were similar between groups, with adverse events occurring in 64% of dupilumab recipients and 67% of omalizumab recipients, the researchers reported. Serious adverse events were reported in 2% of patients in the dupilumab arm and 4% in the omalizumab arm, and a slightly higher proportion of patients discontinued dupilumab due to adverse events (3% vs 1%), although no new safety concerns emerged in the analysis. 'These new results further reinforce those from the pivotal, regulatory phase 3 trials — SINUS-24 and SINUS-52 , where effects on nasal congestion and loss of smell were also observed as early as 4 weeks and showed continued improvement for the duration of the trial,' De Corso told Medscape Medical News . 'For patients living with both CRSwNP and asthma, the availability of a treatment that addresses both conditions effectively and quickly is a substantial advancement.' Michael S. Blaiss, MD, a clinical professor at the Medical College of Georgia at Augusta University, said, 'dupilumab showed statistically superior results on both primary endpoints — nasal polyp score, indicating polyp reduction, and UPSIT, measuring sense of smell improvement. These are key indicators of symptom relief and quality of life for my patients.' 'This type of head-to-head trial is exactly what clinicians have long called for to better guide treatment decisions in managing this complex condition,' he added. Javier Dominguez-Ortega MD, of the Department of Allergy at the Hospital Universitario La Paz, in Madrid, Spain, said EVEREST was 'indeed a highly innovative trial, particularly as it is the first head-to-head study examining two medications indicated for CRSwNP within a clinical trial setting. The preliminary data suggest that dupilumab demonstrates greater efficacy, especially in the area of olfaction, which has been objectively measured through olfactometry.' However, Dominguez-Ortega said that without clinical characteristics of the patients, including their inflammatory profiles prior to inclusion, or their concomitant treatments, drawing definitive conclusions was not possible. Better Sleep for Dermatitis Patients? In another study presented as an electronic poster at the meeting, researchers looked at the effects of dupilumab on sleep in adults with moderate-to-severe atopic dermatitis. The phase 4, double-blind trial, called DUPISTAD, randomly assigned adults to receive 300 mg of dupilumab or placebo every 2 weeks for 12 weeks, followed by a 12-week open-label extension. Actigraphy, using a wrist-wearable device, measured sleep disturbance objectively and non-invasively, while subjective measurement comprised patients' perceptions of sleep defined as the ratio of total sleep time to total time in bed. The mean difference from baseline to week 12 provided an estimate of weekly average sleep efficiency. In addition, actigraphy was studied in a subset of patients with poor sleep efficiency (≤ 70%) at baseline. A total of 127 patients received dupilumab and 60 received placebo. Patients reported significant sleep efficiency improvements with dupilumab based on sleep diaries but actigraphy did not generate consistent results. 'While patients reported significant sleep efficiency improvements following dupilumab treatment, actigraphy assessment was inconclusive,' the researchers reported. 'In this study, most patients had acceptable sleep efficiency at baseline, highlighting the limitations of wrist actigraphy to objectively assess sleep in patients with AD. The characteristics of AD may mean that these wrist-wearable devices are not appropriate to evaluate sleep.' Sensors mounted on walls and other nonwearable devices might better detect body movement at night and provide more accurate information about itching and sleep disturbance, they added. De Corso reported receiving funding from AstraZeneca, Firma, GlaxoSmithKline, Novartis, Regeneron, and serving on an advisory board and receiving fees from Sanofi. Blaiss has received speaking fees from Sanofi, Regeneron, and AstraZeneca, and consulting fees from Novartis and GlaxoSmithKline. Dominguez-Ortega has received consultation fees and compensation for participation in company sponsored speaker's events from AstraZeneca, CHIESI, Sanofi, Novartis, ALK, Leti Pharma, Cipla, Allergy Therapeutics GlaxoSmithKline, and Gebro. The EVEREST trial was funded by Sanofi, in collaboration with Regeneron Pharmaceuticals.
Medscape
20-06-2025
- Business
- Medscape
FDA Approves Dupilumab for Bullous Pemphigoid
Dupilumab has been approved by the FDA for the treatment bullous pemphigoid in adults, the manufacturer Regeneron announced. Dupilumab (Dupixent), a human monoclonal antibody that inhibits interleukin (IL)-4 and IL-13 signaling, is now approved in the United States for eight diseases, including atopic dermatitis, asthma, chronic rhinosinusitis with nasal polyps, eosinophilic esophagitis, and prurigo nodularis. Dupilumab, administered by subcutaneous injection, is the first targeted treatment to be approved in the United States for bullous pemphigoid, according to the company's press release. The approval follows a supplemental New Drug Application filed with the FDA in February 2025 and is based on data from ADEPT, a pivotal phase 2/3 study in more than 100 adults with moderate-to-severe bullous pemphigoid known as, according to Regeneron. The study's design was published in Advances in Therapy. In the study, 106 patients were randomized to 300 mg of subcutaneous dupilumab or a placebo injection every 2 weeks, added to standard-of-care oral corticosteroids. At 36 weeks, 18.3% of patients in the dupilumab group achieved the primary endpoint of sustained disease remission compared with 6.1% of those in the placebo group. The study defined sustained remission as a combination of complete clinical remission and no relapse after an oral corticosteroid taper by 16 weeks, with no use of rescue therapy during the study period. More patients treated with dupilumab achieved a clinically meaningful reduction in itching (38.3% vs 10.5%), and the median cumulative oral corticosteroid dose in the dupilumab-treated group was 2.8 g vs 4.1 g in the placebo group, according to the company release. The most common adverse events among patients receiving dupilumab (affecting 2% or more) compared with those receiving placebo were arthralgia, conjunctivitis, blurred vision, herpes viral infections, and keratitis. One patient receiving dupilumab also developed acute generalized exanthematous pustulosis; no cases were reported among those receiving placebo. The dupilumab study was funded by Sanofi and Regeneron, the companies co-developing dupilumab.
Yahoo
20-06-2025
- Health
- Yahoo
Press Release: Dupixent approved in the US as the only targeted medicine to treat patients with bullous pemphigoid
Dupixent approved in the US as the only targeted medicine to treat patients with bullous pemphigoid Approval based on pivotal results showing improvements in sustained disease remission and reductions in itch and oral corticosteroid use compared to placebo in adults with BP BP is a chronic, debilitating, and relapsing rare skin disease affecting approximately 27,000 adults in the US whose disease is uncontrolled by systemic corticosteroids Dupixent is now approved in the US to treat eight distinct diseases with underlying type 2 inflammation, including diseases of the skin, gut, and respiratory system that affect a broad range of patients, from infants to elderly people Paris and Tarrytown, NY, June 20, 2025. The US Food and Drug Administration (FDA) has approved Dupixent (dupilumab) for the treatment of adult patients with bullous pemphigoid (BP). BP primarily affects elderly patients, and is characterized by intense itch, painful blisters, and lesions, as well as reddening of the skin. It can be chronic and relapsing with underlying type 2 inflammation. The blisters and rash can form over much of the body and cause the skin to bleed and break down, resulting in patients being more prone to infection and affecting their daily functioning. Available treatment options are limited and can add to overall disease burden by suppressing a patient's immune system. Executive Director, International Pemphigus and Pemphigoid Foundation 'People affected by bullous pemphigoid endure unrelenting itch and painful blisters that can damage the skin. Until now, these primarily elderly patients have had limited therapeutic options available, with potential side effects that have often added to their burden. The approval of Dupixent for bullous pemphigoid brings a novel treatment approach to patients and their caregivers, and we are grateful for the tireless efforts of the scientific community who helped us reach this critical milestone.' Global Therapeutic Area Head, Immunology and Oncology Development, Sanofi 'Until now, treating bullous pemphigoid was very challenging for elderly patients struggling with the debilitating impact of blisters and lesions, and potentially co-morbid conditions. By addressing two central drivers of the underlying type 2 inflammation that contributes to bullous pemphigoid, Dupixent is the first targeted medicine to allow patients the potential to achieve sustained remission and reduce itch. This approval in the US is important for the thousands of patients living with bullous pemphigoid, and we look forward to working with regulators around the world to bring this innovative medicine to more patients in need.' The FDA approval is based on data from the pivotal ADEPT phase 2/3 study that evaluated the efficacy and safety of Dupixent compared to placebo in adults with moderate-to-severe BP. Patients were randomized to receive Dupixent 300 mg (n=53) or placebo (n=53) added to standard-of-care oral corticosteroids (OCS). During treatment, all patients underwent a protocol-defined OCS tapering regimen if control of disease activity was maintained. During the FDA review, the analyses were updated; the FDA-approved results at 36 weeks in the label for Dupixent compared to placebo are: 18.3% of patients experienced sustained disease remission compared to 6.1% (12.2% difference; 95% confidence interval: -0.8% to 26.1%), the primary endpoint 38.3% of patients achieved clinically meaningful itch reduction compared to 10.5% Median cumulative OCS dose was 2.8 grams compared to 4.1 grams In this elderly population, the most common adverse events (≥2%) more frequently observed in patients on Dupixent compared to placebo were arthralgia, conjunctivitis, blurred vision, herpes viral infections, and keratitis. Additionally, one case of acute generalized exanthematous pustulosis was reported in one patient treated with Dupixent and zero patients treated with placebo. Board co-Chair, President, and Chief Scientific Officer at Regeneron 'This approval extends the remarkable ability of Dupixent to transform treatment paradigms for people living with a variety of diseases with underlying type 2 inflammation, from common conditions like asthma and atopic dermatitis, to rarer ones such as eosinophilic esophagitis and prurigo nodularis, and now including bullous pemphigoid. Dupixent has shown the potential to improve the most challenging effects of bullous pemphigoid, while helping some patients achieve sustained disease remission and decreased oral corticosteroid use. Additionally, this approval further reinforces the demonstrated safety profile of Dupixent in a broad age range of patients, from infants to elderly people, and across dermatological, respiratory, and gastrointestinal diseases.' The FDA evaluated Dupixent under priority review, which is reserved for medicines that represent potentially significant improvements in efficacy or safety in treating serious conditions. Dupixent was previously granted orphan drug designation by the FDA for BP, which applies to investigational medicines intended for the treatment of rare diseases that affect fewer than 200,000 people in the US. Additional regulatory applications are also under review around the world, including in the EU, Japan, and China. About the Dupixent BP pivotal studyADEPT was a randomized, phase 2/3, double-blind, placebo-controlled study evaluating the efficacy and safety of Dupixent in 106 adults with moderate-to-severe BP for a 52-week treatment period. After randomization, patients received Dupixent or placebo every two weeks after an initial loading dose, along with OCS treatment. During treatment, OCS taper was initiated after patients experienced two weeks of sustained control of disease activity. OCS tapering could start between four to six weeks after randomization and was continued if disease control was maintained, with the intent of completion by 16 weeks. After OCS tapering, patients were only treated with Dupixent or placebo for at least 20 weeks (rescue treatment could be used if required). The primary endpoint evaluated the proportion of patients achieving sustained disease remission at 36 weeks. Sustained disease remission was defined as complete clinical remission with completion of OCS taper by 16 weeks without relapse after completion of the OCS taper and no rescue therapy use during the 36-week treatment period. Relapse was defined as appearance of ≥3 new lesions a month or ≥1 large lesion or urticarial plaque (>10 cm in diameter) that did not heal within a week. Rescue therapy could include treatment with high-potency topical corticosteroids, OCS (including increase of OCS dose during the taper or re-initiation of OCS after completion of the OCS taper), or systemic non-steroidal immunosuppressive medications, or immunomodulating biologics. Select secondary endpoints evaluated at 36 weeks included: Proportion of patients with ≥4-point reduction in Peak Pruritus Numerical Rating Scale (scale 0-10) Total cumulative OCS dose About DupixentDupixent (dupilumab) is an injection administered under the skin (subcutaneous injection) at different injection sites. In adults with BP, Dupixent 300 mg is administered every other week after an initial loading dose, and in combination with a tapering course of oral corticosteroids. Dupixent is intended for use under the guidance of a healthcare professional and can be given in a clinic or at home after training by a healthcare professional. Dupixent is a fully human monoclonal antibody that inhibits the signaling of the interleukin-4 (IL4) and interleukin-13 (IL13) pathways and is not an immunosuppressant. The Dupixent development program has shown significant clinical benefit and a decrease in type 2 inflammation in phase 3 studies, establishing that IL4 and IL13 are two of the key and central drivers of the type 2 inflammation that plays a major role in multiple related and often co-morbid diseases. Sanofi and Regeneron are committed to helping patients in the US who are prescribed Dupixent gain access to the medicine and receive the support they may need with the DUPIXENT MyWay® program. For more information, please call 1-844-DUPIXENT (1-844-387-4936) or visit Dupixent has received regulatory approvals in more than 60 countries in one or more indications including certain patients with atopic dermatitis, asthma, chronic rhinosinusitis with nasal polyps, eosinophilic esophagitis, prurigo nodularis, chronic spontaneous urticaria, chronic obstructive pulmonary disease, and BP in different age populations. More than one million patients are being treated with Dupixent globally. Dupilumab development programDupilumab is being jointly developed by Sanofi and Regeneron under a global collaboration agreement. To date, dupilumab has been studied across more than 60 clinical studies involving more than 10,000 patients with various chronic diseases driven in part by type 2 inflammation. In addition to the currently approved indications, Sanofi and Regeneron are studying dupilumab in a broad range of diseases driven by type 2 inflammation or other allergic processes in phase 3 studies, including chronic pruritus of unknown origin and lichen simplex chronicus. These potential uses of dupilumab are currently under clinical investigation, and the safety and efficacy in these conditions have not been fully evaluated by any regulatory authority. About RegeneronRegeneron (NASDAQ: REGN) is a leading biotechnology company that invents, develops and commercializes life-transforming medicines for people with serious diseases. Founded and led by physician-scientists, our unique ability to repeatedly and consistently translate science into medicine has led to numerous approved treatments and product candidates in development, most of which were homegrown in our laboratories. Our medicines and pipeline are designed to help patients with eye diseases, allergic and inflammatory diseases, cancer, cardiovascular and metabolic diseases, neurological diseases, hematologic conditions, infectious diseases, and rare diseases. Regeneron pushes the boundaries of scientific discovery and accelerates drug development using our proprietary technologies, such as VelociSuite®, which produces optimized fully human antibodies and new classes of bispecific antibodies. We are shaping the next frontier of medicine with data-powered insights from the Regeneron Genetics Center® and pioneering genetic medicine platforms, enabling us to identify innovative targets and complementary approaches to potentially treat or cure diseases. For more information, please visit or follow Regeneron on LinkedIn, Instagram, Facebook or X. About Sanofi Sanofi is an R&D driven, AI-powered biopharma company committed to improving people's lives and delivering compelling growth. We apply our deep understanding of the immune system to invent medicines and vaccines that treat and protect millions of people around the world, with an innovative pipeline that could benefit millions more. Our team is guided by one purpose: we chase the miracles of science to improve people's lives; this inspires us to drive progress and deliver positive impact for our people and the communities we serve, by addressing the most urgent healthcare, environmental, and societal challenges of our time. Sanofi is listed on EURONEXT: SAN and NASDAQ: SNY. 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These statements concern, and these risks and uncertainties include, among others, the nature, timing, and possible success and therapeutic applications of products marketed or otherwise commercialized by Regeneron and/or its collaborators or licensees (collectively, 'Regeneron's Products') and product candidates being developed by Regeneron and/or its collaborators or licensees (collectively, 'Regeneron's Product Candidates') and research and clinical programs now underway or planned, including without limitation Dupixent® (dupilumab) for the treatment of bullous pemphigoid as discussed in this press release; uncertainty of the utilization, market acceptance, and commercial success of Regeneron's Products and Regeneron's Product Candidates and the impact of studies (whether conducted by Regeneron or others and whether mandated or voluntary), including the studies discussed or referenced in this press release, on any of the foregoing; the likelihood, timing, and scope of possible regulatory approval and commercial launch of Regeneron's Product Candidates and new indications for Regeneron's Products, such as Dupixent for the treatment of chronic pruritus of unknown origin, lichen simplex chronicus, and other potential indications; the ability of Regeneron's collaborators, licensees, suppliers, or other third parties (as applicable) to perform manufacturing, filling, finishing, packaging, labeling, distribution, and other steps related to Regeneron's Products and Regeneron's Product Candidates; the ability of Regeneron to manage supply chains for multiple products and product candidates and risks associated with tariffs and other trade restrictions; safety issues resulting from the administration of Regeneron's Products (such as Dupixent) and Regeneron's Product Candidates in patients, including serious complications or side effects in connection with the use of Regeneron's Products and Regeneron's Product Candidates in clinical trials; determinations by regulatory and administrative governmental authorities which may delay or restrict Regeneron's ability to continue to develop or commercialize Regeneron's Products and Regeneron's Product Candidates; ongoing regulatory obligations and oversight impacting Regeneron's Products, research and clinical programs, and business, including those relating to patient privacy; the availability and extent of reimbursement or copay assistance for Regeneron's Products from third-party payors and other third parties, including private payor healthcare and insurance programs, health maintenance organizations, pharmacy benefit management companies, and government programs such as Medicare and Medicaid; coverage and reimbursement determinations by such payors and other third parties and new policies and procedures adopted by such payors and other third parties; changes in laws, regulations, and policies affecting the healthcare industry; competing drugs and product candidates that may be superior to, or more cost effective than, Regeneron's Products and Regeneron's Product Candidates (including biosimilar versions of Regeneron's Products); the extent to which the results from the research and development programs conducted by Regeneron and/or its collaborators or licensees may be replicated in other studies and/or lead to advancement of product candidates to clinical trials, therapeutic applications, or regulatory approval; unanticipated expenses; the costs of developing, producing, and selling products; the ability of Regeneron to meet any of its financial projections or guidance and changes to the assumptions underlying those projections or guidance; the potential for any license, collaboration, or supply agreement, including Regeneron's agreements with Sanofi and Bayer (or their respective affiliated companies, as applicable), to be cancelled or terminated; the impact of public health outbreaks, epidemics, or pandemics on Regeneron's business; and risks associated with litigation and other proceedings and government investigations relating to the Company and/or its operations (including the pending civil proceedings initiated or joined by the U.S. Department of Justice and the U.S. Attorney's Office for the District of Massachusetts), risks associated with intellectual property of other parties and pending or future litigation relating thereto (including without limitation the patent litigation and other related proceedings relating to EYLEA® (aflibercept) Injection), the ultimate outcome of any such proceedings and investigations, and the impact any of the foregoing may have on Regeneron's business, prospects, operating results, and financial condition. 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Medscape
19-06-2025
- Health
- Medscape
Dupilumab Linked to Higher Psoriasis Risk in AD
Treating atopic dermatitis (AD) with dupilumab vs other systemic agents increased the risk of developing psoriasis over 3 years, a cohort study found. METHODOLOGY: Addressing postmarketing reports of psoriasis in patients treated with dupilumab for AD, researchers conducted a population-based retrospective cohort study of 214,430 adults with AD from the TriNetX Global Collaborative Network, with a 3-year follow-up. Analyses were completed on October 19, 2024. The study compared 9860 adults newly prescribed dupilumab vs 9860 prescribed other systemic agents, which were corticosteroids, methotrexate, cyclosporine, azathioprine, or mycophenolate mofetil. The mean age in both groups was about 45 years; about 55% were women; about half were White, 18% were Black, and 10% were Asian. The primary outcome measure was incident psoriasis, and the secondary outcome was psoriatic arthritis (PsA). TAKEAWAY: Over 3 years, 2.0% of patients on dupilumab developed psoriasis vs 1.1% of those taking other systemic agents ( P < .001). < .001). Psoriasis risk was significantly higher in patients on dupilumab (hazard ratio [HR], 1.58; 95% CI, 1.25-1.99). The number needed to harm (NNH) for psoriasis was 94 for dupilumab vs the other systemic agents. Psoriasis risk was also higher in patients on dupilumab who were older than 60 years (HR, 1.77; 95% CI, 1.22-2.58), men (HR, 1.55; 95% CI, 1.08-2.22), women (HR, 1.63; 95% CI, 1.19-2.24), and White (HR, 1.43; 95% CI, 1.05-1.93). At 3 years, PsA incidence with dupilumab vs other systemic agents was similar (0.20% vs 0.13%; P = .53). The risk was not statistically significant (HR, 1.97; 95% CI, 0.75-5.18). IN PRACTICE: The study found an increased relative risk for psoriasis among those treated with dupilumab, the study authors wrote, adding that an estimated NNH of 94 reflected the limited clinical relevance of the absolute risk, and 'risk should be weighed against dupilumab's proven efficacy in treating AD.' They noted that the rate of psoriasis was in the range of psoriasis prevalence in general AD populations, suggesting that 'dupilumab may act more as a trigger rather than a decisive factor in promoting psoriatic eruption in patients with AD.' SOURCE: The study was led by Teng-Li Lin, MD, Dalin Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation in Chiayi, Taiwan. It was published online on June 18 in JAMA Dermatology . LIMITATIONS: Limitations included the observational design, possible misclassification bias in outcome reporting, and absence of information on AD severity, physician specialties, photodocumentation, and treatment response. Because the database only supported time-fixed medication exposure analyses, data on dosage, duration, and adherence were unavailable. DISCLOSURES: The research received support from the National Science Technology Council and Taichung Veterans General Hospital, both in Taiwan. The authors had no competing interests.
