Latest news with #dupilumab
Medscape
31-07-2025
- Health
- Medscape
Dupilumab Controls Cancer Rx-Related Skin Toxicities
TOPLINE: Patients with antibody-drug conjugate (ADC)-related skin reactions had higher response rates and fewer treatment discontinuations when treated with dupilumab than with systemic steroids. METHODOLOGY: Researchers evaluated 163 patients at Memorial Sloan Kettering Cancer Center who received an ADC from January 2020 through September 2024, with follow-up until December 2024. The analysis included 27 adult patients with ADC-induced dermatologic adverse events (dAEs); 11 were treated with dupilumab (63.6% women; 81.8% White) and 16 were treated with systemic steroids alone (37.5% women; 81.2% White). Researchers analyzed the severity of dAEs, treatment responses, and cancer treatment discontinuation rates. TAKEAWAY: In the dupilumab group, 82% of patients received enfortumab vedotin for genitourinary malignancies, and 46% received pembrolizumab. Clinical presentations of dAEs included eczematous eruptions in 54% of patients, morbilliform eruptions in 46%, and vesiculobullous eruptions in 27%. In the steroid-treated group, all patients received enfortumab vedotin with pembrolizumab for genitourinary malignancies. In the dupilumab group, 70% of patients experienced grade 3 events, whereas 56% in the steroid-only group experienced grade 2 reactions. In the dupilumab group vs the steroid-only group, 73% vs 56% of patients achieved complete response, and 27% vs 25% achieved partial response of skin reactions, respectively. Among those on dupilumab, the median time to first clinical response was 24 days, and the median time to best clinical response was 52 days. In the dupilumab group, no patients discontinued treatment because of dAEs vs 43.8% in the steroid-only group (P < .05). IN PRACTICE: 'Dupilumab appears promising as a steroid-sparing treatment of ADC-induced cutaneous toxicities,' which 'are difficult to manage and can disrupt cancer treatment,' the study authors wrote. 'Further research is essential to explore its broader utility and economic feasibility,' they added. SOURCE: The study was led by Ian Nykaza, BS, of the Dermatology Service, Department of Medicine at Memorial Sloan Kettering Cancer Center, New York City. It was published online on July 30 in JAMA Dermatology. LIMITATIONS: Limitations included the small study size, retrospective design, treatment heterogeneity, and limited ADC diversity. DISCLOSURES: This study was supported by the National Institutes of Health/National Cancer Institute's Cancer Center Support Grant P30 CA008748. Several authors reported receiving personal fees and research funding from various sources. This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication.
Medscape
17-07-2025
- Health
- Medscape
Lebrikizumab Shows Cost Benefits in Atopic Dermatitis Care
TOPLINE: The introduction of lebrikizumab, a novel monoclonal antibody targeting interleukin-13 for severe atopic dermatitis (AD), was associated with cost savings of approximately €3.3 million over 3 years for the Italian National Healthcare System, according to a budget impact analysis model. The adoption of lebrikizumab increased from 1198 patients in year 1 to 5849 patients by year 3, resulting in cumulative savings through reduced drug acquisition and adverse event management costs. METHODOLOGY: This budget impact analysis model compared two scenarios over 3 years from the Italian National Healthcare System perspective: scenario A with current standard biologic agents (dupilumab and tralokinumab) and scenario B including lebrikizumab alongside existing treatments. This analysis included 11,978 patients with severe AD eligible for systemic therapy, with projected growth to 14,973 patients in the first year, 18,716 in the second year, and 23,395 in the third year. Market shares for dupilumab, tralokinumab, and, in the intervention scenario, lebrikizumab were applied to the eligible population annually. The model incorporated drug acquisition, disease management, and adverse event management costs. A one-way sensitivity analysis was conducted to assess the model's robustness by evaluating the impact of individual parameters with ±20% variation. TAKEAWAY: The implementation of lebrikizumab resulted in an expenditure of €785,594 in the first year, followed by €1,693,126 in the second year and €2,395,402 in the third year, totalling approximately €3.3 million over the 3-year period. A market penetration analysis showed that lebrikizumab usage increased from 8% in year 1 to 25% by year 3, whereas dupilumab usage decreased from 74% in year 1 to 59% by year 3 and tralokinumab usage decreased from 18% to 16%. Sensitivity analyses revealed that the number of eligible patients and injection site reaction costs were the primary drivers of the cost-saving findings. Adverse event management costs decreased by €490,817 cumulatively. In scenario B, the number of patients treated with lebrikizumab increased from 1198 in the first year to 5849 in the third year. IN PRACTICE: "The introduction of lebrikizumab in Italy could reduce the overall costs for patients with severe AD, who can be treated with biologic agents, in line with AIFA [Italian Medicine Agency] reimbursement criteria. Lebrikizumab is associated with improved patient management and cost saving for the Italian NHS [National Healthcare System]. This data could serve as valuable information for healthcare decision makers to optimize the value derived from the treatment and management of patients with severe AD," the authors of the study wrote. SOURCE: This study was led by Ippazio Cosimo Antonazzo, Research Centre on Public Health (CESP), University of Milano-Bicocca, Monza, Italy. It was published online on July 09, 2025, in Dermatology and Therapy. LIMITATIONS: The analysis was based on projected utilisation rates of lebrikizumab, which may not be generalisable to populations with different adoption rates of the drug. The analysis was restricted to monoclonal antibodies and did not include JAK inhibitors, which could have resulted in a different economic impact. Additionally, this study considered only direct medical costs from the Italian National Healthcare System perspective, excluding patient-incurred costs or potential savings from accessing lebrikizumab. DISCLOSURES: This study was supported by Almirall S.p.A., Milan, Italy. Several authors reported receiving grants and personal fees and having other ties with various sources. Additional disclosures are noted in the original article. This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication.
Medscape
10-07-2025
- 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.
