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EBGLYSS For Eczema: What To Know About The Newly FDA-approved Drug From Eli Lilly
EBGLYSS is now approved for adults and children 12 years or older who have moderate-to-severe atopic dermatitis.
Atopic dermatitis, or eczema, is characterized by itchy skin most often located on the arms or behind the knees, but which can appear anywhere. With scratching, the skin becomes red or otherwise discolored, can become swollen, and crack, weeping clear fluid or blood. It may then crust over and scale as it heals.
In less extreme cases, the itching may be intermittent as the condition goes into remission and the skin clears up. If the condition gets worse, as it frequently does, such respites become fewer and further between.
As skin cracks and heals, opportunistic bacteria may take advantage of the wound.
In addition, as healing occurs, the skin thickens with a layer of scar tissue coming between the person with atopic dermatitis and the itch, making it ever harder to reach and quiet.
People from families whose members have the condition or allergies such as hay fever and asthma are more likely to develop atopic dermatitis. Girls and women develop it more often than boys and men, and it is more common among Hispanic and Black children.
The condition usually appears during infancy or when one is a child, though it may appear at any time in one's life.
There are topical and other drug treatments available, but finding an effective controlling treatment can be difficult.
According to Tien Nguyen, MD, a board-certified dermatologist at MemorialCare Orange Coast Medical Center in Fountain Valley, CA, who was involved in clinical trials that led to EBGLYSS' eventual approval, atopic dermatitis is the result of pro-inflammatory cytokine activity.
In addition to causing itching, these cytokines — small proteins that play key roles in regulating the activity of immune cells — signal a cell's nucleus to create more cytokines like themselves, resulting in spiraling inflammation, and thus more itching and more cytokines.
There are several cytokines associated with atopic dermatitis, he explained. The primary drivers of atopic dermatitis are IL-4 and IL-13, although IL-13 is considered the dominant force in the condition. IL-31 is also implicated.
Lilly's EBGLYSS inhibits production of IL-13. There are already drugs on the market that target cytokines related to atopic dermatitis, but not all work for all people, and EBGLYSS is therefore a welcome addition to the dermatologist's arsenal.
Nguyen cautioned that dermatologists prefer to use one cytokine-targeting drug at a time for safety reasons, rather than attempting to hit all suspect cytokines at once. This makes a new, first-line biologic drug that targets IL-13 particularly welcome.
EBGLYSS — its chemical name is lebrikizumab-lbkz — was approved by the FDA based on the results of a pair of 52-week clinical trials — ADvocate 1 and ADvocate 2 — and the ADhere studies.
The ADvocate trials found the drug appropriate for adults and children at least 12 years old who weighed over 88 pounds (approximately 40 kilograms), and whose atopic dermatitis was not being controlled by atopic treatments.
Adhere was a 16-week randomized, double-blind, placebo-controlled, parallel-group, global, Phase 3 study that evaluated the drug's safety and efficacy.
Treatment with EBGLYSS begins with an initial startup dose of two 250 mg injections at weeks zero and two, and a 250 mg injection every 2 weeks until week 16. Subsequently, EBGLYSS is administered as a single 250 milligrams (mg) per 2 milliliters (mL) injection monthly, with or without topical corticosteroids.
Averaging the ADvocate results, 38% of participants had clear or nearly clear skin at 16 weeks into the trial. For 10%, those results were achieved just 4 weeks into the trial. For those who had clear or nearly clear skin at 16 weeks, 77% continued to do so at 1 year with monthly dosing of EBGLYSS.
Among the common side effects of EBGLYSS were eye and eyelid inflammation, including redness, swelling and itching. Some also experience injection site reactions and shingles (herpes zoster).
It is hard to overstate the effect that continual itching can have on a person who has atopic dermatitis.
Hannah Kopleman, MD, of Kopleman Aesthetic Surgery, described a patient who, before treatment, "dealt with constant itching, painful flareups, and frequent infections that not only affected their physical comfort but also their emotional well-being. It impacted their sleep, ability to focus at work, and social interactions."
"Atopic dermatitis can be incredibly debilitating for many patients, both physically and emotionally," Kopleman emphasized.
She noted that this same patient, after successful treatment — "which included new biologics like EBGLYSS" — flareups became less frequent, and their symptoms significantly lessened.
"They reported being able to sleep through the night for the first time in years, which improved their energy levels and mood. They were able to wear short sleeves without feeling self-conscious, and their overall quality of life improved dramatically."
– Hannah Kopleman, MD
"With the FDA's approval of drugs like EBGLYSS, we're able to offer more effective and tailored treatments that can make a real difference in managing the condition and giving patients their confidence — and life — back," Kopleman said.
Almirall To Present New Data On Biologics For Psoriasis And Atopic Dermatitis And Celebrates 80 Years Of Innovation At The EADV Congress
New clinical data on Almirall's biologics portfolio demonstrates further opportunities to positively impact patients and the medical community
New data to be presented on tildrakizumab for the treatment of moderate-to-severe psoriasis in adults from the POSITIVE study, the first clinical trial in dermatology to assess patients' wellbeing as a primary endpoint
Lebrikizumab 3-year sustained moderate-to-severe atopic dermatitis control data will be presented as a late-breaker additional new data include response rates in absolute values and long-term data in patients that are either inadequately controlled or not eligible for cyclosporine treatment
Almirall's broad presence at the 33rd EADV Congress – at the company's 80th anniversary - highlights eight decades of dedication to innovation and delivering solutions to positively impact people's health and lives
BARCELONA, Spain, September 23, 2024--(BUSINESS WIRE)--Almirall, S.A. (ALM), a global pharmaceutical company dedicated to medical dermatology, today announced its participation in the 33rd Congress of the European Academy of Dermatology and Venereology (EADV), taking place in Amsterdam from September 25 to 28, 2024. This year, Almirall marks its 80th anniversary, celebrating eight decades of innovation and commitment to delivering products positively impacting people's health and lives.
At the congress, Almirall will present 34 abstracts detailing the latest research on lebrikizumab for moderate-to-severe atopic dermatitis in adolescents and adults, tildrakizumab and Almirall's CAL/BDP cream for moderate-to-severe plaque psoriasis in adults, as well as tirbanibulin for actinic keratosis. The company will also host two symposia, providing a platform for experts to discuss current data, share insights, and facilitate discussions about the treatment of these chronic conditions with advanced biologics.
Impact of the treatment of psoriasis on patient wellbeing: new data from the POSITIVE study
Almirall will unveil new interim data on the treatment of adults with moderate-to-severe plaque psoriasis with tidrakizumab at 52 weeks from the POSITIVE clinical study. The POSITIVE study is the first clinical trial in dermatology to use the WHO-5 Wellbeing Index as a primary endpoint. The 5-item World Health Organization Wellbeing Index is a validated questionnaire that assesses health-related subjective psychological wellbeing in a variety of chronic diseases. The different sub-analyses presented during the congress reinforce the effectiveness of tildrakizumab on signs and symptoms in skin and beyond.
Almirall will host the symposium "Advancing Psoriasis Management for Long-Term Patient Outcomes", featuring experts such as Prof. Dr. Diamant Thaçi from the University of Lübeck, Prof. Dr. Ulrich Mrowietz from the University Medical Center Schleswig-Holstein, and Prof. Anna López Ferrer from the Hospital de la Santa Creu i Sant Pau in Barcelona. The discussion will emphasize on the importance of tailoring treatments to individual patients, the latest real-world evidence, and practical strategies for clinical success managing psoriasis, with opportunities for interactive discussion with leading experts.
Advancing atopic dermatitis disease management
Almirall will also present new data on lebrikizumab, a biologic approved for the treatment of moderate-to-severe atopic dermatitis. The late-breaking presentation will report lebrikizumab's data over three years of continuous treatment, alongside new data on the rates of absolute endpoints and its effectiveness in patients inadequately controlled or ineligible for cyclosporine. The Almirall symposium entitled "Precision in AD: How Lebrikizumab is Changing the Treatment Paradigm" will feature the experts Marjolein Bruin-Weller, from the National Expertise Center for Atopic Dermatitis at the Department of Dermatology and Allergology of the University Medical Center Utrecht; Andrew Blauvelt from Portland, US, and Sascha Gerdes from the Center for Inflammatory Skin Diseases of the University Medical Center Schleswig-Holstein Campus Kiel. Discussions will focus on the clinical impact of lebrikizumab and offer a chance for participants to engage with leading specialists in this field.
Almirall celebrating 80 years of innovation
2024 marks a significant milestone for Almirall as the company celebrates 80 years of innovation and commitment to delivering impactful solutions to help improve patients' lives. With a rich history in the pharmaceutical industry and a strong focus on medical dermatology, Almirall has built a robust pipeline addressing various diseases and using different therapeutic modalities. Leading innovating in medical dermatology is enabled by Almirall's close collaboration with the dermatology community and patient-centric mindset. Celebrating its 80th anniversary, Almirall reaffirms its dedication to advancing skin science and developing novel treatments to benefit patients and the dermatology community around the world.
For more information about Almirall's 80th-anniversary celebrations, visit almirall80years.Com
ANNEX: 33rd EADV Congress presentations and poster details:
Satellite Symposium on psoriasis: Advancing Psoriasis Management for Long-Term Patient Outcomes
- Chair, Prof. Dr. Diamant Thaçi, Lübeck, Germany- Prof. Dr. Anna López-Ferrer, Barcelona, Spain- Prof. Dr. Ulrich Mrowietz, Kiel, Germany
Thursday 26th September at 17:45 (CEST) / Room G104-G105 (SAT 11.04).
Satellite Symposium on atopic dermatitis: Precision in AD: how lebrikizumab is changing the treatment paradigm
- Chair, Prof. Dr. Marjolein de Bruin-Weller, Utrecht, The Netherlands- Dr. Andrew Blauvelt, Lake Oswego, US- Prof. Dr. Sascha Gerdes, Kiel, Germany
Friday 27th September at 13:00 (CEST) / Room G104-G105 (SAT 11.06).
A total of 37 abstracts have been accepted by the EADV for their annual meeting.
Ebglyss® (lebrikizumab)
1. Late breaking news: Efficacy and safety of lebrikizumab is maintained up to 3 years in patients with moderate-to-severe atopic dermatitis: ADvocate 1 and ADvocate 2 to ADjoin long-term extension trial
2. Absolute EASI response achieved by lebrikizumab over 16 weeks in patients with moderate-to-severe atopic dermatitis
3. Absolute itch and quality of life response with lebrikizumab through 52 weeks
4. Absolute EASI response achieved with lebrikizumab over 52 weeks in patients with moderate-to-severe atopic dermatitis
5. Absolute response of lebrikizumab at Week 52 in patients with moderate-to-severe atopic dermatitis who did not achieve protocol-defined response after initial 16 weeks of treatment
6. Improvement across disease dimensions with lebrikizumab in combination with topical corticosteroids in atopic dermatitis inadequately controlled or ineligible to cyclosporine: results from the ADvantage study
7. Lebrikizumab improves signs and symptoms of moderate-to-severe atopic dermatitis in patients inadequately controlled or ineligible for cyclosporine: week 52 results of a phase 3 clinical study (ADvantage)
8. Lebrikizumab in monotherapy improves the signs of moderate-to-severe atopic dermatitis across different body regions including the head and neck over one year of treatment
9. Number needed to treat with lebrikizumab in monotherapy at Week 16 in patients with moderate-to-severe atopic dermatitis
Ilumetri® (tildrakizumab)
1. Improving the well-being of patients with moderate to severe plaque psoriasis and involvement of impactful areas with Tildrakizumab
2. Effectiveness and Nail Assessment in Psoriasis and Psoriatic Arthritis (NAPPA) of tildrakizumab patients with nail psoriasis: 52-week results from the phase IV POSITIVE Austrian subset.
3. Effectiveness of tildrakizumab in patients with moderate-to-severe psoriasis located in special areas: 52-week results from the POSITIVE study
4. High effectiveness of tildrakizumab in bio-naïve and bio-experienced patients with moderate-to-severe psoriasis: 52-week results from the POSITIVE study
5. High effectiveness of tildrakizumab regardless of baseline characteristics in patients with moderate-to-severe psoriasis: 52-week results from the POSITIVE study
6. Patient-reported well-being using tildrakizumab for psoriasis in a real-world setting: 52-week interim data of the phase IV POSITIVE study
7. Safety of tildrakizumab in patients with moderate-to-severe psoriasis: 52-week data from the phase IV POSITIVE study
8. Effectiveness of tildrakizumab for itch, pain, and fatigue in patients with moderate-to-severe psoriasis: 52-week results from the real-world POSITIVE study
9. Quality of life, work productivity and treatment satisfaction with tildrakizumab in moderate-to-severe psoriasis patients: 52-week interim data of the real-world POSITIVE study
10. Impact of patient psoriasis on partner well-being in a real-world setting: 52-week interim data of the phase IV POSITIVE study
11. Efficacy and safety of tildrakizumab through Week 28 in patients with early vs late-onset moderate-to-severe plaque psoriasis: A post hoc analysis of reSURFACE 1 and reSURFACE 2
Wynzora® (CAL/BDP)
1. Impact of calcipotriene and betamethasone dipropionate cream with PAD technology (CAL/BPD PAD cream) on scalp-PGA success, S-mPASI and clinician satisfaction among patients with mild-to-moderate scalp psoriasis in routine clinical practices in Europe. An interim analysis of the PRO-SCALP study.
2. Impact of calcipotriene and betamethasone dipropionate cream with PAD technology (CAL/BPD PAD cream) on patient symptoms, functioning, emotions, level of itching, and sleep quality among patients with mild-to-moderate scalp psoriasis in routine clinical practices in Europe. An interim analysis of the PRO-SCALP study.
3. Patient preference over other topicals, perception of cream usability, treatment adherence and satisfaction among patients with mild-to-moderate scalp psoriasis using calcipotriene and betamethasone dipropionate cream with PAD technology (CAL/BPD PAD cream) in routine clinical practices in Europe. An interim analysis of the PRO-SCALP study.
4. Best responders to calcipotriol and betamethasone dipropionate PAD-cream: post-hoc analysis from pooled MC2-01-C2 and MC2-01-C7 phase III trials at week 4 and week 8.
5. Cost per responder analysis of calcipotriol plus betamethasone dipropionate cutaneous PAD cream for the topical treatment of mild to moderate plaque psoriasis in Italy.
6. Patient benefit assessment of topical treatment in psoriasis: Validation of the PBI-TOP questionnaire in a longitudinal study.
Klisyri® (tirbanibulin) and actinic keratosis
1. Lack of correlation between number of baseline actinic keratoses and local tolerability signs severity in patients treated with tirbanibulin over a 100 cm2 area: results from a Phase 3 study
2. Real-world evidence of tirbanibulin for actinic keratosis in Germany. Insights into patient-reported outcomes, safety and effectiveness
3. Efficacy and safety of tirbanibulin 1% ointment for the treatment of actinic keratosis in conditions close to routine clinical practice in Spain and Italy (TIRBASKIN study)
4. Patient and physician-reported outcomes with tirbanibulin 1% ointment for actinic keratosis in conditions close to routine clinical practice in Spain and Italy (TIRBASKIN study)
5. Enhancement of sun-damaged skin qualities with tirbanibulin (SunDamage Study)
6. Actinic cheilitis: Diagnosis and monitoring after treatment with Tirbanibulin using optical coherence tomography
7. Diagnosis and treatment of patients with actinic keratosis in France: REAKT study Actinic keratosis in France: an avoidable risk of skin cancer, unexpectedly also for people aged under 65 years (REAKT study)
8. Actinic keratosis in France: disease perceptions, expectations, and behaviors of patients (REAKT study).
Poster availability date and time: From 25 September 2024 (07.00 CEST) until 3 months post congress.Location: https://eadv.Org/congress/, and e-poster area
About Almirall
Almirall is a global pharmaceutical company dedicated to medical dermatology. We closely collaborate with leading scientists, healthcare professionals, and patients to deliver our purpose: to transform the patients' world by helping them realize their hopes and dreams for a healthy life. We are at the forefront of science to deliver ground-breaking, differentiated medical dermatology innovations that address patients´ needs.
Almirall, founded in 1944 and headquartered in Barcelona, is publicly traded on the Spanish Stock Exchange (ticker: ALM, total revenue in 2023: €898.8 MM, 1900 employees globally). Almirall products help to improve the lives of patients every day and are available in over 100 countries.
For more information, please visit https://www.Almirall.Com/
Legal notice:
This document includes only summary information and is not intended to be exhaustive. The facts, figures, and opinions contained in this document, in addition to the historical ones, are "forward-looking statements." These statements are based on the information currently available and the best estimates and assumptions that the Company considers reasonable. These statements involve risks and uncertainties beyond the control of the Company. Therefore, actual results may differ materially from those declared by such forward-looking statements. The Company expressly waives any obligation to revise or update any forward-looking statements, goals, or estimates contained in this document to reflect any changes in the assumptions, events, or circumstances on which such forward-looking statements are based, unless required by the applicable law.
View source version on businesswire.Com: https://www.Businesswire.Com/news/home/20240923201861/en/
Contacts
Corporate Communications:corporate.Communication@almirall.ComPhone: (+34) 659 614 173
Investor Relations:investors@almirall.ComPhone: (+34) 93 291 30 87
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Ebglyss, A New Biologic Treatment For Atopic Dermatitis, Gets FDA Approval
People with moderate-to-severe atopic dermatitis, the most common form of eczema, don't always get adequate relief from topical treatments like steroid creams and ointments. Now they have a new option: The U.S. Food and Drug Administration (FDA) just approved Ebglyss (lebrikizumab-lbkz), a biologic treatment for adults and children ages 12 years and older.[1]
This once-a-month injectable drug belongs to a class of medicines called targeted interleukin-13 (IL-13) inhibitors, and offers a new systemic option to combat the underlying inflammation in people living with atopic dermatitis, clearing skin and alleviating itch.
The approval of Ebglyss has been highly anticipated because the data on the phase 3 studies is so strong, says Amy McMichael, MD, a dermatologist who specializes in treating people of color with dermatologic conditions at Atrium Health Wake Forest Baptist in Winston Salem, North Carolina. (Dr. McMichael was not involved in any of this research.) One study that focused exclusively on people of color determined that the medication provided consistent results no matter an individual's skin tone.
"People can have a reduction in signs of their disease, relief from itch, and are able to reimagine what they can do with their lives now that they can function better," says Mark Genovese, MD, senior vice president of immunology development at Eli Lilly, the drug's manufacturer.
Nearly 40 Percent of People Achieved Clear Skin in 16 WeeksThe approval of Ebglyss is based on three pivotal phase 3 trials, ADvocate 1, ADvocate 2, and ADhere, which included a total of over 1,000 participants ages 12 and older with moderate-to-severe eczema who were unable to control their symptoms with topical prescription medications.
Key findings from the ADvocate 1 and 2 trial included:
Skin Clearance In an average of Advocate 1 and 2, 38 percent of participants achieved clear or almost-clear skin at 16 weeks with Ebglyss (versus 12 percent with placebo).
Ten percent of people taking Ebglyss for four weeks achieved clear or almost-clear skin.
Long-Term Efficacy Of the people who experienced cleared skin, 77 percent maintained it at one year with once-monthly dosing.
Additionally, 48 percent of those who were switched to placebo at week 16 maintained their improvement at one year.
Itch Relief Significant itch relief at 16 weeks was experienced by 43 percent of participants, with some people reporting relief as soon as two weeks into treatment.
Side Effects The most common side effects of Ebglyss included eye and eyelid inflammation, such as redness, swelling, and itching; injection site reactions; and shingles (herpes zoster).
Ebglyss Proves Effective in People of ColorIn a first-of-its-kind study, Ebglyss showed improvement in skin clearance and itch relief in a small trial of 50 people with darker skin tones, which included Black, Asian, Hispanic/Latinx, and American Indian or Alaska Native people. The results have yet to be published in a peer-reviewed journal.
Results at 16 weeks were consistent and similar with earlier trials, with most people experiencing significant improvement, and close to 40 percent achieving clear or almost-clear skin.[2]
People of color are disproportionately affected by atopic dermatitis, often experiencing more severe symptoms, a delay in diagnosis, and a lengthier time frame to find appropriate treatment, according to lead author Andrew Alexis, MD, MPH, a professor of clinical dermatology at Weill Cornell Medicine and a dermatologist at NewYork-Presbyterian/Weill Cornell Medical Center, both in New York City.[2]
A recent national health survey found that about 19 percent of Black children have atopic dermatitis, compared with about 16 percent of white children and 8 percent of Asian children. Another study found that Black children are 1.7 times more likely to develop atopic dermatitis than white children.[3]
"They also have been historically underrepresented in clinical trials, which means we have lacked data pertaining to the treatment of patients with skin of color," said Dr. Alexis.
Because most dermatologic trials often don't include people of color, providers have to assume medications work in all races and ethnicities — even without the data, says McMichael.
"This trial in patients of color shows that this drug is unequivocally effective in patients with skin of color," she says.
How Much Will Ebglyss Cost? According to the Lilly press release, a patient's out-of-pocket cost will depend on multiple factors, including the type of insurance coverage they have or their current phase of coverage.[1]
Lilly is working to ensure broad patient access through collaborations with insurers and health systems, alongside providing support programs such as copay assistance for eligible patients, said a company spokesperson. Covered patients may pay as little as $5 per month.
The list price in the United States for Ebglyss is $3,500 per pen, according to a Lilly spokesperson.
Without insurance, that means a person on a typical dosing schedule would spend $38,500 by week 16.
Ebglyss will be available in the United States in the coming weeks, according to the company press release.
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