Bristol Myers Squibb Presents New Data from Two Trials Demonstrating Sotyktu (deucravacitinib) Efficacy in both Moderate-to-Severe Scalp Psoriasis and in a Real-World Setting
Bristol Myers Squibb (NYSE:BMY) announced positive results from two trials demonstrating Sotyktu (deucravacitinib) efficacy in moderate-to-severe scalp psoriasis and real-world settings. The Phase 3b/4 PSORIATYK SCALP trial showed Sotyktu's superiority over placebo across all primary and secondary endpoints at Week 16. Notably, 48.5% of Sotyktu-treated patients achieved clear/almost clear scalp psoriasis compared to 13.7% on placebo.
The real-world RePhlect registry analysis revealed that six months of Sotyktu treatment was consistent with efficacy outcomes observed in previous clinical studies. Patients achieved significant decreases in disease severity measures, with 67.9% reaching PASI scores ≤3 and 64.1% achieving BSA ≤3%.
Sotyktu's safety profile in PSORIATYK SCALP was consistent with previous trials. These results reinforce Sotyktu as a potential oral standard of care for moderate-to-severe psoriasis, especially with scalp involvement.
Bristol Myers Squibb (NYSE:BMY) ha annunciato risultati positivi da due studi che dimostrano l'efficacia di Sotyktu (deucravacitinib) nella psoriasi del cuoio capelluto da moderata a severa e in contesti reali. Il trial di Fase 3b/4 PSORIATYK SCALP ha mostrato la superiorità di Sotyktu rispetto al placebo in tutti i principali e secondari parametri di valutazione alla Settimana 16. In particolare, il 48,5% dei pazienti trattati con Sotyku ha raggiunto una psoriasi del cuoio capelluto chiara/quasi chiara rispetto al 13,7% del gruppo placebo.
Analisi del registro RePhlect nel mondo reale ha rivelato che sei mesi di trattamento con Sotyktu sono stati coerenti con i risultati di efficacia osservati in studi clinici precedenti. I pazienti hanno ottenuto significative diminuzioni nelle misure di gravità della malattia, con il 67,9% che ha raggiunto punteggi PASI ≤3 e il 64,1% che ha raggiunto una BSA ≤3%.
Il profilo di sicurezza di Sotyktu nel trial PSORIATYK SCALP è stato coerente con studi precedenti. Questi risultati rafforzano Sotyktu come un potenziale standard orale di cura per la psoriasi da moderata a severa, specialmente con coinvolgimento del cuoio capelluto.
Bristol Myers Squibb (NYSE:BMY) anunció resultados positivos de dos ensayos que demuestran la eficacia de Sotyktu (deucravacitinib) en la psoriasis del cuero cabelludo moderada a severa y en entornos del mundo real. El ensayo de Fase 3b/4 PSORIATYK SCALP mostró la superioridad de Sotyhtu sobre el placebo en todos los puntos finales primarios y secundarios a la Semana 16. Notablemente, el 48,5% de los pacientes tratados con Sotyktu alcanzaron una psoriasis del cuero cabelludo clara/casi clara en comparación con el 13,7% del grupo placebo.
El análisis del registro RePhlect en el mundo real reveló que seis meses de tratamiento con Sotyktu fueron coherentes con los resultados de eficacia observados en estudios clínicos anteriores. Los pacientes lograron disminuciones significativas en las medidas de gravedad de la enfermedad, con un 67,9% alcanzando puntajes PASI ≤3 y un 64,1% logrando BSA ≤3%.
El perfil de seguridad de Sotyktu en el ensayo PSORIATYK SCALP fue coherente con ensayos anteriores. Estos resultados refuerzan a Sotyktu como un potencial estándar de tratamiento oral para la psoriasis moderada a severa, especialmente con involucramiento del cuero cabelludo.
브리스톨 마이어스 스퀴브 (NYSE:BMY)는 Sotyktu (deucravacitinib)가 중등도에서 중증의 두피 건선 및 실제 상황에서의 효능을 입증한 두 개의 시험에서 긍정적인 결과를 발표했습니다. 3b/4상 PSORIATYK SCALP 시험에서는 Sotyktu가 16주 차에 모든 주요 및 부차적 평가 기준에서 위약보다 우수한 성과를 보였습니다. 특히 Sotyktu 치료를 받은 환자의 48.5%가 위약의 13.7%에 비해 두피 건선이 깨끗하거나 거의 깨끗한 상태에 도달했습니다.
실제 세계 RePhlect 등록부 분석 결과 Sotyktu 치료 6개월 동안의 효능 결과는 이전 임상 연구에서 관찰된 것과 일치했습니다. 환자들은 질병 심각도 측정에서 유의미한 감소를 달성했으며, 67.9%가 PASI 점수 ≤3에 도달하고 64.1%가 BSA ≤3%에 도달했습니다.
PSORIATYK SCALP의 Sotyktu 안전성 프로필은 이전 시험과 일치했습니다. 이러한 결과는 두피에 영향을 주는 중등도에서 중증 건선에 대한 잠재적인 경구 치료 기준으로 Sotyktu를 강화합니다.
Bristol Myers Squibb (NYSE:BMY) a annoncé des résultats positifs de deux essais démontrant l'efficacité de Sotyktu (deucravacitinib) dans les cas de psoriasis du cuir chevelu de modéré à sévère et dans des contextes réels. L'
L'analyse du registre RePhlect dans le monde réel a révélé que six mois de traitement par Sotyktu étaient cohérents avec les résultats d'efficacité observés dans les études cliniques précédentes. Les patients ont enregistré des diminutions significatives des mesures de gravité de la maladie, avec 67,9 % atteignant des scores PASI ≤3 et 64,1 % atteignant une BSA ≤3%.
Le profil de sécurité de Sotyktu dans l'essai PSORIATYK SCALP était cohérent avec les essais précédents. Ces résultats renforcent Sotyktu comme un potentiel standard de soins oraux pour le psoriasis modéré à sévère, en particulier avec un engagement du cuir chevelu.
Bristol Myers Squibb (NYSE:BMY) hat positive Ergebnisse aus zwei Studien angekündigt, die die Wirksamkeit von Sotyktu (deucravacitinib) bei moderater bis schwerer Kopfhautpsoriasis und in realen Anwendungssettings zeigen. Die Phase 3b/4 PSORIATYK SCALP-Studie zeigte die Überlegenheit von Sotyktu gegenüber Placebo in allen primären und sekundären Endpunkten nach 16 Wochen. Bemerkenswerterweise erreichten 48,5% der mit Sotyktu behandelten Patienten eine klare/fast klare Kopfhautpsoriasis im Vergleich zu 13,7% im Placebo-Gruppe.
Die Analyse des realen RePhlect-Registers ergab, dass sechs Monate Behandlung mit Sotyktu mit den in früheren klinischen Studien beobachteten Wirksamkeitsergebnissen übereinstimmte. Die Patienten erreichten signifikante Reduktionen in den Schweregraden der Erkrankung, wobei 67,9% PASI-Werte ≤3 und 64,1% eine BSA ≤3% erreichten.
Das Sicherheitsprofil von Sotyktu in der PSORIATYK SCALP-Studie stimmte mit früheren Studien überein. Diese Ergebnisse stärken Sotyktu als potenziellen oralen Standard bei moderater bis schwerer Psoriasis, insbesondere mit Beteiligung der Kopfhaut.
- Sotyktu demonstrated superior efficacy over placebo in treating moderate-to-severe scalp psoriasis
- 48.5% of Sotyktu-treated patients achieved clear/almost clear scalp psoriasis vs 13.7% on placebo
- Real-world analysis showed consistent effectiveness with clinical trial results
- 67.9% of patients in real-world study achieved PASI scores ≤3
- 64.1% of patients in real-world study achieved BSA ≤3%
- None.
Insights
The PSORIATYK SCALP trial results are highly significant for patients with moderate-to-severe scalp psoriasis. Sotyktu (deucravacitinib) demonstrated superior efficacy compared to placebo, with
Key secondary endpoints were also met, including
The safety profile aligns with previous Sotyktu trials, with nasopharyngitis and upper respiratory tract infections being the most common adverse events. This consistency in safety data across trials is reassuring for long-term use.
The real-world RePhlect registry data further supports Sotyktu's effectiveness, showing significant improvements in PASI, BSA and IGA scores after six months of treatment. This real-world evidence complements the clinical trial data, suggesting that Sotyktu's benefits translate well to everyday clinical practice.
These positive results for Sotyktu in scalp psoriasis and real-world settings are significant for Bristol Myers Squibb (BMY). Scalp psoriasis affects about
The real-world data from the RePhlect registry is particularly valuable, as it demonstrates Sotyktu's effectiveness outside of controlled clinical trials. This can be a powerful tool for convincing both healthcare providers and payers of the drug's value, potentially leading to broader insurance coverage and increased prescriptions.
With Sotyktu being studied across multiple immune-mediated diseases, these positive results in psoriasis bode well for potential label expansions in the future. This could significantly increase the drug's market potential and long-term revenue prospects for BMY.
Investors should monitor Sotyktu's sales growth and market penetration in the coming quarters, as well as any updates on ongoing trials in other indications, as these factors could materially impact BMY's future financial performance.
In the Phase 3b/4 PSORIATYK SCALP trial Sotyktu was superior to placebo across all primary and secondary endpoints at Week 16, with patients reporting significantly greater improvement in symptoms
Safety profile in PSORIATYK SCALP was consistent with the established safety profile of Sotyktu
In the real-world RePhlect registry of patients, six months of Sotyktu treatment was consistent with the efficacy outcomes observed in the POETYK clinical studies for psoriasis
The new PSORIATYK SCALP efficacy and safety results (oral presentation FC04.07, abstract #5627), patient-reported outcomes (oral presentation FC06.06, abstract #5390) and 23 additional abstracts are being presented at the European Academy of Dermatology and Venereology (EADV) Congress in
“Approximately
The trial also met key secondary endpoints at Week 16, with a significantly higher percentage of patients achieving at least a
Greater improvements were also reported by patients receiving Sotyktu versus placebo, respectively, in achieving the minimum clinically important difference (MCID) for scalp-specific itch (
The safety profile of Sotyktu in PSORIATYK SCALP was consistent with findings in previously conducted clinical trials of Sotyktu in psoriasis. The most common adverse events associated with Sotyktu treatment in the PSORIATYK SCALP trial were nasopharyngitis (
Real-world analysis demonstrates consistent effectiveness with Sotyktu
An interim analysis (poster #P3311, abstract #5500) of the Registry of Psoriasis Health Outcomes: A Longitudinal Real-World Collaboration Study (RePhlect) evaluated 118 patients, 108 of whom had moderate-to-severe plaque psoriasis. This analysis found that the effectiveness after six months of continuous Sotyktu treatment in real-world registry patients was consistent with efficacy outcomes observed in the POETYK PSO clinical studies in patients living with moderate-to-severe plaque psoriasis.
Findings showed that patients in the overall group achieved statistically significant mean decreases in measures of disease severity (
“These data further demonstrate the safety and efficacy of Sotyktu for the treatment of psoriasis in high-impact areas, such as the scalp, and include the first analysis from our RePhlect registry providing evidence highlighting the real-world benefit of Sotyktu for the treatment of moderate-to-severe plaque psoriasis,” said Daniel Quirk, MD, MPH, MBA, senior vice president, worldwide Immunology and Neuroscience medical affairs, Bristol Myers Squibb. “We believe Sotyktu has the potential to be the systemic therapy that healthcare providers turn to when treating adult patients with moderate-to-severe psoriasis, especially those with scalp involvement. Overall, these promising results reinforce once-daily Sotyktu as a potential oral standard of care as we continue to lead in TYK2 innovation.”
Sotyktu is also being studied in clinical trials across multiple immune-mediated diseases.
Bristol Myers Squibb thanks the patients and investigators involved in the ongoing PSORIATYK SCALP trial and RePhlect study.
About the PSORIATYK SCALP Trial
PSORIATYK SCALP (NCT05478499) is an ongoing, 52-week, Phase 3b/4 multicenter, randomized, double-blind, placebo-controlled trial evaluating the efficacy and safety of Sotyktu in patients with moderate-to-severe scalp psoriasis, as defined by scalp-specific Physician’s Global Assessment (ss-PGA) ≥3, Psoriasis Scalp Severity Index (PSSI) ≥12 and Scalp Surface Area (SSA) ≥
The Week 16 efficacy and safety analysis included 154 patients (Sotyktu, n=103; placebo, n=51).
The primary endpoint was the percentage of patients who achieved a ss-PGA score of 0 or 1 (clear/almost clear) at Week 16. Key secondary endpoints were the percentage of patients who achieved a PSSI response 90, defined as at least a
About the Registry of Psoriasis Health Outcomes: A Longitudinal Real-World Collaboration Study (RePhlect)
RePhlect (NCT05744466) is a prospective, observational, real-world study of adult patients with dermatologist-diagnosed psoriasis, with a targeted sample size of 2,500 Sotyktu patients in six countries (
RePhlect North American cohort (
The design and conduct of the RePhlect North American cohort study was a collaborative effort between CorEvitas and Bristol Myers Squibb, with financial support for the research provided by Bristol Myers Squibb. The CorEvitas Psoriasis Registry was developed in collaboration with the National Psoriasis Foundation.
About Psoriasis
Psoriasis is a widely prevalent, chronic, systemic immune-mediated disease that substantially impairs patients’ physical health, quality of life and work productivity. Psoriasis is a serious global problem, with at least 100 million people worldwide impacted by some form of the disease, including around 14 million people in
Scalp psoriasis, which occurs in approximately
About Sotyktu (deucravacitinib)
Sotyktu (deucravacitinib) is an oral, selective, allosteric tyrosine kinase 2 (TYK2) inhibitor with a unique mechanism of action, representing a new class of small molecules. It is the first selective TYK2 inhibitor in clinical studies across multiple immune-mediated diseases. Bristol Myers Squibb scientists designed Sotyktu to selectively target TYK2, thereby inhibiting signaling of interleukin (IL)-23, IL-12 and Type 1 interferons (IFN), key cytokines involved in the pathogenesis of multiple immune-mediated diseases. Sotyktu achieves a high degree of selectivity by binding to the regulatory domain of TYK2, resulting in allosteric inhibition of TYK2 and its downstream functions. Sotyktu selectively inhibits TYK2 at physiologically relevant concentrations. At therapeutic doses, Sotyktu does not inhibit JAK1, JAK2 or JAK3.
Bristol Myers Squibb: Pioneering Paths Forward in Immunology to Transform Patients’ Lives
Bristol Myers Squibb is inspired by a single vision – transforming patients’ lives through science. For people living with immune-mediated diseases, the debilitating reality of enduring chronic symptoms and disease progression can take a toll on their physical, emotional and social well-being, making simple tasks and daily life a challenge. Driven by our deep understanding of the immune system that spans over 20 years of experience, and our passion to help patients, the company continues to pursue pathbreaking science with the goal of delivering meaningful solutions that address unmet needs in rheumatology, gastroenterology, dermatology and pulmonology. We follow the science, aiming to tailor therapies to individual needs, improve outcomes and expand treatment options by working to identify mechanisms with the potential to achieve long-term remission – and perhaps even cures – in the future. By building partnerships with researchers, patients and caregivers to deliver innovative treatments, Bristol Myers Squibb strives to elevate patient care to new standards and deliver what matters most – the promise of living a better life.
SOTYKTU
SOTYKTU® (deucravacitinib) is indicated for the treatment of moderate-to-severe plaque psoriasis in adults who are candidates for systemic therapy or phototherapy.
Limitations of Use:
SOTYKTU is not recommended for use in combination with other potent immunosuppressants.
IMPORTANT SAFETY INFORMATION
CONTRAINDICATIONS
SOTYKTU is contraindicated in patients with a history of hypersensitivity reaction to deucravacitinib or to any of the excipients in SOTYKTU.
WARNINGS AND PRECAUTIONS
Hypersensitivity: Hypersensitivity reactions such as angioedema have been reported. If a clinically significant hypersensitivity reaction occurs, institute appropriate therapy and discontinue SOTYKTU.
Infections: SOTYKTU may increase the risk of infections. Serious infections have been reported in patients with psoriasis who received SOTYKTU. The most common serious infections reported with SOTYKTU included pneumonia and COVID-19. Avoid use of SOTYKTU in patients with an active or serious infection. Consider the risks and benefits of treatment prior to initiating SOTYKTU in patients:
- with chronic or recurrent infection
- who have been exposed to tuberculosis
- with a history of a serious or an opportunistic infection
- with underlying conditions that may predispose them to infection.
Closely monitor patients for the development of signs and symptoms of infection during and after treatment. A patient who develops a new infection during treatment should undergo prompt and complete diagnostic testing, have appropriate antimicrobial therapy initiated and be closely monitored. Interrupt SOTYKTU if a patient develops a serious infection. Do not resume SOTYKTU until the infection resolves or is adequately treated.
Viral Reactivation
Herpes virus reactivation (e.g., herpes zoster, herpes simplex) was reported in clinical trials with SOTYKTU. Through Week 16, herpes simplex infections were reported in 17 patients (6.8 per 100 patient-years) treated with SOTYKTU, and 1 patient (0.8 per 100 patient-years) treated with placebo. Multidermatomal herpes zoster was reported in an immunocompetent patient. During PSO-1, PSO-2, and the open-label extension trial, the majority of patients who reported events of herpes zoster while receiving SOTYKTU were under 50 years of age. The impact of SOTYKTU on chronic viral hepatitis reactivation is unknown. Consider viral hepatitis screening and monitoring for reactivation in accordance with clinical guidelines before starting and during therapy with SOTYKTU. If signs of reactivation occur, consult a hepatitis specialist. SOTYKTU is not recommended for use in patients with active hepatitis B or hepatitis C.
Tuberculosis (TB): In clinical trials, of 4 patients with latent TB who were treated with SOTYKTU and received appropriate TB prophylaxis, no patients developed active TB (during the mean follow-up of 34 weeks). One patient, who did not have latent TB, developed active TB after receiving 54 weeks of SOTYKTU. Evaluate patients for latent and active TB infection prior to initiating treatment with SOTYKTU. Do not administer SOTYKTU to patients with active TB. Initiate treatment of latent TB prior to administering SOTYKTU. Consider anti-TB therapy prior to initiation of SOTYKTU in patients with a past history of latent or active TB in whom an adequate course of treatment cannot be confirmed. Monitor patients for signs and symptoms of active TB during treatment.
Malignancy including Lymphomas: Malignancies, including lymphomas, were observed in clinical trials with SOTYKTU. Consider the benefits and risks for the individual patient prior to initiating or continuing therapy with SOTYKTU, particularly in patients with a known malignancy (other than a successfully treated non-melanoma skin cancer) and patients who develop a malignancy when on treatment with SOTYKTU.
Rhabdomyolysis and Elevated CPK: Treatment with SOTYKTU was associated with an increased incidence of asymptomatic creatine phosphokinase (CPK) elevation and rhabdomyolysis compared to placebo.
Discontinue SOTYKTU if markedly elevated CPK levels occur or myopathy is diagnosed or suspected. Instruct patients to promptly report unexplained muscle pain, tenderness or weakness, particularly if accompanied by malaise or fever.
Laboratory Abnormalities: Treatment with SOTYKTU was associated with increases in triglyceride levels. Periodically evaluate serum triglycerides according to clinical guidelines during treatment. SOTYKTU treatment was associated with an increase in the incidence of liver enzyme elevation compared to placebo. Evaluate liver enzymes at baseline and thereafter in patients with known or suspected liver disease according to routine management. If treatment-related increases in liver enzymes occur and drug-induced liver injury is suspected, interrupt SOTYKTU until a diagnosis of liver injury is excluded.
Immunizations: Prior to initiating therapy with SOTYKTU, consider completion of all age-appropriate immunizations according to current immunization guidelines including prophylactic herpes zoster vaccination. Avoid use of live vaccines in patients treated with SOTYKTU. The response to live or non-live vaccines has not been evaluated.
Potential Risks Related to JAK Inhibition: It is not known whether tyrosine kinase 2 (TYK2) inhibition may be associated with the observed or potential adverse reactions of Janus Kinase (JAK) inhibition. In a large, randomized, postmarketing safety trial of a JAK inhibitor in rheumatoid arthritis (RA), patients 50 years of age and older with at least one cardiovascular risk factor, higher rates of all-cause mortality, including sudden cardiovascular death, major adverse cardiovascular events, overall thrombosis, deep venous thrombosis, pulmonary embolism, and malignancies (excluding non-melanoma skin cancer) were observed in patients treated with the JAK inhibitor compared to those treated with TNF blockers. SOTYKTU is not approved for use in RA.
ADVERSE REACTIONS
Most common adverse reactions (≥
SPECIFIC POPULATIONS
Pregnancy: Available data from case reports on SOTYKTU use during pregnancy are insufficient to evaluate a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. Report pregnancies to the Bristol-Myers Squibb Company’s Adverse Event reporting line at 1-800-721-5072.
Lactation: There are no data on the presence of SOTYKTU in human milk, the effects on the breastfed infant, or the effects on milk production. SOTYKTU is present in rat milk. When a drug is present in animal milk, it is likely that the drug will be present in human milk. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for SOTYKTU and any potential adverse effects on the breastfed infant from SOTYKTU or from the underlying maternal condition.
Hepatic Impairment: SOTYKTU is not recommended for use in patients with severe hepatic impairment.
SOTYKTU is available in 6 mg tablets.
Please see
About Bristol Myers Squibb
Bristol Myers Squibb is a global biopharmaceutical company whose mission is to discover, develop and deliver innovative medicines that help patients prevail over serious diseases. For more information about Bristol Myers Squibb, visit us at BMS.com or follow us on LinkedIn, Twitter, YouTube, Facebook and Instagram.
Cautionary Statement Regarding Forward-Looking Statements
This press release contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995 regarding, among other things, the research, development and commercialization of pharmaceutical products. All statements that are not statements of historical facts are, or may be deemed to be, forward-looking statements. Such forward-looking statements are based on current expectations and projections about our future financial results, goals, plans and objectives and involve inherent risks, assumptions and uncertainties, including internal or external factors that could delay, divert or change any of them in the next several years, that are difficult to predict, may be beyond our control and could cause our future financial results, goals, plans and objectives to differ materially from those expressed in, or implied by, the statements. These risks, assumptions, uncertainties and other factors include, among others, that results of future post-marketing studies will be consistent with the results of these studies, that Sotyktu (deucravacitinib) for the indication described in this release may not be commercially successful, any marketing approvals, if granted, may have significant limitations on their use, and that continued approval of Sotyktu for such indication may be contingent upon verification and description of clinical benefit in additional confirmatory trials. No forward-looking statement can be guaranteed. Forward-looking statements in this press release should be evaluated together with the many risks and uncertainties that affect Bristol Myers Squibb’s business and market, particularly those identified in the cautionary statement and risk factors discussion in Bristol Myers Squibb’s Annual Report on Form 10-K for the year ended December 31, 2023, as updated by our subsequent Quarterly Reports on Form 10-Q, Current Reports on Form 8-K and other filings with the Securities and Exchange Commission. The forward-looking statements included in this document are made only as of the date of this document and except as otherwise required by applicable law, Bristol Myers Squibb undertakes no obligation to publicly update or revise any forward-looking statement, whether as a result of new information, future events, changed circumstances or otherwise.
corporatefinancial-news
View source version on businesswire.com: https://www.businesswire.com/news/home/20240925005092/en/
Bristol Myers Squibb
Media Inquiries:
media@bms.com
Investors:
investor.relations@bms.com
Source: Bristol Myers Squibb
FAQ
What were the primary results of the PSORIATYK SCALP trial for Sotyktu (BMY)?
How did Sotyktu (BMY) perform in the real-world RePhlect registry study?
What were the most common side effects of Sotyktu (BMY) in the PSORIATYK SCALP trial?
When and where were the Sotyktu (BMY) trial results presented?
