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New Positive Data From Phase 3 SPROUT Trial, Studying Otezla (apremilast) in Children Ages 6-17 With Moderate to Severe Plaque Psoriasis
Positive Results From the Phase 3 DISCREET Study, Investigating Clinical Efficacy and Safety of Otezla in Patients With Moderate to Severe Genital Psoriasis
New Rocatinlimab Phase 2 Analyses Highlight Emerging Clinical Profile in Moderate to Severe Atopic Dermatitis
THOUSAND OAKS, Calif. , Aug. 30, 2022 /PRNewswire/ -- Amgen (NASDAQ:AMGN) today announced that clinical and real-world data from across its inflammation portfolio, including both established treatments and pipeline assets, will be presented at the 31st European Academy of Dermatology and Venereology (EADV), taking place in Milan, Italy , Sept. 7-10, 2022 .
Presentations will cover a range of clinical data for Otezla® (apremilast), including positive, 16-week results from the Phase 3 SPROUT study in children ages 6-17 with moderate to severe plaque psoriasis. Successful 16-week results from the Phase 3 DISCREET study, assessing the efficacy and safety of Otezla® (apremilast), in patients with moderate to severe genital psoriasis will also be presented. Furthermore, there will be data presented on the role of Otezla in patients with plaque psoriasis featuring special area skin involvement or persistent itch, incorporating data and analyses from the EMBRACE and ADVANCE studies.
Other research highlights being presented from Amgen's portfolio include a late-breaking post-hoc analysis from the rocatinlimab (AMG 451/KHK4083) Phase 2b study with a focus on patients with moderate to severe head and neck atopic dermatitis and a biomarker analysis of blood and tissue samples in subjects treated with rocatinlimab. Finally, a new analysis of the multinational UPLIFT survey on the impact of psoriasis involvement in special locations on quality of life will be presented.
"The research that will be presented at EADV reinforces the strength of Amgen's inflammation portfolio and our continued support for patients living with autoimmune skin diseases like plaque psoriasis and moderate to severe atopic dermatitis. We remain committed to delivering novel therapies which address pressing treatment gaps that continue to exist for patients," said David M. Reese , M.D., executive vice president of Research and Development at Amgen.
Key Abstracts and Presentation Times:
Abstracts can be found on the EADV website.
About SPROUT SPROUT (PPS0-003) a phase 3, multi-center, randomized, double-blind, placebo-controlled study to assess the efficacy and safety of Otezla® (apremilast) in pediatric patients from 6 through 17 years of age with moderate to severe plaque psoriasis (defined as BSA involvement of ≥ 10, PASI score of ≥ 12, sPGA score of ≥ 3). A total of 245 patients were randomized 2:1 to receive Otezla 20 mg (patients 20kg to 50 kg) twice daily or Otezla 30 mg (patients ≥ 50 kg) twice daily or placebo for the first 16 weeks. All patients then received Otezla during an open-label extension phase through week 52.
The primary endpoint was the percentage of patients with sPGA response [defined as a sPGA score of clear (0) or almost clear (1) with greater than or equal to 2-point reduction from baseline] at week 16.
About DISCREET DISCREET (PSOR-025) is a Phase 3, multicenter, randomized, placebo-controlled, double-blind study evaluating the efficacy and safety of Otezla® (apremilast), in patients with moderate to severe genital psoriasis (defined as modified sPGA-G score ≥ 3). Patients also had moderate to severe plaque psoriasis (sPGA score ≥ 3) with BSA involvement ≥ 1% in a non-genital area and had an inadequate response or intolerance to topical therapy for psoriasis affecting the genital area. The study randomized 289 patients 1:1 to receive Otezla 30 mg twice daily or placebo for the first 16 weeks. Following the 16-week placebo-controlled, double-blind phase of the trial, patients continued or switched to Otezla during the extension phase of the study and were treated through week 32.
The primary endpoint was the proportion of patients who achieve modified sPGA-G response at week 16 (defined as modified sPGA-G score of clear (0) or almost clear (1) with at least a 2-point reduction from baseline at Week 16).
About ADVANCE ADVANCE (NCT03721172) is a Phase 3, multicenter, randomized, placebo-controlled, double-blind study evaluating the efficacy and safety of Otezla® (apremilast), in patients with mild to moderate plaque psoriasis (defined as BSA involvement of 2% to 15%, Psoriasis Area and Severity Index (PASI) score of 2 to 15, sPGA score of 2 to 3). In this study, 595 patients were randomized 1:1 to receive Otezla (n=297) 30 mg twice daily or placebo (n=298) for the first 16 weeks. All patients then received Otezla during an open-label extension phase through week 32.
The primary endpoint was the percentage of patients with sPGA response [defined as a sPGA score of clear (0) or almost clear (1) with a >2 point reduction from baseline] at week 16.
About EMBRACE EMBRACE (NCT03774875) is a phase 4, multicenter, randomized, placebo-controlled, double-blind study evaluating the efficacy and safety of Otezla® (apremilast), over 52 Weeks in patients with plaque psoriasis not controlled by topicals. A total of 277 patients, who had psoriasis in one or more 1 special areas, a Psoriasis Area and Severity Index (PASI) score between 3 and 10 and Dermatology Life Quality Index (DLQI) score above 10, were randomized (2:1) to receive Otezla or placebo from Weeks 0 to 16, after which all patients continued with Otezla or were switched from placebo to Otezla until Week 52.
The primary endpoint was DLQI response (4-point reduction or more) at Week 16. Secondary endpoints included DLQI score, Itch Numeric Rating Scale, skin discomfort/pain visual analog scale, affected body surface area, and Patient Benefit Index response (score 1 or more). Safety analyses included all patients treated with Otezla at any time.
About the UPLIFT Survey In 2020, Amgen conducted the global Understanding Psoriatic Disease Leveraging Insights for Treatment (UPLIFT) survey exploring the evolution of attitudes and behaviors of 3,806 people living with psoriasis and psoriatic arthritis, 473 dermatologists and 450 rheumatologists in eight countries in North America , Europe and Asia . The survey was conducted in 2020 and was overseen by an academic steering committee of thought leaders in dermatology and rheumatology. The survey builds upon findings from the 2012 Multinational Assessment of Psoriasis and Psoriatic Arthritis (MAPP) survey, a first-of-its-kind study conducted by Celgene that looked in-depth at the effect of psoriasis and psoriatic arthritis on people living with these conditions.
About APPRECIATE APPRECIATE (NCT02740218) is a multinational, observational, retrospective, cross-sectional study in patients treated for psoriasis with Otezla, conducted across seven countries (Austria , Germany , Ireland , Spain , Sweden , Switzerland , and UK) from May 2016 to October 2019 . The aim of this post-hoc analysis was to explore the agreement of patients and physicians on specific body locations affected by psoriasis (genital, non-genital inverse, palmoplantar, scalp) by comparing data collected by from both adult patients and their dermatologists.
About REALIZE REALIZE (NCT03757013) is a longitudinal multicenter observational study assessing adult patients from French clinical practice with moderate to severe chronic plaque psoriasis, that had been prescribed Otezla according to the French label up to four weeks previously. Data were collected at 0, 6 and 12 months of follow-up, including patient and disease characteristics, patient benefit index questionnaire (PBI; range 0 [no patient-relevant benefit] to 4 [maximum patient-relevant benefit]), nine-item Treatment Satisfaction Questionnaire for Medication (TSQM-9; range 0-100), Dermatology Life quality Index (DLQI; range 0 to 30) and adverse events (AEs).
About Psoriasis Psoriasis is a serious, chronic inflammatory disease that causes raised, red, scaly patches to appear on the skin, typically affecting the outside of the elbows, knees or scalp, though it can appear on any location.1 Approximately 125 million people worldwide have psoriasis, including around 14 million people in Europe and more than 8 million people in the United States .2,3 About 80% of those patients have plaque psoriasis.4
About Otezla® (apremilast) Otezla® (apremilast) is an oral small-molecule inhibitor of phosphodiesterase 4 (PDE4) specific for cyclic adenosine monophosphate (cAMP). PDE4 inhibition results in increased intracellular cAMP levels, which is thought to indirectly modulate the production of inflammatory mediators. The specific mechanism(s) by which Otezla exerts its therapeutic action in patients is not well defined.
Since its initial FDA approval in 2014, Otezla has been prescribed to more than 700,000 patients worldwide.5
Otezla® (apremilast) U.S. INDICATIONS Otezla® (apremilast) is indicated for the treatment of adult patients with plaque psoriasis who are candidates for phototherapy or systemic therapy.
Otezla is indicated for the treatment of adult patients with active psoriatic arthritis.
Otezla is indicated for the treatment of adult patients with oral ulcers associated with Behçet's Disease.
Otezla® (apremilast) U.S. IMPORTANT SAFETY INFORMATION
Please click here for the full Prescribing Information for Otezla.
About Atopic Dermatitis Atopic dermatitis is a chronic inflammatory disease that causes excessively dry, itchy skin that can be painful. Repeated scratching can cause the skin to thicken, harden or become vulnerable to infection. Atopic dermatitis is the most common form of eczema – affecting 1-3% of adults worldwide – and the prevalence is increasing. The disease typically manifests in childhood followed by other allergy symptoms.
About Rocatinlimab (AMG 451/KHK4083) Rocatinlimab (AMG 451/KHK4083) is an investigational, potential first-in-class anti-OX40 monoclonal antibody that inhibits and reduces the number of OX40+ pathogenic T cells responsible for orchestrating the atopic dermatitis inflammatory response.
Amgen and Kyowa Kirin Collaboration On June 1, 2021 , Amgen and Kyowa Kirin entered into an agreement to jointly develop and commercialize AMG 451/KHK4083. Under the terms of the agreement, Amgen will lead the development, manufacturing, and commercialization for AMG 451/KHK4083 for all markets globally, except Japan , where Kyowa Kirin will retain all rights. If approved, the companies will co-promote the asset in the United States and Kyowa Kirin has opt-in rights to co-promote in certain other markets including Europe and Asia . The initial AMG 451/KHK4083 antibody was discovered in collaboration between Kyowa Kirin US Research and La Jolla Institute for Immunology.
About TEZSPIRE® (tezepelumab-ekko) TEZSPIRE is a first-in-class human monoclonal antibody that works on the primary source of inflammation: the airway epithelium, which is the first point of contact for viruses, allergens, pollutants and other environmental insults. Specifically, TEZSPIRE targets and blocks TSLP, a key epithelial cytokine that sits at the top of multiple inflammatory cascades and initiates an overreactive immune response to allergic, eosinophilic and other types of airway inflammation associated with severe asthma.6,7 TSLP is released in response to multiple triggers associated with asthma exacerbations, including allergens, viruses and other airborne particles.6,7
Expression of TSLP is increased in the airways of patients with asthma and has been correlated with disease severity.6,8 Blocking TSLP may prevent the release of pro-inflammatory cytokines by immune cells, resulting in the prevention of asthma exacerbations and improved asthma control.6,8 By working at the top of the cascade, TEZSPIRE helps stop inflammation at the source and has the potential to treat a broad population of severe asthma patients.6,8
TEZSPIRE is also in development for other potential indications including chronic obstructive pulmonary disease, chronic rhinosinusitis with nasal polyps, chronic spontaneous urticaria and eosinophilic esophagitis (EoE). In October 2021 , tezepelumab was granted Orphan Drug Designation by the FDA for the treatment of EoE.
TEZSPIRE® (tezepelumab-ekko) U.S. Indication TEZSPIRE is indicated for the add-on maintenance treatment of adult and pediatric patients aged 12 years and older with severe asthma.
TEZSPIRE is not indicated for the relief of acute bronchospasm or status asthmaticus.
TEZSPIRE® (tezepelumab-ekko) Important Safety Information CONTRAINDICATIONS Known hypersensitivity to tezepelumab-ekko or excipients.
WARNINGS AND PRECAUTIONS Hypersensitivity Reactions Hypersensitivity reactions (e.g., rash and allergic conjunctivitis) can occur following administration of TEZSPIRE. These reactions can occur within hours of administration, but in some instances have a delayed onset (i.e., days). In the event of a hypersensitivity reaction, initiate appropriate treatment as clinically indicated and then consider the benefits and risks for the individual patient to determine whether to continue or discontinue treatment with TEZSPIRE.
Acute Asthma Symptoms or Deteriorating Disease TEZSPIRE should not be used to treat acute asthma symptoms, acute exacerbations, acute bronchospasm, or status asthmaticus.
Abrupt Reduction of Corticosteroid Dosage Do not discontinue systemic or inhaled corticosteroids abruptly upon initiation of therapy with TEZSPIRE. Reductions in corticosteroid dose, if appropriate, should be gradual and performed under the direct supervision of a physician. Reduction in corticosteroid dose may be associated with systemic withdrawal symptoms and/or unmask conditions previously suppressed by systemic corticosteroid therapy.
Parasitic (Helminth) Infection It is unknown if TEZSPIRE will influence a patient's response against helminth infections. Treat patients with pre-existing helminth infections before initiating therapy with TEZSPIRE. If patients become infected while receiving TEZSPIRE and do not respond to anti-helminth treatment, discontinue TEZSPIRE until infection resolves.
Live Attenuated Vaccines The concomitant use of TEZSPIRE and live attenuated vaccines has not been evaluated. The use of live attenuated vaccines should be avoided in patients receiving TEZSPIRE.
ADVERSE REACTIONS The most common adverse reactions (incidence ≥3%) are pharyngitis, arthralgia, and back pain.
USE IN SPECIFIC POPULATIONS There are no available data on TEZSPIRE use in pregnant women to evaluate for any drug-associated risk of major birth defects, miscarriage, or other adverse maternal or fetal outcomes. Placental transfer of monoclonal antibodies such as Tezepelumab-ekko is greater during the third trimester of pregnancy; therefore, potential effects on a fetus are likely to be greater during the third trimester of pregnancy.
Please see the TEZSPIRE full Prescribing Information.
You may report side effects related to AstraZeneca products by clicking here.
About ABP 654 ABP 654 is being developed as a biosimilar candidate to STELARA® (ustekinumab), an approved human interleukin-12 and interleukin-23 antagonist indicated for the treatment of moderate to severe plaque psoriasis in adults and pediatric patients (6 years or older) who are candidates for phototherapy or systemic therapy, active psoriatic arthritis in adults and pediatric patients (6 years or older), as well as for adult patients with moderately to severely active Crohn's disease and moderately to severely active ulcerative colitis. ABP 654 has the same pharmaceutical form, dosage strength, route of administration and dosing regimen as United States -licensed and European Union (EU)-approved ustekinumab.
About Amgen Amgen is committed to unlocking the potential of biology for patients suffering from serious illnesses by discovering, developing, manufacturing and delivering innovative human therapeutics. This approach begins by using tools like advanced human genetics to unravel the complexities of disease and understand the fundamentals of human biology.
Amgen focuses on areas of high unmet medical need and leverages its expertise to strive for solutions that improve health outcomes and dramatically improve people's lives. A biotechnology pioneer since 1980, Amgen has grown to be one of the world's leading independent biotechnology companies, has reached millions of patients around the world and is developing a pipeline of medicines with breakaway potential.
Amgen is one of the 30 companies that comprise the Dow Jones Industrial Average and is also part of the Nasdaq-100 index. In 2021, Amgen was named one of the 25 World's Best Workplaces™ by Fortune and Great Place to Work™ and one of the 100 most sustainable companies in the world by Barron's.
For more information, visit www.amgen.com and follow us on www.twitter.com/amgen.
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CONTACT: Amgen, Thousand Oaks Michael Strapazon , 805-313-5553 (Media) Jessica Akopyan , 805-447-0974 (Media) Arvind Sood , 805-447-1060 (Investors)
1 National Psoriasis Foundation. About Psoriasis. Available at: https://www.psoriasis.org/about-psoriasis. Accessed June 10, 2022 . 2 National Psoriasis Foundation. Statistics. Available at: https://www.psoriasis.org/content/statistics. Accessed June 10, 2022 . 3 Ortonne JP, Prinz JC. Alefacept: a novel and selective biologic agent for the treatment of chronic plaque psoriasis. Eur J Dermatol. 2004;14(1):41–45. 4 National Psoriasis Foundation. Plaque Psoriasis. Available at: https://www.psoriasis.org/about-psoriasis/types/plaque. Accessed June 10, 2022 . 5 Amgen Data on File. 6 Menzies-Gow A, et al. Tezepelumab in Adults and Adolescents with Severe, Uncontrolled Asthma. N Engl J Med. 2021;384:1800-1809. DOI: 10.1056/NEJMoa2034975. 7 Varricchi G, et al. Thymic Stromal Lymphopoietin Isoforms, Inflammatory Disorders, and Cancer. Front Immunol. 2018; 9: 1595. 8 Li Y, et al. Elevated Expression of IL-33 and TSLP in the Airways of Human Asthmatics In Vivo: A Potential Biomarker of Severe Refractory Disease. J Immunol. 2018; 200: 2253–2262.
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