OTEZLA® (Apremilast) Showed Meaningful Improvements in Clinical and Quality-of-Life Measures of Psoriasis Beyond Those Captured by Assessing Skin Alone
Celgene Corporation (NASDAQ:CELG) today announced the results of two post hoc sub-analyses of clinical trials for OTEZLA® (apremilast) at the 27th European Academy of Dermatology and Venereology (EADV) Congress in Paris, France. Findings suggest OTEZLA offered meaningful improvements in outcomes important to patients with moderate to severe plaque psoriasis, which may not be captured by common measures of treatment efficacy that focus only on skin clearance, such as Psoriasis Area Severity Index (PASI) 75.
Plaque psoriasis is a multi-faceted disease that can manifest in numerous ways. Each patient has a different experience, and many are concerned about effects that go beyond the skin. This need for patient-centric care has been recognized by the World Health Organization – a shift in the focus from treating the skin lesions of psoriasis to addressing the needs of the whole patient.
“Only considering skin clearance may not fully capture the effect a treatment may have on an individual’s disease burden and its impact on daily life,” said Dr. Denis Jullien, Department of Dermatology and Venereology, Edouard Herriot Hospital, Lyon, France and an author of the study. “For example, itching, which is not accounted for by PASI, is cited by over a third of patients as their overriding quality-of-life issue. These new analyses of OTEZLA studies can help inform both prescribers and patients when evaluating treatment decisions.”
The findings include a new post hoc sub-analysis of the phase 3 ESTEEM 1 trial assessing clinical and quality-of-life outcomes for patients with moderate to severe plaque psoriasis who did not achieve PASI 75 (a 75 percent reduction in PASI) at either weeks 32 or 52, but continued OTEZLA treatment in this time period (n=203/844).
For patients who did not achieve a PASI 75 at weeks 32 or 52, more than half achieved a 50 percent reduction in PASI score (PASI 50) at weeks 32 and 52 following treatment with OTEZLA. This improvement, when taken together in disease-specific quality-of-life measures, may more reliably indicate clinically meaningful benefit. For example, itching, as measured by Visual Analogue Scale (VAS), was reduced from baseline by approximately 30 percent during weeks 4 to 52 in those patients (n=134) who were treated with OTEZLA from baseline and weeks 20 to 52 in patients (n=69) who were switched from placebo to OTEZLA at week 16. Quality of life, as measured by the Dermatology Life Quality Index (DLQI), was improved by at least 5 points in the two groups during the same time period.
Manifestations that are highly visible, such as scalp and nail psoriasis, can have a substantial effect on quality of life. A separate post hoc sub-analysis of the ESTEEM 1, 2 and UNVEIL studies examined changes in scalp and nail psoriasis, along with quality of life, following treatment with OTEZLA. The sub-analysis included patients who had nail psoriasis (n=768 in ESTEEM 1 and 2 and 73 in UNVEIL) or moderate to very severe scalp psoriasis (n=1,049 in ESTEEM 1 and 2 and 129 in UNVEIL) at baseline.
At week 32 in ESTEEM and UNVEIL, clearance of nail psoriasis [Nail Psoriasis Severity Index (NAPSI)=0] among patients receiving OTEZLA from baseline was achieved by 31.3 percent (n=146/466) and 36.2 percent (n=17/47) of patients, respectively. Among patients who were switched from placebo to OTEZLA at week 16, NAPSI clearance at week 32 was achieved by 15.5 percent (n=37/239) and 26.1 percent (n=6/23) of patients, respectively.
Among patients with moderate to severe scalp psoriasis at baseline, clear or minimal involvement of scalp psoriasis [Scalp Physician’s Global Assessment (ScPGA) response of 0 or 1] was achieved by greater proportions of patients receiving OTEZLA versus placebo at week 16 in both trials: 45.2 percent (n=351/694) versus 22.5 percent (n=80/355), respectively, in ESTEEM and 44.1 percent (n=30/68) versus 33.3 percent (n=23.3) in UNVEIL.
Of patients who had nail psoriasis or moderate to very severe scalp psoriasis at baseline, a DLQI of 0 or 1 was achieved by greater proportions of patients receiving OTEZLA versus placebo at week 16 [28.7 percent (n=206/719) versus 8.1 percent (n=29/358), respectively, in ESTEEM and 23.7 percent (n=23/97) versus 10.6 percent (n=5/47) in UNVEIL].
“The ESTEEM and UNVEIL clinical trials continue to provide important learnings about OTEZLA for the treatment of psoriasis as well as quality of life for people who live with this chronic condition,” said Volker Koscielny, Vice President Global Medical Affairs, Inflammation & Immunology at Celgene. “These sub-analyses of UNVEIL and ESTEEM suggest that appropriate patients with moderate to severe plaque psoriasis who experience manifestations beyond skin may benefit from treatment with OTEZLA.”
Psoriasis affects 125 million people worldwide, including around 14 million people in Europe and 7.5 million people in the United States. It is a chronic and systemic inflammatory disorder, and is immune-mediated, meaning it is caused by an immune reaction in the body.
Psoriasis lesions can often be found on areas close to the joints such as the elbows and knees but can also appear on the scalp. Nail psoriasis affects up to 50 percent of people with psoriasis. Up to 84 percent of people with psoriasis experience itching, and over a third of patients actually cite itch as the most important factor contributing to their disease.
Around 75 percent of people living with psoriasis believe it has a negative impact on their quality of life and 83 percent of patients with psoriasis actively conceal the visible signs of their disease.
ESTEEM 1 and 2 are two large pivotal phase 3 randomized, placebo-controlled studies evaluating OTEZLA in patients with a diagnosis of moderate to severe plaque psoriasis for at least 12 months prior to screening, and who were also candidates for phototherapy and/or systemic therapy. Approximately 1,250 patients were randomized 2:1 to receive either OTEZLA 30 mg twice daily or placebo after an initial five-day titration period, for the first 16 weeks, followed by a maintenance phase from weeks 16-32 in which placebo patients were switched to OTEZLA 30 mg twice daily through week 32, and a randomized withdrawal phase for responders from week 32 to week 52 based on their initial OTEZLA randomization and Psoriasis Area and Severity Index (PASI) 75 response (ESTEEM 1) or (PASI) 50 (ESTEEM 2). A 5-year extension study of ESTEEM 1 and 2 is ongoing.
UNVEIL is the first prospective, randomized, controlled study to evaluate the clinical efficacy and safety of OTEZLA in patients with moderate plaque psoriasis (defined as a BSA involvement of 5-10 percent and sPGA of 3 based on a 0 to 5 scale) who were naïve to systemic and biologic therapies. Patients (n=221) were randomized 2:1 to receive either OTEZLA 30 mg twice daily or placebo for 16 weeks, followed by an open-label extension phase in which placebo patients were switched to OTEZLA through week 52. All doses were titrated over the first week of treatment. At baseline, more than 80 percent of patients had previously received topical therapy. The primary endpoint was the mean percentage change from baseline in the product of Physician's Global Assessment (PGA) and BSA (percent) at week 16.
About OTEZLA ® (apremilast)
OTEZLA® (apremilast) 30 mg tablets 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.
U.S. PRESCRIBING INFORMATION
OTEZLA® (apremilast) is indicated for the treatment of patients with moderate to severe plaque psoriasis who are candidates for phototherapy or systemic therapy.
IMPORTANT SAFETY INFORMATION
OTEZLA® (apremilast) is contraindicated in patients with a known hypersensitivity to apremilast or to any of the excipients in the formulation
Warnings and Precautions
Diarrhea, Nausea and Vomiting: Cases of severe diarrhea, nausea, and vomiting were associated with the use of OTEZLA. Most events occurred within the first few weeks of treatment. In some cases, patients were hospitalized. Patients 65 years of age or older and patients taking medications that can lead to volume depletion or hypotension may be at a higher risk of complications from severe diarrhea, nausea, or vomiting. Monitor patients who are more susceptible to complications of diarrhea or vomiting; advise patients to contact their healthcare provider. Consider OTEZLA dose reduction or suspension if patients develop severe diarrhea, nausea, or vomiting
Depression: Carefully weigh the risks and benefits of treatment with OTEZLA for patients with a history of depression and/or suicidal thoughts/behavior, or in patients who develop such symptoms while on OTEZLA. Patients, caregivers, and families should be advised of the need to be alert for the emergence or worsening of depression, suicidal thoughts or other mood changes, and they should contact their healthcare provider if such changes occur
Psoriasis: Treatment with OTEZLA is associated with an increase in depression. During clinical trials, 1.3% (12/920) of patients reported depression compared to 0.4% (2/506) on placebo; Depression was reported as serious in 0.1% (1/1308) of patients exposed to OTEZLA, compared to none in placebo-treated patients (0/506). Suicidal behavior was observed in 0.1% (1/1308) of patients on OTEZLA, compared to 0.2% (1/506) on placebo. One patient treated with OTEZLA attempted suicide; one patient on placebo committed suicide
Weight Decrease: Monitor body weight regularly; evaluate unexplained or clinically significant weight loss, and consider discontinuation of OTEZLA
Psoriasis: Body weight loss of 5-10% occurred in 12% (96/784) of patients treated with OTEZLA and in 5% (19/382) of patients treated with placebo. Body weight loss of ≥10% occurred in 2% (16/784) of patients treated with OTEZLA compared to 1% (3/382) of patients treated with placebo
Drug Interactions: Apremilast exposure was decreased when OTEZLA was co-administered with rifampin, a strong CYP450 enzyme inducer; loss of OTEZLA efficacy may occur. Concomitant use of OTEZLA with CYP450 enzyme inducers (e.g., rifampin, phenobarbital, carbamazepine, phenytoin) is not recommended
Psoriasis: Adverse reactions reported in ≥5% of patients were (OTEZLA%, placebo%): diarrhea (17, 6), nausea (17, 7), upper respiratory tract infection (9, 6), tension headache (8, 4), and headache (6, 4)
Use in Specific Populations
Pregnancy and Nursing Mothers: OTEZLA is Pregnancy Category C; it has not been studied in pregnant women. Use during pregnancy only if the potential benefit justifies the potential risk to the fetus. It is not known whether apremilast or its metabolites are present in human milk. Caution should be exercised when OTEZLA is administered to a nursing woman
Renal Impairment: OTEZLA dosage should be reduced in patients with severe renal impairment (creatinine clearance less than 30 mL/min); for details, see Dosage and Administration, Section 2, in the Full Prescribing Information
Please click here for Full Prescribing Information.
Celgene Corporation, headquartered in Summit, New Jersey, is an integrated global pharmaceutical company engaged primarily in the discovery, development and commercialization of innovative therapies for the treatment of cancer and inflammatory diseases through next‐generation solutions in protein homeostasis, immuno‐oncology, epigenetics, immunology and neuro‐inflammation. For more information, please visit www.celgene.com. Follow Celgene on Social Media: @Celgene, Pinterest, LinkedIn, Facebook and YouTube.
This press release contains forward-looking statements, which are generally statements that are not historical facts. Forward-looking statements can be identified by the words “expects,” “anticipates,” “believes,” “intends,” “estimates,” “plans,” “will,” “outlook” and similar expressions. Forward-looking statements are based on management’s current plans, estimates, assumptions and projections, and speak only as of the date they are made. We undertake no obligation to update any forward-looking statement in light of new information or future events, except as otherwise required by law. Forward-looking statements involve inherent risks and uncertainties, most of which are difficult to predict and are generally beyond our control. Actual results or outcomes may differ materially from those implied by the forward-looking statements as a result of the impact of a number of factors, many of which are discussed in more detail in our Annual Report on Form 10-K and our other reports filed with the U.S. Securities and Exchange Commission.
Hyperlinks are provided as a convenience and for informational purposes only. Celgene bears no responsibility for the security or content of external websites.
Patrick E. Flanigan III, 908-673-9969
Corporate Vice President, Investor Relations
Catherine Cantone, 908-897-4256
Senior Director, Corporate Communications
About Business Wire
For more than 50 years, Business Wire has been the global leader in press release distribution and regulatory disclosure.
Subscribe to releases from Business Wire
Subscribe to all the latest releases from Business Wire by registering your e-mail address below. You can unsubscribe at any time.
Latest releases from Business Wire
HCL and Google Cloud Expand Partnership to Digitally Transform Commerce4.6.2020 17:00:00 EEST | Press release
HCL Technologies (HCL), a leading global technology company, and Google Cloud today announced the expansion of their strategic partnership to bring HCL's software offerings, starting with HCL Commerce, to Google Cloud. Google Cloud will be the preferred cloud platform for HCL Commerce, providing global, secure and elastic infrastructure to power businesses’ eCommerce strategies. Under this partnership, HCL also intends to leverage Anthos to enable multi-cloud and hybrid-cloud deployments of HCL Commerce. HCL Commerce is a leading, cloud-native Commerce platform used by innovative businesses across multiple industries and around the world to drive more than $100 billion in annual client revenues. With a strong track-record of delivering rock-solid performance, scalability and functionality, HCL Commerce today is at the forefront of many organizations’ digital commerce strategies. It stretches far beyond an initial transaction and enables businesses to respond to evolving market conditio
European Commission Grants Marketing Authorisation for DARZALEX®▼(daratumumab) Subcutaneous Formulation for all Currently Approved Daratumumab Intravenous Formulation Indications4.6.2020 17:00:00 EEST | Press release
The Janssen Pharmaceutical Companies of Johnson & Johnson announced today that the European Commission (EC) has granted marketing authorisation for DARZALEX®▼ (daratumumab) subcutaneous (SC) formulation for the treatment of adult patients with multiple myeloma (MM). Daratumumab SC is administered as a fixed dose, which significantly reduces treatment time, from hours to approximately three to five minutes, when compared to daratumumab intravenous (IV) formulation.1 In addition, only the first dose of daratumumab SC needs to be administered in an environment where resuscitation facilities are available. The approval applies to all current daratumumab indications in frontline and relapsed/refractory settings, and patients currently on daratumumab IV can switch to the SC formulation should they choose to. Data supporting the approval show that daratumumab SC demonstrated a consistent overall response rate (ORR) and a similar safety profile compared with daratumumab IV in patients with rel
AT&T® México Selects MATRIXX Software for Prepaid Platform Replacement4.6.2020 16:00:00 EEST | Press release
MATRIXX Software today announced that AT&T® México, a subsidiary of AT&T® USA and one of the largest mobile players in the Mexican market, is deploying MATRIXX Software’s cloud native digital commerce platform for its prepaid customers. MATRIXX Digital Commerce is replacing multiple legacy Intelligent Network (IN) and Business Support Systems (BSS) to provide a future-proof, web-scale BSS that will allow for greater innovation and business agility. MATRIXX will support both the AT&T brand and UNEFON brand on a single platform. The industry’s leading solution for real-time cloud native rating and convergent charging for 5G(CCS) and 4G(OCS), MATRIXX Digital Commerce was selected after a rigorous evaluation process that included multiple vendors. “We are proud to be working with AT&T México as they continue to be an innovator in their market,” said Glo Gordon, CEO, MATRIXX Software. “The proliferation of connected devices, increasing data consumption and 5G network rollouts are driving CS
Moody’s Analytics Forecast: Resurgence of COVID-19 Could Cause Global Economic Depression4.6.2020 15:00:00 EEST | Press release
According to the Moody’s Analytics baseline economic forecast, real global GDP will fall by 4.5% this year as a result of COVID-19. Our base case for the US suggests that it will take until mid-decade for the economy to return to full-employment. Mark Zandi, Chief Economist at Moody’s Analytics, describes the outlook in a new paper, Handicapping the Paths for the Pandemic Economy . “COVID-19 has caused massive damage to the global economy. Quickly reopening economies will boost growth by unleashing pent-up demand, but will also raise the specter of a re-intensification of COVID-19 and another economic downdraft, which could lead to a worldwide depression. We construct our economic forecasts to help market participants navigate this daunting uncertainty and make better decisions,” said Mr. Zandi. The Moody’s Analytics baseline economic forecast represents our view of the most likely trajectory for the global economy. The baseline forecast is part of a set of 12 forecast scenarios, updat
Vertex Enhances Integrated Tax Solution for SAP® Ariba®4.6.2020 14:13:00 EEST | Press release
Vertex, Inc., a leading provider of tax technology and services, announced enhancements to its solutions integration with SAP® Ariba® Buying and Invoicing, providing customers with timely, advanced tax insights within their procurement and supply chain processes. Vertex launched an SAP Ariba Tax API and the Vertex Indirect Tax for Procurement with SAP Ariba app extension in 2018, enabling companies to obtain tax calculations from within SAP Ariba Buying and Invoicing, while also supporting the requisition and invoice reconciliation phases of the tax process. This integration with SAP Ariba solutions helps calculate tax at the purchase requisition, invoice reconciliation and final tax determination phases, carrying tax from the purchase requisition to the purchase order. The integrated solution is now enhanced to distinguish between vendor charged, buyer payable, self-assessed and value-added reverse charge taxes, as well as multiple levels of jurisdictions. SAP Ariba solutions provide
Moody’s Analytics Tops 14 International Categories in FocusEconomics Analyst Forecast Awards4.6.2020 14:00:00 EEST | Press release
Moody’s Analytics, a global provider of financial intelligence, ranks #1 in 14 international categories in the 2020 FocusEconomics Analyst Forecast Awards. These awards include #1 Best Overall Forecaster – Hong Kong, plus the top ranking in five other forecast categories across 12 countries. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20200604005200/en/ #1 Best Overall Forecaster – Hong Kong #1 Interest Rate Forecaster – Austria #1 Interest Rate Forecaster – Italy #1 Interest Rate Forecaster – Portugal #1 Interest Rate Forecaster – Bahrain #1 Inflation Forecaster – Belgium #1 Inflation Forecaster – Malaysia #1 Current Account Forecaster – Brazil #1 Current Account Forecaster – Uruguay #1 Fiscal Balance Forecaster – Croatia #1 Fiscal Balance Forecaster – Peru #1 GDP Forecaster – Malaysia #1 GDP Forecaster – Slovenia #1 GDP Forecaster – Tunisia We also took second or third place in an additional 29 categories including: #2 Be
In our pressroom you can read all our latest releases, find our press contacts, images, documents and other relevant information about us.Visit our pressroom