Celgene Announces Phase 3 STYLE Study of OTEZLA® (apremilast) in Moderate to Severe Scalp Psoriasis Met Primary Endpoint
Celgene Corporation (NASDAQ:CELG) today announced results from the phase 3 STYLE study, which showed that OTEZLA® (apremilast) 30 mg twice daily achieved a highly statistically significant improvement in the primary endpoint of the Scalp Physician’s Global Assessment (ScPGA) response [defined as ScPGA score of clear (0) or almost clear (1) with at least a 2-point reduction from baseline] at week 16 compared with placebo.
In addition to achieving the primary endpoint, statistical significance was also met for the secondary endpoint of the whole body itch numeric rating scale (NRS) [defined as at least a 4-point reduction from baseline] at week 16 with OTEZLA versus placebo.
The safety profile was generally consistent with the known safety profile of OTEZLA, and no new safety signals were identified in the trial. Treatment-emergent adverse events that occurred in at least 5 percent of patients in either treatment group were diarrhea (30.5 percent for OTEZLA and 10.8 percent for placebo), nausea (21.5 percent and 5.9 percent, respectively), headache (11.5 percent and 4.9 percent) and vomiting (5.5 percent and 2.0 percent).
“The scalp is the most commonly affected area in moderate to severe plaque psoriasis, impacting up to 80 percent of patients,” said Terrie Curran, President, Celgene Inflammation and Immunology. “The area is difficult to treat with topical therapies, and clinical data from systemic therapies are limited. We are encouraged by the significant improvements in this trial and look forward to sharing these data to further enhance the OTEZLA label.”
STYLE is a phase 3, multicenter, randomized, placebo-controlled, double-blind study evaluating the efficacy and safety of OTEZLA in subjects with moderate to severe plaque psoriasis of the scalp. The study enrolled 303 people who were randomized 2:1 to receive OTEZLA 30 mg twice daily or placebo for the first 16 weeks.
About Plaque Psoriasis
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 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.
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.
Nina Goworek, 908-673-9711
Executive Director, Investor Relations
Catherine Cantone, 908-897-4256
Senior Director, Corporate Communications
For more than 50 years, Business Wire has been the global leader in press release distribution and regulatory disclosure.
Tilaa tiedotteet sähköpostiisi
Haluatko tietää asioista ensimmäisten joukossa? Kun tilaat mediatiedotteemme, saat ne sähköpostiisi välittömästi julkaisuhetkellä. Tilauksen voit halutessasi perua milloin tahansa.
Lue lisää julkaisijalta Business Wire
AURAK Gains SACSCOC Accreditation15.12.2018 13:49 | Tiedote
The Southern Association of Colleges and Schools Commission on Colleges (SACSCOC) officially announced the accreditation of the American University of Ras Al Khaimah (AURAK) at its 2018 Annual Meeting which was held in New Orleans, Louisiana, in the United States of America. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20181215005017/en/ AURAK delegation during the SACSCOC conference in New Orleans” (Photo: AETOSWire) SACSCOC, the regional body for the accreditation of degree-granting higher education institutions in the Southern United States, has a membership of more than 800 institutions in the Southern states and other international sites approved by SACSCOC that award associate, baccalaureate, master’s, and/or doctoral degrees. SACSCOC also awards accreditation to other international institutions of higher education that satisfy all its requirements and demonstrate compliance with its accreditation standards. AURAK now
Lehman Brothers Treasury Announces Plans for Partial Wind-Down14.12.2018 20:41 | Tiedote
Lehman Brothers Treasury Co. B.V. in liquidation (“LBT”) today, through its U.S. counsel Kramer Levin Naftalis & Frankel LLP, announced that LBT is planning a final cash distribution to its creditors. Professional holders of eligible notes will have the option to retain their investment by electing to receive substitute notes of one (or a few) series. Such election shall take place through a solicitation process. As a consequence, LBT will be able to reduce the number of series of notes outstanding from more than 3,700 to one or a few. Noteholders electing to receive substitute notes will be afforded the same economic entitlement to distributions received by LBT from Lehman Brothers Holdings Inc. (“LBHI”) through the substitute notes. The substitute notes will be denominated in U.S. dollars and future distributions will be made in U.S. dollars only. Noteholders who are not professional investors, or hold notes that are not eligible for substitution, or do not elect to receive substitut
Takeda Receives Positive CHMP Opinion for ADCETRIS® (brentuximab vedotin) for the Treatment of Adult Patients with Previously Untreated CD30+ Stage IV Hodgkin Lymphoma in Combination with AVD14.12.2018 20:00 | Tiedote
Takeda Pharmaceutical Company Limited (TSE: 4502) today announced that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion for the extension of the marketing authorization of ADCETRIS (brentuximab vedotin) and recommended its approval in combination with AVD in adult patients with previously untreated CD30+ Stage IV Hodgkin lymphoma. ADCETRIS is an antibody-drug conjugate (ADC) directed at CD30, a defining marker of Hodgkin lymphoma. ADCETRIS is currently not approved as a therapy for previously untreated Hodgkin lymphoma in Europe. “For a large number of previously untreated Hodgkin lymphoma patients diagnosed with Stage IV disease, progression will occur with current treatments, highlighting a true unmet need in this population,” said Anna Sureda, M.D., Ph.D., Head of the Hematology Department and Hematopoietic Stem Cell Transplant Programme, Institut Català d'Oncologia - Hospital Duran i Reynals. “In the ECHELON-1 cl
Diamond CBD, POTN Subsidiary, Enters the $46 Billion Coffee Market With the Release of Premium Line of CBD-Infused Coffee & Tea K-Kup Capsules14.12.2018 18:42 | Tiedote
Diamond CBD Inc., wholly owned subsidiary of PotNetwork Holdings, Inc. (OTC Pink: POTN), a leader in hemp extraction and innovative CBD products for the wellness market, enters the Coffee segment, an industry expected to reach revenues of $46 Billion in 2018. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20181214005308/en/ Experience a cup of Chill (Photo: Business Wire) Produced in accordance with a universal K-Cup design, these pods fit in almost all modern single cup coffee makers, making it an easily integrated enhancement to any environment, delivering 25mgs of CBD in a tasty favorite beverage at less than $5 per cup. This new line of premium Chill Coffee Capsules was recently added to the Company’s broad range of cannabinoid and natural hemp products. Each box comes with 4 individual capsules in original chill coffee, decaf chill coffee, chill black tea, and chill green tea flavors. The unit price for each box is $10.00
Henley & Partners Enlarges Executive Committee to Manage Expansion and Growth14.12.2018 17:00 | Tiedote
Residence- and citizenship-by-investment programs have firmly established themselves over the past few years as the new frontier in terms of freedom, flexibility, and future-readiness, both for the countries issuing these programs and for the individual investors participating in them. The societal and economic value these programs generate is undisputed. The investment migration industry as a whole is currently grossing roughly USD 18 billion per year, with an expectation that it will hit the USD 20 billion mark very soon. Foreign direct investment (FDI) is now considered the lifeblood of economic growth for many developing and recovering smaller countries around the world. As such, the number of investment migration programs has been increasing rapidly, from just a handful of programs in the 1980s and 1990s to over 100 countries that now have investment migration provisions in their laws. There are more than 60 active programs today, with Moldova and Montenegro — both fast-growing Eu
Vargatef® plus docetaxel could be an option after failure of immunotherapy in lung cancer14.12.2018 12:07 | Tiedote
Boehringer Ingelheim announced today the first interim results of VARGADO, an ongoing non-interventional study in routine clinical practice in Germany evaluating the efficacy and safety of Vargatef® (nintedanib) and docetaxel in patients with stage III/IV locally advanced or metastatic non-small cell lung cancer (NSCLC) of adenocarcinoma histology. The study consists of three cohorts, two of which allow for prior treatment with immune checkpoint inhibitors (ICIs) either in combination with chemotherapy in the first-line or as monotherapy in the second-line of treatment. The interim results from Cohort B (first-line chemotherapy, second-line immune checkpoint inhibitors, third-line Vargatef® plus docetaxel) were presented today at ESMO Immuno-Oncology Congress 2018 in Geneva.1 Despite a limited sample size, the VARGADO study adds to the body of evidence for nintedanib in lung adenocarcinoma following pre-treatment with chemotherapy and ICIs.1,3 The addition of nintedanib to docetaxel ha
Uutishuoneessa voit lukea tiedotteitamme ja muuta julkaisemaamme materiaalia. Löydät sieltä niin yhteyshenkilöidemme tiedot kuin vapaasti julkaistavissa olevia kuvia ja videoita. Uutishuoneessa voit nähdä myös sosiaalisen median sisältöjä. Kaikki STT Infossa julkaistu materiaali on vapaasti median käytettävissä.Tutustu uutishuoneeseemme