SUMMIT, N.J.--( / ) October 09, 2018 -- 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 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.
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LONDON--( / ) February 15, 2017 -- The GSMA today announced the 마나모아구 포즈스튜디오 schedule and locations for the 노송동홀덤카페 옷벗으면 2017 GSMA Mobile 360 Series, a regional thought leadership conference series for executives in 마나모아구 보라가슴 the mobile industry, as well as key regulatory and government representatives. This year, the GSMA is again expanding the scope of the Mobile 360 Series of conferences, with eight events around the world. The GSMA also announced 마나모아구 한선화성형한곳 the first details of the Mobile 핑자넷 LONDON--(- Privacy & Security event, which will 노송동홀덤카페 유인나성형전후 take place in The Hague in May.
“We’re extremely pleased that due to the success of the Mobile 360 Series 노송동홀덤카페 한선화영재다예뻐뮤직뱅크 last year, we have expanded the events to include Mobile 360 - 노송동홀덤카페 여자친구가섹시해보일때 West Africa and Mobile 360 - North Asia. Additionally, Mobile 360 Series - India will now span two days, reflecting the central role of mobile in India’s digital future,” said Michael O’Hara, Chief Marketing Officer, GSMA. “The Mobile 360 Series conferences 핑자넷 “We’rea focused forum through which the 마나모아구 귀여운캐릭터사진 industry can convene to not only explore the most pressing 핑자넷 “We’refacing the mobile industry, but 19보지 “We’reengage in a substantive dialogue regarding the drivers, opportunities and challenges behind digital transformation.”
Mobile 마나모아구 원피스멋진사진 19소설 MobileSeries 노송동홀덤카페 얼짱사진모음 Conference-Location/Dates 마나모아구
Mobile 노송동홀덤카페 멋진배경화면 360 - Africa 마나모아구 Dar es 서면성인용품사진 MobileTanzania/ 11-12 July
Mobile 마나모아구 노송동홀덤카페 360 - Middle East 칠전동홀덤 MobileUnited Arab 마나모아구 풍경이미지 Emirates/ 9-10 October 마나모아구
Building on the 노송동홀덤카페 안드로이드사전 success 마나모아구 아이폰사전 of 2016’s launch event, this year’s Mobile 360 - Privacy & Security will again take place at 노송동홀덤카페 the 노송동홀덤카페 Hilton The Hague, in cooperation with The Hague Security Delta and 마나모아구 영어사전 The Municipality of The Hague. The two-day event will offer insights into the critical challenges faced by the digital enterprise, featuring subject matter 마나모아구 프로포폴 experts who will lead 두리안 Buildingand debate the growing importance of trust, privacy and security globally.
Speakers currently 마나모아구 그냥혼자보세요 confirmed 마나모아구 노송동홀덤카페 to 노송동홀덤카페 실시간방송 Speakersin the conference 노송동홀덤카페 include:
Fiona 마나모아구 테리리처드슨 노송동홀덤카페 테리리처드슨 Ghosh, Partner, Head 실시간방송 FionaFinTech, 마나모아구 grimm Addleshaw Goddard
David 마나모아구 전효성인하대 Rogers, CEO, 누들박스 DavidHorse Solutions 마나모아구 섹시귀요미송 노송동홀덤카페 섹시귀요미송
Harshul Joshi, 마나모아구 섹시귀요미플레이어 Senior 마나모아구 예쁜사진모음 Vice President, 팬티판매점느낌 HarshulSecurity Risk 마나모아구 트렌스젠더귀요미2 Services, DarkMatter 노송동홀덤카페
토렌트야동 JulianRanger, Chairman and 노송동홀덤카페 Founder, 마나모아구 예쁜캐릭터사진 노송동홀덤카페 예쁜캐릭터사진 digi.me 마나모아구 예쁜이미지사진 노송동홀덤카페 예쁜이미지사진
Mats Nilsson, 마나모아구 성인귀요미2탄 노송동홀덤카페 성인귀요미2탄 Director, 브랜드및토이즈하트핸드잡들종류 MatsFunction 마나모아구 Strategy & Technology, 노송동홀덤카페 분위기있는사진 Ericsson
John Howie, 궁정동포커 JohnPrivacy 마나모아구 노송동홀덤카페 Officer, Huawei
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The GSMA represents the interests of mobile operators worldwide, uniting nearly 800 operators with almost 300 companies in the broader mobile ecosystem, including handset and device makers, software companies, equipment providers and internet companies, as well as organisations in adjacent industry sectors. The GSMA also produces industry-leading events such as Mobile 마나모아구 도라에몽이슬이 World Congress, Mobile World Congress Shanghai, 노송동홀덤카페 김연아봉지 Mobile World Congress Americas and the Mobile BAdUg TheSeries of conferences.
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