Apremilast treatment resulted in improved health-related quality of life during 16 weeks of therapy in ESTEEM 2
Apremilast significantly increased work productivity and improved work limitations compared with placebo at week 16 in pooled analyses of ESTEEM 1 and 2
A new analysis of the ESTEEM 2 trial demonstrated that treatment with
apremilast 30 mg twice daily after 16 weeks significantly improved
health-related quality of life compared with placebo. Significant
improvement was seen in a variety of these standardized measures,
including the Dermatology Quality of Life Index (DLQI), the Patient
Health Questionnaire, the European Quality of Life 5 Dimensions
Questionnaire and the
At Week 16, more than 70 percent of patients who received apremilast 30
mg twice daily achieved clinically meaningful improvement in DLQI of at
least 5-points. Approximately half of patients treated with apremilast
30 mg twice daily also achieved at least a 50 percent improvement from
baseline in the
"Psoriasis can affect many aspects of patients' lives, including
emotional health, day-to-day activities and functional and social
The results of a work productivity analysis of pooled data from 1250 patients from the ESTEEM 1 and 2 trials demonstrated that, compared with placebo, treatment with apremilast significantly increased work productivity (P=0.031) and reduced work limitations (P=0.035) at 16 weeks.
Patients in this study completed the Work Limitation Questionnaire (WLQ)—a 25-item questionnaire that assessed the degree to which employed individuals are experiencing on-the-job limitations due to their health problems as well as the health-related productivity loss—at baseline and week 16. Four categories of work limitations were used to calculate the WLQ index—physical demands, mental demands, time management demands and output demands. The WLQ scale scores were then converted into an estimate of productivity loss.
"The toll of psoriasis on patients, the healthcare system, and the
economy is significant and underappreciated," said
Apremilast was approved on
The views expressed and the techniques presented by the speakers at
About ESTEEM 1 and 2
ESTEEM 1 and 2 are two large pivotal phase III randomized, placebo-controlled studies evaluating apremilast 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 or systemic therapy. Approximately 1,257 patients were randomized 2:1 to receive either apremilast 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 apremilast 30 mg twice daily through week 32, and a randomized withdrawal phase for responders from week 32 to week 52 based on their initial apremilast randomization and Psoriasis Area and Severity Index (PASI)-75 response. Approximately 30 percent of all patients had received prior phototherapy and 54 percent had received prior conventional systemic and/or biologic therapy. Approximately one-third of patients had not received prior phototherapy, conventional systemic nor biologic therapy. A total of 18 percent of patients had a history of psoriatic arthritis.
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 apremilast exerts its therapeutic action in psoriasis or psoriatic arthritis is not well defined.
Apremilast is indicated for the treatment of patients with moderate to severe plaque psoriasis who are candidates for phototherapy or systemic therapy.
Apremilast is also indicated for the treatment of adult patients with active psoriatic arthritis.
IMPORTANT SAFETY INFORMATION
Apremilast is contraindicated in patients with a known hypersensitivity to apremilast or to any of the excipients in the formulation.
Warnings and Precautions
Depression: Treatment with apremilast is associated with an increase in adverse reactions of depression. During clinical trials, 1.3% (12/920) of patients treated with apremilast reported depression compared to 0.4% (2/506) on placebo; 0.1% (1/1308) of apremilast patients discontinued treatment due to depression compared with none on placebo (0/506). Depression was reported as serious in 0.1% (1/1308) of patients exposed to apremilast, compared to none in placebo-treated patients (0/506). Suicidal behavior was observed in 0.1% (1/1308) of patients on apremilast, compared to 0.2% (1/506) on placebo. One patient treated with apremilast attempted suicide; one patient on placebo committed suicide.
Carefully weigh the risks and benefits of treatment with apremilast for patients with a history of depression and/or suicidal thoughts/behavior, or in patients who develop such symptoms while on apremilast. 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.
Weight Decrease: Body weight loss of 5-10% occurred in 12% (96/784) of patients treated with apremilast and in 5% (19/382) of patients treated with placebo. Body weight loss of ≥10% occurred in 2% (16/784) of patients treated with apremilast compared to 1% (3/382) of patients treated with placebo. Monitor body weight regularly; evaluate unexplained or clinically significant weight loss, and consider discontinuation of apremilast.
Drug Interactions: Apremilast exposure was decreased when apremilast was
co-administered with rifampin, a strong
Adverse reactions reported in ≥5% of patients were (apremilast%, 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: apremilast 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 apremilast is administered to a nursing woman.
Renal Impairment: apremilast 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.
Psoriasis is an immune-mediated, non-contagious chronic inflammatory
skin disorder of unknown cause. The disorder is a chronic recurring
condition which varies in severity from minor localized patches to
complete body coverage. Plaque psoriasis is the most common type of
psoriasis. About 80 percent of people who develop psoriasis have plaque
psoriasis, which appears as patches of raised, reddish skin covered by
silvery-white scales. These patches, or plaques, frequently form on the
elbows, knees, lower back, and scalp. Psoriasis occurs nearly equally in
males and females. Psoriasis is believed to be most common in Caucasians
and slightly less common in other ethnic groups. Worldwide, psoriasis is
most common in Scandinavia and other parts of northern
Celgene International Sàrl, located in Boudry,
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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 other reports filed with the
Celgene International Sàrl
Vice President, Investor Relations
Director, Corporate Communications
Source: Celgene International Sàrl
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