英文原文:Oral OTEZLA? (apremilast) Long-Term Safety and Efficacy Data in Patients with Moderate to Severe Plaque Psoriasis Presented at AAD
Improvements in the severity of preexisting nail, scalp and palmoplantar psoriasis achieved at week 16 were maintained in OTEZLA responders through week 52 in ESTEEM 2
OTEZLA improved the severity of palmoplantar psoriasis at week 16 in a subset of patients across three trials
Long-term safety profile for up to 104 weeks in ESTEEM 1 was consistent with previously reported data from OTEZLA clinical trial programs, with no new safety signals and no clinically meaningful changes in laboratory values
SUMMIT, N.J.--(BUSINESS WIRE)-- Celgene Corporation (NASDAQ: CELG) today announced that results from long-term efficacy and safety analyses of the ESTEEM phase III clinical trial program of Otezla? (apremilast) were presented at the 73rd Annual Meeting of the American Academy of Dermatology (AAD) in San Francisco, California. OTEZLA is the Company's oral, selective inhibitor of phosphodiesterase 4 (PDE4) approved for the treatment of patients with moderate to severe plaque psoriasis who are candidates for phototherapy or systemic therapy and for the treatment of adults with active psoriatic arthritis.
In ESTEEM 1 and 2, patients were randomized to treatment with OTEZLA 30 mg twice daily or placebo for the first 16 weeks. At week 16, patients either continued on OTEZLA or were switched from placebo to OTEZLA 30 mg twice daily through week 32. Patients initially randomized to OTEZLA who achieved a Psoriasis Area and Severity Index (PASI)-75 response (ESTEEM 1) or PASI-50 response (ESTEEM 2) at week 32 were then re-randomized to either OTEZLA 30 mg twice daily or placebo.
"Long-term data are critical in psoriasis, since patients may deal with this disease throughout their lives," said Jeffrey Crowley, M.D., Bakersfield Dermatology, Bakersfield, CA. "Having two-year safety results along with data showing that OTEZLA can provide long-term improvements in difficult-to-treat symptoms can be helpful for dermatologists and patients who are looking for different treatment options."
ESTEEM 2: 52-Week Data Observed in Patients with Nail, Scalp and Palmoplantar Involvement
An analysis of data from ESTEEM 2 presented at AAD showed sustained improvements at week 52 among PASI-50 responders (patients who achieved a 50 percent reduction in PASI at week 32) in difficult-to-treat areas such as nails, scalp and the palms of the hands and soles of the feet (known as palmoplantar psoriasis).
Among patients who had nail psoriasis at baseline with a Nail Psoriasis Severity Index (NAPSI) greater than or equal to one, 45 percent (78/175) of those treated with OTEZLA 30 mg twice daily had at least a 50 percent improvement in NAPSI (NAPSI-50) at week 16, compared with 19 percent (17/91) of those treated with placebo (P < 0.0001). NAPSI-50 achievement was generally maintained for up to 52 weeks in patients (69 percent, n=35) who received OTEZLA at baseline who were PASI-50 responders.
Of those patients who had moderate to very severe scalp psoriasis at baseline, 41 percent (72/176) of those treated with OTEZLA 30 mg twice daily had a Scalp Physician Global Assessment (ScPGA) score of clear (zero) or minimal (one) at week 16, compared with 17 percent (16/93) of those treated with placebo (P < 0.0001). ScPGA score of zero or one achievement was generally maintained for up to 52 weeks in patients (63 percent, n=32) who received OTEZLA at baseline who were PASI-50 responders.
Among patients who had moderate to severe psoriasis on their palms and feet at baseline, 65 percent (17/26) of those treated with OTEZLA 30 mg twice daily had a Palmoplantar Psoriasis Physician Global Assessment (PPPGA) score of clear (zero) or almost clear (one) at week 16, compared with 31 percent (5/16) of those treated with placebo (P=0.0315). PPPGA score of zero or one achievement was sustained up to week 52 (n=4 of 4 patients) in patients randomized to OTEZLA who were PASI-50 responders at week 32.