SUMMIT (dpa-AFX) - Celgene International Sàrl, a wholly-owned subsidiary of Celgene Corp. (CELG), announced the results from additional efficacy and safety analyses of OTEZLA (apremilast) from the ESTEEM phase III clinical trial program.
Apremilast is the Company's oral, selective inhibitor of phosphodiesterase 4 (PDE4), for patients with moderate to severe plaque psoriasis who are candidates for phototherapy or systemic therapy.
The company said that an analysis of ESTEEM 2 demonstrated that apremilast significantly improved psoriasis in difficult-to-treat areas such as: the palms of the hands and feet (known as palmoplantar psoriasis), nails and scalp.
Among patients who had nail psoriasis at baseline (n=266), 45 percent treated with apremilast 30 mg twice daily had at least a 50 percent improvement in this symptom at week 16, compared with 19 percent of those treated with placebo (P<0.0001). After 32 weeks of treatment with apremilast 30 mg twice daily, 55 percent of patients achieved at least a 50 percent improvement.
Of those patients who had moderate to severe psoriasis on their palms and feet at baseline (n=42), 65 percent had these symptoms reduced to clear or almost clear at week 16. Improvements over baseline in nail, scalp and palmoplantar psoriasis were seen for up to 32 weeks.
An analysis of ESTEEM 1 and 2 found that apremilast improved skin discomfort/pain. Patients report that pruritus (itching) is one of the most common and bothersome symptoms of psoriasis.
Significantly greater improvements in itching scores at week 16 were seen for patients treated with apremilast 30 mg twice daily (decreases of 31.5 in ESTEEM 1 and 33.5 in ESTEEM 2) compared with placebo (decreases of 7.3 in ESTEEM 1 and 12.2 in ESTEEM 2; P<0.0001 for both trials).
A post-hoc analysis found that improvements in itching and in skin discomfort/pain with apremilast 30 mg twice daily were observed as early as week 2 and were maintained through week 32.
Long-term (52-week) results from 411 patients in the ESTEEM 2 trial demonstrated durability of clinical responses achieved with apremilast. For those patients who were treated with apremilast 30 mg twice daily for 52 weeks and who achieved a 50 percent improvement in Psoriasis Area and Severity Index (PASI) at week 32, mean improvements in PASI remained stable between weeks 32 and 52 (74 percent to 77 percent).
Analysis of data from ESTEEM 2 did not identify new or unexpected adverse events (AEs) for patients treated with apremilast, and the rate of AEs did not increase in frequency over time.
Copyright RTT News/dpa-AFX