By Reuters Staff NEW YORK (Reuters Health) – Apremilast is effective in patients with difficult-to-treat psoriasis of the scalp and nails, according to long-term results of two phase 3 trials. One-Year Data Shows Apremilast Effective in Severe Scalp, Nail Psoriasis Biologic DMARDs Prove Effective for Psoriatic Arthritis & Combination DMARDs Show Promise for RA Secukinumab Effective. Apremilast, a phosphodiesterase 4 (PDE4) inhibitor, showed efficacy against psoriatic arthritis in the PALACE 1 trial. Response was maintained at 52 weeks, and scalp and nail psoriasis also improve.10.
A total of 1255 patients were randomized (2:1) to apremilast 30 mg twice daily or placebo. Apremilast reduces the severity of nail/scalp psoriasis. Missing data were handled with the last observation carried forward methodology. Efficacy data were assessed for the full analysis set (all randomized patients). 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).
Severe disease Severe psoriasis requires phototherapy or systemic therapies such as retinoids, methotrexate, cyclosporine, apremilast, or biologic immune modifying agents. Topical calcitriol ointment has been prescribed in Europe for years, and is now available in the United States. It is also effective for the treatment of psoriatic arthritis and psoriatic nail disease. The association between psoriasis and arthritis was first made in the mid-19th century, but psoriatic arthritis was not clinically distinguished from rheumatoid arthritis (RA) until the 1960s. Psoriatic nail changes, which may be a solitary finding in patients with psoriatic arthritis, may include the following:. Arthroscopic synovectomy has been effective in treating severe, chronic, monoarticular synovitis. Results from ESTEEM 1 which is Celgene’s first Phase III study for aprelimast in psoriasis, have been presented at the American Academy of Dermatology annual meeting in Miami. 1 and 2 studies for psoriasis, is expected in the second half of this year while Celgene will file a separate New Drug Application for psoriatic arthritis in the first quarter of 2013.
Apremilast, An Oral Phosphodiesterase 4 Inhibitor, In Patients With Difficult-to-treat Nail And Scalp Psoriasis: Results Of 2 Phase Iii Randomized, Controlled Trials (esteem 1 And Esteem 2)
One-Year Data Shows Apremilast Effective in Severe Scalp, Nail Psoriasis. Nail psoriasis can be treated effectively using topical treatments, intralesional treatments, and systemic treatments, but an optimal effect may take up to 1 year. The aim of that review was to cover all published data on the treatment of nail psoriasis, including not only data from RCTs but also from other studies and case reports. Vice President, General Counsel and Corporate Secretary, effective June 1, 2015. 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. The new drugs, however, show even greater degrees of improvement. The most common, affecting 90 of patients, is plaque psoriasis, which results in raised, inflamed, scaly patches on the skin, scalp and nails. The safety data are generally reassuring, but the drugs are still new, and trial data are available for only up to a year or two of use. Response was maintained at 52 weeks, and scalp and nail psoriasis also improve.10. PSOLAR data did not show a statistically significant increased risk of MACE with any of the biologic agents. Phototherapy is an effective treatment modality for psoriasis, yet one to which dermatology residents have little exposure.