Otezla Recommended for Approval to Treat Psoriatic Arthritis

Celgene recently announced that Otezla (apremilast) received a positive final appraisal determination from the National Institute for Health and Care Excellence (NICE).

NICE recommends the use of apremilast in patients with active psoriatic arthritis who have had an inadequate response, or are unable to tolerate previous treatment with disease modifying anti-rheumatic drugs (DMARDs), according to a press release from Celgene.

"Psoriatic arthritis is a chronic disease that causes significant strain on NHS resources," said Dr Helena Marzo-Ortega, honorary senior lecturer and consultant at Leeds Teaching Hospitals National Health Service (NHS) Trust. "Addressing the symptoms of both psoriasis and psoriatic arthritis, the availability of Otezla on the NHS marks a major milestone in the management of psoriatic arthritis."

Psoriatic arthritis is common among individuals aged 30 to 50, and approximately 296,000 patients in the UK have the disease. The disease affects the skin and joints, and can inhibit patient’s ability to complete day-to-day activities, such as walking or getting dressed.

NICE originally issued negative guidance in September 2015, according to the press release. Apremilast was then reappraised under the organization’s Rapid Review process.

NICE now recommends the drug as a monotherapy, or in combination with DMARDs for adult patients if they have peripheral arthritis with 3 or more tender or swollen joints, and if their disease was not controlled by the use of 2 or more standard DMARDs, Celgene reported.

Apremilast was recommended by the Scottish Medicines consortium earlier this year. This latest recommendation allows patients in England and Wales to access the psoriatic arthritis treatment.

Apremilast works in patients by reducing the activity of the phosphodiesterase 4 enzyme, which is associated with inflammation. By reducing this enzyme, apremilast can control inflammation associated with psoriatic arthritis, and reduce signs and symptoms of the disease, according to the release.

The PALACE clinical development program is one of the largest to be conducted in these patients. In the studies, the investigators found that more patients taking apremilast achieved ACR 20 compared with placebo at 16 weeks.

Apremilast has been shown to improve swollen and tender joints, dactylitis, enthesitis, and significantly improve physical function.

Common adverse events associated with treatment were diarrhea and nausea, which were reported to resolve within 4 weeks.

Apremilast first received approval by the European Medicines Agency in 2015 to treat patients who did not respond to prior DMARD treatment. It was also licensed by the European Commission for the treatment of chronic plaque psoriasis, according to the press release.

"We are delighted that patients in England and Wales can now access Otezla via the NHS, bringing availability in line with patients in Scotland,” concluded Dr Dani Thomas, Medical Director, Celgene UK & Ireland. “Otezla’s novel mechanism of action and oral administration provides psoriatic arthritis patients with a much needed treatment option. Celgene will continue our dedication to develop and deliver innovative medicines for people affected by diseases where there is a high unmet need."