FDA Approves Otezla for Active Psoriatic Arthritis

by U.S. Medicine

May 12, 2014

SUMMIT, NJ — Clinicians have a new tool in their arsenal to treat active psoriatic arthritis.

The Food and Drug Administration recently approved Otezla (apremilast) to treat adults with active psoriatic arthritis (PsA). The drug is marketed by Celgene Corporation, Summit, NJ.

Currently approved treatments for PsA — which usually occurs after patients are diagnosed with psoriasis and causes joint pain, stiffness and swelling — include corticosteroids, tumor necrosis factor (TNF) blockers, and an interleukin-12/interleukin-23 inhibitor.

“Relief of pain and inflammation and improving physical function are important treatment goals for patients with active psoriatic arthritis,” said Curtis Rosebraugh, MD, MPH., director of the Office of Drug Evaluation II in the FDA’s Center for Drug Evaluation and Research. “Otezla provides a new treatment option for patients suffering from this disease.”

Three clinical trials involving 1,439 patients with active PsA evaluated the safety and effectiveness of Otezla, an inhibitor of phosphodieasterase-4 (PDE-4). Study participants receiving Otezla showed improvement in signs and symptoms of PsA, including tender and swollen joints and physical function, compared to placebo.

The FDA recommends that patients treated with Otezla have their weight monitored regularly by a healthcare professional. In the case of unexplained or clinically significant weight loss, further evaluation should occur with the possibility of discontinuation of treatment. In addition, the agency noted that reports of depression increased compared to placebo in patients using the drug.

A pregnancy exposure registry assessing whether Otezla poses any risks to pregnant women or their unborn is a post-marketing requirement for approval. .

In clinical trials, the most common side effects observed were diarrhea, nausea and headache.

“Patients and physicians have expressed their desire for a safe and effective therapy for psoriatic arthritis that has the potential to simplify patient management. Celgene is excited to be expanding our transformational science into the therapeutic realm of Inflammation and Immunology, with a new approach for patients with psoriatic arthritis,” said Scott Smith, Global Head, Inflammation and Immunology, Celgene Corporation. “The FDA approval of Otezla is good news for patients and healthcare professionals who are looking for a different way to manage this disease.”


Related Articles

Automation Speeds Results and Increases Accuracy for Point-of-Care Testing at Walter Reed NMMC

With a long history of point of care testing at both of its predecessor organizations, the Walter Reed National Military Medical Center (WRNMMC) laboratory services staff were keenly aware of the advantages of using portable testing devices to obtain rapid patient assessments.

Obesity Is on the Rise in Veterans, Especially VHA Patients

Obesity is increasing among veterans, and the implications are potentially dire because the condition is associated with a range of serious health conditions, according to new research.


U.S. Medicine Recommends


More From 2014 issues

2014 Issues

VA Slammed for Slow Action Against Officials Behind Wait-Time Scandal

Legislators: Only Four Senior Executives Removed by Mid-November

2014 Issues

VA Launches Largest Overhaul Ever as McDonald Pushes Reforms

WASHINGTON - New VA Secretary Robert McDonald continues to methodically tackle the issues that have caused a breakdown in efficient veteran care over the last few years, now pushing the agency to undertake the largest reorganization since its founding.

2014 Issues

VA’s IT Security Controls Cited for 15th Year in a Row

Controversial Scheduling System Will Be Replaced in 2015

2014 Issues

Study Offers New Statistics on How Many OEF/OIF Veterans Have PTSD

WASHINGTON — In the last decade, the development of multiple molecular-targeted therapies has dramatically altered the treatment landscape for advanced renal cell carcinoma (RCC). The rate of new drug approvals has outpaced the ability of... View Article

2014 Issues

Danger of Pneumonia Increases with Veterans’ Worsened Health Status

WASHINGTON — In the last decade, the development of multiple molecular-targeted therapies has dramatically altered the treatment landscape for advanced renal cell carcinoma (RCC). The rate of new drug approvals has outpaced the ability of... View Article

Facebook Comment

Subscribe to U.S. Medicine Print Magazine

U.S. Medicine is mailed free each month to physicians, pharmacists, nurse practitioners, physician assistants and administrators working for Veterans Affairs, Department of Defense and U.S. Public Health Service.

Subscribe Now

Receive Our Email Newsletter

Stay informed about federal medical news, clinical updates and reports on government topics for the federal healthcare professional.

Sign Up