Long-term use of Celgene‘s treatment Otezla (apremilast) has improved psoriatic-arthritis patients’ symptoms, according to a study.
The improvements included less psoriasis, lower swollen and tender joint counts, less enthesitis — or inflammation where tissue and bone converge — and less dactylitis, or finger and toe inflammation.
Researchers used data from the randomized PALACE 4 clinical trial (NCT01307423) in their research, which they presented at the American College of Rheumatology Annual Meeting.
The team led by Alvin F. Wells, MD, director of the Rheumatology and Immunotherapy Center in Franklin, Wisconsin, examined Otezla’s effectiveness and safety in psoriatic-arthritis patients who had not been treated with disease-modifying antirheumatic drugs (DMARDs).
Researchers randomly assigned patients to three groups. The first 175 received 20 mg a day of Otezla. Another 176 received 30 mg a day. The third group of 175 received a placebo.
Patients whose swollen and tender joint counts had not improved by at least 20% by the 16th week were deemed not to have responded to the treatment. Those who had been on Otezla continued to receive their previous doses. Those in the placebo group were randomly reassigned to either the group getting 20 mg of Otezla or the group getting 30 mg.
In the 24th week, everyone in the placebo group was randomly assigned to one of the two Otezla groups.
Eighty-eight percent of the 309 patients who started the third year of treatment completed the 156-week course, the researchers said in a news release.
By the 52nd week, 58 percent of the patients on 30 mg of Otezla and 55.4 percent on 20 mg showed a 20 percent improvement in the American College of Rheumatology’s (ACR20’s) measure of psoriatic-arthritis symptoms.
The ACR-measured improvement that was seen in Week 52 held up in Week 156, the researchers said.
In addition, patients’ mean swollen and tender joint counts continued to be lower in the 156th week, as did the mean increase in their Health Assessment Questionnaire-Disability Index (HAQ-DI) score.
Researchers also reported that in the 156th week, 63 percent of patients on 30 mg of Otezla and 60. 4 percent on 20 mg had a Maastricht Ankylosing Spondylitis Enthesitis Score (MASES) of 0. The scale measures the severity of enthesitis, an inflammation of entheses, or places where tendons or ligaments connect with bone.
Between weeks 104 and 156, the most common adverse reactions were upper respiratory tract infection and nasopharyngitis, or throat inflammation, the researchers said.
The U.S. Food and Drug Administration (FDA) approved Otezla as a treatment for certain types of psoriasis and psoriatic arthritis in 2014.
In October 2016, the National Institute for Health and Care Excellence (NICE) recommended Otezla for adults with chronic plaque psoriasis in England and Wales.
