Investigators reported that the efficacy of the medication is supported by a high safety profile, with fleeting and limited adverse events recorded.
New insights from an Italian study on the small molecule apremilast found that usage in real life experience showed efficacy and safety results in patients with plaque psoriasis that were comparable to those detailed in previous randomized controlled trials.
Patients treated with apremilast were shown to have demonstrated a good response to treatment in the first few weeks of the study, at times improving their outcomes over the total 52 weeks of the study.
Adverse events were “transient and mostly self-limiting,” according to investigators.
With their study, Anna Campanati, MD, Dermatological Clinic Department of Clinical and Molecular Sciences, Polytechnic University of the Marche Region, Ancona, and fellow investigators intended to report on the efficacy and safety of the medication in clinical practice in patients with moderate-to-severe plaque psoriasis.
In the spontaneous, open-label, prospective, observational study, Campanati and colleagues enrolled 40 patients with moderate-to-severe plaque psoriasis.
The enrollment period was from May 2018 to December 2018.
Patients were required to be 18 years or older with a diagnosis of more than 12 months at baseline. They were also required to have received previous systemic treatments prior to the study.
Personal anamnestic data and medical information related to psoriatic disease was taken at baseline for each patient, and dermatological examinations and disease severity quantification were also issued through the Psoriasis Area and Severity Index (PASI) and the Dermatology Life Quality Index (DLQI), among others.
After the first visit at the Dermatologic Department, all patients had received 30 mg of apremilast twice daily after 6 days long titration.
Patients were then re-evaluated at weeks 24 and 52, when PASI and DLQI was re-evaluated.
The primary endpoint was to evaluate long-term Apremilast efficacy, and the second endpoint was improvement of quality of life during treatment expressed as patients having achieved DLQI 0-1.
Only 33 of the 44 patients had completely the total evaluation.
Of those, 5 patients (15%) reported a worsening of clinical condition with a decrease of PASI below PASI 50; 10 patients out from 33 (30%) reached PASI 75, 14 patients out from 33 (43%) reached PASI 90 and the remaining 4 patients (12%) reached PASI 100.
Regarding DLQI 0-1 endpoint, 24 patients out of 40 (60 %) achieved the goal with a significative improvement of quality of life after 24 and 52 weeks of treatment with apremilast.
During the study, the average DLQI moved from 10.2 to 1.5 and 60% of patients achieved DLQI 0-1.
Investigators recorded adverse events in 28 patients (70%), including diarrhea (n14; 50%), nausea (n11; 39%), headache (n4; 14%), insomnia (n3; 11%), loss of weight (n3; 11%), and cough (n2; 7%). The remaining 12 patients reported did not report any adverse events.
As with previous extension studies, the present study showed that the medication was largely effective and safe for patients with psoriasis.
During their concluding remarks, the investigators wrote that the study had been conducted prior to the COVID-19 pandemic, and that since then several reports had confirmed the high safety profile of the medication.
Due to this, Campanati and colleagues believed apremilast should be considered a “valid therapeutic resource” for the treatment of plaque psoriasis in frail patients due to its high safety profile.
“The efficacy is supported by an excellent safety profile,” the team wrote. “Adverse events proved transient and mostly self-limiting. Even in those patients with comorbidities, the use of apremilast did not increase the risk of infections nor affect the course of previous malignancies.”
The study, “LONG-TERM EFFICACY AND SAFETY OF APREMILAST IN THE TREATMENT OF PLAQUES PSORIASIS: A REAL-WORLD, SINGLE-CENTER EXPERIENCE,” was published online Dermatologic Therapy.