Findings of a real-world, single-center study indicated that apremilast was effective and safe long-term in the treatment of moderate-to-severe plaque psoriasis.
Apremilast was shown to be effective and safe long-term in the real-world management of moderate-to-severe plaque psoriasis. Results were published recently in Dermatologic Therapy.
As an FDA-approved PDE4 inhibitor in the treatment of moderate psoriasis and adult psoriatic arthritis (PsA), apremilast’s therapeutic properties in modulating inflammation has also been shown to be effective in the management of nail and scalp psoriasis, with further studies related to the genital region currently underway.
Despite these findings in randomized controlled trials, researchers note that the short- and long-term efficacy and safety observed in limited samples of patients warrants increased investigation in a real-world cohort, in which scarce data on the real life use of apremilast in patients with plaque psoriasis exists.
Conducting a spontaneous, open-label, prospective, observational study, they enrolled 40 patients with moderate-to-severe plaque psoriasis (Psoriasis Area Severity Index [PASI] ≥10 and/or Dermatology Life Quality Index [DLQI] ≥ 10 and/or body surface area [BSA] ≥ 10) who were treated at the Dermatological Clinic Department of Clinical and Molecular Sciences, Polytechnic Marche University from May 2018 to December 2018 (mean [SD] age, 64.1 [13.1]; 37.5% had PsA; 65% male).
“All included patients had a long history of psoriasis (mean [SD], 25.4 [12.56] years) and they had received previous treatments….among them 42.5% were multi-drug failure, while the remaining 57.5 % recurred to apremilast as second line of treatment,” noted researchers.
Participant data on PASI, BSA, Physician Global Assessment (PGA), and DLQI were assessed at baseline and at 24 and 52 weeks after treatment initiation. Primary efficacy endpoints evaluated the percentage of patients that achieved PASI 75, PASI 90, and PASI 100 and percentage of patients reaching Minimal Disease Activity (PGA = 0 or 1; DLQI = 0 or 1), both at week 24 and 52 of treatment.
Secondary measurements examined the percentage of patients that achieved DLQI equal to 0 or 1 at week 24 and 52, as well as long-term safety of apremilast. At baseline, median PASI was 13.6, median PGA was 3.5, median BSA was 21, and median DLQI was 10.2.
In their findings, baseline figures were all statistically different at week 24 and 52 after initiating apremilast treatment (P < .05). For the primary endpoint, the percentage of patients who achieved PASI 75, PASI 90, and PASI 100 was 47.5%, 30%, and 10%, and 25%, 35%, and 10% at week 24 and 52, respectively.
Moreover, Minimal Disease Activity was reached by approximately half of patients at week 24 (n = 21) and at week 52 (n = 20), with 60% of patients achieving and maintaining the secondary outcome of DLQI 0 or 1 at week 24 until week 52. Adverse events were reported by 28 patients, in which the most common were diarrhea, nausea, headache, insomnia, and loss of weight.
“All the adverse events were noticed at the beginning of the treatment and they have been resolved without concomitant medications, except for 2 cases of diarrhea, which led to discontinuation of the treatment with apremilast just 2 weeks after the beginning of therapy,” noted researchers. “Seven patients out of 40 have withdrawn from the study at the end of the observation period.”
In concluding, the study authors highlighted that real-world findings of apremilast therapy confirmed the levels of efficacy and safety obtained in clinical trials, particularly how good initial response to treatment is predictive of the maintenance or improvement of patient outcomes over 52 weeks.
“The efficacy is supported by an excellent safety profile even in frail patients,” they added.
Radi G, Campanati A, Diotallevi F, et al. Long-term efficacy and safety of apremilast in the treatment of plaques psoriasis: A real-world, single-center experience. Dermatol Ther. Published online October 26, 2021. doi:10.1111/dth.15179