Real‐world effectiveness and safety of apremilast in psoriasis at 52 weeks: a retrospective, observational, multicentre study by the Spanish Psoriasis Group

Abstract

Background Little has been published on the real-world effectiveness and safety of apremilast in psoriasis. Objectives To evaluate the effectiveness, safety and drug survival of apremilast at 52 weeks in patients with moderate to severe plaque psoriasis or palmoplantar psoriasis in routine clinical practice. Methods Retrospective, multicentre study of adult patients with moderate to severe plaque psoriasis or palmoplantar psoriasis treated with apremilast from March 2016 to March 2018. Results We studied 292 patients with plaque psoriasis and 85 patients with palmoplantar psoriasis. The mean (SD) Psoriasis Area and Severity Index (PASI) score was 10.7 (7.0) at baseline and 3.0 (4.2) at 52 weeks. After 12 months of treatment, 73.6% of patients had a PASI score of 3 or less. In terms of relative improvement by week 52, 49.7% of patients achieved PASI-75 (≥75% reduction in PASI score) and 26.5% achieved PASI-90. The mean physician global assessment score for palmoplantar psoriasis fell from 4.2 (5.2) at baseline to 1.3 (1.3) at week 52. Overall drug survival after 1 year of treatment with apremilast was 54.9 %. The main reasons for treatment discontinuation were loss of efficacy (23.9%) and adverse events (15.9%). Almost half of the patients in our series (47%) experienced at least one adverse event. The most common events were gastrointestinal problems. Conclusions Apremilast may be a suitable alternative for the treatment of moderate to severe psoriasis and palmoplantar psoriasis. Although the drug has a good safety profile, adverse gastrointestinal effects are common.

Effectiveness and clinical predictors of drug survival in psoriasis patients receiving apremilast: A registry analysis

“…Similar findings for PASI 75 and PASI 90 responses at 3 and 12 months were recently reported from Spanish and Italian cohorts. 25 , 35 However, in our LOCF/worst-case scenario analysis, the clinical effectiveness of apremilast plateaued at 3 to 6 months after treatment start ( Figs 2 and 3 ), in accordance with recently published guidelines suggesting that drug effectiveness should be evaluated at 16 weeks after the start of treatment. 5 …”

“…For instance, lower 12-month survival rates were detected in insurance claims databases from France (30.7%) and the United States (2.6%) 24 , 36 and in the Slovenian psoriasis registry (20.0%). 13 However, rates similar to ours were seen in retrospective observational studies from Spain (54.9%) 25 and Japan (53.4%), 28 although the apremilast-treated cohorts in most of those studies were smaller than ours.…”

“…Most biologics have similar overall drug survival rates (per drug within a certain range), but the 12-month survival rates of apremilast range widely by study, from 2.6% to 55.4%. 24 , 25 Decreased biologic drug survival is associated with female sex, previous biologic exposure, and obesity. 26 For most biologics, metabolic conditions (ie, hypertension, diabetes, and metabolic syndrome and its associated comorbidities) increase the risk of treatment discontinuation, although this was not the case for apremilast in a previous study.…”

“… 27 However, 1 study has shown that the risk of apremilast discontinuation does increase in obese patients receiving it [hazard ratio (HR): 1.2]. 25 The risk of apremilast discontinuation also appears to increase in patients with palmoplantar pustulosis suffering from depression 8 but not in patients with concomitant psoriatic arthritis. 28 Note, however, that most studies of apremilast drug survival (except 1 study from Spain with 377 patients) 25 enrolled relatively few patients (ie, 35, 94, and 138 patients) and were therefore insufficiently powered to fully determine what parameters influence drug survival.…”

Skin manifestations in spondyloarthritis

“…Efficacies of abatacept and apremilast in PsO, HS, PG, rSpA, nrSpA and PsA. The size of the circle presents the level of evidence, the colour represents the level of efficacy in the indicated disease 217,[222][223][224][225][226][227][228]. As standards of therapeutic efficacies in PsO PASI90, in HS HiSCR, in SpA ASAS40 and in PsA ACR50 are used.…”