Otezla effectiveness and safety study

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This study in Greece looked at the effectiveness and safety of Otezla (apremilast) in biologic-naïve patients with moderate psoriasis.

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Background:
Apremilast is an oral phosphodiesterase-4 inhibitor indicated for patients with moderate-to-severe chronic plaque psoriasis and active psoriatic arthritis.

Objectives:
To examine the effectiveness of apremilast on Dermatology Life Quality Index (DLQI), Psoriasis Area and Severity Index (PASI), and nail, scalp, and palmoplantar involvement, when administered prior to biologics.

Methods:
This 52-week real-world study included biologic-naive adults with moderate psoriasis (psoriasis-involved body surface area 10% to <20%, or PASI 10 to <20 and DLQI 10 to <20). Apremilast was initiated ≤7 days before enrolment. Data from the first 100 eligible patients who completed 24 weeks (W24) of observation (or were prematurely withdrawn) are presented in this interim analysis using the last-observation-carried-forward imputation method.

Results:
Eligible patients (mean age: 49.9 years; 71.0% males; median disease duration: 8.0 years) were consecutively enrolled between April and October 2017, by 18 dermatology specialists practicing in hospital outpatient settings in Greece. Baseline DLQI (median: 12.0) and PASI (median: 11.7) scores improved (P<0.001) at all post-baseline timepoints (Weeks 6, 16, and 24; W24 median decreases: 9.0 and 9.4 points, respectively). At W24, DLQI ≤5, DLQI 0 or 1, and PASI-75 response rates were 63.0%, 25.0%, and 48.0%, respectively. The Nail Psoriasis Severity Index score in patients with baseline nail involvement (n=57) decreased at all post-baseline timepoints (P<0.001; W24 median decrease: 20.0 points). At W24, 50.0% and 51.7% of patients with baseline scalp (n=76) and palmoplantar (n=29) involvement, respectively, achieved post-baseline Physician’s Global Assessment (PGA) score 0 or 1 if baseline score was ≥3, or 0 if baseline score was 1 or 2. The adverse drug reaction rate was 21.0% (serious: 2.0%).

Conclusions:
These interim results indicate that through 24 weeks, apremilast improved quality of life and reduced disease severity in biologic-naive patients with moderate plaque psoriasis, while demonstrating safety consistent with the known safety profile.

Source: onlinelibrary.wiley.com

*Early view funding unknown

Otezla