Otezla (apremilast) quality of life, efficacy, and safety study

[Fred]

Otezla (apremilast) significantly improved skin-related quality of life in patients with psoriasis.

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Introduction/Background:
Manifestations of psoriasis in special areas are difficult to treat and are associated with a high disease burden and significant quality of life (QoL) impairment. Topical therapies may be inadequate for these patients, necessitating systemic treatment.

Objective:
The objective of EMBRACE was to evaluate the impact on QoL, efficacy, and safety of apremilast 30 mg BID in patients with limited skin involvement with plaque psoriasis manifestations in special areas and impaired QoL.

Methods:
EMBRACE (NCT03774875) was a phase 4, randomized, placebo-controlled, multinational study. Patients had plaque psoriasis not controlled by topical therapy; lack of response, contraindication, or intolerance to conventional first-line systemic therapy; psoriasis in ≥1 special area (including visible locations, scalp, nails, genital areas, or palmoplantar areas); Psoriasis Area and Severity Index (PASI) ≥3 to ≤10; and Dermatology Life Quality Index (DLQI) >10. The primary endpoint was DLQI response (≥4-point reduction) at Week 16.

Results:
Of 277 randomized patients (apremilast: n=185; placebo: n=92), 221 completed Week 16 (apremilast: n=152; placebo: n=69). The primary endpoint (≥4-point reduction in DLQI at Week 16) was met by significantly more patients receiving apremilast (73.3%) versus placebo (41.3%; P<0.0001). Significantly greater improvement in affected body surface area (BSA) and PASI was observed with apremilast versus placebo at Week 16. There were also significantly greater improvements with apremilast versus placebo in itch numeric rating scale (−2.5 vs −0.9, P<0.0001) and skin discomfort/pain visual analog scale (−21.5 vs −5.4, P=0.0003) and greater achievement of Patient Benefit Index ≥1 (77% vs 40%, P<0.0001) at Week 16. No new safety signals were observed.

Conclusions:
Apremilast significantly improved skin-related QoL in patients with limited skin involvement with plaque psoriasis in special areas and highly impaired QoL. The safety profile was consistent with prior apremilast studies.

Source: onlinelibrary.wiley.com

*Early view funding unknown

Otezla

[mataribot]

I am not a fan of systemic treatment for a small limited amount of psoriasis. From my experience, it just makes it worse in the long run if treatment is discontinued. There are non steroid creams on the market and more on the way. I would think that would be a better option try first.

And besides, outside the US, Otezla isn't going to be the first choice of treatment - it's to expensive and there are a lot more cheaper options.