Orta ve Şiddetli Plak Psoriasiste Apremilast Tedavisinin Klinik Etkinliği ve Güvenilirliği: Gerçek Yaşam Deneyimi

Öz

Apremilast, orta-şiddetli plak tip psoriasis tedavisinde onaylanmış oral bir fosfodiesteraz-4 inhibitörüdür. Etkinlik ve güvenilirliği randomize kontrollü çalışmalarda gösterilmiş olmakla birlikte, gerçek yaşam verileri sınırlıdır. Bu çalışmada, orta-şiddetli plak psoriasisli hastalarda apremilastın gerçek yaşam koşullarındaki etkinliği ve güvenilirliğinin değerlendirilmesi amaçlanmıştır. Bu retrospektif gözlemsel çalışmaya apremilast ile tedavi edilen orta-şiddetli plak psoriasis tanılı 50 erişkin hasta dahil edildi. Demografik ve klinik özellikler kaydedildi. Hastalık şiddeti, Psoriasis Alan ve Şiddet İndeksi (PASI) kullanılarak başlangıçta ve 2., 4. ve 8. haftalarda değerlendirildi. Tedavi yanıtı PASI iyileşme oranlarına (PASI 75 ve PASI 100) göre belirlendi. Yan etkiler kaydedildi. Çalışma popülasyonu 29 kadın ve 21 erkek hastadan oluşmakta olup, ortalama yaş 43 ± 5,5 yıl ve ortalama hastalık süresi 12 ± 3,1 yıl idi. Otuz dört hasta biyolojik tedavi almamış, 16 hasta ise daha önce biyolojik tedavi deneyimine sahipti. Ortalama PASI skoru başlangıçta 18,3 iken, 2. haftada 12,3’e, 4. haftada 10,8’e ve 8. haftada 7,2’ye geriledi. Dördüncü haftada hastaların %42’sinde PASI 75 ve %18’inde PASI 100 yanıtı elde edilirken, bu oranlar 8. haftada sırasıyla %58 ve %34’e yükseldi. En sık bildirilen yan etkiler bulantı (%28), baş ağrısı (%18) ve diyare (%16) olup, çoğu hafif ve geçici nitelikteydi. Apremilast, orta-şiddetli plak psoriasisli hastalarda gerçek yaşam koşullarında hızlı ve klinik olarak anlamlı bir iyileşme sağlarken, olumlu bir güvenlilik profili göstermiştir. Bu bulgular, apremilastın rutin klinik pratikte etkili ve iyi tolere edilen bir sistemik tedavi seçeneği olduğunu desteklemektedir.

Anahtar Kelimeler

• Apremilast
• Psoriasis
• Gerçek yaşam
• PASI

Etik Beyan

Etik onay no: Sağlık Bilimleri Üniversitesi İzmir Şehir Hastanesi İzmir Tıp Fakültesi Etik Kurul Onay No: 2026/23

Clinical Effectiveness and Tolerability of Apremilast in Moderate-to-Severe Plaque Psoriasis: Insights from Real-World Practice Moderate-to-Severe Plaque Psoriasis: Insights from Real-World Practice

Öz

Apremilast is an oral phosphodiesterase-4 inhibitor approved for the treatment of moderate-to-severe plaque psoriasis. Although its efficacy and safety have been demonstrated in randomized controlled trials, real-world data remain limited. This study aimed to evaluate the real-world effectiveness and safety of apremilast in patients with moderate-to-severe plaque psoriasis. This retrospective observational study included 50 adult patients with moderate-to-severe plaque psoriasis treated with apremilast. Demographic and clinical characteristics were recorded. Disease severity was assessed using the Psoriasis Area and Severity Index (PASI) at baseline and at weeks 2, 4, and 8. Treatment response was evaluated based on PASI improvement rates (PASI 75 and PASI 100). Adverse events were documented. The study population consisted of 29 females and 21 males, with a mean age of 43 ± 5.5 years and a mean disease duration of 12 ± 3.1 years. Thirty-four patients were biologic-naïve and 16 were biologic-experienced. Mean PASI score decreased from 18.3 at baseline to 12.3 at week 2, 10.8 at week 4, and 7.2 at week 8.  At week 4, PASI 75 and PASI 100 responses were achieved by 42% and 18% of patients, respectively, increasing to 58% and 34% by week 8. The most common adverse events were nausea (28%), headache (18%), and diarrhea (16%), most of which were mild and transient. Apremilast demonstrated rapid and clinically meaningful improvement in disease severity with a favorable safety profile in patients with moderate-to-severe plaque psoriasis. These real-world findings support apremilast as an effective and well-tolerated systemic treatment option in routine clinical practice.

Anahtar Kelimeler

• Apremilast
• Psoriasis
• Real World Data
• PASI

Etik Beyan

Institutional ethics approval no: University of Health Science, Izmir City Hospital Ethics Committee Approval No: 2026/23

Kaynakça

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