Psöriasis hastalarında IL-17 ve IL-23 inhibitör tedavilerinin etkinlik, güvenlik, ilaçta sağkalım ve inflamatuvar parametreler üzerine etkisinin retrospektif incelenmesi
Retrospective analysis of efficacy, safety, drug survival and inflammatory parameters of IL-17 and IL-23 inhibitor treatments in psoriasis patients
- Tez No: 830447
- Danışmanlar: DOÇ. DR. İLTERİŞ OĞUZ TOPAL
- Tez Türü: Tıpta Uzmanlık
- Konular: Dermatoloji, Dermatology
- Anahtar Kelimeler: Belirtilmemiş.
- Yıl: 2023
- Dil: Türkçe
- Üniversite: Sağlık Bilimleri Üniversitesi
- Enstitü: Prof. Dr. Cemil Taşcıoğlu Şehir Hastanesi
- Ana Bilim Dalı: Deri ve Zührevi Hast. Ana Bilim Dalı
- Bilim Dalı: Belirtilmemiş.
- Sayfa Sayısı: 106
Özet
Amaç: Psöriasis, hastaların hayat kalitesini belirgin şekilde bozan, sistemik inflamatuvar bir hastalıktır. Psöriasis patogenezinde interlökin (IL)-23/Th17 sitokin-hücre aksının önem kazanmasıyla, tedavide biyolojik ajan yolculuğu yönünü IL-17 ve IL-23 inhibitörlerine çevirmiştir. IL-17 ve IL-23 inhibitörleri faz III ve gerçek yaşam çalışmalarında etkili ve güvenli olarak raporlanmasına rağmen, elde edilen veriler IL-17 ve IL-23 inhibitörlerini karşılaştırma açısından kısıtlı kalmaktadır. Bu çalışmada, orta-şiddetli psöriasis için ülkemizde kullanımı mevcut olan guselkumab, risankizumab, sekukinumab, iksekizumab tedavilerinden birini almış hastaların, 1 yıllık gerçek yaşam verileri incelenerek; tedavilerin etkinlik, güvenlik, ilaçta sağkalım süreleri ve inflamatuvar parametreler üzerine etkilerinin araştırılıp karşılaştırılması ve ilaç kesilmesini öngören belirleyici değişkenlerin ortaya çıkarılması amaçlanmıştır. Gereç ve Yöntem: Çalışmaya Kasım 2021 - Kasım 2022 tarihleri arasında Prof. Dr. Cemil Taşcıoğlu Şehir Hastanesi Dermatoloji Kliniği ve Bakırçay Üniversitesi Çiğli Eğitim Araştırma Hastanesi Dermatoloji Kliniği psöriasis polikliniklerinde orta-şiddetli psöriasis tanısı ile takip edilen, endikasyon dahilinde standart doz guselkumab, risankizumab, sekukinumab, iksekizumab tedavilerinden birini almış ve/veya almakta olan, 18 yaş ve üzeri psöriasis hastaları dahil edildi. Çalışma retrospektif, gerçek yaşam kohort çalışması olarak tasarlandı. Çalışmada her ilaç grubunda 25 kişi olmak üzere toplam 100 hasta vardı. Tüm hastaların bir yıllık (52 hafta) dosya verileri retrospektif olarak değerlendirilip demografik özellikleri, ilaçta etkinlik, güvenlik, sağkalım, C-reaktif protein (CRP) ve sistemik inflamasyon indeksi (Sİİ) parametreleri takip haftalarına göre analiz edilerek karşılaştırıldı. İlaç kesilmesini öngören faktörler araştırıldı. Bulgular: Demografik özellikler gruplar arasında benzerdi. 52. haftada guselkumab, risankizumab ve iksekizumab grubunun psöriasis alan ve şiddet indeksi (PAŞİ) ortalaması, sekukinumab alan gruba göre istatistiksel olarak anlamlı düzeyde düşük bulundu (p:0,001). 52. haftada PAŞİ 50, 75, 90 ve 100'e ulaşan hastaların oranı, sekukinumab için en düşüktü (sırasıyla p:0.004, p:0.012, p:0.001, p:0.008). Dermatoloji yaşam kalite indeksi (DYKİ) ortalaması 52. haftada guselkumab ve risankizumab grubunda, sekukinumabtan anlamlı düşükken (sırasıyla p:0.001, p
Özet (Çeviri)
Aim: Psoriasis is a systemic inflammatory disease that significantly impairs the life quality of the patients. The biological agent journey in treatment has turned to interleukin (IL)-17 and IL-23 inhibitors, with the understanding of the importance of the IL-23/Th17 cytokine-cell axis in the pathogenesis of psoriasis. Although IL-17 and IL-23 inhibitors have been reported as effective and safe in phase III and real-life studies, the data obtained are limited for comparing IL-17 and IL-23 inhibitors. In this study, it was aimed to investigate and compare the efficacy, safety, drug survival times and inflammatory parameters by retrospectively examining the 1-year real-world data of patients who received one of the treatments such as guselkumab, risankizumab, secukinumab, ixekizumab, which are available in our country for moderate-to-severe psoriasis, and to reveal the determinant variables. Materials and Methods: The study was conducted between November 2021 and November 2022 at Prof. Dr. Cemil Taşcıoğlu City Hospital Dermatology Clinic and Bakırçay University Çiğli Training and Research Hospital Dermatology Clinic follow-up outpatient clinics. Psoriasis patients aged 18 years and older, followed up with the diagnosis of moderate-severe psoriasis, who received and/or were taking one of the standard doses of guselkumab, risankizumab, secukinumab, ixekizumab within the indications, were included in the study. In the study, there were a total of 100 patients, 25 in each drug group. File data of all patients for one year (52 weeks) were evaluated retrospectively, and demographic characteristics, drug efficacy, safety, survival, c-reactive protein (CRP) and systemic inflammation index (SII) parameters were analyzed and compared according to follow-up weeks. Factors predicting drug discontinuation were investigated. Results: Demographic characteristics were similar between groups. At 52 weeks, the mean psoriasis area and severity index (PASI) of the guselkumab, risankizumab, and ixekizumab groups was statistically significantly lower than the group receiving secukinumab. The rates of patients achieving PASI 75, 90, and 100 at week 52 was highest for risankizumab. The rates of patients achieving PASI 75, 90, and 100 was the lowest for secukinumab statistically significant. While the mean dermatology quality of life index (DLQI) was lower than secukinumab in the guselkumab and risankizumab groups at week 52, there was no significant difference between them and ixekizumab. At 52 weeks, the mean visual analogue scale skin pruritus (VASP) was statistically significantly higher in the secukinumab group compared to risankizumab. Adverse effects rates were similar in all treatment groups. However, injection site reaction was significantly higher in the ixekizumab group than in the other groups. At 52 weeks, drug survival was statistically significantly higher in the guselkumab group than in the ixekizumab and secukinumab groups. At 52 weeks, drug survival was statistically significantly higher in the risankizumab and ixekizumab groups compared to the secukinumab group. Secukinumab had the lowest drug survival. In univariate Cox regression analysis, a family history of psoriasis in first-degree relatives and a high initial PASI value; In the multivariate Cox regression analysis, being a primary school graduate, having a family history of psoriasis in second degree relatives, and switching from anti-TNF-α therapy were defined as the factors predicting drug discontinuation. There was no statistically significant difference between the groups in CRP and SII values at baseline and follow-up weeks. Conclusion: Our study showed that higher PASI 90 and 100 responses were achieved with IL-23 inhibitors than with IL-17 inhibitors in the period from week 24-28 to week 52 in psoriasis. Risankizumab was found to be as fast-acting as IL-17 inhibitors. In terms of PASI 100 responses, from week 12-16 to week 52, the highest response was seen in the risankizumab group. Although the mean of PASI, DYKI, and VASP in all treatment groups decreased from baseline at each follow-up week; risankizumab was found to be the group with the highest efficacy in relieving itching, improving quality of life, and clearing skin lesions. This rate was followed by guselkumab, iksekizumab and secukinumab, respectively. IL-23 inhibitors had higher on drug survival rates. The lowest drug survival rate at 52 weeks was observed in the secukinumab group with a rate of 43.1%. Although the number of biological treatments used previously did not affect drug retention, it was determined that switching from anti-TNF-α treatments that was a risk factor for discontinuing the drug. Serious side effects were not observed in our study, and it was observed that these treatments had a positive safety profile. It was observed that all biological agents suppressed inflammation and caused a decrease in CRP and SII values. In the treatment of psoriasis, the discovery of inflammatory cytokines and treatments for them has led to an increase in treatment options. Biological treatments suppress inflammation and improve quality of life. However, because the dominant pathogenetic mechanism is not known for each patient and there are accompanying environmental factors, patient-specific options should be determined when deciding on treatment. Our study may help individualize treatment and choice treatment by enabling the comparison of real-life data of guselkumab, risankizumab, ixekizumab, and secukinumab. Prospective studies with larger sample groups are needed to confirm these data.
Benzer Tezler
- Plak psoriasis hastalarında IL-12/23 ve IL-17 inhibitör tedavilerinin klinik sonuçlarının retrospektif analizi
Retrospective analysis of clinical results of IL-12/23 and IL-17 inhibitor treatments in plaque psoriasis patients
SELMA YASTI
Tıpta Uzmanlık
Türkçe
2024
DermatolojiBursa Uludağ ÜniversitesiDeri ve Zührevi Hast. Ana Bilim Dalı
PROF. DR. KENAN AYDOĞAN
- Sistemik konvansiyonel ve/veya biyolojik ajan tedavisi alan 65 yaş ve üzeri orta-şiddetli psöriasis hastalarının demografik özellikleri ve tedavi yanıtlarının değerlendirilmesi
Evaluation of demographic characteristics and treatment response of moderate-to-severe psoriasis patients aged 65 years and older receiving systemic conventional and/or biological agent therapy
TAHA YİĞİT BAŞAR
Tıpta Uzmanlık
Türkçe
2024
DermatolojiSağlık Bilimleri ÜniversitesiDermatoloji Ana Bilim Dalı
DR. ZEYNEP TOPKARCI
- Psöriasis tedavisinde kullanılan biyolojik ajanların sistemik immün inflamasyon indeksi üzerindeki etkilerinin değerlendirilmesi
Evaluation of the effects of biological agents used in the treatment of psoriasis on the systemic immune inflammation index
GİZEM GÖKÇEDAĞ ÜNSAL
Tıpta Uzmanlık
Türkçe
2023
DermatolojiSağlık Bilimleri ÜniversitesiDeri ve Zührevi Hast. Ana Bilim Dalı
UZMAN ZEYNEP TOPKARCI
- Psoriazis hastalarında kullanılan IL-17 ve IL-23 inhibitörlerinin laboratuvar parametrelerine etkisi
The effect of IL-17 and IL-23 inhibitors in psoriasis patients on laboratory parameters
BURAK EKİNCİ
Tıpta Uzmanlık
Türkçe
2023
DermatolojiSağlık Bilimleri ÜniversitesiDeri ve Zührevi Hast. Ana Bilim Dalı
PROF. DR. ŞİRİN YAŞAR
- Saçlı deri psoriazis ve deri psoriaziste histopatolojik açıdan ve immünohistokimyasal olarak ölçülen TNFα, IL17 ve IL23 ekspresyonları açısından karşılaştırılması
Comparison of scalp psoriasis and body psoriasis in terms of histopathologically and immunohistochemically measured TNFα, IL17, and IL23 expressions
SHOHRAT ARAZOV
Tıpta Uzmanlık
Türkçe
2024
DermatolojiNecmettin Erbakan ÜniversitesiDeri ve Zührevi Hast. Ana Bilim Dalı
PROF. DR. RECEP DURSUN