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Psoriasis tanısı ile en az iki farklı biyolojik alan hastaların tek biyolojik ilaç alan hastalarla klinik ve demografik özelliklerinin retrospektif olarak karşılaştırılması

Comparison of clinical and demographic characteristics of patients with psoriasis receiving a single biologic agent and those receiving at least two different biologic agents: A retrospective study

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  1. Tez No: 870342
  2. Yazar: FATMA KÜBRA GÜL ÇİFTÇİ
  3. Danışmanlar: DOÇ. DR. ALGÜN POLAT EKİNCİ
  4. Tez Türü: Tıpta Uzmanlık
  5. Konular: Dermatoloji, Dermatology
  6. Anahtar Kelimeler: Belirtilmemiş.
  7. Yıl: 2023
  8. Dil: Türkçe
  9. Üniversite: İstanbul Üniversitesi
  10. Enstitü: Tıp Fakültesi
  11. Ana Bilim Dalı: Deri ve Zührevi Hast. Ana Bilim Dalı
  12. Bilim Dalı: Belirtilmemiş.
  13. Sayfa Sayısı: 120

Özet

Giriş ve Amaç: Psoriasis tüm dünyada sıklığı ortalama %2-4 arasında değişen, primer olarak deriyi tutan ancak eklemleri de etkileyebilen, obezite, hipertansiyon, diabetes mellitus, dislipidemi, kardiyovasküler hastalıklar, psikiyatrik hastalıklar gibi birçok komorbiditenin eşlik edebildiği kronik inflamatuar sistemik bir hastalıktır. Başlıca tedavi seçenekleri; topikal tedaviler, fototerapi, sistemik konvansiyonel tedaviler ve biyolojik ilaçlardır. Hastaların yaklaşık %20'si orta veya şiddetli tutulumla karakterize olup bu hastalarda öncelikle metotreksat, siklosporin veya asitretin gibi sistemik konvansiyonel tedaviler ve/veya fototerapi bunların kontrendike olduğu, kullanılamadığı veya başarısız olduğu durumlarda biyolojik ilaçlar kullanılmaktadır. Biyolojik ilaçlar hastalık patogenezinde kritik rolü olan sitokinleri inhibe ederek hedefe yönelik tedavi şansı sunarlar. Bu ilaçların psoriasis tedavisinde kullanılmasıyla tedavide yeni bir çağ açılmıştır. Bazı hastalarda artık tek ilaçla hastalıksız deri hedefine ulaşılabilmektedir. Ancak bazı hastalarda primer ya da sekonder yanıtsızlık gibi nedenlerle ilaç değişikliği ihtiyacı doğmaktadır. Hastalar arasındaki bu yanıt farklılığının sebepleri henüz bilinmemektedir. Bu çalışma ile İstanbul Tıp Fakültesi Deri ve Zührevi Hastalıklar Anabilim Dalı Psoriasis Polikliniği'nde takip edilen tek biyolojik ilaç kullanan hastalar ile birden fazla biyolojik ilaç alan hastaların klinik ve demografik özelliklerinin karşılaştırılarak birden fazla ilacın kullanıldığı hastalarda ilaç değişikliğine etki eden faktörlerin araştırılması ve bağımsız risk faktörlerinin tespit edilmesi planlandı. Gereç ve Yöntem: İstanbul Tıp Fakültesi Deri ve Zührevi Hastalıklar Anabilim Dalı Psoriasis Polikliniği'nde Ocak 2005 ile Kasım 2022 tarihleri arasında takipli olan ve psoriasis tanısı ile biyolojik ilaç tedavisi verilen hastaların dosyaları retrospektif olarak tarandı. Tüm hastalar için yaşı, cinsiyeti, takip süresi, hastalık süresi, psoriasis başlangıç yaşı, ilk biyolojik ilaç başlangıç yaşı, ilk biyolojik ilaç öncesi hastalık süresi, sigara ve alkol kullanımı, ailede psoriasis öyküsü, ek psoriasis alt tipi, saçlı deri, palmoplantar bölge, genital bölge, tırnak tutulumu, eşlik eden hastalıklar (üveit, inflamatuar bağırsak hastalığı, tiroid hastalığı, periferik sinir hastalığı, hepatit B taşıyıcılığı, vitiligo, pulmoner hastalık), komorbiditeler (psoriatik artrit, psikiyatrik hastalık, malignite öyküsü, hipertansiyon, diabetes mellitus, dislipidemi, obezite, koroner arter hastalığı, hepatosteatoz, serebrovasküler olay), psoriatik artrit şekli, psoriatik artrit tutulum zamanı, biyolojik ilaçtan önce kullandığı konvansiyonel tedaviler, fototerapi öyküsü, sırasıyla kullanılan biyolojik ilaçlar, biyolojik ilaç öncesi bazal PASI değeri, biyolojik ilaç kesilme nedenleri kaydedildi. Hastalar tek biyolojik ilaç kullananlar ve birden fazla biyolojik ilaç kullananlar olmak üzere iki gruba ayrılarak kaydedilen parametreler karşılaştırıldı. İstatistiksel analizler için SPSS 22.0 (Statistical Packages of Social Sciences) programı kullanıldı. Çalışma verileri normal dağılıma uygunluğuna bağlı olarak tanımlayıcı istatistiksel metotlar (ortalama, standart sapma, medyan, frekans, yüzde, çeyrekler açıklığı, minimum, maksimum) ile değerlendirildi. Nicel verilerin normal dağılıma uyup uymadığı Shapiro-Wilk testiyle ve grafiksel incelemelerle kontrol edildi. Kategorik verilerin karşılaştırılmasında ki-kare testi ve Fisher kesin olasılık testi kullanıldı. Sürekli veriler normal dağılıma uyuyorsa Student t-test, uymuyorsa Mann Whitney U testi ile karşılaştırıldı. Biyolojik ilaç değişikliği için bağımsız risk faktörlerini saptamak amacıyla multivariate analizi olarak lojistik regresyon analizi kullanıldı. Univariate analizlerde p

Özet (Çeviri)

Introduction and Objective: Psoriasis is a chronic inflammatory systemic disease that primarily affects the skin but can also involve the joints, with a prevalence ranging from 2% to 4% worldwide. It is often associated with various comorbidities such as obesity, hypertension, diabetes mellitus, dyslipidemia, cardiovascular diseases, and psychiatric disorders. The main treatment options include topical therapies, phototherapy, conventional systemic therapies, and biologic agents. Approximately 20% of patients have moderate to severe involvement, for whom conventional systemic therapies such as methotrexate, cyclosporine, or acitretin, and/or phototherapy are primarily used initially. However, in cases where these agents are contraindicated, inappropriate or unsuccessful, biological drugs, which are targeted therapies by inhibiting cytokines that play a critical role in the pathogenesis of the disease, are used. A new era has opened in psoriasis with the use of biological drugs. Some patients can now achieve disease-free skin with a single medication. However, some patients require switching due to primary or secondary unresponsiveness. The reasons for this different response among patients are still unknown. This study aims to compare the clinical and demographic characteristics of patients receiving a single biologic agent with those receiving multiple biologic agents at the Psoriasis Clinic of Istanbul Faculty of Medicine, Department of Dermatology and Venereology. The study also aims to investigate factors influencing switching and determine independent risk factors in patients receiving multiple biological agents. Materials and Methods: The medical records of patients diagnosed with psoriasis who were under follow-up and received biologic therapy between January 2005 and November 2022 at the Psoriasis Clinic of Istanbul Faculty of Medicine, Department of Dermatology and Venereology, were retrospectively reviewed. Various parameters were recorded for all patients, including age, gender, duration of follow-up, duration of the disease, age at onset of psoriasis, age at initiation of the first biologic agent, duration of the disease before the first biologic agent, smoking and alcohol use, family history of psoriasis, additional psoriasis subtypes, involvement of scalp, palmoplantar region, genital area, and nail, associated diseases (uveitis, inflammatory bowel disease, thyroid disease, peripheral nerve disease, hepatitis B carrier status, vitiligo, pulmonary disease), comorbidities (psoriatic arthritis, psychiatric disorders, history of malignancy, hypertension, diabetes mellitus, dyslipidemia, obesity, coronary artery disease, hepatosteatosis, cerebrovascular events), subtype of psoriatic arthritis, time of psoriatic arthritis involvement, conventional therapies used before biologic agents, history of phototherapy, sequentially used biologic agents, baseline PASI (Psoriasis Area and Severity Index) score before biologic agents, and reasons for discontinuation of the biologic agents. The patients were divided into two groups: those receiving a single biologic agent and those receiving multiple biologic agents. The recorded parameters were compared between the two groups. Statistical analysis was performed using SPSS 22.0 (Statistical Packages of Social Sciences). Descriptive statistical methods (mean, standard deviation, median, frequency, percentage, interquartile range, minimum, maximum) were used to evaluate the study data. The normal distribution of quantitative data was assessed using the Shapiro-Wilk test and graphical examinations. The chi-square test and Fisher's exact probability test were used for the comparison of categorical data. If continuous data followed a normal distribution, Student's t-test was applied; otherwise, the Mann-Whitney U test was used for comparison. Logistic regression analysis was employed to determine independent risk factors of switching in patients receiving multiple biologic agents. Results: A total of 314 patients diagnosed with psoriasis and receiving biologic therapy were included in the study. Among them, 185 patients (58.9%) received a single biologic agent, while 129 patients (41.1%) received multiple biologic agents. In the group receiving multiple biological drugs, compared to the group receiving a single biological drug, statistically significant differences were found in the baseline PASI score, frequency of erythroderma, nail involvement, psoriatic arthritis, dactylitis, earlier onset of skin involvement before joint involvement, diabetes mellitus, obesity, dyslipidemia, hepatosteatosis, and the use of conventional treatment alongside the first biological drug. Univariate logistic regression analysis revealed that disease duration, follow-up duration, baseline PASI score, nail involvement, history of erythroderma, psoriatic arthritis, dactylitis, cardiovascular/metabolic comorbidity, obesity, diabetes mellitus, dyslipidemia, and hepatosteatosis were positively associated with the likelihood of switching biologic medication, while the age of psoriasis onset showed a negative association. In the multivariate reduction model, the significant independent differentiating factors associated with switching of biologic drug were early age of onset of psoriasis, psoriatic arthritis, history of erythroderma, at least one cardiovascular and/or metabolic comorbidity, and receiving additional conventional treatment with the first biological drug. In the multivariate logistic regression analysis using the Forward LR method, erythroderma was identified as the independent factor with the highest predictive power for switching. When early age of onset of psoriasis, psoriatic arthritis, erythroderma, cardiovascular and/or metabolic comorbidity, and receiving additional conventional treatment with the first biological drug were evaluated together, the predictive accuracy rate for switching was found to be 68.5%. Among patients who switched medication, the most common reason for discontinuing the first biological drug was secondary treatment failure (n=62, 48.1%). This was followed by adverse effects (n=22, 17.1%), primary treatment failure (n=20, 15.5%), social reasons (n=14, 11%) such as patient preference, pregnancy, relocation, ineffectiveness in the joint (n=7, 5.4%), and comorbidity (n=4, 3.1%). In the group where switching occurred, the second biological drug used by patients was most frequently discontinued due to secondary treatment failure (n=29, 37.6%). This was followed by adverse effects (n=14, 18.2%), primary treatment failure (n=13, 17%), ineffectiveness in joint involvement (n=11, 14.2%), and social reasons (n=10, 13%) such as patient preference, pregnancy, relocation. When comparing patients based on their first biological drug used, no statistically significant differences were found between the two groups for etanercept, adalimumab, and certolizumab. Infliximab and efalizumab were more frequently used as the initial biological drug in the group receiving multiple biological drugs, while ustekinumab, secukinumab, and anti-IL23 inhibitors (guselkumab and risankizumab) were statistically significantly more common as the first biological drug in the group receiving a single biological drug. Conclusions: This retrospective study provides insights into the clinical and demographic characteristics of patients receiving a single biologic agent versus multiple biologic agents for psoriasis treatment. Younger age of onset of psoriasis, presence of psoriatic arthritis, history of erythroderma, at least one cardiovascular and/or metabolic comorbidity, and receiving additional conventional therapy with the first biologic were identified as independent risk factors for drug switching. Therefore, to act prudently as a dermatologist, we recommended to screen each patient for cardiovascular and/or metabolic comorbidities, control modifiable risk factors, and assess psoriatic arthritis at baseline and periodically thereafter. When suspected, patients should be referred to relevant specialists.

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