Evaluation of serial QuantiFERON-TB Gold in tube test results and tuberculosis infection status in patients with psoriasis receiving anti-IL-17 treatment (secukinumab and ixekizumab): Real-world data from a tuberculosis-endemic country.

BACKGROUND: In comparison with TNF-α inhibitors, anti-IL-17A agents are considered to have a lower risk of active tuberculosis (TB) or latent TB infection (LTBI) reactivation. METHODS: In this study, we aimed to evaluate the TB infection status and serial QuantiFERON-TB-Gold in tube test (QFT) results of psoriasis patients using IL-17 inhibitors (secukinumab [SEC] and ixekizumab [IXE]) in a real-world setting from a tuberculosis-endemic country. Patients who used an anti-IL-17 agent for at least 3 months in our follow-up were included in the study. Patients' clinical and demographic features, baseline QFT results and latest QFT results (if any), and TB infection status were noted from the past medical records. RESULTS: A total of 717 patients, of whom 333 (46.4%) were female, were included in the study. The cumulative exposure time to an anti-IL-17 agent was 14,147 patient-months, 9743 patient-months for SEC and 4404 patient-months for IXE. Also, 459 (SEC = 305/IXE = 154) patients used an anti-IL-17 agent for ≥ 12 months. Of these, 125 had positive baseline QFT results. In all, 334 had negative baseline QFT results. The latest QFT result of 309 was also negative (persistent seronegative group). During follow-up, the QFT results of 10 patients changed from negative to positive (positive seroconversion group). Seven of them were using SEC and three were using IXE, respectively. No case of active TB infection was detected. CONCLUSION: In our study, the positive seroconversion rate of 10/334 seems high, but this did not translate to active disease. However, closer monitoring may be required, especially in patients with advanced age, the presence of PsA, long disease duration and long anti-IL-17 treatment duration.

Long-term efficacy, safety, and drug survival of secukinumab in patients with psoriasis in Turkey: a retrospective analysis of real-world experience.

Introduction: Secukinumab (SEC) has been shown to be highly effective and safe in the treatment of moderate to severe plaque psoriasis (PsO), but data on SEC's long-term drug survival are limited. Aim: To analyse the survival rate of SEC and its predictive factors of survival, together with the drug safety and efficacy. Material and methods: Data of 268 patients who received SEC between May 2018 and April 2022 with moderate to severe psoriasis and/or psoriatic arthritis were analysed retrospectively. Psoriasis Area Severity Index (PASI) was used to define effectiveness. Drug survival was examined using the Kaplan-Meier analysis and Cox regression analysis was used to analyse predictive factors. Results: PASI 75/90/100 responses achieved at week 16 (89.5%, 78%, and 16.2%, respectively) were well maintained at week 52 (96.3%, 90.7%, and 15.4%, respectively). The drug survival probability rates for SEC were 94.4% at 12 months, 88.4% at 24 months, 78.6% after 3 years, 52.7% after 4 years. Concomitant treatments, dose escalation and family history of psoriasis were associated with a higher risk for SEC withdrawal. Conclusions: Close monitoring may improve SEC survival in psoriasis patients who require dose escalation and concomitant drugs.

Efficacy and Safety of Omalizumab Updosing in Chronic Urticaria: A Retrospective Study.

Omalizumab is an effective and safe treatment option with licensed doses in patients with chronic spontaneous urticaria (CSU); however, some patients are not responsive to licensed doses and require updosing. As studies concerning updosing were insufficient, the present study evaluated the effectiveness and safety of omalizumab updosing (300 mg every 2 weeks) in CSU patients. Data of CSU patients treated with omalizumab were analyzed retrospectively. As an outcome measure, physician assessment of treatment response (complete response [CR], partial response, and unresponsiveness) was used. In all, 49 patients depicting CR to omalizumab 300 mg every 4 weeks and 54 patients treated with omalizumab 300 mg every 2 weeks were included in the study. Mean duration of the disease in updosing group was significantly lengthier than the CR group. The mean percentage level of eosinophils and basophils was significantly higher in the CR group. The history of systemic corticosteroid and oral cyclosporine treatment was significantly more frequent in the updosing group. Treatment with omalizumab 300 mg every 2 weeks for 12 weeks led to CR in 41 patients (75.9%). Our results confirmed the efficacy and safety of omalizumab updosing. Low baso-phil and eosinophil levels could also be important factors in defining the need for updosing.

Ixekizumab treatment in patients with moderate-to-severe plaque psoriasis in a real-world clinical setting.

BACKGROUND: The efficacy and safety reports of ixekizumab for moderate-to-severe plaque psoriasis may vary between clinical trials and real-world studies. AIM: To analyze the real-world data of ixekizumab therapy to evaluate its efficacy and safety and highlight the factors influencing the treatment response in the real-world scenario. PATIENTS/METHODS: Data of 82 adult patients with moderate-to-severe chronic plaque psoriasis are included in this study. Psoriasis area severity index (PASI) 75/90/100 responses at 4, 16, 24, and 48 weeks were analyzed retrospectively from patient charts by examining demographic and clinical characteristics of the patients, especially their previous biologic experience, obesity, and involvement of hard-to-treat areas. RESULTS: PASI75, PASI90, and PASI100 responses were achieved in 92.4%, 86.1%, and 26.6% patients at week 16 and maintained till week 48 in 92.3%, 86.5%, and 17.3% patients. PASI90 responses in obese patients were significantly lower than non-obese patients at week 4 (33.3% vs. 69.6%, p = 0.042), but this difference was minimized by week 16 (82.4% vs. 90%, p = 0.405). PASI90 responses in biologic-naive patients were significantly higher than biologic-experienced patients at week 16 (p = 0.015). Involvement of hard-to-treat areas was negatively associated with PASI90 responses at week 16 (OR: 1591805.842; 95% CI: 1.223-2071404486740.201; p = 0.047). CONCLUSION: Ixekizumab provides an effective and safe biologic treatment option to patients with moderate-to-severe plaque psoriasis. Obesity, though it affects the early treatment response (till week 4), does not upset the overall treatment response beyond week 16. Previous biologic exposure and involvement of hard-to-treat areas are important prognostic factors for achieving high PASI responses in psoriatic patients.

A real life experience with ustekinumab: The effectiveness of 45 mg on patients greater than 80 kg but lower than 100 kg.

Ustekinumab is a fully human monoclonal antibody has been demonstrated efficacious and safe in clinical trials. However, there are few real-life data evaluating the efficacy of ustekinumab. The aim of this retrospective follow up study was showing the efficacy in 58 adult patients with moderate to severe psoriasis treated at least 24 weeks with ustekinumab. The efficacy was evaluated as PASI75, PASI90, and PASI100 response rates at week 4, 12, 24, and 36 in patient groups according to the treatment dose, weight, biologic treatment naivety, and obesity. PASI75, PASI90, and PASI100 response rates were 79.3%, 62.1%, and 8.6% respectively, at week 12 and, 92.5%, 71.7% and 9.4%, respectively, at week 36. PASI75, PASI90, and PASI100 responses were generally higher in naive patients to the biologic therapy. Also, the responses were generally higher in non-obese patients at 4 and 12 weeks. According to the weight categories, PASI100 response rates were higher in the 81-99 kg group at week 12. In conclusion, ustekinumab is an effective and safe treatment option for moderate to severe psoriasis patients. It seems to be more effective in biologic treatment naive patients and non-obese patients. A 45 mg dose of ustekinumab seems to be effective in patients weighing 99 kg or less.

Is dupilumab effective in adult-onset atopic dermatitis: Real-life experience of 16 patients.

BACKGROUND: Dupilumab is approved for the treatment of atopic dermatitis (AD). However, there are few studies demonstrating its efficacy and safety, particularly in the treatment of adult-onset AD. OBJECTIVE: The aim of this study is to evaluate the real-life experience regarding the efficacy and safety of dupilumab in the treatment of adult-onset AD. METHODS: This study is a case series in retrospective design. Patients with the diagnosis of adult-onset AD, using dupilumab at a standard dose for at least 3 months, were included in the study. Demographic and laboratory data of the cases, data regarding to dupilumab treatment, were recorded. The eczema area severity index (EASI) and the visual analog scale (VAS) for itch were used to evaluate treatment efficacy. RESULTS: A total of 16 patients, 6 female and 10 male, were included. The median age was 41 years, the median age of the disease onset was 37.5 years, and the median duration of the disease was 90 months. The median duration of the dupilumab treatment was 10.5 months. The mean percent reduction from baseline in EASI score was 85.8 ± 12.2 at 3 months, 90.7 ± 9.3 at 6 months, and 93.1 ± 5 at 12 months. The mean percent reduction from baseline in VAS itch score was 82.2 ± 8.6 at 3 months. Acute vestibular neuritis was developed in one patient during the dupilumab therapy and resolved with anti-inflammatory therapy. CONCLUSION: Dupilumab seems to be highly effective and safe in the treatment of adult-onset AD. The present study is important as it is the first study to evaluate this patient group specifically.

Clinical efficacy and safety of secukinumab for psoriasis in a real-world setting in Turkey.

OBJECTIVES: The aim of this study was to examine the real-life efficacy and safety of secukinumab for psoriasis (PsO) along with the factors that could have an effect on clinical response. METHODS: Data in the charts of 121 patients with chronic PsO who were initiated secukinumab treatment between May-2018 and April-2020 with an observation period of up to 52 weeks were retrospectively analyzed. Demographic and clinical characteristics of patients, Psoriasis Area and Severity Index (PASI) scores and side effects were evaluated. RESULTS: A 75%, 90%, and 100% reduction in the baseline PASI score was observed in 84.3%, 68.6%, and 18.2% of patients at week 16, respectively. Obesity and previous biologic experience were important predictive factors for PASI 75 response at week 16. CRP levels, previous biological experience and age at PsO onset are found to be important factors in defining the need for updosing. Side-effect rates (9.7%) were not higher among patients with concomitant medications (13.6%) and dose escalation (13.3%). CONCLUSION: Our results are in line with the efficacy and safety profiles of secukinumab in PsO reported previously. Dose escalation and the addition of concomitant medications may increase response rates.