Efficacy and safety of secukinumab (IL-17A inhibitor) in treating moderate to severe plaque psoriasis in real-world clinical practice: A Canadian multicenter retrospective study

2017 ◽  
Vol 76 (6) ◽  
pp. AB114 ◽  
Keyword(s):  
Clinical Practice ◽  
Retrospective Study ◽  
Real World ◽  
Plaque Psoriasis ◽  
Efficacy And Safety ◽  
Severe Plaque Psoriasis

scholarly journals Effective and Safe Treatment of Psoriatic Disease with the Anti-IL-23p19 Biologic Tildrakizumab: Results of a Real-World Prospective Cohort Study in Nonselected Patients

Dermatology ◽  
2021 ◽  
pp. 1-5
Author(s):  
Katharina A. Drerup ◽  
Claudia Seemann ◽  
Sascha Gerdes ◽  
Ulrich Mrowietz
Keyword(s):  
Cohort Study ◽  
Real World ◽  
Plaque Psoriasis ◽  
Prospective Cohort ◽  
Registry Data ◽  
Comparable Efficacy ◽  
Routine Practice ◽  
Efficacy And Safety ◽  
Phase 3 ◽  
Severe Plaque Psoriasis

<b><i>Background:</i></b> After registration of drugs, evidence about efficacy and safety is solely based on data of phase 2/3 clinical trial programs. A major drawback is the selection of patients following inclusion/exclusion criteria. There is a considerable time and knowledge gap between study and registry data that evaluate real-world evidence (RWE). To close this gap, prospective cohort data are helpful. <b><i>Objectives:</i></b> Soon after tildrakizumab, an interleukin 23p19-inhibitor, was registered for moderate-to-severe plaque psoriasis, a prospective single-center cohort study was established to evaluate efficacy and safety of tildrakizumab in daily practice. <b><i>Methods:</i></b> Following approval of tildrakizumab, patients with moderate-to-severe plaque psoriasis eligible for systemic treatment were included into the Kiel Tildra Cohort (KTC) and followed using routine assessments of efficacy, psoriasis area and severity index (PASI), body surface area (BSA), dermatology life quality index (DLQI), itch (visual analog scale), and safety. Data of the KTC were compared to the respective phase 3 clinical trials. <b><i>Results:</i></b> The KTC included 150 patients differing substantially from those in the trial program. There was a high rate of previous systemic (87.3%) and biologic (31.8%) therapy and of comorbidity in the KTC as compared to the phase 3 studies. Due to the best practice approach, baseline PASI was lower in the KTC, but DLQI was similar in both groups. At the time of this analysis, 126 patients completed week 28, 92 patients week 52, and 58 patients week 76, respectively. There was a constant improvement in PASI, BSA, DLQI, and itch from baseline until week 76. There was no clinically meaningful laboratory abnormality. <b><i>Conclusions:</i></b> Patients treated in routine practice with tildrakizumab differed substantially from the phase 3 studies. Despite systemic pre-treatment and increased comorbidity, tildrakizumab showed comparable efficacy and safety in the KTC. Prospective cohort studies are a suitable tool to generate RWE before registry data become available.

Efficacy and Safety of Apremilast Monotherapy for Moderate to Severe Psoriasis: Retrospective Study

2018 ◽  
Vol 22 (3) ◽  
pp. 290-296 ◽  
Author(s):  
Arvin Ighani ◽  
Jorge R. Georgakopoulos ◽  
Linda L. Zhou ◽  
Scott Walsh ◽  
Neil Shear ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Clinical Trials ◽  
Real World ◽  
Plaque Psoriasis ◽  
Safety Data ◽  
Retrospective Chart Review ◽  
Oral Drug ◽  
Efficacy And Safety ◽  
Full Spectrum ◽  
Severe Plaque Psoriasis

Background: Apremilast is a new oral drug for the treatment of moderate to severe plaque psoriasis that reduces inflammation by inhibiting phosphodiesterase 4. Its efficacy and safety data are limited; hence, real-world outcomes are important for elucidating the full spectrum of its adverse events (AEs) and expanding generalizability of clinical trial findings. Objective: Assess the efficacy and safety of apremilast monotherapy in real-world practice. Methods: A retrospective chart review was conducted in 2 academic dermatology practices. Efficacy was measured as the proportion of patients achieving a ≥75% reduction from baseline Psoriasis Area and Severity Index score (PASI-75) or a Psoriasis Global Assessment (PGA) score of 0 (clear) or 1 (almost clear) at 16 weeks. Safety was measured as the proportion of patients reporting ≥1 AE at 16 weeks. Results: Thirty-four patients were included. Efficacy: 19 patients (55.9%) achieved PASI-75 or PGA 0/1. Safety: 23 patients (67.6%) experienced ≥1 AEs. Five patients (14.7%) withdrew treatment prior to week 16 due to AEs. One patient withdrew treatment due to mood lability and depression. Common AEs included headache (32.4%), nausea (20.6%), diarrhoea (14.7%), weight loss (8.8%), and loose stool (8.8%). Conclusion: Apremilast monotherapy had higher efficacy with similar safety outcomes in the real world compared to clinical trials. There were higher proportions of reported headaches compared to clinical trials. This study supports the apremilast monotherapy clinical trial findings, suggesting that it has an acceptable safety profile and significantly reduces the severity of moderate to severe plaque psoriasis. Limitations include the retrospective nature of the study.

Ixekizumab (Interleukin 17A Antagonist): 12-week Efficacy and Safety Outcomes in Real-world Clinical Practice

2018 ◽  
Vol 23 (2) ◽  
pp. 174-177 ◽  
Author(s):  
Jorge R. Georgakopoulos ◽  
Michelle Phung ◽  
Arvin Ighani ◽  
Jensen Yeung
Keyword(s):  
Clinical Practice ◽  
Real World ◽  
Plaque Psoriasis ◽  
Current Knowledge ◽  
Therapeutic Option ◽  
Injection Site Reaction ◽  
Retrospective Chart Review ◽  
Phase Iii ◽  
Physician Global Assessment ◽  
Efficacy And Safety

Background: Current knowledge of the efficacy and safety of ixekizumab is limited to data from phase III randomized controlled trials (RCTs). A gap exists in our understanding of treatment outcomes of this newly available biologic in real-world clinical practice. Objective: This study explores the efficacy and safety of ixekizumab in non-RCT patients to compare real-world outcomes to those reported in RCTs. Methods: We conducted a multicentre, retrospective chart review of patients treated with ixekizumab therapy for moderate-to-severe plaque psoriasis. Efficacy (Psoriasis Area and Severity Index score of 75 or Physician Global Assessment of 0 or 1) and safety (reported adverse events [AEs]) were assessed following a 12-week treatment period. Results: Of the 60 patients included, 45 (75.0%) achieved efficacious outcomes after 12 weeks of ixekizumab treatment. Twenty-two (36.7%) patients experienced one or more AEs, of whom only 3 (5.0%) withdrew from treatment as a result. Common AEs included injection site reaction/erythema/pain (13.3%) and dermatitis (5.0%). Conclusion: Ixekizumab has shown to be a safe and effective therapeutic option for plaque psoriasis in real-world practice. It does not appear that patients experience more AEs in real-world clinics than those in clinical trials.

scholarly journals Real-world efficacy of biological agents in moderate-to-severe plaque psoriasis: An analysis of 75 patients in Taiwan

PLoS ONE ◽  
2020 ◽  
Vol 15 (12) ◽  
pp. e0244620
Author(s):  
Yu-Chen Chen ◽  
Yi-Ting Huang ◽  
Chao-Chun Yang ◽  
Edward Chia-Cheng Lai ◽  
Cheng-Han Liu ◽  
...  
Keyword(s):  
Clinical Data ◽  
Real World ◽  
Plaque Psoriasis ◽  
Severity Index ◽  
Tertiary Hospital ◽  
Biological Agents ◽  
Efficacy And Safety ◽  
Real World Data ◽  
Severe Plaque Psoriasis ◽  
Asian Populations

Background Real-world clinical data on psoriasis patients receiving different biological agents is needed, especially in Asian populations. Objectives Our aim is to compare and analyze the efficacy and safety profile of four biological agents (etanercept, adalimumab, ustekinumab and secukinumab) in a real-world setting in Taiwan. Methods We retrospectively analyzed the clinical data of all patients with moderate-to-severe plaque psoriasis (Psoriasis Area and Severity Index (PASI) ≥ 10) who received etanercept, adalimumab, ustekinumab or secukinumab between January 2011 and December 2018 in a tertiary hospital in Taiwan. Results A total of 119 treatment episodes in 75 patients were included in this study. Ustekinumab was used in 49 treatment episodes, followed by secukinumab in 46 treatment episodes, adalimumab in 14 treatment episodes and etanercept in 10 treatment episodes. The proportion of the biologic-naïve was highest in etanercept (100%) and lowest in secukinumab (23.9%). The PASI-75, -90 and -100 were the highest in secukinumab (91.3%, 82.6%, 41.3%, respectively), followed by ustekinumab (79.6%, 44.9%, 16.3%), adalimumab (64.3%, 28.6%, 7.1%) and etanercept (50.0%, 30.0%, 0%). The rate of adverse events that required treatment was highest for secukinumab (15.2%), followed by adalimumab (14.3%), ustekinumab (8.2%), and etanercept (0%), including 4 cases of infections, 2 cases of cardiovascular diseases and 4 cases of cancers. Conclusions This real world data showed differential efficacy and safety of the four biological agents.

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