scholarly journals P70: Real‐world effectiveness of guselkumab in achieving absolute PASI thresholds and mean DLQI scores in patients with moderate‐to‐severe plaque psoriasis: analysis of the BADBIR registry following 6 months of treatment

2021 ◽  
Vol 185 (S1) ◽  
pp. 59-59
Keyword(s):  
Real World ◽  
Plaque Psoriasis ◽  
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.

Real-world data on the efficacy and safety of apremilast in patients with moderate-to-severe plaque psoriasis

2018 ◽  
Vol 32 (7) ◽  
pp. 1173-1179 ◽  
Author(s):  
E. Papadavid ◽  
N. Rompoti ◽  
K. Theodoropoulos ◽  
G. Kokkalis ◽  
D. Rigopoulos
Keyword(s):  
Real World ◽  
Plaque Psoriasis ◽  
Efficacy And Safety ◽  
Real World Data ◽  
Severe Plaque Psoriasis ◽  
World Data

26698 Characteristics and disease burden in patients with mild to moderate vs severe plaque psoriasis in real-world settings: Results from the Corrona Psoriasis Registry

2021 ◽  
Vol 85 (3) ◽  
pp. AB113
Author(s):  
Bruce Strober ◽  
Angel Cronin ◽  
Tin-chi Lin ◽  
Jaqueline O’Brien ◽  
Kelechi Emeanuru ◽  
...  
Keyword(s):  
Real World ◽  
Plaque Psoriasis ◽  
Disease Burden ◽  
Severe Plaque Psoriasis
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