Short-Term Evaluation of the Real-World Efficacy and Safety of Dupilumab for the Treatment of Moderate-to-Severe Atopic Dermatitis: A Canadian Multicenter Retrospective Cohort Study

Background Systemic therapy for atopic dermatitis (AD) has been challenging with limited safe and efficacious long-term treatment options. In 2017, dupilumab was approved in the United States, Europe, and Canada as the first targeted therapy for patients with moderate-to-severe AD. Despite promising efficacy and safety results in clinical trials, our understanding of dupilumab in clinical practice remains limited with few studies outside clinical trials in literature. Objective The aim of this study is to evaluate the efficacy and safety of dupilumab in clinical practice and discuss any differences in results between clinical trials and real-world results. Methods A retrospective chart review was conducted of consecutive patients receiving dupilumab treatment at two tertiary hospitals in Toronto, Canada, between December 2017 and May 2019. The primary efficacy endpoint was measured by Investigator’s Global Assessment (IGA) score of 0/1 at 16 weeks and all adverse events (AEs) experienced by patients were recorded. Results Of the 93 patients included in the study, 51 (55%) reached IGA 0/1 and 38 (41%) experienced ≥1 AE. There were no severe AEs or discontinuation prior to 16 weeks due to an AE. Conclusions These findings suggest a higher IGA-based efficacy profile with no newly identified safety concerns in patients treated with dupilumab at two tertiary hospitals in Toronto, Canada, compared to those in randomized controlled trials.

Download Full-text

Short term efficacy and safety of dupilumab for treatment of moderate-to-severe atopic dermatitis in real-world practice: A Canadian retrospective study

Journal of the American Academy of Dermatology ◽

10.1016/j.jaad.2019.10.087 ◽

2019 ◽

Vol 81 (4) ◽

pp. AB433

Keyword(s):

Atopic Dermatitis ◽

Retrospective Study ◽

Real World ◽

Severe Atopic Dermatitis ◽

Efficacy And Safety ◽

Short Term ◽

Term Efficacy

Download Full-text

An observational study «FOLLITROPIN» comparing the efficacy of follitropin alpha biosimilar: the real-world data

Obstetrics Gynecology and Reproduction ◽

10.17749/2313-7347/ob.gyn.rep.2021.212 ◽

2021 ◽

Vol 15 (1) ◽

pp. 5-21

Author(s):

D. P. Kamilova ◽

M. M. Ovchinnikova ◽

E. Sh. Ablyaeva ◽

M. M. Leviashvili ◽

N. S. Stuleva ◽

...

Keyword(s):

Clinical Trials ◽

Clinical Practice ◽

Observational Study ◽

Clinical Efficacy ◽

Real World ◽

Ovarian Stimulation ◽

Successful Implementation ◽

Efficacy And Safety ◽

The Real ◽

Real Clinical Practice

Introduction. The efficacy and safety of biosimilar follitropin alpha have been demonstrated in randomized blinded prospective clinical trials of phases I and III. Unfortunately, there is a gap between the clinical trials and real clinical practice data. The real-world patient data helps to create an evidence-based background for successful implementation of medicine at everyday practice in a nonselected population.Aim: to investigate the efficacy of follitropin alpha biosimilar therapy (Primapur®) in nonselected real-world population.Materials and Methods. A retrospective observational anonymized cohort study of follitropin alpha biosimilar (Primapur®) as a pre-filled pen injector with a dose adjustment of 5 IU, aimed to investigate its efficacy and safety in a nonselected population with indications to assisted reproductive technologies (ART) was carried out. The ovarian stimulation (OS) protocols included: monotherapy protocols with using only Primapur®; mixed protocols (recombinant and urinary-derived gonadotropins); short protocols with using antagonists of gonadotropin-releasing hormone (GnRH) and long protocols with GnRH agonists. The stimulation protocols were analyzed with Primapur® application for at least 5 days.Results. The overall clinical efficacy of ovarian stimulation cycles (N = 5484) was: oocytes retrieved - 9.5 ± 7.2, mature (MII) - 6.8 ± 6.6, fertilized (2PN) - 6.1 ± 5.8, clinical pregnancy per ET (PR) - 38.4 %. Mixed gonadotropin protocols (N = 2625) vs. monotherapy with Primapur® (N = 2859): oocytes retrieved - 8.6 ± 6.8 vs. 10.3 ± 7.4 (p < 0.001), mature (MII) - 6.7 ± 6.2 vs. 7.7 ± 6.9 (p < 0.001), fertilized (2PN) - 5.8 ± 5.2 vs. 7.2 ± 6.2 (p < 0.001). There were statistically significant differences between oocyte yields in mixed vs. monotherapy protocols due to subgroup differences, including age, body mass index (BMI) and IVF/ICSI attempts. No statistically significant differences were found for PR: 39.3 % vs. 37.6 % (p = 0.314). Monotherapy protocols with GnRH antagonist OS (N = 2183) vs. GnRH agonist (N = 676) revealed: oocytes retrieved - 10.5 ± 7.5 vs. 9.6 ± 7.0 (p = 0.032), mature (MII) - 7.6 ± 6.9 vs. 6.7 ± 5.7 (p < 0.001), fertilized (2PN) - 7.3 ± 6.3 vs. 5.7 ± 5.0 (p < 0.001). There were statistically significant differences between BMI and IVF/ICSI attempts. No statistically significant differences were found for PR: 37.9 % vs. 35.9 % (p = 0.482). All medicines were well tolerated and no serious adverse reactions were reported.Conclusion. This was the largest retrospective observational study conducted in the field of fertility in Russia and involved 5484 ovarian stimulation protocols at 35 IVF clinics. The obtained results demonstrated similar clinical efficacy for follitropin alpha biosimilar Primapur® in different OS protocols in real clinical practice.

Download Full-text

Efficacy and safety of dupilumab in Japanese adults with moderate‐to‐severe atopic dermatitis: a subanalysis of three clinical trials

British Journal of Dermatology ◽

10.1111/bjd.18565 ◽

2019 ◽

Vol 183 (1) ◽

pp. 39-51 ◽

Cited By ~ 5

Author(s):

N. Katoh ◽

Y. Kataoka ◽

H. Saeki ◽

M. Hide ◽

K. Kabashima ◽

...

Keyword(s):

Clinical Trials ◽

Atopic Dermatitis ◽

Severe Atopic Dermatitis ◽

Efficacy And Safety ◽

Japanese Adults

Download Full-text

Clinical Trials in Schizophrenia with Results for the Real World

CNS Spectrums ◽

10.1017/s1092852900026638 ◽

2006 ◽

Vol 11 (S7) ◽

pp. 9-13 ◽

Cited By ~ 7

Author(s):

Diana O. Perkins

Keyword(s):

Clinical Trials ◽

Clinical Practice ◽

Real World ◽

Clinical Decision Making ◽

Treatment Options ◽

Healthcare Providers ◽

Clinical Decision ◽

Clinical Practices ◽

Treatment Protocols ◽

The Real

AbstractMost clinical data for antipsychotics come from studies designed to test the efficacy and safety of the drugs under ideal conditions, in limited subgroups of patients. In contrast, practical clinical trials (PCTs) are designed to test the effectiveness of different treatment options under conditions that more accurately reflect actual clinical practice. Consequently, PCTs are able to provide information that can be utilized by healthcare providers and other decision makers. Characteristics of PCTs include a clinically relevant question, a representative sample of patients and practice settings, sufficient power to identify modest relevant effects, randomization to protect against bias, uncertainty regarding the outcome of treatment, assessment and treatment protocols that enact best clinical practices, simple and relevant outcomes, and limited subject and investigator burden. The Clinical Antipsychotic Trials of Intervention Effectiveness (CATIE) research program is an example of a PCT. The CATIE study illustrates how PCTs, when properly designed, might be helpful in informing clinical decision making. Because the CATIE study was designed to reflect the effectiveness of antipsychotics under naturalistic clinical conditions, its results should have particular applicability to the arena of clinical practice. This article provides a discussion of the differences between efficacy and effectiveness studies. In assessing the practical utility of results from the CATIE study, much can be learned on how to shape future studies of effectiveness so as to better generate data that are applicable to the “real world.”

Download Full-text

Efficacy and safety of abrocitinib for the treatment of moderate-to-severe atopic dermatitis: a meta-analysis of randomized clinical trials

Journal of Dermatological Treatment ◽

10.1080/09546634.2021.1961997 ◽

2021 ◽

pp. 1-24

Author(s):

Bikash Ranjan Meher ◽

Rashmi Ranjan Mohanty ◽

Biswa Mohan Padhy

Keyword(s):

Clinical Trials ◽

Atopic Dermatitis ◽

Randomized Clinical Trials ◽

Meta Analysis ◽

Severe Atopic Dermatitis ◽

Efficacy And Safety

Download Full-text

Developing real-world comparators for clinical trials in chemotherapy-refractory patients with gastric cancer or gastroesophageal junction cancer

Gastric Cancer ◽

10.1007/s10120-019-01008-9 ◽

2019 ◽

Vol 23 (1) ◽

pp. 133-141 ◽

Cited By ~ 3

Author(s):

Ian Chau ◽

Dung T. Le ◽

Patrick A. Ott ◽

Beata Korytowsky ◽

Hannah Le ◽

...

Keyword(s):

Gastric Cancer ◽

Clinical Trial ◽

Clinical Trials ◽

Clinical Practice ◽

Real World ◽

Treatment Options ◽

Gastroesophageal Junction ◽

Eligibility Criteria ◽

Asian Patients ◽

Baseline Characteristics

Abstract Background There are few third-line or later (3L+) treatment options for advanced/metastatic (adv/met) gastric cancer/gastroesophageal junction cancers (GC/GEJC). 3L+ Nivolumab demonstrated encouraging results in Asian patients in the ATTRACTION-2 study compared with placebo (12-month survival, 26% vs 11%), and in Western patients in the single-arm CheckMate 032 study (12-month survival, 44%). This analysis aimed to establish comparator cohorts of US patients receiving routine care in real-world (RW) clinical practice. Methods A 2-step matching process generated RW cohorts from Flatiron Health’s oncology database (January 1, 2011–April 30, 2017), for comparison with each trial: (1) clinical trial eligibility criteria were applied; (2) patients were frequency-matched with trial arms for baseline variables significantly associated with survival. Median overall survival (OS) was calculated by Kaplan–Meier analysis from last treatment until death. Results Of 742 adv/met GC/GEJC patients with at least 2 prior lines of therapy, matching generated 90 US RW ATTRACTION-2-matched patients (median OS: 3.5 months) versus 163 ATTRACTION-2 placebo patients (median OS: 4.1 months), and 100 US RW CheckMate 032-matched patients (median OS: 2.9 months) versus 42 CheckMate 032 nivolumab-treated patients (median OS: 8.5 months). Baseline characteristics were generally similar between clinical trial arms and RW-matched cohorts. Conclusions We successfully developed RW cohorts for comparison with data from clinical trials, with comparable baseline characteristics. Survival in US patients receiving RW care was similar to that seen in Asian patients receiving placebo in ATTRACTION-2; survival with nivolumab in CheckMate 032 appeared favorable compared with US RW clinical practice.

Download Full-text