Understanding Complex Synergistic Drivers: Mitigating Placebo Response in Rheumatoid Arthritis Clinical Trials, Part 1 of 3
Novel therapeutic agents, like biological disease-modifying antirheumatic drugs (bDMARDs) and targeted synthetic disease-modifying antirheumatic drugs (tsDMARDs), have transformed the prognostic landscape for people living with rheumatoid arthritis (RA) in recent years. However, the future looks potentially a great deal less promising. Year after year, one randomized, double-blind, placebo-controlled trial after another, placebo response rates have […]
Placebo Response in Randomised Controlled Trials of Systemic Therapies for Cutaneous Lupus Erythematosus: A Systematic Review and Meta-Analysis
Authors: LĂ©garĂ©, S., Lin, S., Vahey, S., Ovalles-Bonilla, J. G., D’Angelo, P., Jankicevic, J., & Bissonnette, R. Read more on pubmed
Nine Strategies to Address High Placebo Response in Systemic Lupus Erythematosus (SLE) Clinical Trials
In systemic lupus erythematosus (SLE) trials, the placebo arm is never truly placebo; it reflects the clinical reality of background therapy distorting the signal. High placebo rates in lupus trials continue to be a major obstacle to detecting the statistical incremental value of an investigational product (IP). Enrolled patients randomized to placebo are virtually always […]
Durability of Response to Icotrokinra in Adults With Moderate-to-Severe Plaque Psoriasis: One-Year Results From the Phase 3, Placebo- and Active Comparator-Controlled ICONIC-ADVANCE 1 & ICONIC-ADVANCE 2 Trials
Authors: Linda Stein Gold, April W Armstrong, Jennifer Soung, Ronald B Vender, Ălvaro GonzĂĄlez Cantero, Matthias Hoffmann, Scott T Guenthner, H Chih-Ho Hong, Dedee F Murrell, Eingun James Song, Leon Kircik, Matthias Augustin, Maxwell Sauder, Sascha Gerdes, Ofelia Reyes-Servin, Bassey Effiom Edem, Jennifer Campbell, Kellen Cresswell, Lea Kephart, Shu Li, Ya-Wen Yang, Robert Bissonnette Read […]
What Placebo Response Data in Atopic Dermatitis Trials are Actually Telling Us
Placebo response, which has emerged as an important determinant of interpretability and success in atopic dermatitis (AD) clinical trials, is frequently a predictable consequence of conducting high-quality clinical studies in a disease characterized by inherent variability over time. Modern AD programs increasingly acknowledge placebo response as a structural feature rather than an anomaly. Adaptive designs, […]
Placebo Response in Clinical Trials for Hidradenitis Suppurativa
Potential contributors to placebo rates in hidradenitis suppurativa (HS) clinical trials include underlying disease variability, the relative lack of efficacy of current therapies, and the requirement for rescue therapy and/or concomitant medications. More specifically, the contributors to placebo response lie in the difficulty in evaluating disease severity in HS, lack of non-physician or patient-assessed objective measures […]
Navigating Placebo Response in Dermatology Trials â AAD Breakfast Event
Innovaderm was in New Orleans for the 2023 edition of the AAD congress and hosted its 4th Breakfast Event: Spotlight on Hidradenitis Suppurativa (HS).
When Placebo Plus Standard of Care Clouds the Signal: Unmasking the âPlacebo Problemâ in Lupus Clinical Trials
Dr. Juan Ovalles, Senior Director of Rheumatology at Indero, discusses how high placebo response rates driven by background therapy complicate lupus drug trials, and outlines evolving strategies in trial design, clinical practice, and pharmacist-led care to ensure investigational biologics are fairly evaluated and appropriately used in systemic lupus erythematosus. Read More
How to Manage Placebo Response Rate in Atopic Dermatitis- Analyzing High Placebo-Response Rates
Welcome to the final installment of the series on placebo response rate in atopic dermatitis (AD). The first articles of this series shed light on the complexities and nuances of placebo response rates in AD and on strategies on how to ensure a reasonable response rate. This third and final article dives into the analysis of high placebo-response rates and […]
Episode 6: Dr. Bissonnette â How to Manage Placebo Response Rate in Atopic Dermatitis
Episode Notes Resources: The Role of Skin Barrier Dysfunction in Atopic Dermatitis Understanding Tape Stripping and Its Use in Clinical Research Using Biomarkers in Clinical Research Art of Protocol Writing for Atopic Dematitis Today marks a unique occasion as we are joined by our chief executive officer and medical director at Innovaderm, a company he […]
