Joel M Gelfand MD MSCE’s Post

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James J. Leyden Professor of Dermatology & Epidemiology, Director Center for Clinical Sciences in Dermatology, Director Psoriasis & Phototherapy Treatment Center at University of Pennsylvania Perelman School of Medicine

The Feb 8 issue of #NEJM just landed in my mailbox. I wrote the editorial "Psoriasis - More Progress but more questions" I discuss the latest stunning advance, Johnson & Johnson's phase 2 trial of an ORAL IL-23 receptor antagonist PEPTIDE for #psoriasis. I make the following points: 1. JNJ-77242113 achieved #PASI90 in 60% of patients - similar to some of our best biologics but in a pill! 2. General well tolerated but two #infections (SAEs COVID and an infected cyst) + and one suicide attempt need to be further evaluated in larger trials 3. #Obesity appeared to impact efficacy and having to take it twice a day on an empty stomach may diminish efficacy in real world settings 4. The progress made in developing drugs that clear psoriasis is tempered by a relative lack of progress in understanding the effect of the treatments on preventing #psoriaticarthritis #diabetes & #cardiovasculardisease To further advance the science and management of psoriasis the next generation of trials will need to have a #pragmatic, randomized design, active comparators, larger sample sizes and longer durations to determine which treatments, if any, restore not only the skin to normal but also the patient's overall health and lifespan. Only then will the full promise of these advances be realized.

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Adrián Alejandro Schejtman

Director Médico en Centro Dermatologico Schejtman Investigador principal Docente Adscripto en Dermatología UBA Ex Jefe de Servicio Hospital Municipal Dr. Raúl F. Larcade San Miguel Buenos Aires.

9mo

Quienes hacemos investigación clínica desde hace más de 10 años, ya con experiencia formada, tenemos la posibilidad de elegir qué estudios llevar adelante y en cuáles no participar. Esta experiencia nos permite realizar algunas preguntas, que el Dr Gelfand también se las hace en esta editorial. Hemos visto reducir la extensión de los protocolos de más de 80 semanas a 52 semanas, y en los últimos meses, hemos recibido enmiendas para estudios de fase III a punto de iniciar, para reducir su duración a 24 semanas. En este punto me pregunto: podemos evaluar objetivos primarios y secundarios en tan poco tiempo?. Que tan valederos son esas evaluaciones?. Obviamente, hoy contamos con los estudios de “vida real”, que suplen a aquellos estudios tan prolongados a la hora de evaluar eventos adversos. Por otro lado, comparto la necesidad de un comparador activo más que placebo. Considero se conseguirían datos más fiables a la hora de evaluar eficacia de la nueva molécula. Por último, es sumamente necesario muestras más grandes y mayor número de sitios con mayor dispersión geográfica para obtener mejor y más objetiva muestra.

Michelle Longmire

Co-Founder and CEO @ Medable, Inc.

9mo

Joel M Gelfand MD MSCE - your editorial is outstanding and demonstrates the need for clinical research to look beyond narrow clinical endpoints and to the entire patient and person. We know as physicians, there is so much more to health. It’s a great call to action and in many ways aligns with Robert Califf’s editorial on what’s needed to accelerate progress in chronic disease, also in this issue of NEJM Group.

Mohsin Shah, MBBS, MSCE

Associate Director, Global Integrated Evidence - Epidemiology & RWE Oncology at Boehringer Ingelheim

9mo

Congratulations on publishing an editorial in #NEJM, Joel M Gelfand MD MSCE! Thank you for the thoughtful piece 👏

Henry W. Lim

President, International League of Dermatological Societies; Former chair, Derm, Henry Ford Health

9mo

Great editorial, Joel!

Read it... Eye opener..... psoriasis beyond skin and PASI

Mary Regina Boland

Assistant Professor of Data Science in Mathematics at Saint Vincent College

8mo

Congratulations! super exciting!

Binh Ngo

Clinical Professor of Dermatology at University of Southern California

8mo

Amazing Joel! Congratulations!

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