Friday, November 18, 2011

Secukinumab to treat Rheumatoid Arthritis –A Phase II Trial

Secukinumab is an Anti-Interleukin 17A Monoclonal Antibody.
A phase II trial on efficacy and safety of secukinumab reported by Marc C. Genovese et al. didn’t achieve the primary efficacy endpoint after one year. Still too early to quit secukinumab, as this is due to an increase in ACR20 response in the placebo group between weeks 12 and 16; ACR20 in the secukinumab 75mg group was achieved in 47%, in the 150 mg group also in 47%, and in the 300 mg group in 54%, with placebo achieving ACR20 response in 36%, so the verum groups achieved higher precentages of ACR20 but did not reach statistical significance. We’ll have to wait a little while longer to have this worked out and will probably see more during the next meetings either at #EULAR12 in Berlin or at #ACR2012 in Washington.

[SUN] 401
One Year Efficacy and Safety Results of a Phase II Trial of Secukinumab in Patients with Rheumatoid Arthritis.
Mark C. Genovese1, Patrick Durez2, Hanno B. Richards3, Jerzy Supronik4, Eva Dokoupilova5, Jacob A. Aelion6, Sang-Heon Lee7, Christine E. Codding8, Herbert Kellner9, Takashi Ikawa10, Sophie Hugot3, Gregory Ligozio11 and Shephard Mpofu3.
1Stanford University, Palo Alto, CA, 2Cliniques Universitaires Saint-Luc, Universite´ Catholique de Louvain, Brussels, Belgium, 3Novartis Pharma AG, Basel, Switzerland, 4NZOZ Centrum Medyczne Artur Racewicz, Bialystok, Poland, 5Medical Plus s.r.o, Uherske Hradiste, Czech Republic, 6Arthritis Clinic, Jackson, TN, 7Konkuk University Medical Center, Seoul, South Korea, 8Health Research of Oklahoma, Oklahoma City, OK, 9Centre for Inflammatory Joint Diseases, Munich, Germany, 10Kobe–Konan Yamate Clinic, Kobe, Japan, 11Novartis Pharmaceuticals Corporation, East Hanover, NJ
Conclusion: The primary efficacy endpoint was not achieved in this trial possibly due to an unexplained increase in ACR20 in the placebo group between weeks 12 (24%) and 16 (36%). However, ACR20-responders at Week 16 experienced maintenance or improvement of efficacy through Week 52 with highest efficacy in patients who remained on 150mg throughout the trial. Patients on secukinumab who were non-responders at Week 16 did not gain much additional efficacy benefit after dose escalation. Secukinumab was well tolerated and the rate and frequency of AEs remained stable over time without unexpected safety findings.

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