Brodalumab Backlash Save

On May 26, RheumNow.com reported that Amgen and Astra-Zenica suspended drug development for the IL-17 inhibitor brodalumab. Although brodalumab had progressed to phase III trials, drug development was halted over concerns about suicidal ideation and behavioral issues that could potentially lead to restrictive labeling. Further discussion on this decision was prompted with the results of several trials presented that the World Congress of Dermatology (WCD).

Dr. Richard Langley reported the results of the AMAGINE-3 trial– 1,881 psoriasis patients randomized to ustekinumab (Stelara) at the approved dosing, placebo, or brodalumab at either 140 mg or 210 mg subcutaneously – noted that rates of depression and suicidal ideation were similarly low in the ustekinumab and brodalumab groups during the 52-week study, and there were no suicide attempts. At the same time brodalumab significantly out-performed ustekinumab with a PASI75 of 85.1%, compared with 69.2% for ustekinumab.   Dr. Alan Menter found a similar lack of safety signals and impressive efficacy in the 1 year, 1831 patient AMAGINE-2 trial. 

Although the constructs and binding sites for the different IL-17 inhibitors are different, no suicide signal was reported with secukinumab (recently FDA approved as Cosentyx) or ixekizumab, which is in phase III clinical trials.

AstraZeneca officials said in a separate statement that they will review all the brodalumab data in detail and make a decision as soon as possible regarding whether to pursue unilateral development of the biologic agent.