Clinical Trials Ongoing for Brodalumab

Brodalumab, an interleukin (IL) 17 inhibitor, is currently in early clinical trials (Phase 1b and Phase 2) for a number of different autoimmune diseases.¹ Amgen recently terminated its co-development and commercialization agreement with AstraZeneca for the brodalumab investigational program in trials for moderate to severe plaque psoriasis, psoriatic arthritis and axial spondyloarthritis. Amgen’s decision to sever ties with AstraZeneca for this compound was due to the potential for restrictive labeling (if approved) because of suicidal ideation and suicidal behavior already identified in brodalumab trials. AstraZeneca continues to investigate this agent.²

As of April 24, 2015, AstraZeneca’s plan was to have Amgen submit the New Drug Application in 2015 or 2016. There is a good chance this application will be delayed.

Three clinical trials have been completed investigating brodalumab for managing moderate to severe plaque psoriasis (n=4,342). The moderate to severe plaque psoriasis trials were either placebo controlled or used an active treatment arm (ustekinumab 45 mg or 90 mg). Endpoints at Week 12 included PASI and static physician’s global assessment (sPGA). In the placebo-controlled trial, brodalumab treatment led to significant improvements in clinical and patient reported outcomes.³ Open-label extensions for these studies are ongoing.

Three clinical trials for psoriatic arthritis (n=1,281) are ongoing. These trials compare two strengths of subcutaneous brodalumab (140 mg or 210 mg) to placebo. The primary endpoint of these trials is the ACR20 response at Week 16. A secondary endpoint in one of the three studies is a radiographic joint assessment and PASI 75, HAQ-PI and PSI. Estimated completion of all three of the psoriatic arthritis trials is expected in the first quarter of 2016.

Michele B. Kaufman, PharmD, CGP, RPh, is a freelance medical writer based in New York City and a pharmacist at New York Presbyterian Lower Manhattan Hospital.

References

1. Amgen. News Release: Amgen to terminate participation in co-development and commercialization of brodalumab. 2015 May 22.
2. AstraZeneca. AstraZeneca Clinical Trials Appendix Anti-IL-17RA (brodalumab) Psoriasis & psoriatic arthritis development programmes. 2015 April 24.
3. Papp K, Reich K, Leonardi C, et al. Efficacy and safety of brodalumab in patients with moderate to severe plaque psoriasis: Results of AMAGINE-1, a Phase 3, randomized, double-blind, placebo-controlled study through week 12. 2015. J Amer Acad Dermatol. May;72(5):AB233–275.