Game On: Head-to-head Trials to Enhance Competition in PsO Market

An increase in head-to-head trials will enhance the competition within the psoriasis market, according to GlobalData.

The first major biologics that were released were anti-tumor necrosis factor (anti-TNF) drugs, such as AbbVie’s Humira, Pfizer’s Enbrel, and Johnson and Johnson’s (J&J’s) Remicade. In recent years, a new wave of interleukin-targeting biological therapies, such as interleukin 17 (IL-17) and interleukin 23 (IL-23) inhibitors, have been approved and have begun to impact the use and sale of currently marketed anti-TNFs. Pharmaceutical companies are now at a stage where they are not just conducting clinical trials comparing their drugs to placebos, but are undertaking head-to-head trials to compare safety and efficacy between biologics. There have been a number of head-to-head clinical trials that compare the safety and efficacy of anti-IL-23 biologics with anti-TNFs, anti-IL-17s compared to anti-TNFs, and anti-IL-17s compared to anti-IL-23 biologics.

“Data from head-to-head clinical trials can be interpreted by physicians and be a source of influential information when choosing a treatment option,” says Vikesh Devlia, MSc, Pharma Analyst at GlobalData. “With increased competition in the psoriasis market, it is clear that more head-to-head trials could provide better information that can be used by physicians to guide their decisions on choosing the best biologics for their patients.”

Head-to-head trials show more frequent intervals where patients are monitored, and the US Food and Drug Administration and European Medicines Agency are known to grant approval based on early endpoints that are likely to predict clinical benefit. These types of trials also break the mold and do not follow the typical model of trial design. However, they allow the comparison of an investigational medicine to a placebo and a currently used medicine.

 “Variations in the duration of therapy provide different points of data that can be used to compare the treatments,” adds Devlia. “Competition between pharmaceutical companies to develop the most efficacious drugs could increase as there will be a desire for these companies to hold the largest market share, and head-to-head trials have the potential to drive sales of new biologics in an already overcrowded market.”