The is a highly competitive market and the first major biologics that were released were anti-tumour 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.
ÎÛÎÛÂþ®‹ companies are now at a stage where they are not just conducting clinical trials comparing their drugs to placebos, but are conducting head-to-head trials to compare safety and efficacy between biologics. There are already numerous biologics entrenched in the treatment algorithm of psoriasis with good efficacy and safety profiles, and GlobalData believes that an increase in head-to-head trials will enhance the competition within the immuno-dermatology market, which will better demonstrate safety and efficacy between biological therapies.
Head-to-head clinical trials are a powerful way of testing medicines against one another. These types of trials aid in identifying if there are better treatment options compared to the biologic standard of care or a first-in-class biologic. Data from these trials can be interpreted by physicians and be a source of powerful information when choosing a treatment option. 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.
In one such study conducted by J&J, VOYAGE 2, 71% of patients treated with the IL-23 inhibitor Tremfya (guselkumab) achieved a Psoriasis Area and Severity Index (PASI) 90 score after 24 weeks of treatment compared to 51% of patients treated with Humira. Similarly, Eli Lilly demonstrated in the UNCOVER-3 trial that 68% of patients treated with the IL-17 inhibitor Taltz (ixekizumab) achieved a PASI 90 score after 12 weeks of treatment compared to 26% of patients treated with Pfizer’s Enbrel.
Even more strongly, the AMAGINE-2 and AMAGINE-3 clinical trials, conducted by , showed that IL-17 inhibitor Siliq (brodalumab) had superior results compared to J&J’s IL-12/23 inhibitor Stelara (ustekinumab): 36% of patients who received 210mg of Siliq achieved a PASI 100 score after 12 weeks of treatment compared to 19% of patients who received Stelara. Furthermore, 85% of patients who received 210mg of Siliq for 12 weeks achieved a PASI 75 score compared to 60% of patients who were treated with Stelara.
Benefits of head-to-head trials
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. Furthermore, head-to-head trials show more frequent intervals where patients are monitored; the FDA and EMA are known to grant approval based on early endpoints that are likely to predict clinical benefit.
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By GlobalDataThese types of trials also break the mould 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. 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.
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