Psoriasis development criteria more competitive than ever, says GlobalData

The psoriasis (PsO) market has typically been dominated by injectable biologics. However, this segment has become fairly saturated, given the number of different efficacious biologics already available. As a result, drug manufacturers now have no choice but to continue setting and exceeding increasingly high clinical development standards to gain a foothold in this mature field, as noted by key opinion leaders (KOLs) interviewed by GlobalData, a leading data and analytics company.

Tiffany Chan, Immunology Analyst at GlobalData comments: “While previously the Psoriasis Area and Severity Index (PASI) score (PASI 75) was widely used as a standard moderate-to-severe PsO trial endpoint, KOLs noted that this is no longer sufficient to be competitive in the current market. Many drugs in recent years have been able to achieve the PASI 90 or even full skin clearance, as measured by the PASI 100. Agents still using the PASI 75 are now assumed to be in development for mild-to-moderate PsO patients.

“Additionally, many pivotal and post-marketing trials are also incorporating the IGA or sPGA as co-primary endpoints in addition to the PASI system. KOLs noted that the IGA and sPGA are more widely understood by non-researching clinicians, which reflects the competitive nature of the field and the need to stake a claim in both the minds and prescription pads of community prescribers.”

In addition to more rigorous clinical endpoints becoming the norm, the monitoring interval for primary endpoints is also extended compared to previous years. While initial primary endpoints in PsO trials have typically been assessed at 12 weeks of therapy, the primary endpoints of several trials have been stretched out to 52 weeks and beyond, representing the need to show long-term efficacy results in this chronic condition.

Chan continues: “Physicians interviewed by GlobalData expressed the need to understand the long-term efficacy and safety of therapies, since they often only see patients once a year or even less frequently. Drug manufacturers are using head-to-head comparator trials both before and after drug approval to establish their products’ clinical and commercial positioning within the treatment landscape.”

The main factors that are driving the competition within the PsO market are safety and efficacy; as a result, there are currently several head-to-head trials being conducted to prove that newer biologics are more efficacious compared to the gold-standard treatments. TNF-inhibitor Humira (adalimumab) has been a commonly used comparator for biologic trials, though others have also utilized IL-12/23 inhibitor Stelara (ustekinumab) and IL-17 inhibitor Cosentyx (secukinumab).

KOLs expressed an interest in these trials being adequately large to compare the two active agents with statistical power, utilizing several hundred patients at a minimum. Notably, BMS’ deucravacitinib is currently being investigated in comparison to Otezla. KOLs praised this trial design for its clinical utility in establishing where deucravacitinib might fit into their current treatment paradigm.

Chan concludes: “Long-term clinical data from both pre- and post-marketing studies are increasingly important tools in guiding physician prescribing patterns. The bar for clinical endpoints continues to rise, with many studies utilizing more robust endpoints than those seen five years ago. Additionally, head-to-head trials comparing pipeline agents against well-established drugs are becoming necessary for drugs to stake a claim in the market.”