Next Generation Biologics, Janssen's Tremfya, Eli Lilly's Taltz, and Novartis' Cosentyx, Raising the

The past three years have brought with them a flurry of branded biologic approvals in dermatology, including four biologics for psoriasis alone (Cosentyx in January 2015, Taltz in March 2016, Siliq in February 2017, and Tremfya in July 2017). The new psoriasis options have left many US dermatologists slightly overwhelmed, but also excited that their armamentarium is being regularly refreshed, with each new approval arguably boasting skin efficacy rates higher than the last.

Though psoriasis is not unique to other biologic-treated immunology indications in terms of having a host of new treatment options with alternate mechanisms of action (MOA), dermatologists may be gravitating to alternate MOA agents earlier in the treatment algorithm compared to their gastroenterology and rheumatology counterparts. A recent study with 100 dermatologists surveyed in February reveals that at approximately six months post-approval, over half of dermatologists have prescribed Tremfya, and among those current users, nearly 30 percent of all scripts for the IL-23 inhibitor were written as a first-line biologic. Follow-up analysis with respondents who reported generous first-line Tremfya use uncovered that it was largely made possible due to Janssen's patient assistance program, Janssen CarePath.

Though the efficacy of the newest alternate MOA biologics in psoriasis surpasses most previous standards, dermatologists appear largely divided on which of the newest agents brings the most to the table. For now, Cosentyx seems to be garnering the most favor, though Janssen's Stelara is not far behind. Of note, Tremfya is preferred by nearly one-fifth of respondents, surpassing that of Taltz, which had been steadily making in-roads prior to this latest addition from Janssen.

Despite positive perceptions and uptake of Cosentyx, Taltz, and now Tremfya, the picture isn't always rosy for new market entrants, even those boasting high efficacy in clinical trials. Ortho Dermatologics' (previously Valeant's dermatology portfolio) Siliq has not enjoyed the same reception as its preceding IL-17 inhibitors or Tremfya. At a year post-approval and over six months post-launch, only ten percent of dermatologists have prescribed Siliq to date and one-third have no intentions of ever using the product, largely because they feel they have plenty of other options with similar or better efficacy, that do not carry a black box warning and do not have a required Risk Evaluation Mitigation Strategy (REMS) program.

As the psoriasis market is becoming increasingly competitive, it becomes incumbent for smaller players, such as Siliq and those looking for near-term entry, to find their niche. For example, UCB's Cimzia, which is currently seeking a label-expansion to include plaque psoriasis, has recently reported data from their CRIB and CRADLE studies highlighting that use of Cimzia resulted in minimal to no placental transfer from mother to infant and that there was minimal to no transfer of Cimzia through breast milk. If Cimzia does gain FDA approval in psoriasis, it would be the fourth branded TNF-inhibitor for psoriasis, what could be viewed as an unnecessary addition; however, evidenced safety in women of childbearing age, an attribute rated of high importance to the safety-conscious dermatologists, could provide a solid foothold for the brand.

The next likely entrant charged with carving their niche will be Sun Pharma's tildrakizumab, which could receive an FDA green light by mid-year. With Tremfya off to a stellar start, it will be imperative for the second to market IL-23 inhibitor to prove some additional value right out of the gate. The need for tildrakizumab's differentiation will become even more crucial as AbbVie's IL-23 inhibitor, risankizumab, is hot on its heels and boasts extremely positive clinical trial efficacy, as well as a less onerous dosing schedule compared to Tremfya.

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