J & J’s guselkumab (trade name: Tremfya) has recently been applied for marketing in China, which is called the "best psoriasis drug" owing to its separately defeating adalimumab and secukinumab in the head-to-head studies, with sales reaching USD544 million in 2018, showing the potential of becoming a blockbuster.

There have been 3 blockbuster drugs for psoriasis marketed so far in China this year, including J & J’s ustekinumab (trade name: Stelara), Novartis’ secukinumab (trade name: Cosentyx), and the Chinese-produced benvitimod, showing that the competition in China’s psoriasis drug market has started to turn white-hot.

Defeating adalimumab and secukinumab in the head-to-head studies

Approved for marketing by the FDA on July 13, 2017, guselkumab is used to treat moderate to severe plaque psoriasis in adults. Guselkumab is the first anti-IL-23 monoclonal antibody marketed in the world, with the initial dose administered by subcutaneous injection at Week 0, Week 4 and 100mg every 8 weeks thereafter.

In VOYAGE 1 and VOYAGE 2 studies, treated with guselkumab, 70% patients attained more than 90% skin cleanliness at week 16, and the proportion of patients attaining PASI 90 exceeded 90% at week 28, with the response maintained through week 48. In the head-to-head study with adalimumab, the skin cleanliness of guselkumab group was superior to adalimumab at week 16, week 24, and week 48.

According to the 48-week results of the head-to-head PKECLIPSE Phase III study of guselkumab and secukinumab for the treatment of moderate to severe plaque psoriasis, in the guselkumab treatment group, the psoriasis area and severity index improved by more than 90% (PASI 90, primary endpoint) reached 84.5%, compared with 70% in the secukinumab treatment group. If you want to get more information on psoriasis, then Pharmasource, a professional pharma platform providing information on hospital supply companies and pharma industry, would be your best choice.

Biological drugs becoming the R&D hotspot

As a common, chronic, non-communicable, painful, disfiguring, crippling immunoinflammatory disease, psoriasis belongs to chronic autoimmune disease. Up to 125 million people in the world have psoriasis. From the perspective of global incidence by county, it is most commonly seen in populations in Northern Europe and Australia while less seen in the population in East Asia. There are about 6 million psoriasis patients in China.

Psoriasis is mainly divided into four types: vulgaris type (plaque, guttate, inverse), pustular type, erythrodermic type, and arthropathic type, wherein, plaque psoriasis patients account for more than 90% of psoriasis patients. The cause of psoriasis is complex and is currently considered mainly due to T cell dysregulation, which results in keratinocyte hyperproliferation and terminal differentiation changes, leading to less attached cuticles and psoriasis characteristic plaques. Both genetic and environmental factors will induce keratinocytes to secrete tumor necrosis factor (TNF) which further activates dendritic cell (DC). The activated DC produces interleukin IL-23 to cause T helper 17 (TH17) cell differentiation. TH17 cells secrete IL-17A, which causes psoriatic skin to change. Therefore, TNF-ɑ, IL-23, and IL-17A are considered key targets in the treatment of moderate to severe plaque psoriasis.

Psoriasis treatment is divided into drug treatment and non-drug treatment, with the former including drugs for external use, systemic drugs, TCM treatment, and biological agents, with the latter including physiotherapy, hydrotherapy, diet therapy, and psychotherapy, etc.

As a new "weapon" against psoriasis, biological agents marks another major advance in the psoriasis treatment history, however, they are expensive and have problems such as adverse reactions. Biological agents for psoriasis are currently divided into two categories, including drugs with many indications, such as adalimumab, etanercept, and infliximab, and also mainstream drugs, such as ustekinumab and secukinumab.

Read More: Mainstream psoriasis drugs marketed in the world

About  the Author:    

Caicai, a Master of Pharmacy from Shanghai Jiaotong University, used to work in the Institute of Science and Technical Information. Currently as a practitioner in the drug surveillance system, she is good at interpreting industry regulations, pharmaceutical research developments, etc.

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