(019) Initial and subsequent biological therapies for patients with psoriasis vulgaris during 2010-2021 in Japan

Background: Four classes of biologics, i.e., tumor necrosis factor-α inhibitors (TNFi), interleukin (IL)-12/23 inhibitor (IL-12/23i), IL-17 inhibitors (IL-17i) and IL-23 inhibitors (IL-23i), have been approved for the treatment of psoriasis vulgaris (Pso) in Japan since 2010, 2011, 2015 and 2018, respectively. Despite the increasing availability of biologics, the real-world selection of initial and subsequent biologics for the treatment of Pso has not been evaluated.

Objectives: To provide real-world evidence (RWE) of biologic selection and switching for the treatment of Pso in Japan.

Methods: This cohort study used the Japanese Medical Data Vision database, which contains hospital-based claims data from over 40 million patients in Japan. Patients who were diagnosed with Pso and initiated biologics from Jan 1, 2010 to Dec 31, 2021 were selected. Patients were required to have ≥1 diagnosis of Pso during the 6-month baseline period prior to the first identified biologic prescription (i.e., the initial biologic). Bio-switch was defined as when patients discontinued the initial biologic and switched to a subsequent biologic within a time window of twice the administration interval of the initial biologic. Both initial and subsequent biologic use will be examined by calendar year and the most commonly used biologics will be reported.

Results: Overall, 4,196 patients initiated biologics for the treatment of Pso (i.e., new biologic users), of which 718 (17.1%), 757 (18.0%), 1,581 (37.7%), and 1,140 (27.2%) patients received TNFi, IL-12/23i, IL-17i and IL-23i as the initial biologic, respectively. The most common initial biologics were TNFi from 2010 to 2014, IL-12/23i from 2015 to 2016, IL-17i from 2017 to 2019, and IL-23i from 2020 to 2021.

There were 814 patients (19.4% of 4,196) who switched to a subsequent biologic. Among these bio-switch cases, patients who initiated biologic with a TNFi (n=161) were most likely to switch to an IL-17i (38.5%, 62/161); patients who initiated biologic with either an IL-12/23i (n=296) or IL-17i (n=232) were most likely to switch to an IL-23i (IL-12/23i group: 57.4%, 170/296; IL-17i group: 45.7%, 106/232); patients who initiated an IL-23i (n=125) were almost equally likely to switch to another IL-23i (40%, 50/125) or to an IL-17i (41.6%, 52/125). Overall, IL-23i was the most common subsequent biologic, accounting for 43.3% (353/814) of the bio-switch cases, followed by the IL-17i (36.6%, 298/814), TNFi (14.0%, 114/814) and IL-12/23i (6.0%, 49/814).

Conclusions: The study provided RWE for biological therapy practices during a 12-year period in Japan, showing that biologic selection and switching were associated with biologic available time frame. Further research is warranted to understand reasons for these drug use patterns in Japan.