DRUG OVERVIEW
Stelara (ustekinumab; Johnson & Johnson/Mitsubishi Tanabe) is a high-affinity, fully human monoclonal antibody that targets the p40 subunit of cytokines interleukin (IL)-12 and IL-23 proteins that occur in the immune system. Stelara is currently approved for the treatment of psoriasis, psoriatic arthritis, and Crohn’s disease, and is undergoing Phase III trials in ulcerative colitis.
TABLE OF CONTENTS
4 OVERVIEW
4 Drug Overview
5 Product Profiles
5 Stelara : Crohn’s disease
19 Stelara : Psoriatic arthritis (PsA)
33 Stelara : Ulcerative colitis
40 Stelara : Psoriasis
LIST OF FIGURES
11 Figure 5: Filgotinib for Crohn’s disease – SWOT analysis
12 Figure 4: Filgotinib for Crohn’s disease – SWOT analysis
13 Figure 21: Datamonitor Healthcare’s drug assessment summary of Stelara in Crohn’s disease
36 Figure 11: Datamonitor Healthcare’s drug assessment summary of Cimzia in Crohn’s disease
37 Figure 25: Datamonitor Healthcare’s drug assessment summary of Tysabri in Crohn’s disease
38 Figure 6: Ozanimod sales for Crohn’s disease across the US, Japan, and five major EU markets, by country, 2016–25
52 Figure 28: Datamonitor Healthcare’s drug assessment summary of ozanimod in Crohn’s disease
53 Figure 15: Upadacitinib for Crohn’s disease – SWOT analysis
LIST OF TABLES
5 Table 1: Stelara drug profile
17 Table 2: Stelara sales for Crohn’s disease across the US, Japan, and five major EU markets, by country ($m), 2016–25
20 Table 3: Stelara drug profile
22 Table 4: Stelara pivotal trial data in psoriatic arthritis
34 Table 5: Stelara drug profile
41 Table 6: Stelara drug profile
43 Table 7: Stelara pivotal trial data in adult psoriasis
46 Table 8: Stelara pivotal trial data in adolescent psoriasis
47 Table 9: Stelara late-phase trial data in psoriasis
49 Table 10: Cumulative rates of adjudicated major adverse cardiovascular events in five-year follow-up study on Stelara
patients
49 Table 11: Treatment-emergent infections in patients treated with Stelara through up to five-year follow-up