Humira (adalimumab; AbbVie/Eisai) is a recombinant human immunoglobulin G1 monoclonal antibody that acts as a tumor necrosis factor (TNF) inhibitor. In the US and EU, Humira is marketed by AbbVie, while in Japan, Abbott partnered with Eisai in 1999 to commercialize and develop the biologic.
Humira is approved for use in several autoimmune indications, namely rheumatoid arthritis, psoriatic arthritis, axial spondyloarthritis, Behçet’s syndrome, ulcerative colitis, juvenile idiopathic arthritis, Crohn’s disease, hidradenitis suppurativa, non-infectious uveitis, and plaque psoriasis
CONTENTS
5 OVERVIEW
5 Drug Overview
6 Product Profiles
6 Humira : Crohn’s disease
26 Humira : Axial spondyloarthritis (axSpA)
41 Humira : Rheumatoid arthritis (RA)
53 Humira : Psoriatic arthritis (PsA)
66 Humira : Ulcerative colitis
79 Humira : Psoriasis
LIST OF FIGURES
16 Figure 1: Humira for Crohn’s disease – SWOT analysis
17 Figure 2: Datamonitor Healthcare’s drug assessment summary of Humira in Crohn’s disease
18 Figure 3: Datamonitor Healthcare’s drug assessment summary of Humira in Crohn’s disease
22 Figure 4: Humira sales for Crohn’s disease across the US, Japan, and five major EU markets, by country, 2016–25
32 Figure 5: Humira for axial spondyloarthritis – SWOT analysis
33 Figure 6: Datamonitor Healthcare’s drug assessment summary of Humira in axial spondyloarthritis
34 Figure 7: Datamonitor Healthcare’s drug assessment summary of Humira in axial spondyloarthritis
37 Figure 8: Humira sales for axial spondyloarthritis across the US, Japan, and five major EU markets, by country, 2016–25
48 Figure 9: Humira for rheumatoid arthritis – SWOT analysis
49 Figure 10: Datamonitor Healthcare’s drug assessment summary of Humira in rheumatoid arthritis
50 Figure 11: Datamonitor Healthcare’s drug assessment summary of Humira in rheumatoid arthritis
60 Figure 12: Humira for psoriatic arthritis – SWOT analysis
61 Figure 13: Datamonitor Healthcare’s drug assessment summary of Humira for psoriatic arthritis
62 Figure 14: Datamonitor Healthcare’s drug assessment summary of Humira for psoriatic arthritis
73 Figure 15: Humira for ulcerative colitis – SWOT analysis
74 Figure 16: Datamonitor Healthcare’s drug assessment summary of Humira for ulcerative colitis
75 Figure 17: Datamonitor Healthcare’s drug assessment summary of Humira for ulcerative colitis
88 Figure 18: Humira for psoriasis – SWOT analysis
89 Figure 19: Datamonitor Healthcare’s drug assessment summary of Humira in psoriasis
90 Figure 20: Datamonitor Healthcare’s drug assessment summary of Humira in psoriasis
LIST OF TABLES
6 Table 1: Humira drug profile
8 Table 2: Humira pivotal trial data in adult Crohn’s disease
12 Table 3: Humira pivotal trial data in pediatric Crohn’s disease
15 Table 4: Humira ongoing trials in Crohn’s disease
23 Table 5: Humira sales for Crohn’s disease across the US, Japan, and five major EU markets, by country ($m), 2016–25
26 Table 6: Humira drug profile
28 Table 7: Humira pivotal trial data in axial spondyloarthritis
31 Table 8: Humira late-phase trial data in axial spondyloarthritis
38 Table 9: Humira sales for axial spondyloarthritis across the US, Japan, and five major EU markets, by country ($m), 2016–25
42 Table 10: Humira drug profile
44 Table 11: Humira pivotal trial data in rheumatoid arthritis
46 Table 12: Humira late-phase trial data in rheumatoid arthritis
54 Table 13: Humira drug profile
56 Table 14: Humira pivotal trial data in psoriatic arthritis
59 Table 15: Humira late-phase trial data in psoriatic arthritis
67 Table 16: Humira drug profile
69 Table 17: Humira pivotal trial data in ulcerative colitis
72 Table 18: Humira ongoing late-phase trials in ulcerative colitis
80 Table 19: Humira drug profile
82 Table 20: Humira pivotal trial data in adult psoriasis
83 Table 21: Humira pivotal trial data in pediatric psoriasis
84 Table 22: Humira late-phase trial data in psoriasis
87 Table 23: Humira ongoing late-phase clinical trials in psoriasis
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