Drug Overview
Tremfya (guselkumab; Johnson & Johnson/MorphoSys) is a fully human immunoglobulin G1-lambda monoclonal antibody that inhibits interleukin (IL)-23-specific intracellular and downstream signaling. Tremfya has been engineered using MorphoSys’s Human Combinatorial Antibody Library antibody technology to specifically bind the p19 subunit of IL-23, unlike Stelara (ustekinumab; Johnson & Johnson/Mitsubishi Tanabe) which binds to the p40 subunit of IL-23 as well as IL-12. Tremfya is approved for use in psoriasis in the US, and is under development in psoriatic arthritis (PsA). Johnson & Johnson has indicated that it plans to file for approval of Tremfya in PsA by 2019.17
TABLE OF CONTENTS
4 PRODUCT PROFILES
4 Tremfya : Psoriatic arthritis (PsA)
12 guselkumab : Psoriasis
LIST OF FIGURES
8 Figure 1: Tremfya for psoriatic arthritis – SWOT analysis
9 Figure 2: Datamonitor Healthcare’s drug assessment summary of Tremfya for psoriatic arthritis
10 Figure 3: Datamonitor Healthcare’s drug assessment summary of Tremfya for psoriatic arthritis
22 Figure 4: Guselkumab for psoriasis – SWOT analysis
23 Figure 5: Datamonitor Healthcare’s drug assessment summary of guselkumab in psoriasis
24 Figure 6: Datamonitor Healthcare’s drug assessment summary of guselkumab in psoriasis
LIST OF TABLES
5 Table 1: Tremfya drug profile
6 Table 2: Tremfya Phase III trials in psoriatic arthritis
7 Table 3: Tremfya Phase IIa trial data in psoriatic arthritis
13 Table 4: Guselkumab drug profile
14 Table 5: Guselkumab late-phase trials in psoriasis
20 Table 6: Results for Phase IIb X-PLORE trial of guselkumab in psoriasis
21 Table 7: Safety results for Phase IIb X-PLORE trial of guselkumab in psoriasis