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Rheumatology
Rheumatoid Arthritis Edition
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Chapter 5

Emerging Parenteral Biologic Therapies for Rheumatoid Arthritis

Editor-in-Chief: Philip J. Mease, MD
Contributing Editor: Kathryn F. Hobbs, MD
Medical Writer: Lauren A. Cerruto

Other Parenteral Agents in Development for RA

More parenteral agents are currently in phase II and phase III development (Table).47-67

Table. Additional Parenteral Biologics in Phase II and Phase III Development for RA47-67

Drug
Mechanism of Action
Phase of Development
(Link to Results of Study Protocol)
N
MM-093
Phase II trial reported potential therapeutic benefit and good tolerability with MM-093 21 mg SC weekly added to current MTX47
Phase II study of MM-093 60 mg SC weekly added to current MTX in patients with inadequate response to MTX completed48
11
100*
260*
LY2127399
Phase II trial reported clinical benefit and good tolerability with 3 doses added to MTX50
Phase II trial of 6 LY2127399 doses in patients with active disease despite MTX completed51
136
158
990,
1002,
555,
1505*

KB003
208*
ATN-103
Phase I/II study of ascending doses of ATN-103 in patients on stable MTX completed57
252
260*
SBI-087
Targets CD20 antigen
200*
Canakinumab (ACZ885)
274
80,
78, 115
LY2189102
IL-1 beta inhibitor
2 phase II trials completed: a dose escalation trial64 and a study of LY2189102 added to MTX in patients with inadequate response to TNF-alpha inhibitors65
104, 100
Fezakinumab (ILV-094)
IL-22 inhibitor
Phase II study of various doses added to MTX, completed66
195
MDX-1100
Phase II trial of MDS-1100 added to stable MTX reported clinical benefit and good tolerability67
70

*Estimated enrollment.

Abbreviations: AFP, alpha-fetoprotein; BAFF, B-cell activating factor; GM-CSF, granulocyte-macrophage colony-stimulating factor.

Belatacept, a second-generation T-cell costimulation modulator like abatacept, demonstrated preliminary efficacy in a dose-finding, placebo-controlled phase I/II study published in 2002,68 but has not progressed to phase III trials in RA. Belatacept was recently granted FDA approval for the prevention of organ rejection in adult kidney transplant patients.69


Conclusion

A greater understanding of the underlying mechanisms in the pathophysiology of RA has enhanced exploration of novel therapeutic approaches to targeting the main immunologic pathways in RA. Encouraging results in early clinical trials have led to continued development for several new parenteral drugs, some of which are entering phase III trials. Ongoing research will confirm the efficacy and safety of these novel parenteral agents, and potentially expand current treatment options in RA.

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