One-year Efficacy and Safety Results of Secukinumab in Patients With Rheumatoid Arthritis: Phase II, Dose-finding, Double-blind, Randomized, Placebo-controlled Study

@article{Genovese2014OneyearEA,
  title={One-year Efficacy and Safety Results of Secukinumab in Patients With Rheumatoid Arthritis: Phase II, Dose-finding, Double-blind, Randomized, Placebo-controlled Study},
  author={Mark C. Genovese and Patrick Durez and Hanno B. Richards and Jerzy Supronik and Eva Dokoupilov{\'a} and Jacob A. Aelion and Sang-Heon Lee and Christine E. Codding and Herbert Kellner and Takashi Ikawa and Sophie Hugot and Gregory Ligozio and Shephard Mpofu},
  journal={The Journal of Rheumatology},
  year={2014},
  volume={41},
  pages={414 - 421}
}
Objective. To evaluate the longer-term safety and efficacy of secukinumab, a fully human monoclonal antiinterleukin-17A antibody, in patients with rheumatoid arthritis. Methods. In this 52-week, double-blind, placebo-controlled (up to Week 20) study (NCT00928512), patients responding inadequately to disease-modifying antirheumatic drugs (DMARD) or biologics were randomized to receive monthly subcutaneous injections of secukinumab (25, 75, 150, or 300 mg), or placebo. The efficacy and safety… 
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References

SHOWING 1-10 OF 31 REFERENCES
Efficacy and safety of secukinumab in patients with rheumatoid arthritis: a phase II, dose-finding, double-blind, randomised, placebo controlled study
TLDR
The safety profile of secukinumab was consistent with that seen with other biological agents, and most adverse events (AE) were mild to moderate in severity, and there were no unexpected safety signals and no specific organ-related toxicities.
Treatment of rheumatoid arthritis with the selective costimulation modulator abatacept: twelve-month results of a phase iib, double-blind, randomized, placebo-controlled trial.
TLDR
Abatacept was associated with significant reductions in disease activity and improvements in physical function that were maintained over the course of 12 months in patients with RA that had remained active despite methotrexate (MTX) therapy.
Brief report: a phase IIa, randomized, double-blind, placebo-controlled trial of apilimod mesylate, an interleukin-12/interleukin-23 inhibitor, in patients with rheumatoid arthritis.
TLDR
The results do not support the notion that IL-12/IL-23 inhibition by apilimod is able to induce robust clinical improvement in RA and suggest that increasing the dosage did not improve clinical efficacy.
LY2439821, a humanized anti-interleukin-17 monoclonal antibody, in the treatment of patients with rheumatoid arthritis: A phase I randomized, double-blind, placebo-controlled, proof-of-concept study.
TLDR
LY2439821 added to oral DMARDs improved signs and symptoms of RA, with no strong adverse safety signal noted, and supports neutralization of IL-17 as a potential novel goal for the treatment of RA.
The efficacy and safety of rituximab in patients with active rheumatoid arthritis despite methotrexate treatment: results of a phase IIB randomized, double-blind, placebo-controlled, dose-ranging trial.
TLDR
Both rituximab doses were effective and well tolerated when added to MTX therapy in patients with active rheumatoid arthritis, although intravenous glucocorticoid premedication improved tolerability during the first ritUXimab infusion.
Anakinra for Rheumatoid Arthritis: A Systematic Review
TLDR
Anakinra is a relatively safe and modestly efficacious biologic therapy for RA and more studies are needed to evaluate safety and efficacy, especially in comparison to other therapies, and adverse event data for the longterm use of anakinra have yet to be assessed.
Tocilizumab: the first interleukin-6-receptor inhibitor.
  • A. Sebba
  • Medicine
    American journal of health-system pharmacy : AJHP : official journal of the American Society of Health-System Pharmacists
  • 2008
TLDR
Tocilizumab, a novel IL-6R inhibitor, may be beneficial for the treatment of RA in patients who do not respond to methotrexate or disease-modifying antirheumatic drugs.
Ustekinumab: a review in the treatment of plaque psoriasis and psoriatic arthritis.
TLDR
Though long-term safety concerns remain, ustekinumab adds to the current treatment armamentarium and holds promise to improve quality of life.
Emerging drugs for rheumatoid arthritis.
  • P. Voulgari
  • Medicine
    Expert opinion on emerging drugs
  • 2008
TLDR
Progress in understanding of RA pathophysiology led to the identification of new therapeutic targets, which include pro-inflammatory cytokines, T and B cells, adhesion molecules, chemokines and intra- and extracellular signaling pathways, which can provide new treatment strategies.
Effects of AIN457, a Fully Human Antibody to Interleukin-17A, on Psoriasis, Rheumatoid Arthritis, and Uveitis
TLDR
The results demonstrate that IL-17A participates in psoriasis, rheumatoid arthritis, and uveitis and that the antibody against this cytokine may be an effective therapeutic agent, and warrant larger clinical trials to assess further the safety and efficacy of AIN457.
...
1
2
3
4
...