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A phase III, multicenter, randomized, double-blind, placebo-controlled, parallel-group study of 2 dosing regimens of fostamatinib in patients with rheumatoid arthritis with an inadequate response to a tumor necrosis factor-α antagonist.

Author: BenhamouClaude, DuffieldEmma L, FudmanEdward, GenoveseMark C, KavanaughArthur, KeystoneEdward C, LamplKathy, O'BrienChris, PoileyJeffrey, SpindlerAlberto J, WeinblattMichael E, van der HeijdeDésirée M

Research Support, Non-U.S. Gov'tResearch funding provided by government agencies outside the United States.
Clinical Trial, Phase IIIA Phase III trial is a trial that further rigorously verifies the efficacy and safety of a new drug or treatment, whose efficacy and safety have been confirmed in a Phase II trial, in a large number of patients, and evaluates whether it is superior to existing treatments.
Comparative StudyResearch that compares multiple groups/interventions to determine differences/similarities in outcomes/characteristics.
Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
Multicenter StudyResearch conducted in collaboration with multiple research institutions. It aims to collect a wide range of data and obtain more generalizable results.
Randomized Controlled TrialA clinical trial that randomly assigns participants to treatment and control groups to evaluate the effects of an intervention.

Overview

In a 24-week study comparing fostamatinib to placebo in patients with rheumatoid arthritis (RA), fostamatinib 100 mg bid achieved statistical improvements in ACR20 response at 24 weeks versus placebo. Fostamatinib 100 mg bid for 4 weeks then 150 mg qd did not show this improvement. The most common adverse events were diarrhea, hypertension, and headache.
Paper Details　
Original Abstract of the Article :
OBJECTIVE: Our 24-week study (NCT01197755; OSKIRA-3) compared the efficacy and safety of fostamatinib versus placebo in patients taking background methotrexate treatment with active rheumatoid arthritis (RA) and an inadequate response to a single tumor necrosis factor-α antagonist. METHODS: Adult p...See full text at original site
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引用元：
https://doi.org/10.3899/jrheum.140238

データ提供：米国国立医学図書館（NLM）

Fostamatinib: A New Hope for Rheumatoid Arthritis?

This study investigates the potential of fostamatinib, a novel medication, for treating rheumatoid arthritis (RA). The researchers conducted a large, randomized, double-blind, placebo-controlled trial comparing fostamatinib to placebo in patients with RA who had not responded well to a previous TNF-α antagonist. The study found that fostamatinib, at a dosage of 100 mg twice daily, significantly improved RA symptoms compared to placebo. However, at a higher dose of 150 mg once daily, the improvement was not statistically significant. The study also noted potential side effects, including diarrhea, high blood pressure, and headache.

Fostamatinib: A Promising but Complex Treatment

This study suggests that fostamatinib might be a viable treatment option for patients with RA who are not responding to other therapies. The positive results for the 100 mg twice daily dose are encouraging. However, the study also highlighted the potential side effects associated with the medication.

Navigating Rheumatoid Arthritis Treatment

This study underscores the importance of careful consideration when choosing treatment options for RA. It's essential to discuss potential benefits and risks with your healthcare provider and to monitor your response to treatment closely.

Dr.Camel's Conclusion

This study investigates the potential of fostamatinib, a novel medication, for treating rheumatoid arthritis (RA). The researchers conducted a large, randomized, double-blind, placebo-controlled trial comparing fostamatinib to placebo in patients with RA who had not responded well to a previous TNF-α antagonist. The study found that fostamatinib, at a dosage of 100 mg twice daily, significantly improved RA symptoms compared to placebo. However, at a higher dose of 150 mg once daily, the improvement was not statistically significant. The study also noted potential side effects, including diarrhea, high blood pressure, and headache. This study suggests that fostamatinib might be a viable treatment option for patients with RA who are not responding to other therapies. The positive results for the 100 mg twice daily dose are encouraging. However, the study also highlighted the potential side effects associated with the medication.

Date :
  1. Date Completed 2016-01-06
  2. Date Revised 2022-04-08
Further Info :

Pubmed ID

25225285

DOI: Digital Object Identifier

10.3899/jrheum.140238

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・Effects of fostamatinib
SNS
PICO Info
in preparation
Languages

English

Positive IndicatorAn AI analysis index that serves as a benchmark for how positive the results of the study are. Note that it is a benchmark and requires careful interpretation and consideration of different perspectives.

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