We hope that by now we have convinced you that clinical trials are not a health hazard or just shots in the blind – over the last couple of years we’ve posted a lot of articles here on the FindMeCure blog about clinical trial myths, your rights when considering participation, the possible benefits of entering a clinical trial or receiving a drug in development even you don’t qualify for the trial, and how to choose the right clinical trial for you.

But just in case you need a bit more convincing, we’d like to acquaint you with two drugs recently approved by the FDA which can tangibly improve the lives of people living with arthritis – both the result of clinical trials.

Kevzara, Rheumatoid arthritis

Kevzara is developed by the Sanofi Company and it was approved in May 2017. Its target group is people with moderate to severe RA who do not respond well to the standard DMARDs (disease-modifying antirheumatic drugs) treatment. Kevzara can be used as a single-drug treatment or combined with other therapies (such as methotrexate or any regular DMARD) once every two weeks as a subcutaneous injection of 200 mg.

RA in a nutshell

Kevzara is a biologic. It is an interleukin-6 (IL-6) receptor blocker. Wait, what? Okay, here’s the simple explanation: IL-6 is a cytokine produced by cells such as T and B-cells and lymphocytes to name a few, and it’s connected to inflammation. So, Kevzara works by inhibiting IL-6-bound receptors.

Kevzara is approved by the FDA thanks to the results of two randomized, double-blind, placebo-controlled clinical trials and the people who participated in them – adults with moderately to severely active RA and inadequate response to MTX (methotrexate) or TNF-α antagonists (in the second clinical trial).

Though the results of the trials are positive enough for the FDA to approve Kevzara, it comes with its side effects as any other drug does. And because it affects the immune system (remember our article on biologics?), the adverse effects include (but are not limited to) infections and increased risk of some kinds of cancer[1].

Zilretta – specifically developed with Оsteoarthritis knee pain in mind

Zilretta is a product of Flexion Therapeutics and it got an FDA approval in October 2017 and it’s specifically developed with osteoarthritis knee pain in mind. It uses the extended-release method, which as you can probably guess, means you don’t have to take the drug daily. Zilretta is injected into the joint and its microspheres, which contain the medicine, slowly break down over the course of about 3 months and release the medicine.

about OA

Zilretta however, is a corticosteroid – which means it might not be an option for you if you’re allergic to corticosteroids or have an inadequate reaction to them. It’s also not intended for repeat use, and as other corticosteroids it’s associated with possible side effects such as infections or reduced ability to fight them, weakened bones, mood changes, reversible effects on hormone production[2].

Zilretta works by activating anti-inflammatory transcription factors and inhibiting inflammatory transduction pathways… in a nutshell, it fights inflammation. The drug demonstrated reduced pain intensity in the international, randomized, double-blind, placebo- and active-controlled clinical trial, on which the FDA based its approval.

You can check for promising clinical trials for either RA or OA on our search platform. Simply use the search field below by typing your condition, location, and other details!

 

Article by Nelly Katsarova

 

[1] https://www.kevzara.com/what-is-kevzara

[2] https://zilretta.com/

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