Clinical Trials for New Rheumatoid Arthritis Drugs – Hope for the Future
As mentioned in a recent post (When RA Treatments Fail to Work), up to 40% of RA patients do not respond to the current set of treatment options. This can be extremely discouraging. But hope could be around the corner because there are always many new drugs being tested for RA.
The United States Food and Drug Administration (FDA), the agency that approves drugs for medical use, requires an extensive clinical trial testing system that includes four phases.1 Phase 1 is early testing with a small group of patients. Phase 2 extends the testing to a larger group and Phase 3 is extensive testing with many patients. If things go well in terms of drug efficacy and safety after Phase 3 trials, the FDA may approve the drug for use in the open market. Phase 4 testing occurs after the drug is approved and can add to existing safety and efficacy data.
A recent search of the Clinical Trials database revealed that there are 1,716 current trials related to rheumatoid arthritis. Some of these trials are actively recruiting patients, some are enrolling by invitation only, some are closed and in process, and others are completed. Clinical trials may be funded major pharmaceutical companies and be conducted at clinics and hospitals around the country. Sometimes smaller companies develop the drug and a large company, who then funds the extensive clinical trails, purchases the rights to the drug. Once a clinical trial ends and the results are deemed positive, they are typically presented at conferences and published in peer-reviewed scientific journals. The drug companies then make a case to the FDA for approval in the open market. Once that occurs, a major marketing campaign begins. The most recently approved RA drug in the United States is Xeljanz that is marketed by Pfizer.2 Unlike many of the biological drugs that must be injected or infused, it is taken orally in pill form. However, this drug was not approved by the European Union because the safety risks were not deemed to outweigh the benefits of the drug.3 Two such experimental drugs that are currently in Phase 3 clinical trials for RA include Sarilumab from Regeneron/Sanofi and Baricitinib from Incyte/Lily. Sarilumab4 is a subcutaneously injected antibody and Baricitinib5 is an orally administered pill, both of which show positive early results in clinical trials. Not all experimental drugs will obtain approval and make it to market. In fact, the majority of drugs tested never make it to market. But the fact that there are many RA drugs in phase 2 and 3 trials gives hope that new treatments may be on the horizon.
If you are a RA patient who has not responded to a variety of treatments, you may be eligible to participate in a clinical trial. Speak to your rheumatologist and visit the government’s website - http://clinicaltrials.gov. Continued developing and testing of new drugs is an important process which can bring new, more effective treatments and possibly even a cure to RA someday.
On a scale of 1(low) to 5(high), how difficult is it for you to talk about having RA?