Tag: health

MichaAbelesBiosimilarUsageRheumaticDiseases

Recommendations Issued about Biosimilar Usage for Rheumatic Diseases

The treatment of choice for rheumatic diseases has traditionally been the use of biological agents called bio-originators. These agents are derived from microorganisms, animals or humans. The increasing cost of these agents has put effective treatment out of the reach of many disease sufferers.

A group of international rheumatologists, patient representatives and specialists in related fields conducted a scientific review to determine if the use of “biosimilars” can help give patients greater access to treatment. Biosimilars are substances that have been approved by the FDA because they are so similar to bio-originators that are already in use.

The task force addressed three questions. The first was the matter of cost. Biosimilars introduce more competition in the market and are expected to result in lower prices. It was predicted that the savings would be about 35 percent. In the United States, for a product with only one biosimilar available, the savings was only about 15 percent. The task force hopes that as more biosimilars become available, the cost savings will be more fully realized.

The second question was in regard to extrapolation. An example is the best way to explain extrapolation. If a bio-originator is used to treat conditions A, B and C, full extrapolation would mean that as soon as the FDA approves the biosimilar for condition A, it could also be used to treat conditions B and C. The task force was in agreement that the more cautious route of doing additional testing for each condition should be followed.

The third question investigated by the task force looked at the implications of having a patient switch from the bio-originator to a biosimilar. The data regarding biosimilars for rheumatic diseases strongly suggest that this switch is safe and produces no drop in effectiveness. The decision to switch from one to the other, however, should only be made by the doctor in consultation with the patient.

One topic that still requires further research is the question of interchangeability. Interchangeability means that the biosimilar is truly equivalent in every meaningful way to the bio-originator. This can only be determined if patients are switched from one to the other and back at least three times. If there are no differences found regarding safety, effectiveness, reaction of the immune system, or side effects between a group that undergoes the switching and a group that only uses the bio-originator, the two products can be called interchangeable.

MichaAbelesSmokeExposureChildhoodRA

Smoke Exposure in Childhood Can Boost Chances of Getting RA

Each year The European League Against Rheumatism (EULAR), an organization that represents the patient, healthcare professional and professional societies of rheumatology in the European Union, holds the Annual European Congress of Rheumatology. Not only does this forum serve as a space where rheumatology professionals can connect with patient organizations from all across Europe, but is also helps rheumatologists engage with other professionals and learn about new findings in the field.

If you recall my previous blog, Medicines May Help to Prevent Arthritis, EULAR may sound familiar to you because this blog was based on a report from this forum as well. As a follow-up to my previous blog, I’d also like to talk about another interesting finding that was presented at the conference: secondhand smoke exposure from cigarettes in childhood can boost chances of getting rheumatoid arthritis (RA).

“This is the first demonstration of a rheumatoid arthritis risk associated with passive smoking,” explained Raphaèle Seror, M.D., a professor of rheumatology at the University of Paris–South and a practicing rheumatologist at the Hospital Bicetre Kremlin Bicetre, at the European Congress of Rheumatology.

The French rheumatologist and her team analyzed data collected from more than 70,000 French women, which followed their health for more than 20 years. Then, the team identified a cohort of women who had confirmed RA based on their self-report of having incident RA, which occurs after a health-depleting action such as excessive alcohol consumption or smoking, during a follow-up study.

This cohort of women who had confirmed incident RA totaled 389 women. Majority of those women had a history of smoking or being exposed to secondhand smoke. In fact, the analysis showed that women who had a history of second-hand smoke were exposed to it as children — and they were all exposed at an estimated more than an hour every day. These women actually showed to have a 43% higher rate of incident RA compared to women who never smoked or never had a history of secondhand smoke exposure.

To further confirm the suspicions of the link between smoking and RA incidence, 37% of women with a history of smoking without childhood exposure had the likelihood of developing RA, and 73% of women who had both secondhand smoke exposure as children and smoked into adulthood were likely to develop RA.

Although this study only analyzed women, it can be evident that we can say the same for men as well. Regardless, “secondhand smoke exposure to children was about as potent a trigger for future rheumatoid arthritis as active smoking by an adult,” says a report from Rheumatology News.

Were you frequently exposed to secondhand smoke as a child? Do you smoke today? It’s probably a good idea to make an appointment with your local rheumatologist to get yourself checked for RA.

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