RA News: Pfizer Pill Beats Methotrexate, Alcohol Reduces RA Risk, Periodontal Disease High
Pfizer oral JAK “superior” to methotrexate
Pfizer released a statement about their two year study, ORAL Start, which puts their new oral JAK treatment for Rheumatoid Arthritis directly up against methotrexate. The oral medication, currently called tofacitinib, is taken twice daily in either 5 or 10 mg doses. “Tofacitinib was found to be superior to MTX with statistically significant changes shown in inhibiting structural damage, as measured by change from baseline in modified Total Sharp Score (mTSS), and in reducing signs and symptoms of RA, as measured by ACR70 response rates. Both primary endpoints assessed tofacitinib versus MTX at six months.”
Read the full Pfizer tofacitinib versus methotrexate results press release on BusinessWire.
Possible delay in final FDA approval of tofacitinib
Pfizer also announced that the FDA has recently requested additional analysis of data relating to the New Drug Application of tofacitinib. As Pfizer provides the FDA with this information this month, it is less likely the FDA will approve the application by August 21, the date estimated according to the Prescription Drug User Fee Act. In May, the advisory committee recommended approving tofacitinib in an 8-2 vote.
Another alcohol and Rheumatoid Arthritis study
Swedish researchers found a 37% decreased risk of Rheumatoid Arthritis in women who drank over four glasses of alcohol per week compared with women who drank less than one glass or none at all, with one glass being 15 g of ethanol. The study examined over 34,000 women born between 1914 and 1948 and followed up between 2003 and 2009. The women who drank three servings of alcohol per week in both 1987 and 1997, suggesting “long term alcohol consumption,” experienced a 52% decreased risk of RA compared to women who never drank.
Read more of Long term alcohol intake and risk of rheumatoid arthritis in women: a population based cohort study in the British Medical Journal.
Periodontal disease and Rheumatoid Arthritis study
A recent study confirms that, compared with healthy counterparts, people with Rheumatoid Arthritis are more likely to experience periodontal disease. RA patients experienced more than four times as much periodontal disease which was defined as a pocket depth of greater than 3 mm. Pocket depth was also associated with higher blood levels of ACPA (anti-CCP test), which makes sense with previous studies about periodontal disease and Rheumatoid Arthritis.
See “Periodontal disease is significantly higher in non-smoking treatment-naive rheumatoid arthritis patients: results from a case-control study” in the Annals of Rheumatic Diseases.
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Recommended reading
- RA News Vol. 8: Predicting TNF Response, Prednisone Increases Remission, New Mayo Clinic Heart Disease Risk Study
- Rheumatoid Arthritis and Periodontal Disease
- What Causes Rheumatoid Arthritis Disease to Trigger?
- More posts about tofacitinib / Pfizer’s RA JAK treatment
- Lots more rheum news stories
On the alcohol study—now I know why my RA didn’t bother me much from age 21 thru about age 29. LOL.
hehe. good to know. and for me, I was busy nursing babies during those yrs which is supposed to ward of RA as well. So of course I drank little or never and I’ll never know if it could’ve helped protect me.
Great article Kelly. I am very familiar with the JAX protocols. These are very important to Pfizer as they were originally targeted on psoriatic arthritis. I would imagine an entire team of colleagues on working on the FDA response. The FDA has begun to ask more and more for responses due to the potential for suicidal ideations with many new compounds in the CNS and inflamatory response specialties. Here’s hoping this is another alternative for us beside MTX. MTX and I had a very short time together due to severe migraines and my rhemy not believing in treating the migraines. Still on sulfazaladine and now CIMZIA. Hoping for big things!
thanks, we’ve been following the JAK & a couple more in the pipeline for a while. I know several folks have found JAK a big help but then I also have met a couple of people who get remission from mtx. Individual differences, what I call our “immune fingerprint” are what make this so tough. Some may have bad reactions to these, but others will have lives saved. My goal is to explain that the disease itself is dangerous enough that for many patients, the risks of the disease outweigh the risks of the tx.
Amen on that! I am trying most anything right now that my rheumy suggests….sorry I meant JAK (my former boss would get me on that typo as these were in his portfolio of studies). The pain is so intense sometimes….inside and out. I took the big step on Saturday. My hair was just falling out in huge clumps so I bought a wig a week ago but Saturday…my hair stylist took the scissors and cut it all off (what didn’t fall out in her hand). Surprisingly all is still ok, the sun came up this morning and I am still walking!
Thanks again Kelly.
I finally found a dentist 5 yrs ago who didn’t treat my dental problems like they were my fault. He also explained that some of my meds caused dry mouth and so my teeth were more likely to get cavities / gums to get sore / more tartar buildup / etc. Such a relief to have a dentist understand, and for me to stop blaming myself!
Re: the alcohol findings. Since stress is a factor in RA, I wonder if the women who drank more than 4 times a week long term felt less stressed and therefore perhaps delayed or avoided onset of RA. Just a random thought.
My rheum was involved in this JAK study. He submitted me for it, but I was rejected. I think because I wasn’t in “enough” pain. I hope they get it approved soon because I would like to try it and I know he will put me on it. I am very close to firing him, but I think I will hold off until this is approved.
Alcohol…it figures. I HATE alcohol. I did read a book on RA from the late 1800’s and the doctor (in the UK) talked about giving his patients “bitter beer” and seeing them recover from the brink of death to normal, productive lives.
Champagne always makes me feel more festive!!
However when on med’s not such a good idea.