Arthritis & Joint Conditions

Data on Tofacitinib Offers Mixed Results for Safety and Effectiveness

Many arthritis patients are anxious to know how the clinical trials are progressing for Pfizer's oral biologic drug, tofacitinib, which is being developed as a treatment for rheumatoid arthritis. New data released this month revealed that tofacitinib was as effective as Abbott's self-injectable drug Humira. However, more patients experienced serious side effects. Sounds like mixed results, right?
Actually, the incidence of overall adverse events was considered similar for tofacitinib and Humira -- although the proportion of patients who developed serious side effects was numerically higher for tofacitinib. But it's important to note, while the number was higher, the number was still considered small. These findings were derived from a 12-month trial comparing tofacitinib and Humira, called ORAL Standard. The trial involved 717 patients with moderate to severe rheumatoid arthritis who continued taking methotrexate. The patients were divided into four treatment groups: 5 mg tofacitinib twice daily, 10 mg tofacitinib twice daily, Humira injections every two weeks, or placebo.
While more study details will be released at the American College of Rheumatology in November, it looks like Pfizer will seek FDA approval by the end of this year for tofacitinib (possibly for both doses). While effectiveness seems not to be in question, safety will get some scrutiny. Also released were results from a pooled analysis of late-stage tofacitinib trials, altogether involving 6,200 patients. Pfizer concluded that mortality rates were consistent with what is typically associated with standard treatments given to slow progression of arthritis symptoms. Stay tuned.

How to Handle Unsolicited Advice About Arthritis

I don't know anyone with arthritis who hasn't encountered a well-meaning person armed with unsolicited advice for how to deal with the disease. It can be a friend, family member, or even a stranger. The recipient of the advice has two goals: to remember the person likely meant well, and not to become too annoyed. But let's face it, unsolicited advice can be annoying.
If you have arthritis, you have some experience in dealing with it. That's not to say you know everything or that you are unwelcoming of suggestions that have some basis. You have a treatment plan that has been recommended by your doctor. Unsolicited advice is not usually more valuable than your existing treatment. What is the best way to handle unsolicited advice? What should you say? Check out our suggestions in How to Handle Unsolicited Advice About Arthritis.

Share Your Arthritis Story

If you have arthritis, you have a story to tell. We learn from each other, so sharing your story can be very helpful to others. How old were you when you were diagnosed with arthritis? Was it a prolonged process to get an appointment with a doctor and go through diagnostic procedures? Without discussing specific treatments (because they are so individual to each person's case), did you go through several changes in your treatment plan?
How has arthritis affected your quality of life? How has arthritis impacted your role as a spouse, parent, employee, or friend? Share the highs and lows of living and coping with arthritis. Share Your Arthritis Story.

Osteoporosis Medications: FDA Panel Wants Label to Clarify Duration of Use

Fosamax was the first bisphosphonate approved by the FDA in 1995. Today, there are several, including Boniva, Actonel, and Reclast, as well as generic versions. They are widely-prescribed drugs for the prevention or treatment of osteoporosis. Bisphosphonates work by inhibiting bone resorption to prevent loss of bone mass and are very effective for decreasing the risk of fractures due to osteoporosis. However, safety concerns have become as issue within the last few years. Bisphosphonates have been associated with atypical subtrochanteric and femoral fractures, osteonecrosis of the jaw, and esophageal cancer. These concerns have brought forward questions regarding long-term use of bisphosphonates.
According to MedPageToday.com, on September 9, 2011, an advisory panel to the FDA voted 17 to 6 to recommend that labeling for bisphosphonates should further clarify the duration of use. The panel stopped short of defining exactly what it should be though. The confusion comes from a lack of data. There was discussion of recommending drug holidays to patients (meaning, patients would stop use of bisphosphonates for a period of time) but there is insufficient data to support the recommendation. Bottom line -- there is a lack of strong clinical evidence that bisphosphonates work better with long-term use, but also a lack of solid evidence that long-term use is harmful. It seems there is plenty of concern however.