Clinical Studies With Triamcinolone Acetonide Suspension

Peter Salgo, MD: There was this McAlindon study. Is that what you were quoting before, or is there new data?

Richard Iorio, MD: There are several studies related to this product. This study refers to maintenance of articular cartilage in patients who receive this drug. I think we’d all be a little skeptical about this, but that’s what they found.

Andrew Spitzer, MD: McAlindon is a fantastic researcher. The study that we’re talking about is repeated every 3 months—an injection of standard triamcinolone acetonide. It is not related and not a part of the extended-release. This is standard crystalline Kenalog, basically. This showed a decrease in cartilage volume and slight worsening of the osteoarthritis. And this was a study that was done, as least as far as I can tell from reading it a number of times, where the repeated doses were given without necessarily reassessing symptoms at those different points in time.

The assessment of the efficacy, relative to saline, was done only at 3-month intervals—when you would already expect for the standard, immediate-release steroid to have waned, in terms of its clinical effects. So, there were some problems with the study. Nevertheless, it raises a little bit of a red flag about what repeated exposure at very high levels of steroid, with these pulses at every 3 months, might do over the long haul.

Peter Salgo, MD: And that was the pulsed, regular noncapsulated steroid?

Richard Iorio, MD: Not with the long-acting drug. It was with the regular.

Andrew Spitzer, MD: While there was synovitis and some evidence of osteoarthritis, these were not the patients that we typically see in our practices—who are pretty far along the spectrum, where the cartilage is already quite diseased.

Richard Iorio, MD: Another interpretation of the same data could be, “Well, these people got more active because they were less symptomatic. Therefore, this led to more degradative issues with the cartilage.”

Paul Lachiewicz, MD: Peter, just to be complete, can we also discuss these clinics that are sprouting up and are injecting growth factors into knees, and platelet-rich plasma, and who knows what?

Peter Salgo, MD: Be my guest. I’m backing off on this one.

Paul Lachiewicz, MD: Both our academy and the scientific literature that I’ve looked at has not shown very good results with this or that it’s of any value. What do you think, Rich?

Richard Iorio, MD: There have been some less-than-stellar studies that have shown minor improvements in people. There’s a huge placebo effect with these injections. If you pay $5000 for an injection, you’re likely to say that it worked.

Paul Lachiewicz, MD: Yes. It’s very, very expensive. I was surprised.

Richard Iorio, MD: And, they’re not usually covered by insurance.

Andrew Spitzer, MD: What I tell patients who come in and ask about this is, there’s one person who definitely has an improvement in their overall quality of life as a result of the injection. That’s the injector who’s getting the $10,000. The bottom line is, there is a reasonable attempt to explore new avenues with mesenchymal stem cells with platelet-rich plasma. But, as a recent article suggests in our literature, there’s such heterogeneity of these studies. Things have not been standardized. It’s really not ready for prime time.

Transcript edited for clarity.