Before 2011 becomes a distant memory, Psoriasis Cure Now felt it would be useful to highlight what we believe were the top psoriasis and psoriatic arthritis stories of 2011. The year included bad news about a promising treatment from Abbot
t, as well as a psoriasis sub-plot to one of the more ridiculous media sensations of our age, the Kardashians.
Here are the Top Four from where we sit:
#4: Phil Mickelson’s golf troubles
When psoriatic arthritis first struck golf great Phil Mickelson in the summer of 2010, he was ranked #2 in the world of golf, and was pushing toward his dream of becoming the #1-ranked golfer in the world. Since then, he has received world-class medical care and is reportedly using a leading psoriasis and psoriatic arthritis treatment. But his golf ranking had slid to #12 as of December 2011.
Is it related to his psoriatic arthritis? We certainly don’t know, and given his professionalism and temperament, he would never make excuses for a rough patch in his game (and #12 in the world is nothing to sneeze at, it usually takes us 12 shots for a par 3 hole). It could just be Father Time having an impact, or the natural ebb and flow of sports performance at these elite levels.
But psoriatic arthritis patients would not be surprised if the disease were adversely impacting his performance. Even the best treatments cannot always guarantee a return to one’s pre-psoriasis-flare health. And when you are competing against the best in the world, even small amounts of pain, stiffness and swelling that often remain even during treatment could be the difference between winning and ending up a few strokes back. Mickelson is an inspiration to so many of us, and we hope he continues to wow golf fans for decades to come. But his post-diagnosis golf struggles are a powerful reminder of the toll that psoriasis and psoriatic arthritis can take, and it would not be a bad thing if the general public came to understand that.
#3: For FDA-approved biologics, no news is good news
Another year has passed with the use of biologics for psoriasis, and no new safety concerns emerged in 2011 from the long-term use of biologics. Given that the typical psoriasis patient will live with psoriasis for 50 years, the importance of long-term safety of psoriasis treatments cannot be overstated. While specific figures are hard to come by, we now have patients with rheumatoid arthritis, psoriasis and psoriatic arthritis, and Crohn’s disease who have been using biologics for longer than 5, 7 or in some cases, even 10 years. These patients are not experiencing higher rates of serious adverse events than patients who have used biologic treatments for shorter periods. This absence of bad news is very good news. If it holds, it could mean that biologics may offer a truly long-term option for psoriasis patients that combines long-term safety with long-term effectiveness.
(Of course, this does not mean biologics are without real and potentially serious risks. See our biologics pages for more on the risks and benefits of these treatments.)
#2: Kim Kardashian has psoriasis!
And she is talking about it on Twitter and her TV show! And others are talking about it in gossip magazines! Oh my gosh! Is this a good development or a bad one? We’re not sure, nor are our supporters. Many psoriasis patients were upset with her portrayal of her psoriasis on her “reality” TV show—it especially rankled those with severe psoriasis, as the psoriasis that appeared on the show looked relatively mild. (Of course, for someone whose income depends on being a model, even minor skin symptoms could be a big deal professionally.)
Others were thrilled by her coming forward, and the attention she can bring to the disease. After all, she is a worldwide media phenomenon, with more than 12 million people now following her on Twitter!
We, for our part, remain uncommitted. If the messages she conveys about psoriasis are scientifically sound and sensitively delivered, her fame can educate millions about this disease. But if she is just chasing ratings or if she promotes questionable treatments to make a fast buck, then her fame will set us all back. In this case, the old cliché to “stay tuned” really is all we can do at this point.
Above all, we wish her well. Psoriasis is no fun, even for those who can keep it hidden. For someone who is photographed every time she leaves her home, it must be particularly unwelcome.
#1: Abbott abandons extremely promising psoriasis treatment briakinumab
The biggest psoriasis story of 2011 was the one that received all too little media attention. Abbott, the company behind the biologic blockbuster Humira (adalimumab), was in large, late-stage clinical trials of what was expected to be its next blockbuster, a biologic called ABT-874 or briakinumab. (Some reports already had its future brand-name as Ozespa.)
The treatment was highly effective in its clinical trials. The buzz among physicians participating in the patient trials was palpable, and psoriasis patients in the trials were effusive in their praise of it. In one large study, two-thirds of patients had achieved a 75% improvement in symptoms after a year of treatment, and in another, at 24 weeks, more than one-third had achieved a 100% improvement. (Anecdotal reports from other patients who had been in a multi-year trial of the treatment suggested the strong results could be sustained even longer.)
But then examination of the trial results indicated that major adverse cardiovascular events (MACE) including heart attack, stroke and related fatalities had been seen in a few patients being treated with briakinumab (in addition to some malignancies that are of concern with all biologics). Some evidence seemed to suggest that the MACE events occurred in patients with other cardiovascular risk factors, and also tended to occur early in treatment. But given that cardiovascular risk factors are common among psoriasis patients, this doomed briakinumab, and Abbott terminated the psoriasis trials, withdrew its FDA application for the treatment, cancelled or abandoned plans for trials in other diseases, and pretty much ended public work on this seemingly-most-promising experimental treatment.
Patients in the trials were (and many still are) deeply distressed by its end. Some had been in extended trials of briakinumab for four years or more, with spectacular results. We received heart-wrenching emails from numerous briakinumab patients who desperately hoped to be able to continue this experimental treatment that had proved so successful for them, without any apparent side effects.
[You can read comments from briakinumab patients who chose to post publicly here and here (comments appear at the bottom of those pages). We received many other, similar comments via email and phone.]
Here are some of the unanswered questions we and those who have contacted us have about briakinumab:
* Did Abbott terminate its briakinumab clinical trials in psoriasis and Crohn’s disease (1) because it found the safety risks unacceptably high? Or (2) does it believe the risks were manageable given the benefits, but gave up because it believes the US Food and Drug Administration would wrongly have blocked FDA approval, given these safety issues? Or (3) does it believe briakinumab’s business prospects were doomed by the MACE events even if the FDA would approve it, given doctors’ legitimate fears of lawsuits and patients’ safety concerns?
* Did patients with no known cardiovascular risk factors experience some of these MACE events? If not, couldn’t this treatment still be extremely valuable (and safe) for many patients? Or would a combination of FDA rules, physicians’ legitimate fear of lawsuits, and competition from other treatments make this a poor business proposition for Abbott?
* Is Abbott planning any further study of briakinumab in psoriasis or any other disease or has the company made a decision that its briakinumab program is over?
* If the briakinumab development program has been terminated, would Abbott consider selling the rights to briakinumab to another company if there were interest?
* Do scientists have any theories why we see unacceptable levels of MACE events in briakinumab but not Stelara (ustekinumab), which also targets IL-12 and IL-23?
Our heart goes out to the briakinumab patients who experienced serious health problems while in the clinical trials. We are grateful that patients participate in these trials, which advance our scientific knowledge and ultimately help all psoriasis patients. We also feel for the many patients whose treatment success was cut short by the abrupt cancellation of their clinical trial. We hope they have found alternative treatments that are providing them relief.
This episode also reminds us how difficult and costly drug development is. Abbott does not get a refund for its years of study and tens of millions of dollars spent developing briakinumab. It would have made a ton of money had it made it to market, and it would have helped a lot of people. But the current view of most experts is that fatalities are not acceptable in psoriasis treatments, given the other treatment options currently available and the perceived level of seriousness of psoriasis and psoriatic arthritis. We’ll leave that debate for another day.
[A different psoriasis treatment, the FDA-approved Raptiva (efalizumab), was withdrawn from the market in 2009, after at least three deaths were tied to it. That withdrawal also proved frustrating for the patients who were doing well on the treatment (including, reportedly, model CariDee English). The first product liability trial related to a fatality allegedly caused by Raptiva is scheduled for June 2012 in California.]
Let’s keep fighting for safe and effective treatment options and hope that every psoriasis patient can soon find relief.
Category: Biologics, Patient Stories, Psoriasis Cure Now, Psoriasis Research, psoriatic arthritis, Public policy issues
Tags: Abbott, Briakinumab, Enbrel, Humira, Kim Kardashian, Phil Mickelson, Stelara, Top Psoriasis Stories