The Drug That Helps Phil's Game

When Phil Mickelson beat Tiger Woods at Pebble Beach this weekend he said, "I believe now more so that what I am doing is correct and that I'm able to play some of my best golf."  Reading between the lines of his comments, we see a rousing endorsement for the biological drug Enbrel, which Mickelson publically promoted shortly after announcing his 2010 diagnosis with psoriatic arthritis--an auto-immune disease that attacks the joints and can rob people of the ability to even button their shirts let alone beat Tiger Woods.

The difference between TNF-alpha inhibitors and steroids like Prednisone (the previous standard treatment for such auto-immune disorders) is like the difference between laser guided missiles and the fire-bombs used to flatten entire cities during WW II.

That Mickelson is able to play elite golf with his diagnosis is nothing short of miraculous.  While it's always desirable to try gentler remedies, patients and doctors have noted a major game-change with the Enbrel class of drugs known as Tumor Necrosis Factor-alpha Antagonists, which work by tamping down the immune protein (TNF-alpha) that runs wild, attacking healthy tissues in certain autoimmune diseases including Mickelson's arthritis, and the Inflammatory Bowel Diseases Crohn's and Ulcerative Colitis.

The difference between TNF-alpha inhibitors and steroids like Prednisone (the previous standard treatment for such auto-immune disorders) is like the difference between laser guided missiles and the fire-bombs used to flatten entire cities during WW II. The new biological agents effictively minimize symptoms while allowing patients to lead relatively normal lives by suppressing a tiny portion of the immune system.  

Recently, the users of these drugs had additional good news, along with Mickelson's seemingly happy results. While TNF-alpha inhibitors are a huge biopharm success story (Enbrel's sister drug Humira is poised to become the nation's top selling drug this year) they come with a host of frightening warnings about dangerous side-effects, most all of which have to do with the immune system being compromised--there's a generally elevated risk of infections spiriling out of control and a minutely elevated risk of developing a deadly cancer.  

But a recent large-scale study of 16,000 people taking the drugs published in the Journal of the American Medical Association found no elevated risk of infection associated with TNF-alpha inhibitors. That should come as no surprise to people using the drugs successfully, but a huge relief to those considering starting them.

Cost is the other major issue for TNF-alpha inhibitors, which come with a hefty co-pay and are unaffordable for all but the wealthiest people without insurance. But even this downside received a possible solution last week when the FDA created the first shortcut to the U.S. market for "biosimilar" drugs—cheaper (rather like generic) versions of expensive and complex medicines like Enbrel made from biological matter. Drug companies will no doubt extend their patents to counter cheaper copycats, but it's at least progress in reducing the costs.

All in all it's been a good year for people taking these brave new drugs.

Update on Friday, June 8, 2012 at 3:52PM by Kathy

from WSJ.com

It’s not always fun being compared to the competition. But Embrel's main competition, Humira is under attack for being on top.

But, Roche Holdings AG took the chance with a head-to-head study it financed pitting its rheumatoid arthritis treatment Actemra against the market-leader Humira, Abbott Laboratories’ blockbuster.

Actemra fared better at reducing arthritis symptoms—swollen, painful joints—according to the study results, presented Friday morning at a European arthritis conference. Actemra is made by Roche’s Genentech unit.

Roche has been positioning its drug as a first pick for doctors and patients in the increasingly crowded rheumatoid arthritis market, long dominated by Humira, which is expected to have $9 billion in sales this year. At least seven other drug makers market are developing biologic arthritis treatments, according to a report from research firm Datamonitor. Pfizer and a partnership between Lilly and Incyte have pills in development, an easier alternative to the injectable treatments now on the market.

Humira’s patent expires at the end of 2016, and at least one other company is runninga clinical trial to test the safety of its own “biosimilar” version of the treatment.

The Roche study, along with other new data including a Bristol-Myers Squibb Co. finding that its arthritis treatment Orencia is comparable to Humira, “raise the prospect of slowing Humira growth,” wrote Credit Suisse stock analyst Catherine Arnold in a note earlier this week, when abstracts of the studies were released. Still, analysts said it was unlikely recent developments would hurt Humira sales soon.

Abbott said the trial used a low dose of Humira, a design element that may have favored Actemra. Also, it evaluated only symptoms of arthritis, and not the physical evidence of disease activity, which can be measured by x-rays, said Elizabeth Hoff, an Abbott spokeswoman.

“Abbott is confident in our ability to continue to grow Humira based on its long term proven efficacy in a broad patient population,” Ms. Hoff said.

The Roche study compared 163 Actemra patients to 162 similar Humira patients over a 24 week period, but was limited to patients taking only a biologic treatment for arthritis. Most arthritis patients receive biologics—including Actemra and Humira—along with other drugs such as methotrexate, because their results are thought to improve in combination.

But, not all patients can tolerate methotrexate, a potent chemotherapy agent with considerable side effects, such as fatigue and increased risk of infections. Roche estimates as many as one-third of rheumatoid arthritis patients don’t do well on that drug. The trial didn’t include any finding the relative effectiveness of Actemra and Humira in combination with other drugs.

Roche hopes doctors will steer more arthritis patients to Actemra if they struggle with methotrexate, rather than advising them to use Humira alone. “These data will be informative to physicians,” Sunil Agarwal, head of Roche’s immunology and infectious diseases section, tells the Health Blog. The head-to-head comparison is the first trial designed to show whether one biologic arthritis treatment is better than another, Agarwal says.

Right now, Actemra is used as a back-up drug for patients who don’t respond to so-called first-line therapies, including Humira. Roche asked the FDA in December to broaden the approval to patients who haven’t yet tried other treatments.