FDA approves Xeljanz (tofacitinib) for rheumatoid arthritis

The FDA just announced the approval of Xeljanz (tofacitinib) for rheumatoid arthritis. Read more here.

We should see some interesting discussions about this given that the 2012 ACR/ARHP Annual Meeting is right around the corner.

American College of Rheumatology annual conference

This year, I'll be attending the American College of Rheumatology annual conference (Nov 5-9 in Chicago) and I'm looking forward to the meeting. There are so many things happening in the world of bone disease, rheumatoid arthritis, lupus, psoriatic arthritis, etc. Here's what some experts are saying:

In terms of basic research, "2011 will see the continued evolution of a systems biology approach to understanding rheumatic diseases," says Richard Loeser, MD, Chief of the Section of Molecular Medicine at Wake Forest University School of Medicine. Rather than studying individual interacting components of biological systems, systems biology takes a global approach using an integrative strategy that involves techniques to observe complete sets of genes and proteins.

In 2011, "expect to see the results of further research on the effect of serotonin in the brain and periphery on bone metabolism," says Chad Deal, MD, Head of the Center for Osteoporosis and Metabolic Bone Disease, Cleveland Clinic.

In 2011, the focus in lupus will be on "treatment, treatment, treatment," says Susan Manzi, MD, MPH, Chair, Department of Medicine, West Penn Allegheny Health System, Director Lupus Center of Excellence.

Learn more about ACR/ARHP Annual Scientific Meeting here.

American College of Rheumatology annual conference

This year, I'll be attending the American College of Rheumatology annual conference (Nov 5-9 in Chicago) and I'm looking forward to the meeting. There are so many things happening in the world of bone disease, rheumatoid arthritis, lupus, psoriatic arthritis, etc. Here's what some experts are saying:

In terms of basic research, "2011 will see the continued evolution of a systems biology approach to understanding rheumatic diseases," says Richard Loeser, MD, Chief of the Section of Molecular Medicine at Wake Forest University School of Medicine. Rather than studying individual interacting components of biological systems, systems biology takes a global approach using an integrative strategy that involves techniques to observe complete sets of genes and proteins.

In 2011, "expect to see the results of further research on the effect of serotonin in the brain and periphery on bone metabolism," says Chad Deal, MD, Head of the Center for Osteoporosis and Metabolic Bone Disease, Cleveland Clinic.

Co-pay support program for patients taking Enbrel (Etanercept)

Amgen and Wyeth Pharmaceuticals have announced the ENBREL Support™ Co-pay Card Program for all eligible patients who take Enbrel (Etanercept). Who's eligible? Well, maybe we should start with those who are not eligible:

This program is not open to uninsured patients or patients receiving prescription reimbursement from federal, state, or government-funded insurance programs (for example, Medicare, Medicaid, etc.) or patients who live in Massachusetts (or where prohibited by law). Restrictions, including monthly maximums, may apply. Offer subject to change or discontinuation without notice.

This co-pay support program may offer:

• 6 months at no co-pay cost, and
• A co-pay of $10 or less per month thereafter (Patients will receive 50% off their co-pay or pay no more than $10 per month—whichever helps more)

The ENBREL Support™ Co-pay Card Program provides patients with up to $750 of assistance per month for months 1-12. For patients with moderate to severe plaque psoriasis who are first starting ENBREL, the program provides up to $1,500 per patient per month for months 1-3. Patient is responsible for costs above these amounts. Participation in the program can be renewed every year.

More than 45,000 people have already used a co-pay card for their ENBREL treatment.
The program is simple for you to share with patients. Direct patients to call 1-888-4ENBREL to enroll today.

Patients who lose their jobs but are covered by private insurance, including COBRA, may receive up to an additional 6 months of ENBREL at no co-pay cost. Potential help for patients who are uninsured or in need of other financial help is also available.

Here are the FDA-approved indications for ENBREL:

• ENBREL is indicated for reducing signs and symptoms, inducing major clinical response, inhibiting the progression of structural damage, and improving physical function in patients with moderately to severely active rheumatoid arthritis. ENBREL can be initiated in combination with methotrexate (MTX) or used alone.
• ENBREL is indicated for reducing signs and symptoms of moderately to severely active polyarticular juvenile idiopathic arthritis in patients ages 2 and older.
• ENBREL is indicated for reducing signs and symptoms, inhibiting the progression of structural damage of active arthritis, and improving physical function in patients with psoriatic arthritis. ENBREL can be used in combination with methotrexate in patients who do not respond adequately to methotrexate alone.
• ENBREL is indicated for reducing signs and symptoms in patients with active ankylosing spondylitis.
• ENBREL is indicated for the treatment of adult patients (18 years or older) with chronic moderate to severe plaque psoriasis who are candidates for systemic therapy or phototherapy.

Click here for additional details of the co-pay support program.

Since Enbrel is a TNF blocker, make sure you read this:

• FDA: Cancer Warnings Required for TNF Blockers

Colchicine receives FDA approval? It's about time!

This may sound a bit odd, but "FDA Approves Colchicine for Acute Gout, Mediterranean Fever." Wait a minute, isn't colchicine a really old drug? Yes, but I guess it's technically been used off-label for all these years. According to the FDA:

Oral colchicine has been used for many years as an unapproved drug with no FDA-approved prescribing information, dosage recommendations, or drug interaction warnings.

So, if that little piece of trivia tickles your brain, then read this full FDA press release about the recent approval of colchicine:

The U.S. Food and Drug Administration has approved Colcrys to treat acute flairs in patients with gout, a recurrent and painful form of arthritis, and patients with familial Mediterranean fever (FMF), an inherited inflammatory disorder. The medication’s active ingredient is colchicine, a complex compound derived from the dried seeds of a plant known as the autumn crocus or meadow saffron (Colchicum autumnale).

Colchicine has been used by healthcare practitioners for many years to treat gout but had not been approved by the FDA. The FDA has an initiative underway to bring unapproved, marketed products like colchicine under its regulatory framework. This initiative promotes the goal of assuring that all marketed drugs meet modern standards for safety, effectiveness, quality and labeling.

Physicians historically have given colchicine hourly for acute gout flares until the flare subsided or they had to stop treatment because the patient began experiencing gastrointestinal problems. A dosing study required as part of FDA approval demonstrated that one dose initially and a single additional dose after one hour was just as effective as continued hourly dosing for acute gout flares, but much less toxic. As a result, the drug is being approved for acute gout flares with the lower recommended dosing regimen.

The FDA is alerting healthcare professionals to this new dosing regimen and also warning about the potential for severe drug interactions when patients take colchicine.

The medicinal value of using colchicum was first identified in the first century A.D. and its use for treating acute gout dates back to 1810. Physicians have prescribed the medication since then. Although single-ingredient colchicine has not been approved by the FDA until now, a combination product containing colchicine and an agent that increased the excretion of uric acid in the urine was approved by the FDA in 1939.

FMF is the most common of the hereditary periodic fever syndromes and is characterized by recurrent episodes of fever, arthritis and painful inflammation of the lining layers of the lungs and abdomen. Though rare in the United States, it is more common in Mediterranean countries. Physicians have prescribed colchicine for FMF for many years based on studies showing that it reduced the frequency of attacks but use of colchicine for FMF had never been approved. With this approval, Colcrys becomes the first drug approved to treat FMF.

Colcrys is manufactured by Mutual Pharmaceutical Company, Inc., Philadelphia.

How's that for an interesting mix of fascinating trivia coupled with some FDA news?

Arzerra (ofatumumab) appears promising for CLL

Arzerra (ofatumumab) appears promising for chronic lymphocytic leukemia (CLL). Ofatumumab (formerly known as HuMax-CD20) is a targeted therapy. It is actually a human monoclonal antibody that targets a distinct antibody binding site (the small loop epitope) of the CD20 molecule on the cell membrane of B cells. It is currently under development for the treatment of CLL and has also shown potential in treating follicular non-Hodgkin’s lymphoma, diffuse large B cell lymphoma, rheumatoid arthritis and relapsing remitting multiple sclerosis. Is it available yet? No. The FDA is currently still reviewing this biologic agent. Here's a snippet from the June GSK press release:

GlaxoSmithKline and Genmab A/S today announced that the United States Food and Drug Administration (FDA) informed the companies that the agency has extended the action date for the ofatumumab BLA application by three months.

The FDA has been slow recently, don't you think? Better safe than sorry? Or, is the FDA being overly-cautious? We don't want to see another Raptiva incident again, do we? Raptiva was voluntarily withdrawn in April by Genentech because of an increased risk of progressive multifocal leukoencephalopathy (PML), a rare and usually fatal disease of the central nervous system. It's difficult to find such rare adverse effects until the drug gets used by the public, so I don't think anyone is faulting either the FDA or Genentech.

Well, let's see what happens with ofatumumab.

CIMZIA and OXO GOOD GRIPS

I love kitchenware made by OXO GOOD GRIPS®. Who would have thought that they would team up with a pharmaceutical company to develop an innovative syringe filled with a biologic agent?

UCB, the biopharmaceutical company that makes CIMZIA (certolizumab pegol), partnered with OXO GOOD GRIPS® to design a syringe that would be easy to use for many people. Sounds like a great idea to me. A soft, non-slip grip should make this easier to use. Should we expect to see more of these "easy to use" syringes for other injectable drugs?

Cimzia is currently the only PEGylated anti-TNF (Tumor Necrosis Factor) approved by the FDA for reducing signs and symptoms of Crohn's disease and maintaining clinical response in adult patients with moderate to severe active disease who have had an inadequate response to usual treatments. Cimzia is also FDA approved for the treatment of adults who have moderately to severely active rheumatoid arthritis (RA).

Anticytokine Therapies - confusing names?

Ever get confused with medical terminology? Happens to me all the time. Anticytokine therapies and other biologics are revolutionizing the treatment of some serious diseases. Here's an example of a patient with psoriasis who responded to alefacept.

When you're talking about some of the newer biologic agents, you may find that they're easy to mix up. Here's a helpful guide regarding nomenclature.

Abbreviations placed at the ends of the names convey specific information relating to their structure:

* "-cept" refers to fusion of a receptor to the Fc part of human IgG1
* "-mab" indicates a monoclonal antibody (mAb)
* "-ximab" indicates a chimeric mAb
* "-zumab" indicates a humanized mAb

Etanercept is a classic example of a TNF receptor fusion protein. Infliximab is a chimeric mAb directed against TNF. Certolizumab and tocilizumab are humanized mAbs.