Juvenile Arthritis: Discoveries Lead to Newer Treatments

X-ray of a 6-year-old’s knee with juvenile idiopathic arthritis (JIA).

Arthritis is a disease that mostly affects older people, right? Not necessarily.

Juvenile arthritis is one of the most common chronic illnesses affecting children. In fact, nearly 300,000 youngsters nationwide have been diagnosed with the disease. The most common symptoms include joint pain, inflammation (swelling), tenderness and stiffness. One early sign may be limping in the morning.

Nikolay Nikolov, a rheumatologist and clinical team leader at the Food and Drug Administration (FDA), says that children with juvenile arthritis and their parents have reason to be optimistic. In the last several years, new therapies have been developed by drug companies and approved by the FDA that moderate the effects and control the disease, likely preventing significant disability in later years.

While no one knows exactly what causes juvenile arthritis, scientists do know it is an autoimmune disorder. The immune system, which normally helps the body fight infection, attacks the body’s own tissue.

There are several subgroups of juvenile arthritis. Known collectively as Juvenile Idiopathic Arthritis (JIA), these diseases start before age 16 and cause swelling in one or more joints lasting at least six weeks.

JIA affects large joints such as knees, wrists, and ankles as well as small joints. Polyarticular JIA, the largest JIA subgroup, affects many joints. Another subgroup is Systemic JIA, which affects the whole body, and usually causes fever and skin rashes.

In the past, the first line of treatment for children with juvenile arthritis has been to relieve pain and inflammation with non-steroidal anti-inflammatory drugs (NSAIDs) such as aspirin and ibuprofen. Children with severe juvenile arthritis have been treated also with drugs that suppress the body’s immune response such as corticosteroids and methotrexate.

But polyarticular and systemic JIA are now also treated with newer medicines called biologics, which are manufactured in or extracted from biological sources.

Biologics: New Treatments for Juvenile Arthritis

“As science at the molecular level has advanced, we’ve learned more about what drives arthritis—the mechanism of the disease—and we are able to identify important targets,” Nikolov says.

These targets include cytokines (molecules that control and drive inflammation in the body) such as tumor necrosis factor (TNF), interleukins (IL), and other naturally occurring proteins involved in stimulating the body’s immune response. Biologics used in the treatment of juvenile arthritis are generally given intravenously or subcutaneously (under the skin), and usually are taken for years. Different biologics tend to work better for different subgroups of the disease. In recent years, FDA has approved several of these treatments. Here are their names, the type of JIA they treat and approval dates:

• Humira (adalimumab) for polyarticular JIA, February 2008
• Orencia (abatacept) for polyarticular JIA, April 2008
• Enbrel (etanercept) for polyarticular JIA, May 1999
• Actemra (tocilizumab) for systemic JIA, April 2011 and polyarticular JIA, April 2013
• Ilaris (canakinumab) for systemic JIA, May 2013.

“In addition to improving the signs, symptoms and physical functioning of patients, many of these biologics have been shown to reduce joint destruction in adults with rheumatoid arthritis (RA), a disease that is related to juvenile arthritis, and thus to change the natural history of the disease,” Nikolov says.

While researchers don’t yet have a lot of long-term safety information on use of these drugs in children, there is significant experience with their use in adults with RA. Biologics used for the treatment of patients with juvenile arthritis are potent drugs that suppress the immune system and can increase the risk of serious infections, including opportunistic (unusual) infections and tuberculosis

Expanding Use of New Treatments to Children

When a drug is found to benefit adults with RA in large clinical trials, drug manufacturers may study it in children with juvenile arthritis to find out if the drug works for them too. In addition, FDA considers the known and potential risks of the drug to determine whether its benefits in treating juvenile arthritis outweigh these risks.

“It’s possible that safety issues might come up in kids that we have not found in adults. For example, these drugs may affect the developing body and immune system in children, and that may warrant changes in the labels to let both health care providers and patients know what are the risks involved, and how to recognize and respond to potential problems,” Nikolov says.

Meantime, scientists continue to work on improving existing treatments for children and search for new treatments that will work better with fewer side effects.

“We don’t have a cure for juvenile arthritis—we’re not there yet,” says Nikolov. “But we’re making progress.”

Goodman And Gilman's The pharmacological Basis of Therapeutics

Dear Doctor,

You can download and use thesebooks for your personal use as such without any modification. But please give the authors the credit they deserve and do not change the author’s name.


An appeal :If any of you have these type of books or links in your collection please mail to us : mijjumaniyar@gmail.com

                                               




                                                                         Click Here

Surgery Notes With Anatomy and Instruments

                 
Dear Doctor,

You can download and use thesebooks for your personal use as such without any modification. But please give the authors the credit they deserve and do not change the author’s name.


An appeal :If any of you have these type of books or links in your collection please mail to us : mijjumaniyar@gmail.com



                                           



                                                           Click Here

FDA Regulatory Affairs

   
                                    
             








                                                          Click Here

British National Formulary Children

       
Dear Doctor,

You can download and use thesebooks for your personal use as such without any modification. But please give the authors the credit they deserve and do not change the author’s name.

An appeal :If any of you have these type of books or links in your collection please mail to us : mijjumaniyar@gmail.com




                                        


                                                         Click Me                        
 


                           

Can an Aspirin a Day Help Prevent a Heart Attack?

• Can an aspirin a day help you ward off a heart attack or stroke?

               That depends.

Scientific evidence shows that taking an aspirin daily can help prevent a heart attack or stroke in some people, but not in everyone. It also can cause unwanted side effects.

According to Robert Temple, M.D., deputy director for clinical science at the Food and Drug Administration (FDA), one thing is certain: You should use daily aspirin therapy only after first talking to your health care professional, who can weigh the benefits and risks.

Who Can Benefit?

"Since the 1990s, clinical data have shown that in people who have experienced a heart attack, stroke or who have a disease of the blood vessels in the heart, a daily low dose of aspirin can help prevent a reoccurrence," Temple says. (A dose ranges from the 80 milligrams (mg) in a low-dose tablet to the 325 mg in a regular strength tablet.) This use is known as "secondary prevention."

However, after carefully examining scientific data from major studies, FDA has concluded that the data do not support the use of aspirin as a preventive medication by people who have not had a heart attack, stroke or cardiovascular problems, a use that is called "primary prevention." In such people, the benefit has not been established but risks—such as dangerous bleeding into the brain or stomach—are still present.

Caution Needed With Other Blood Thinners

When you have a heart attack, it's because one of the coronary arteries (which provide blood to the heart), has developed a clot that obstructs the flow of blood and oxygen to the heart. Aspirin works by interfering with your blood's clotting action.

Care is needed when using aspirin with other blood thinners, such as warfarin, dabigatran (Pradaxa), rivaroxaban (Xarelto) and apixiban (Eliquis).

What about people who have not had heart problems or a stroke but who, due to family history or showing other evidence of arterial disease are at increased risk? Is an aspirin a day a safe and effective strategy for them?

Again, Temple emphasizes, the clinical data do not show a benefit in such people.

He adds, however, that there are a number of ongoing, large-scale clinical studies continuing to investigate the use of aspirin in primary prevention of heart attack or stroke. FDA is monitoring these studies and will continue to examine the evidence as it emerges.

In the Meantime

The bottom line is that in people who have had a heart attack, stroke or cardiovascular problems, daily aspirin therapy is worth considering. And if you're thinking of using aspirin therapy, you should first talk to your health care professional to get an informed opinion, Temple says.

Finally, how much aspirin you take matters. It's important to your health and safety that the dose you use and how often you take it is right for you. Your health care professional can tell you the dose and frequency that will provide the greatest benefit with the least side effects.

If your health care professional recommends daily aspirin to lower the risk of a heart attack and clot-related stroke, read the labels carefully to make sure you have the right product. Some drugs combine aspirin with other pain relievers or other ingredients, and should not be used for long-term aspirin therapy.

Warning: Aspirin-Containing Antacid Medicines Can Cause Bleeding

The next time you reach for an over-the-counter (OTC) product to treat your upset stomach or heartburn, consider whether you should use one of the many antacids that don’t have aspirin.

Why? Aspirin-containing medicines to treat heartburn, sour stomach, acid indigestion, or upset stomach can cause stomach or intestinal bleeding, especially in some people, warns the U.S. Food and Drug Administration (FDA).

Cases of bleeding are rare. In 2009, FDA issued a warning about serious stomach bleeding risk with aspirin and other non-steroidal anti-inflammatory drugs (NSAIDs). Despite that warning, when FDA reviewed its Adverse Event Reporting System database, it found eight new cases of serious bleeding caused by aspirin-containing antacid products since that 2009 warning. Some of those patients required a blood transfusion.

“Take a close look at the Drug Facts label, and if the product has aspirin, consider choosing something else for your stomach symptoms,” says Karen Murry Mahoney, MD, Deputy Director of the Division of Nonprescription Drug Products at FDA. “Unless people read the Drug Facts label when they’re looking for stomach symptom relief, they might not even think about the possibility that a stomach medicine could contain aspirin.”

Mahoney adds: “Today we’re focusing on bleeding risk specifically with antacid-aspirin products used to treat upset stomach or heartburn. We’re not telling people to stop taking aspirin altogether.”

How will you know what OTC medicine to take to get relief from indigestion? Again, it’s important to read the Drug Facts label. It will tell you if the product contains aspirin, and it lists the risk factors for bleeding. If the medicine has aspirin, consider looking for something else  There are plenty of stomach medicines that don’t contain aspirin.

Who’s at Higher Risk of Bleeding

Because aspirin thins the blood, FDA believes the aspirin in these combination medicines is contributing to major bleeding events. People with one or more risk factors have a higher chance of serious bleeding with aspirin-containing antacid products.

You are at higher risk for bleeding with these products if you:

• Are 60 or older.
• Have a history of stomach ulcers or bleeding problems.
• Take drugs that reduce the ability of your blood to clot (also known as anticoagulants or blood-thinning drugs).
• Take steroid medicine, such as prednisone, to reduce inflammation.
• Take other medicines containing NSAIDs, such as ibuprofen or naproxen.
• Drink three or more alcoholic drinks every day.

Warning signs of stomach or intestinal bleeding include feeling faint, vomiting blood, passing black or bloody stools, or having abdominal pain. These are signs that you should consult a health care provider right away.

What if you’ve been taking these products for a long time?

“Some people may have been taking aspirin-containing antacid products frequently for a long time. Apart from the bleeding risk, it’s not normal to have frequent or chronic upset stomach or heartburn. You should talk to a health care provider if that’s happening,” says Mahoney.

Take aspirin regularly? If your health care provider has advised you to take an aspirin a day to help prevent a heart attack or other condition, don’t stop without talking with your doctor first, Mahoney says. Make sure you discuss what kind of medicine you can take in case you get an upset stomach.

How to Settle an Upset Stomach

Consumers have many alternatives for treating heartburn, sour stomach, acid indigestion, and upset stomach. Read the Drug Facts label and look for products that contain an “antacid” or “acid reducer.”

For example, Mahoney says, there are numerous OTC medicines that contain only an antacid, such as calcium carbonate, magnesium hydroxide, or another antacid. These can be used to treat heartburn, sour stomach, acid indigestion, and upset stomach. For frequent heartburn, there are acid reducers, such as proton pump inhibitors (esomeprazole, lansoprazole, omeprazole), or H2 blockers (cimetidine, famotidine, ranitidine).

What Else FDA Is Doing

In 2009, a warning about the risk of serious bleeding was added to the labels of all OTC products that contain NSAIDs, including aspirin-containing antacid products.

FDA is continuing to evaluate this safety issue and plans to convene an advisory committee of external experts in 2017 to provide input regarding whether additional regulatory action is needed, such as adding warnings to the labeling or other actions.

This article appears on FDA's Consumer Updates page, which features the latest on all FDA-regulated products. 

June 6, 2016