Arthritis Treatment News: Novartis’ childhood arthritis drug study achieves primary goal
Novartis’ childhood arthritis drug study achieves primary goal
Novartis (NYSE:NVS) announced Friday its phase 3 trial for its ACZ885 drug for the treatment of systemic juvenile idiopathic arthritis (SJIA) has achieved its primary endpoint.
The phase 3, four-week, randomized, double-blind, placebo-controlled study enrolled 84 children and young adults suffering from SJIA. Each patient was treated with either a single dose of ACZ885, or a placebo.
At the end of the four-week study, 83.7% of patients in the ACZ885 drug group experienced at least a 30% improvement in symptoms, versus 9.8% of patients in the placebo group. Meanwhile, 32.6% of patients in the drug group experienced 100% improvement in symptoms, versus none in the placebo group.
The primary endpoint was a 30% improvement in at least three of the following six variables, the company said: physician’s assessment of disease activity, parent/patient assessment of overall well-being, functional ability, number of joints with active arthritis, number of joints with limited range of motion, and a laboratory measure of the C-reactive protein, an inflammatory agent.
“These data suggest that ACZ885 could become an important treatment option for children living with SJIA, the most difficult-to-treat and severe form of juvenile arthritis, potentially transforming their lives,” said one of the study’s investigators, Professor Pierre Quartier.
“ACZ885 provided rapid and long-lasting symptom relief by targeting interleukin-1 beta, a key inflammatory mediator of the disease.”
Affecting one in every 100,000 children, SJIA is characterized by inflammation affecting the whole body, including most joints. Other symptoms include potentially life-long and recurrent arthritis flares, which can involve skin rash, daily spiking fevers, joint pain, and swelling.
The ACZ885 drug works by inhibiting IL-1 beta, the excessive production of which causes certain inflammatory diseases, like SJIA.
Novartis said its second phase 3 trial of ACZ885, which will determine if the drug can extend the time between arthritic flares and reduce or eliminate corticosteroid use, is ongoing, with results expected to be presented later this year.
Arthritis: What’s truth and what’s myth?
Cracking your knuckles causes arthritis — you probably know that’s an old wives’ tale. Though it could injure ligaments around the joints and lead to weaker grips, there’s no proof every pop puts you one step closer to arthritis — specifically osteoarthritis. Osteoarthritis (OA) develops when the cartilage that cushions the ends of the bones in your joints breaks down. The bones then begin to rub against one another, causing pain. OA is the most common form of arthritis, but there’s no cure, so the more you know, the better. Here are three more misconceptions about OA:
Myth: Arthritis is a natural part of aging.
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Yes, it usually appears after age 45. And yes, the older you are, the more wear and tear you have. But not every older adult develops osteoarthritis. Obesity is also a major risk factor — more weight means more stress on lower body joints.
Myth: Meds should be your first line of treatment.
Reduce pain and improve joint function — that’s the goal of osteoarthritis treatment, and medications (from over-the-counter acetaminophen to prescription pain pills) certainly help. But according to the Arthritis Foundation, simply moving your body is the best medicine for OA, and it’s an effective first step. Gentle exercises, such as walking or swimming, help strengthen muscles and bones, increase flexibility and make joints more stable. That’ll also help you lose weight, which will further reduce joint strain.
Myth: Supplements cure joint pain.
Glucosamine and chondroitin are two that are reputed to battle osteoarthritis, but an analysis of 10 studies showed these supplements don’t do much to relieve pain associated with knee and hip OA. Another supplement that probably doesn’t work: vitamin D. It has been suggested it can help treat knee OA, but it does not appear to lessen the symptoms or slow its progression.
TNF Treatment for Rheumatoid Arthritis Boosts Skin Cancer Risk
Treating rheumatoid arthritis (RA) patients with tumor necrosis factor (TNF) inhibitors appears to increase their risk of developing skin cancer, a new review of prior research indicates.
However, TNF inhibitors, which include infliximab (Remicade), adalimunab (Humira), and etanercept (Enbrel), do not appear to boost the risk for developing other forms of cancer, the researchers added.
The findings stem from an analysis of 21 previous studies conducted between 1998 and 2010, as well as eight study summaries that had been presented at research conferences during the same timeframe. All the studies had focused on the potential for cancer risk in association with the use of standard TNF inhibitors.
“This systematic review and meta analysis provides reassurance to physicians and patients that the treatment of [rheumatoid arthritis] with TNF inhibitors does not increase the risk of malignancy, particularly lymphoma,” the French study team said in a news release from Annals of the Rheumatic Diseases, which published the report in its current online issue.
“However, it does appear to increase the risk of skin cancer, including melanoma,” added the French team, led by Prof. Xavier Mariette from Paris-Sud University’s rheumatology service in Ile de France.
The authors noted that RA has previously been shown to increase the risk for developing certain types of cancer, including both lung cancer and lymphoma, while decreasing the risk for other cancers, including bowel and breast.
However, the question of TNF inhibitor treatments as a cancer risk has remained a subject of debate.
All told, the current review looked at a collection of studies involving more than 40,000 patients who had been exposed to nearly 150,000 years of TNF inhibitor drugs.
Seven of the studies indicated no notable risk increase for any type of cancer associated with the use of TNF meds. Another two long-term studies similarly suggested that while RA patients who had previously had cancer faced a higher likelihood for a second bout, TNF treatments alone posed no additional cancer risk.
But four other studies collectively demonstrated that TNF inhibitors boosted the risk for non-melanoma skin cancer by 45 percent. And another two studies suggested that the RA treatment raised the specific risk for developing melanoma by nearly 80 percent.
Dr. W. Hayes Wilson, chief of rheumatology at Piedmont Hospital in Atlanta, said the findings should help guide physicians on potential RA treatment complications.
“I don’t think this is particularly surprising, given that there’s long been a concern about cancer risk in the back of our minds,” he noted. “And, in fac,t this is somewhat reassuring on the front of solid cancers that there’s nothing to be alarmed about.”
“But while we can perhaps now put aside our worries about other types of cancers, this does give us some indication that we need to be vigilant when it comes to skin cancer,” Wilson added. “And we certainly need to have a high index of suspicion if a patient has a skin abnormality, and make certain that they see their dermatologist.”
Dr. Gott: Ancient treatment uses bees to control pain
Dear Dr. Gott: Do you have any information on “bee sting therapy” for the chronic pain of fibromyalgia?
Dear Reader: This therapy dates back more than 3,000 years in China and involves placing live bees on strategic pressure points of a patient’s body. It is similar to the needles used in acupuncture, but in this instance, the therapy uses stingers to control the pain of diseases such as rheumatism, arthritis, shingles, lupus, herniated discs, MS, diabetes and fibromyalgia. The treatment relies mainly on the poison of the bees, which can help blood circulation, ease pain and reduce inflammation.
Following a sting, adrenal glands produce cortisol, a natural hormone with anti-inflammatory properties. Supposedly the therapy jump-starts the immune system to trigger the production of endorphins, the body’s natural painkiller. Some specialists think a characteristic of the venom is the presence of dopamine, serotonin and norepinephrine, which help heal conditions involving nerve disorders.
Most research and studies have been directed toward managing multiple sclerosis, but that field is expanding to include arthritis and numerous arthritis-related disorders. Of importance is that up to 5 percent of our population is allergic to bees; therefore, patients seeking to use this therapy must always be tested first.
One downside is that some patients simply can’t endure the injections because of the pain involved.
This therapy that has been around for more than 3,000 years is still in its infancy in the United States, and because insufficient research has been documented, the jury is out on whether it is the answer to a more pain-free existence for fibromyalgia and arthritis sufferers.
Dear Dr. Gott: Ever since I was young, I’ve drunk more than others. I’m now in my mid-40s, and it’s not uncommon for me to drink more than a gallon of liquids a day. Almost all of it is water.
There are times now before I go to bed when my mouth gets dry, and I’m thirsty. I know some of my meds cause dry mouth. I have been tested for diabetes because doctors want to rule it out as soon as they hear how much I drink. My blood work is always good, and I wonder if my dry mouth is anything to be concerned about.
Dear Reader: The urge to drink excessive fluids has many potential possibilities other than the diabetes. Heart, liver or kidney failure, specific drugs such as diuretics and anticholinergics, psychogenic polydipsia (excessive thirst), diabetes insipidus (a condition in which the kidneys are unable to conserve water) are a few possibilities. You should eliminate salt from your diet and avoid foods high in sodium.
I recommend you make an appointment with your physician and request additional lab testing to possibly include a CBC with differential, serum calcium level and perhaps more based on your medical history.