Welcome to Rheumatology Center of San Diego
Welcome to Rheumatology Center of San Diego
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Novartis announced on January 15 2016 that the US Food and Drug Administration (FDA) has approved Cosentyx® (secukinumab) for the treatment of two new indications – adults with active ankylosing spondylitis (AS) and active psoriatic arthritis (PsA). AS and PsA are both life-long, painful and debilitating inflammatory diseases that affect the joints and/or spine. If not treated effectively, both conditions can lead to irreversible joint and/or spinal bone damage caused by years of inflammation.
Cosentyx is the first in a new class of medicines called interleukin-17A (IL-17A) inhibitors to treat both AS and PsA. The two new indications follow the earlier FDA approval for Cosentyx in January 2015 to treat adult patients with moderate-to-severe plaque psoriasis, and European approval for AS and PsA in November 2015.
More than 9,600 patients have been treated with Cosentyx in clinical trials across multiple indications, and over 15,000 patients with psoriasis have already been treated in the post-marketing setting. The safety profile of Cosentyx was shown to be consistent with that seen in clinical trials across multiple indications.
Foods to try
Remember, there’s no magic food. But growing evidence suggests that following a healthy diet and adding in specific foods and spices could help fight inflammation and joint pain. Here are six food choices that may be helpful:
1. Broccoli, Brussel sprouts and cabbage. These veggies are part of the cruciferous family, and they are chock full of a compound called sulforaphane, which helps slow broccolidown cartilage damage in joints due to OA, according to a 2013 study involving mice. Admittedly, it’s an early study. But veggies are always a healthy choice.
Try adding broccoli, Brussel sprouts or cabbage to your salad or stir-fry. Other foods rich in sulforaphane include kale and cauliflower.
2. Fatty fish. Fatty fish like salmon, tuna, trout, and mackerel are rich in omega-3 fatty acids, which help fight inflammation and boost heart health. Try adding fish to your diet a couple of times a week. If you’re not a big fan of fish, ask your doctor whether it’s worth taking an omega-3 supplement. Studies have found that omega-3 supplements reduce inflammation in rheumatoid arthritis (RA), but whether they help people with OA isn’t clear.
3. Garlic. Garlic is a member of the allium family—which also includes onions, and leeks. These items contain a compound called diallyl disulfide that may help with a number of diseases—including arthritis. “This compound may have some effect in limiting cartilage-damaging enzymes,” says rheumatologist Scott Zashin, MD, a volunteer clinical professor at the University of Texas Southwestern Medical School in Dallas, and author of Natural Arthritis Treatment. One study noted that people who regularly ate garlic and its relatives had less evidence of hip OA on x-ray images.
4. Tart cherries. Some people with osteoarthritis have found relief from products made from tart cherries. The ingredient in cherries that helps with OA symptoms is the same one that gives this fruit its red color—anthocyanin. A 2013 study of tart cherry juice found that the drink improved symptoms of OA, although not much more than a nontherapeutic drink (placebo). Dr. Zashin conducted two small studiecherriess using a gel made from tart cherries called CherryFlex. One of the studies showed that patients with OA who used this cherry concoction had significant symptom relief. “We found that some patients can actually go off their anti-inflammatory drugs,” he said. However, he cautions that larger trials are needed to confirm that it is the cherries that make a difference in OA pain—and not a placebo effect. Never stop taking your medicines without first talking to your doctor.
5. Turmeric. One of the best-researched inflammation fighters isn’t a food at all, but a spice. Turmeric contains a compound called curcumin. A 2012 review published in the International Journal of Molecular Sciences said that “curcumin could be beneficial in the management of chronic inflammatory-related joint disease, including OA” but authors warned that there is a considerable lack of data regarding side effects and safety. The compound has, however, been used for centuries in India to ward off inflammatory diseases. You’ll find this yellow spice in Indian cuisines—particularly curries—or you can add it to your own dishes.
6. Vitamin C. Antioxidants in vitamin C may slow the progression of OA, research finds. A 2011 study from the University of South Florida reported that people who took vitamin C supplements were 11 percent less likely to develop knee OA than those who didn’t take the supplements. You can safely get vitamin C from fruits like strawberries, kiwi, pineapple, or cantaloupe. However, do not take supplements with much higher doses than the recommended daily allowance of 65 to 85 micrograms, because in large doses vitamin C can increase the risk of kidney stones.
Foods to avoid
Some people find that certain foods aggravate their OA. For example, people have reported that eating foods in the nightshade family – such as eggplant, tomatoes, potatoes and most peppers – increases their pain, although studies haven’t confirmed this.
When it comes to your diet, eat what works for you. I have some patients who find that when they got off gluten and dairies their joints feel better. If you think a particular food is aggravating your OA, try eliminating it from your diet and see how you feel.
Foods high in saturated and trans fats – such as red meat, fried food and packaged baked goods — should be avoided. They are unhealthy in general, and can lead to weight gain, which can make OA symptoms worse.
And if you tend to wash down your meal with a sugary soda – don’t. A 2013 study revealed that OA of the knee tended to get worse in men who drank a lot of sodas.
ARTICLE TAKEN FROM ARTHRITIS FOUNDATION
FDA approval of Zorvolex was based on a double-blind placebo-controlled study which enrolled patients ≥ 40 years of age with clinically and radiographically confirmed (Kellgren-Lawrence grade II-III) hip or knee OA. Eligible patients were chronic NSAID and/or acetaminophen (APAP) users with baseline Western Ontario and McMasters Universities Osteoarthritis Index (WOMAC) pain subscale score ≥ 40 mm by visual analog scale and an osteoarthritis flare (≥ 15 mm increase in WOMAC pain subscale score following discontinuation of NSAID/APAP at screening).
Zorvolex 35 mg three times a day significantly improved WOMAC pain subscale scores from baseline at 12 weeks compared with placebo. Zorvolex 35 mg bid provided numerical improvement in pain at week 12 compared with placebo. Zorvolexc 35 mg three times a day and 35 mg twice a day improved the average total WOMAC score in treated patients over 12 weeks compared with placebo. The most frequent side effects Zorvolex-treated groups were diarrhea, headache, nausea, and constipation. The inclusion of patients with a documented requirement for analgesic therapy (osteoarthritis ‘flare’) at baseline and the high rates of rescue medication usage in the placebo group may have impacted the study outcome for the Zorvolex treatment groups.
The U.S. Food and Drug Administration approved Otezla (apremilast) to treat adults with active psoriatic arthritis (PsA) in March 2014.
PsA is a form of arthritis that affects some people with psoriasis. Most people develop psoriasis first and are later diagnosed with PsA. Joint pain, stiffness and swelling are the main signs and symptoms of PsA. Currently approved treatments for PsA include corticosteroids, tumor necrosis factor (TNF) blockers, and an interleukin-12/interleukin-23 inhibitor.
“Relief of pain and inflammation and improving physical function are important treatment goals for patients with active psoriatic arthritis,” said Curtis Rosebraugh, M.D., M.P.H., director of the Office of Drug Evaluation II in the FDA’s Center for Drug Evaluation and Research. “Otezla provides a new treatment option for patients suffering from this disease.”
The safety and effectiveness of Otezla, an inhibitor of phosphodieasterase-4 (PDE-4), were evaluated in three clinical trials involving 1,493 patients with active PsA. Patients treated with Otezla showed improvement in signs and symptoms of PsA, including tender and swollen joints and physical function, compared to placebo.
Patients treated with Otezla should have their weight monitored regularly by a healthcare professional. If unexplained or clinically significant weight loss occurs, the weight loss should be evaluated and discontinuation of treatment should be considered. Treatment with Otezla was also associated with an increase in reports of depression compared to placebo.
The FDA is requiring a pregnancy exposure registry as a post-marketing requirement to assess the risks to pregnant women related to Otezla exposure.
In clinical trials, the most common side effects observed in patients treated with Otezla were diarrhea, nausea, and headache.
NEWS (Sept 23rd 2014): Oral OTEZLA® (apremilast) Approved by the U.S. Food and Drug Administration for the Treatment of Patients with Moderate to Severe Plaque Psoriasis
Women with chronic autoimmune diseases who take immunosuppressive medications during their first trimester of pregnancy are not putting their babies at significantly increased risk of adverse outcomes, according to a Vanderbilt study released online by the journal Arthritis and Rheumatism. The paper is one of the first to describe risks for medications used to treat autoimmune diseases when taken during pregnancy, according to first author William Cooper, M.D., MPH, Cornelius Vanderbilt Professor of Pediatrics and professor of Health Policy at Monroe Carell Jr. Children’s Hospital at Vanderbilt in Nashville, Tenn. Women with rheumatoid and psoriatic arthritis, ankylosing spondylitis, lupus, scleroderma, and inflammatory bowel disease who filled prescriptions for immunosuppressive treatments during pregnancy were included in the study. The drugs studied included hydroxychloroquine, tumor necrosis factor (TNF) inhibitors and other immunosuppressives such as sulfasalazine and azathioprine. When compared with the women who had medication treatment before, but not during, pregnancy the risk ratios for adverse fetal outcomes associated with immunosuppressive use during pregnancy were not statistically significant, the authors reported.
In an assessment of the scientific literature, reported as a perspective piece today in the New England Journal of Medicine, a UC San Francisco researcher says patients and health care practitioners should focus on getting calcium from the diet, rather than supplements, when possible. “Osteoporosis may result from inadequate calcium intake and it’s quite common for certain segments of our population, such as the elderly, to consume less than the recommend amount,” said Douglas C. Bauer, MD, UCSF professor of Medicine, Epidemiology and Biostatistics. “But a high calcium diet should be the preferred method to receive adequate amounts of the nutrient. The Institute of Medicine’s recommended dosage for post–menopausal women over the age of 50 and men over 70 is 1,200 mg per day. “If it is not possible to consume enough calcium from the diet, the use of calcium supplements is most likely safe and not associated with cardiovascular outcomes,” he said.
This article reviews recommendations regarding calcium intake and uncertainty about benefits as well as potential risks of calcium supplementation. In particular, some studies have suggested an increased cardiovascular risk, but findings have been inconsistent.
The US Food and Drug Administration approved Antares Pharma Inc.’s (ATRS) injectable Otrexup, an alternative to pills for hard to treat arthritis and psoriasis cases. Antares Pharma Inc. stated that Otrexup is the first methotrexate approved by the FDA that patients can administer once a week by themselves using a disposable auto injector.
The medication is “intended for use by adults with active, severe rheumatoid arthritis or psoriasis who haven’t responded to or been able to tolerate first line therapy, and for children with active polyarticular juvenile idiopathic arthritis.” While methotrexate is also used in cancer treatment, Otrexup is not intended for that purpose.
New classification criteria for systemic sclerosis have just been published and are more sensitive than the 1980 criteria, enabling earlier identification and treatment of this disabling autoimmune disease. The 2013 criteria, developed by a joint committee commissioned by the American College of Rheumatology (ACR) and European League Against Rheumatism (EULAR), are published in the ACR journal, Arthritis & Rheumatism. The joint ACR–EULAR committee was led by Dr. Janet Pope from Western University, St. Joseph’s Health Care London in Ontario, Canada, and Dr. Frank van den Hoogen from St. Maartenskliniek in The Netherlands. The committee’s intent was to improve the classification of systemic sclerosis by clustering items and simplifying the weighting of the different criteria. The new criteria set was tested for specificity and sensitivity by comparing scleroderma cases with controls (patients with disorders similar to scleroderma), and validated by experts viewing cases with and without the disease. Based on the new criteria, a patient with thickening of the skin in the middle part of the fingers (from proximal to the metacarpophalangeal joints) would be classified as having systemic sclerosis, regardless of other features. If this criterion was not met, however, then seven items with varying weights would need to be assessed in order to obtain a scleroderma classification: skin thickening of the fingers, fingertip lesions, telangiectasia, abnormal nailfold capillaries, pulmonary arterial hypertension and/or interstitial lung disease, Raynaud’s phenomenon, and SSc–related antibodies.