Tocilizumab Receives Breakthrough Designation for GCA
The FDA granted the designation of breakthrough therapy to tocilizumab (Actemra) for treating GCA (Giant Cell Arteritis). This autoimmune disease causes inflammation of arteries both medium and large in size, predominantly in the head, but also in the aorta and branches of the aorta.1
To date, GCA treatment has been limited to high-dose steroids, which are used as an emergency treatment to prevent vision loss and other damage. Long-term, flare-free remission cannot always be maintained with steroids. Because of the variety of symptoms, GCA patients are usually seen by myriad specialists, including rheumatologists.
The FDA gives a breakthrough designation to expedite the development and review of treatments that show early evidence of potential clinical benefit in serious diseases to ensure patients receive access to medication as quickly as possible. Positive results of tocilizumab use in patients with GCA were seen in the Phase 3 GiACTA study. Patients treated with tocilizumab, initially as combination therapy for six months with glucocorticoids, had sustained remission though one year of treatment compared with patients who received only glucocorticoids for six to 12 months.
Comment: GCA is a serious condition and this is great news.
Study Shows Potential for Early Diagnosis of Arthritis
Pat Anson writing for Pain News Network reported a new study by British researchers has demonstrated the potential for an experimental blood test that can diagnose arthritis in its earliest stages. Such a test could lead to earlier treatment of osteoarthritis (OA) and rheumatoid arthritis (RA), years before joint damage and physical symptoms begin.
Researchers at Warwick Medical School recruited 225 people with early or advanced OA, RA or another inflammatory joint disease, along with a control group of healthy volunteers with no joint problems. Their blood and fluid from affected knee joints were then analyzed with mass spectrometry.
The test found patterns in blood plasma amino acids that were damaged by oxygen, nitrogen and sugar molecules. The damage was highest in the blood samples of patients with OA or RA, and markedly lower in the blood of healthy volunteers — giving researchers identifiable biomarkers that could be used for an early diagnosis.
“This is a big step forward for early-stage detection of arthritis that will help start treatment early and prevent painful and debilitating disease,” said Naila Rabbani, PhD, of Warwick Medical School. “Damage to proteins in the arthritic joint have been known for many years but this is the first time it has been exploited for early-stage diagnosis.
“For the first time we measured small fragments from damaged proteins that leak from the joint into blood. The combination of changes in oxidised, nitrated and sugar-modified amino acids in blood enabled early stage detection and classification of arthritis – osteoarthritis, rheumatoid arthritis or other self-resolving inflammatory joint disease.”
Do the immunosuppressive drugs used in rheumatoid arthritis treatment increase cancer risk? The answer next…
Most immunosuppressive drugs do not significantly increase the risk of breast cancer recurrence
Dr. Lara Pullen writing in Arthritis and Rheumatology reported on a study involving 3 large populations of women with rheumatoid arthritis or inflammatory bowel disease who had undergone surgery for primary breast cancer. What the researchers found was that the risk of breast cancer recurrence in patients who received methotrexate or anti-TNF therapy did not have a significant risk of breast cancer recurrence.
Comment: I think this is reassuring news for clinicians who choose to start methotrexate or anti-TNF therapy in rheumatoid arthritis or inflammatory bowel disease patients with treated breast cancer.
A pair of recent studies look in an interesting place to find commonality among rheumatoid arthritis sufferers:
Ryan Black writing for MD reported on a study published in Genome Medicine from the Mayo clinic. Veena Taneja, Ph D of the Mayo Clinic’s Center for Immunized Medicine said they sought to find a biomarker in the form of gut microbiota. Examining fecal samples of (human) RA patients and their first-degree relatives, the researchers noticed that an abundance of collinsella in the gut was linked to increased RA symptoms.
To test this, they administered collinsella to “humanized” mice, and found that “Mice given [Collinsella aerofaciens] developed arthritis with increased incidence and severity compared with non-treated mice (100 % incidence in treated vs 62.5 % in untreated, P = 0.068).” Their findings indicate that collinsella may be a predictive biomarker for RA in humans.
Comment: Maybe I’ll stay away from pepperoni pizza…
Arthritis drug could reduce risk of having Alzheimer’s disease
Nicholas Bakalar writing for Business Standard reported a drug used to treat rheumatoid arthritis may have benefits against Alzheimer’s disease, researchers report.
Rheumatoid arthritis is an autoimmune disease believed to be driven in part by tumour necrosis factor, or TNF, a protein that promotes inflammation. Drugs that block TNF, including an injectable drug called etanercept, have been used to treat rheumatoid arthritis for many years.
TNF is also elevated in the cerebrospinal fluid of Alzheimer’s patients.
Researchers identified 41,109 men and women with a diagnosis of rheumatoid arthritis and 325 with both rheumatoid arthritis and Alzheimer’s disease. In people over 65, the prevalence of Alzheimer’s disease was more than twice as high in people with rheumatoid arthritis, as in those without it. The study is in CNS Drugs.
But unlike patients treated with five other rheumatoid arthritis drugs, those who had been treated with etanercept showed a significantly reduced risk for Alzheimer’s disease.
Comment: Interesting to see what future developments occur.