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.
Fibromyalgia… it’s more than just minor aches and pains
Fibromyalgia Worsens Psoriatic Arthritis Outcomes
Caitlyn Fitzpatrick writing in MD reported on a recent study. Published in The Journal of Rheumatology, the researchers looked at 73 patients with psoriatic arthritis. Forty-two participants (57.5%) were females and the average age was nearly 52. Clinical disease activity was measured using multiple different scales. Also, using the American College of Rheumatism criteria, fibromyalgia was diagnosed in 13 patients (17.8%) – 12 of which were female.
Twenty-six patients (43.3%) with just psoriatic arthritis met the criteria for minimal disease activity, however, none of the participants who had fibromyalgia did.
The big takeaway here is that the presence of fibromyalgia worsened all psoriatic arthritis disease activity scores.
Comment: Not surprising. The association of fibromyalgia with all forms of inflammatory arthritis is not a good combination.
One very important determinant of response to methotrexate…
Anxiety Prior To Methotrexate Therapy May Result In Non-Response At 6 Months
Reported in Healio… patients with rheumatoid arthritis who experience anxiety prior to the start of methotrexate therapy may have non-response at 6 months due to poor adherence, according to results presented at the EULAR Annual Congress.
“From a long list of lifestyle, clinical and psychosocial predictors at baseline, BMI, smoking and DAS28 score were each shown to significantly predict non-response 6 months after patients had started treatment with methotrexate,” Suzan Verstappen, of the Centre for Musculoskeletal Research at the University of Manchester, United Kingdom, said in a press release. “Of particular interest, however, is the role of participant anxiety on starting treatment with methotrexate in predicting response, which is likely to be the result of its negative effect on adherence.”
A workhorse drug for rheumatoid arthritis causing an excessive number of deaths in Australia
Eight Deaths Linked to Methotrexate in Australia
Dr. Jack Cush writing in Rheumnow reported methotrexate (MTX), a cornerstone drug used to treat rheumatoid arthritis (RA), has led to 90 hospitalizations and 8 deaths according to a recent report from the Medical Journal of Australia.
Many of these events were the result of inappropriate higher or more frequent doses than that prescribed. Such practices led to gastrointestinal tract ulceration, liver toxicity, bone marrow suppression, septicemia, and death.
In a nationwide search of MTX-related death rates, three datasets discovered that over 90 dosing error cases were reported from 2004 to 2015.
Twenty-two died from taking MTX, but only 7 deaths were directly attributed to overdosing. The United States Food and Drug Administration has noted 25 MTX deaths over a four-year timeframe.
The authors recommended changes in packaging and tablet appearance to reduce the incidence of these events.
Comment: Methotrexate is still the disease modifying drug of choice for rheumatoid arthritis. It has to be monitored though.