Advice on contraception, gene therapy, gout treatment


Disease-modifying anti-rheumatic drugs (DMARDs) used in RA may have potential teratogenic effects on the fetus. In an observational study, researchers looked at 2 years of medical records from a rheumatology clinic in Colorado, the primary endpoint being the prevalence and type of contraceptive use in patients aged 18 to 44.

Of the 150 women included in the study, contraceptive methods were observed in 42.7%, the most common method being oral contraceptives, used by 48.4%; 15.6% used a levonorgestrel intrauterine device.

A total of 86 patients were not taking any form of birth control, and only 22% of these patients had received some form of counseling or made a pregnancy plan.

During the reporting period, 44% started a new DMARD and most – 56.1% – were not on contraception at the time. Most of these women did not receive contraceptive advice from their doctor.

First results of gene therapy for osteoarthritis

Investigators recently reported on the safety and potential efficacy of FX201 gene therapy for osteoarthritis. FX201, or humantakinogene hadenovec, is a serotype 5 helper-dependent adenovirus that expresses the interleukin (IL) -1 receptor antagonist (IL-1Ra) as an intra-articular gene therapy, HCPLive reported.

At the recent American Society of Gene & Cell Therapy (ASGCT) virtual meeting, researchers discussed a phase 1 open-label, single-dose escalating trial to assess safety, tolerability, biodistributions and preliminary clinical activity of therapy in patients with severe osteoarthritis of the knee. The ongoing trial follows toxicology studies allowing IND and the production of cGMP on a clinical scale.

Results are from 24-week data from the low-dose cohort (n = 5). The ages of the patients ranged from 30 to 80 years, and all had OA and McMaster University Osteoarthritis Pain Index scores ≥ 4.0 to ≤ 9.0.

Overall, the therapy was considered to be well tolerated; 2 patients presented with self-limited Grade 2 pain, knee swelling and effusion). The investigators indicated that these events could have been related to conservative management of the treatment.

New treatment option for gout?

Treatment options for gout are limited, but recent results have shown that patients maintain a therapeutic response at 6 months when treated with a combination of methotrexate and pegylated uricase.

In comparison, the response rate was only 42% for patients receiving pegloticase alone, a drug very effective in lowering serum uric acid levels, by converting serum uric acid levels to allantoin, Rheumatology Network reported.

The open-label, multicenter efficacy and safety study enrolled 14 men with a history of uncontrolled gout, defined as aUA ≥ 6 mg / dL, with an inability to maintain

Participants received 15 mg / week of oral methotrexate as well as 1 mg / day of folic acid for 4 weeks before and during the 52 weeks of treatment. They then initiated treatment with pegloticase (8 mg intravenously) every 2 weeks in conjunction with follow-up appointments. Patients also adhered to a prophylactic regimen of colchicine and / or nonsteroidal anti-inflammatory drugs (NSAIDs) and / or low-dose prednisone ≤ 10 mg / day. The primary endpoint was the number of patients with sUA levels

After 6 months, 11 out of 14 participants achieved the primary endpoint; all 14 patients tolerated methotrexate and no new safety concerns were noted.


About Hector Hedgepeth

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