Rheumatology Rundown: Birth Control Guidance, Gene Therapy, Gout Treatment

AJMC Staff

Birth control guidance provided to women taking rheumatoid arthritis therapies is lacking, and other rheumatology news reported across MJH Life Sciences™.

Contraception Advice Lacking for Women With RA

Rheumatoid arthritis (RA) affects women of childbearing age, but most don’t currently use contraception nor were they counseled to do so by their health care provider, according to a study reported on by Rheumatology Network.

The disease-modifying antirheumatic drugs (DMARDs) used in RA may have potential teratogenic effects on the fetus. In an observational study, researchers examined 2 years’ worth of medical records from a rheumatology clinic in Colorado, with the primary outcome looking at the prevalence and type of contraceptive use in patients aged between 18 and 44 years old.

Of the 150 women included in the study, contraception methods were observed in 42.7%, with 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 on any form of birth control, and just 22% of those patients had received any form of counseling or developed a pregnancy plan.

During the time period reviewed, 44% started a new DMARD, and most— 56.1%—were not on contraception at the time. Most of those women did not receive guidance about contraception from their physician.

Early Results for Osteoarthritis Gene Therapy

Investigators recently reported on the safety and potential efficacy of FX201 gene therapy for osteoarthritis. FX201, or humantakinogene hadenovec, is a helper-dependent adenovirus serotype 5 that expresses Interleukin (IL)-1 receptor (IL-1Ra) antagonist 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 ascending dose trial in order to assess the therapy’s safety, tolerability, biodistributions, and preliminary clinical activity in patients with moderate-to-severe osteoarthritis in the knee. The ongoing trial follows IND-enabling toxicology studies and clinical-scale cGMP production.

The findings come from 24-week data from the low-dose cohort (n = 5). Patient ages ranged from 30 to 80 years old, and all had Western Ontario and McMaster Universities Osteoarthritis Index pain scores ≥ 4.0 - ≤ 9.0.

Overall, the therapy was considered well-tolerated; 2 patients experienced self-limited grade 2 index pain, swelling, and effusion in the knee). The investigators indicated these events may have been possibly related to conservative treatment management.

New Treatment Option for Gout?

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

By comparison, the response rate was just 42% for patients receiving pegloticase alone, a medication that is highly effective in lowering serum uric acid levels, by converting serum uric acid levels to allantoin, Rheumatology Network reported.

The multicenter, open-label efficacy and safety study enrolled 14 males with a history of uncontrolled gout, defined as an sUA ≥ 6 mg/dL, with an inability to maintain < 6 mg/dL on other therapies, intolerance to urate-lowering therapies (ULT), or functionally limiting tophaceous deposits.

Participants received 15 mg/week oral methotrexate as well as 1 mg/day folic acid for 4 weeks leading up to and throughout the 52 weeks of treatment. They then initiated pegloticase treatment (8 mg intravenous) every 2 weeks in conjunction with follow-up appointments. Patients also adhered to a prophylaxis regimen of colchicine and/or nonsteroidal anti-inflammatory drugs (NSAIDs) and/or low-dose prednisone ≤ 10 mg/day. The primary outcome focused on how many patients had sUA levels of < 6 mg/dL for ≥ 80% of the time during month 6.

At the 6-month mark, 11 out of 14 participants met the primary outcome; all 14 patients tolerated methotrexate and no new safety concerns were noted.