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Monday was another full day of sessions and studies here in Atlanta. Following is my roundup of day two.
The Safety of Methotrexate
Abstract 1890. Dr. Daniel Solomon presented the safety of methotrexate (MTX) from a large prospective cohort of patients who did not have rheumatoid arthritis. This cohort comes form the CIRT study, that was published last year in the NEJM. This trial assessed the ability of MTX to improve cardiovascular outcomes when given to high-risk cardiovascular patients. A total of 4786 patients were randomized to either weekly placebo or methotrexate and followed for a year. In the end, these side effects stood out as being significant:
All adverse events were slightly increased by 17%, most with being mild
Gastrointestinal events (HR 1.91)
Pulmonary events (HR 1.52)
Infectious events (HR 1.15)
Hematologic events (HR 1.15)
Skin cancers (HR 2.0) - including basal-cell, squamous cell and melanoma
Pancytopenia was rare (3 per 1,000 with placebo and 13 per 100 with MTX)
There were few cases of cirrhosis noted in those on methotrexate, but these are not associated with high liver enzyme elevations. Instead, they were seen in patients who had mild to moderate transaminitis (Abstract 2357).
Anakinra in Gout (anaGO) Study
Abstract 1240. Dr. Ken Saag presented the results of a double-blind, controlled trial comparing the efficacy of intramuscular triamcinolone (TAC) to subcutaneous anakinra. A total of 165 patients, who are unsuitable to receive NSAIDs or colchicine, were enrolled and randomized to either 100 or 200 mg qd of anakinra or given TAC 40 mg IM. The primary endpoint in this trial was pain reduction by 72 hours. After these single injections both worked very well acutely. As this was supposed to have been a superiority trial, the data did not show superiority, but instead showed that anakinra and IM TAC worked equally well in managing acute gout. Anakinra was however, shown to be possibly faster acting and was significantly better than steroid on several secondary endpoints. There were no new safety signals.