Miracle Pregnancy

By Nancy Walsh, Staff Writer, MedPage Today

Published: May 02, 2012

Reviewed by Dori F. Zaleznik, MD; Associate Clinical Professor of Medicine, Harvard Medical School, Boston.

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GLASGOW — A registry sponsored by the British Society for Rheumatology (BSR) continues to provide reassuring safety data regarding the more aggressive treatment strategies now used for patients with rheumatoid arthritis, studies presented here confirmed.

It has been well recognized that patients with rheumatoid arthritis have twice the risk for cardiovascular mortality as the larger population (standardized mortality ratio 1.5), according to Audrey Low, MBBS, and colleagues from the University of Manchester in Manchester, England.

With the treatment approach of early escalation of conventional disease-modifying anti-rheumatic drugs (DMARDs) such as methotrexate and leflunomide, including dosage optimization, the excess risk has fallen to 20% for cardiovascular mortality (standardized mortality ratio [SMR] 1.2, 95% CI 1 to 1.5), Low said in a poster session at the BSR annual meeting.

In addition, among patients being treated with tumor necrosis factor (TNF) inhibitors, the standardized mortality ratio stands at 1.6 (95% CI 1.5 to 1.8), which is similar to the background risk, she said.

“That is reassuring, because patients receiving the anti-TNF agents typically have much more disease activity and higher burdens of inflammation, which can contribute to cardiovascular risk,” Low told MedPage Today.

The analyses included all patients enrolled in the registry between 2001 and 2008.

A total of 3,367 patients were receiving escalated DMARD therapy, and 12,051 were being treated with anti-TNF agents.

Those receiving escalated DMARD treatment were older (60 versus 56 years), and had shorter disease duration (6 versus 11 years).

For ischemic heart disease, the risks were:

• Escalated DMARD, SMR 1.4 (95% CI 1 to 1.8)
• Anti-TNF, SMR 1.8 (95% CI 1.6 to 2.1)

For stroke, the risks were:

• Escalated DMARD, SMR 1.1 (95% CI 0.6 to 1.8)
• Anti-TNF, SMR 1.3 (95% CI 0.9 to 1.8)

“So even though the overall pattern is improving, we still need to do better in identifying risk factors for cardiovascular mortality in patients with rheumatoid arthritis,” Low said in conclusion.

In a separate poster presentation, her University of Manchester colleague Louise Mercer, MBBS, reported that there were no new or recurrent genital cancers among women who had a previous history of carcinoma in situ of the cervix and were treated with anti-TNF agents.

“We at the BSR registry get lots of questions from around the country asking if these women can be safely treated with anti-TNF therapy,” she told MedPage Today.

So her group looked at all women in the registry with a diagnosis of cervical intraepithelial neoplasia grade III with or without mention of severe dysplasia prior to receiving anti-TNF treatment.

A total of 48 were on nonbiologic DMARD therapy and 190 were receiving anti-TNF treatment. The patients’ mean age was 50.

Median disease duration was 4.5 years among those on conventional therapy and 10 years among those on TNF inhibitors.

For the DMARD group, there were two incident genital cancers during 159 person-years of follow-up, for a rate of 13 per 1,000 person-years (95% CI 2 to 45).

One of these was a metastatic squamous cell cancer of the vulva, and the other was metastatic cancer of the cervix. In both cases, the carcinoma in situ had developed more than a decade earlier.

In the anti-TNF group, during 893 person-years of follow-up, there were no incident genital cancers, “and we concluded that the treatment appears safe for these women,” Mercer said.

In most cases, it was only through the national cancer registry that the earlier cervical lesions were identified.

“In only about 10% to 15% of cases did the consultant ask about this history and report it,” she added.

Neither of the poster presenters had any disclosures. Two of their investigators reported receiving research grants from several companies, including Merck, Abbott, Pfizer, Roche, and UCB.

Primary source: British Society for Rheumatology

Source reference:
Low A, et al “Cardiovascular mortality rates are elevated in a national cohort of subjects with rheumatoid arthritis compared with the UK general population whether they were or were not treated with biologic drugs: results from the BSRBR” BSR 2012; Abstract 71.

Additional source: British Society for Rheumatology

Source reference:
Mercer L, et al “Outcome of women with previous carcinoma in situ of the cervix with respect to female genital cancer, following treatment with non-biologic DMARD or anti-TNF for rheumatoid arthritis: results from the BSRBR” BSR 2012; Abstract 70.

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