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Risk assessment of polymyositis/dermatomyositis after treatment with injectable bovine collagen implants
C W Hanke1, J A Thomas, W T Lee
1Department of Dermatology, Indiana University, Indianapolis, USA.
Background:
Questions have been raised about a possible relation between injectable collagen and polymyositis and dermatomyositis (PM/DM). Predictions of the prevalence of PM/DM have been based on anecdotal estimates of the duration of follow-up for the collagen-treated population.
Objective:
Our purpose was to study the duration of follow-up for a large sample of collagen-treated patients.
Methods:
Physicians in North America who purchased collagen implants during fiscal year 1988 were categorized according to collagen practice size; one third were randomly invited to participate in the study.
Results:
Review of 2622 patient records yielded an average duration of follow-up of 4 years.
Conclusion:
Five-year incidence rates were used to estimate the expected number of cases of PM/DM in the collagen-treated population. Through June 1993 the expected number was 30.2. The number of confirmed cases after treatment was seven, less than one fourth of the number of cases expected for a model of the collagen-treated population, matched for age, sex, and race.
Insights
Injectable collagen use was studied for its link to polymyositis and dermatomyositis (PM/DM). The study found fewer PM/DM cases than expected in collagen-treated patients, suggesting no significant association.
Area of Science:
- Rheumatology
- Dermatology
- Immunology
Background:
- Investigated potential association between injectable collagen and inflammatory myopathies like polymyositis and dermatomyositis (PM/DM).
- Previous prevalence estimates for PM/DM in collagen-treated populations relied on anecdotal follow-up durations.
Purpose of the Study:
- To determine the duration of patient follow-up in a large cohort receiving injectable collagen treatments.
- To assess the incidence of polymyositis and dermatomyositis in patients treated with injectable collagen.
Main Methods:
- A cohort of North American physicians purchasing collagen implants in fiscal year 1988 was identified.
- One-third of physicians were randomly selected, and their patient records were reviewed, yielding an average follow-up of 4 years for 2622 patients.
Main Results:
- The average duration of follow-up for collagen-treated patients was 4 years.
- Using 5-year incidence rates, the expected number of PM/DM cases was calculated to be 30.2.
- Only seven confirmed cases of PM/DM were observed, significantly less than the expected number.
Conclusions:
- The observed incidence of PM/DM in the collagen-treated population was substantially lower than predicted.
- Findings suggest that injectable collagen is unlikely to be a significant risk factor for developing polymyositis and dermatomyositis.