Risk of Melanoma Among Parkinson’s Disease Patients (TV1030-CNS-50024)

Study type

• Study topic:
  Disease /health condition

  Human medicinal product
• Study type:
  Non-interventional study
• Scope of the study:
  Assessment of risk minimisation measure implementation or effectiveness
• Data collection methods:
  Secondary use of data

Non-interventional study

• Non-interventional study design:
  Cohort

Study drug and medical condition

• Anatomical Therapeutic Chemical (ATC) code:
  (N04BD02) rasagiline

  rasagiline
• Medical condition to be studied:
  Parkinson's disease

Population studied

• Short description of the study population:
  The study population comprised adults aged ≥65 years with diagnosis claims for PD and continuous enrollment for ≥6 months in Medicare Parts A, B, and D fee-for-service coverage who started rasagiline (Cohort A) or a non-rasagiline APD (Cohort B) in 2006- 2015.
• Age groups:
  Adults (65 to < 75 years)

  Adults (75 to < 85 years)

  Adults (85 years and over)
• Special population of interest:
  Other
• Special population of interest, other:
  Patients with Parkinson's disease
• Estimated number of subjects:
  300000

Study design details

• Main study objective:
  To estimate and compare the incidence rate of melanoma PD patients who start treatment with rasagiline and those who start treatment with other anti-Parkinson’s drugs. To examine the association between use of rasagiline and malignant melanoma among PD patients. To estimate and compare the incidence rate of melanoma in PD patients not treated with rasagiline and the rate in subjects without PD.
• Outcomes:
  melanoma
• Data analysis plan:
  Descriptive analyses will compare baseline characteristics of the study cohorts and describe the patterns of anti-Parkinson’s medication use. The incidence of melanoma will be estimated in all cohorts using both validated cases and possible cases for whom medical record information is not available. Incidence rate ratios will be calculated and stratified by relevant confounding variables for each exposure group comparison. Hazard ratios will be estimated using Cox proportional hazards models for each exposure group comparison, with adjustment for covariates. Sensitivity analyses will be performed to evaluate potential detection bias to determine whether rasagiline users may be screened more intensively for melanoma than users of other medications, including the comparison of incidence rates of non-melanoma skin cancer between rasagiline users and users of other anti-Parkinson’s medications.

Documents

Study report

0303432_ICPE_Abstract_Main results_09Feb2021_final for submission

Study, other information

0303432_ICPE2021_Rasagiline and Melanoma_Final_11Aug2021

0303432_ICPE2021_Validation_Saltus_Final_11Aug2021

0303432_ICPE_Abstract_Validation_Rev Dec 2020_clean

Study publications

Johannes CB, Saltus CW, Kaye JA, Calingaert B, Kaplan S, Gordon MF, Andrews EB…

Saltus CW, Kaplan S, Gordon MF, Calingaert B, Andrews EB, Kaye JA, Johannes CB…