Current Studies

Ertugliflozin Study with Merck
Image
Doctors discussing

Project Title: Post-authorization safety study to assess the risk of diabetic ketoacidosis among type 2 diabetes mellitus patients treated with ertugliflozin compared to patients treated with other antihyperglycemic agents (AHA)
Project Sponsor: Merck
Project Status: Current
Product: Ertugliflozin
Conditions: Diabetic ketoacidosis, Type 2 diabetes mellitus
Summary: The Reagan-Udall Foundation for the FDA (FDA Foundation PI: Carla Rodriguez-Watson) was recently awarded a contract to leverage data from the Innovation in Medical Evidence Development and Surveillance (IMEDS) Network to  continue implementation of a study titled: “Post-authorization safety study to assess the risk of diabetic ketoacidosis among type 2 diabetes mellitus  patients treated with ertugliflozin compared to patients treated with other antihyperglycemic agents (AHA)” (EU PAS Register number: EUPAS31378). This work is being conducted to fulfill a requirement from the European Medicines Agency (EMA). The research activities are a collaborative effort between the Merck research team, the IMEDS Operations Center at FDA Foundation, the IMEDS Analytic Center at the Harvard Pilgrim Health Care Institute, and participating IMEDS Network Partners.

  • Click to view the European Union electronic Register of Post-Authorisation Studies (EU PAS) register number (EUPAS31718)
Risankizumab Study with AbbVie
Image
Healthcare professional speaking with pregnant woman in office

Project Title: Pregnancy Exposures and Outcomes in Women with Psoriasis Treated with Risankizumab: A Cohort Study Utilizing Large Electronic Healthcare Databases with Mother-Baby Linkage in the United States
Project Sponsor: AbbVie
Project Status: Current
Product: Risankizumab
Conditions: Psoriasis, Pregnancy
Summary: To help fulfill a requirement from the European Medicines Agency (EMA), IMEDS was contracted to help design and execute a study to assess the safety of Risankizumab among pregnant women with psoriasis. The risk of pregnancy, birth and infant outcomes will be estimated in pregnant women exposed to Risankizumab, as well as in those exposed to comparator biologics including anti-tumor necrosis factor (TNF), interleukin (IL)-17 biologics or their biosimilars (comparator biologic-exposed group). 

To date, research activities include the development of a protocol and statistical analysis plan. Both have been reviewed and approved by the EMA (EU PAS Register number EUPAS39775). Upcoming study activities will include examining the use of Risankizumab during pregnancy. The research activities are a collaborative effort between the AbbVie research team, the IMEDS Operations Center at the FDA Foundation, the IMEDS Analytic Center at the Harvard Pilgrim Health Care Institute, the University of Massachusetts Meyers Primary Care Institute, and participating other IMEDS Network Partners. 

  • Click to view the European Union electronic Register of Post-Authorisation Studies (EU PAS) register number (EUPAS39775)
Entresto® Study with Novartis
Image
Doctor and patient talking in office

Project Title: Database cohort study to assess the risk of serious angioedema with LCZ696 (sacubitril/valsartan; Entresto®) use in Black patients with heart failure in the United States
Project Sponsor: Novartis
Project Status: Current
Product: LCZ696 (sacubitril/valsartan; Entresto®)
Conditions: Serious angioedema, Heart failure
Summary: The Reagan-Udall Foundation for the FDA (FDA Foundation PI: Carla Rodriguez-Watson) was recently awarded a contract to assess the risk of serious angioedema in association with LCZ696 (sacubitril/valsartan; Entresto®) use in Black patients with heart failure in the United States. This unique study leverages data from the Innovation in Medical Evidence Development and Surveillance (IMEDS) Network and the Center for Medicare and Medicaid (CMS). The research activities are a collaborative effort between the Novartis research team, the IMEDS Operations Center at FDA Foundation, the IMEDS Analytic Center at HPHCI, and participating IMEDS Network Partners.

 

Completed Studies

Feasibility Assessment with Pfizer
Image
Medical team discussing around table

Project Title: Feasibility assessment to conduct real-world assessment of risk factors for joint safety outcomes
Project Sponsor: Pfizer
Project Status: Completed
Conditions: Osteoarthritis
Summary:
The Reagan Udall Foundation for the FDA (PI: C Rodriguez-Watson) was awarded a contract to conduct a feasibility assessment to ascertain the ability of
Innovation in Medical Evidence and Development Surveillance (IMEDS) Network to capture information regarding important drug exposures and risk factors for joint safety outcomes in osteoarthritic patients. Data of interest included radiologic reports, images, pharmacy records, and administrative claims data. Research activities included a qualitative assessment to understand available data elements from the health record, data formats, and the time needed to collect those data. A quantitative assessment was also conducted to characterize the population of persons with osteoarthritis and other joint diseases, and their medication experience. This work was a collaborative effort between research teams at the Kaiser Permanente Washington Health Research Institute (KPWHRI), Pfizer, Lilly, the IMEDS Operations Center at FDA Foundation, the IMEDS Analytic Center at Harvard Pilgrim Healthcare Institute, and participating IMEDS Network Partners. The overall findings of the feasibility assessment demonstrated the feasibility of conducting a future post-approval safety study requiring detailed health record data within the IMEDS network.

Rheumatoid Arthritis (RA) Study with Eli Lilly
Image
IMEDS Research Summaries

Estimating the incidence of venous thromboembolism (VTE) among patients receiving routine clinical care for Rheumatoid Arthritis (RA), specifically during treatment with conventional and bDMARDs

Project Title: Risk of venous thromboembolism in rheumatoid arthritis patients treated with biologic and non-biologic DMARDs
Project Sponsor: Eli Lilly and Company
Project Status: Completed
Conditions: Rheumatoid Arthritis, Venous thromboembolism
Summary: Rheumatoid arthritis (RA) is an autoimmune disorder that affects the lining of a patient’s joints and causes painful swelling and joint damage. Biologic disease-modifying anti-rheumatic drugs (bDMARDs) are a type of medication which may prevent the development of joint damage, including rheumatoid arthritis. Individuals with RA have an increased risk of venous thromboembolism (VTE), including pulmonary embolism and deep vein thrombosis, compared with non-RA populations based on several recent studies. Venous thromboembolism (VTE) is a condition in which a blood clot forms in deep veins of the body, posing a significant health risk. The purpose of this IMEDS project was to identify risk factors for VTE among patients receiving treatment with specific disease-modifying antirheumatic drugs (DMARDs) or categories of therapies. Results of the study demonstrated that for each drug class tested, age was an important risk factor for VTE and higher ages were associated with higher rates of VTE. Men also had higher incidence rates of VTE than women. This study demonstrated the collaborative possibilities in the IMEDS network to robustly characterize at-risk populations for health outcomes by leveraging claims data.

Oral Contraceptives and Venous Thromboembolism (VTE) Pilot Study with Pfizer
Image
IMEDS Research Summaries

Estimating the increased risk of thromboembolism (VTE) among patients using 4th generation oral contraceptives (containing drospirenine) compared to 2nd generation (containing levonorgestel)

Project Title:  Oral Contraceptives and VTE across the Sentinel data network – An IMEDS Evaluation pilot assessment 
Project Sponsor: Pfizer
Project Status: Completed
Conditions: Venous thromboembolism (VTE)
Summary: Venous thromboembolism (VTE) is a condition in which a blood clot forms in deep veins of the body, posing a significant health risk. It has been well documented in scientific literature that users of oral contraceptives have an increased risk of VTE. The purpose of this IMEDS pilot project was to determine if there is an increased risk of VTE among patients using 4th generation oral contraceptives (containing drospirenine) compared to 2nd generation (containing levonorgestel). This study used the data network of nine FDA Sentinel data partners to examine the rate of VTE occurring in new users of 2nd and 4th generation oral contraceptives. The cohort consisted of women aged 15-44 who were new oral contraceptive users. Patients that were deemed to have existing VTE risks (such as cancer, chronic cardiovascular diseases, etc) were excluded from the study. The study results summarized the age, sex, and year of users and concluded that rates of VTE were higher for 4th generation oral contraceptives than 2nd generation oral contraceptives. This result is consistent with other existing scientific studies on this topic. This IMEDS pilot project demonstrated the potential of leveraging a large distributed data network to address public health issues and the value in utilizing FDA’s existing resources.

Drug Class Label Change Pilot Study with Pfizer
Image
IMEDS Research Summaries

Estimating the impact of a 2010 drug class label change that warned of a potential increase of bone fracture for drug users and recommended changes

Project Title: Risk Minimization Evaluation in a Distributed Data Network – An IMEDS Evaluation Pilot Assessment of the 2010 Class Label Change for Proton Pump Inhibitors
Project Sponsor: Pfizer
Project Status: Completed
Conditions: Effectiveness of a drug label change, bone fracture, drug use
Summary: Proton-pump inhibitors (PPIs) are a class of drugs that provide the drug user with a long-lasting reduction of stomach acid production. In May 2010, the FDA implemented a class-wide label change regarding the risk of bone fracture for users. The purpose of this IMEDS pilot study was to determine if the drug label change made a significant impact on the manner in which these drugs were used by individuals, including the frequency and duration of the drug use. Using IMEDS data network, the results suggest that the length of PPI drug use, number of long-term users, and occurrence of bone fractures in users were all reduced after the drug labels were changed. The study results demonstrated that the IMEDS program and data network can be used to characterize a) drug use patterns and other outcomes (such as bone fracture decreases) and b) the effectiveness of drug label changes at the population level.