Detection and evaluation of a drug safety signal concerning pancreatic cancer: lessons from a joint approach of three European biologics registers.
نویسندگان
چکیده
OBJECTIVES A high incidence of pancreatic cancer (PCa) in patients exposed to was observed in the German biologics register. To evaluate this possible safety signal, a concerted analysis with the national biologics registers in the UK and Sweden was performed. METHODS Patients with enrolled in the British Society of Rheumatology Biologics Register (BSRBR), the Swedish Rheumatology Register (SRR) or the German Biologics Register [Rheumatoid Arthritis Observation of Biologic Therapy (RABBIT)] were analysed. The patients were exposed to biologic or conventional DMARDs. Outcomes were obtained from physician reports, health authorities and via linkage to national cancer and death registers. Age- and gender-standardized incidence ratios (SIRs) of PCa were calculated based on the expected rates available from the individual national cancer registers. RESULTS Data from 5126 (Germany), 16 930 (UK) and 19 351 (Sweden) RA patients were available for the analysis. The highly discrepant prescription rates of LEF in the respective countries resulted in 11 343 (Germany), 30 787 (UK) and 2518 (S) patient-years of exposure to LEF. Compared with the general population, the incidence of PCa in patients ever exposed to LEF corresponded to a SIR of 3.1 (95% CI 1.3, 6.5) in Germany, 1.05 (95% CI 0.5, 2.1) in the UK and 1.8 (95% CI 0.1, 10.2) in Sweden. CONCLUSION The results of the replication analyses do not support the hypothesis of an increased risk of PCa in patients exposed to treatment with LEF. However, they do not completely rule out concerns, and therefore further verification in other data sets is recommended.
منابع مشابه
DyVSoR: dynamic malware detection based on extracting patterns from value sets of registers
To control the exponential growth of malware files, security analysts pursue dynamic approaches that automatically identify and analyze malicious software samples. Obfuscation and polymorphism employed by malwares make it difficult for signature-based systems to detect sophisticated malware files. The dynamic analysis or run-time behavior provides a better technique to identify the threat. In t...
متن کاملI-18: Evaluating Pregnancy and Long-Term Outcomes of ART
When treating infertile couples by assisted reproductive technologies (ART), all aspects of their care in individual clinics should be evaluated frequently. Results should then be compared with other clinics offering similar treatment. Evaluation of possible adverse longterm outcomes can be achieved by pooling results from individual clinics in national, regional and international registers and...
متن کاملLaunch of a checklist for reporting longitudinal observational drug studies in rheumatology: a EULAR extension of STROBE guidelines based on experience from biologics registries.
The advent and increased use of targeted therapies in rheumatology have stimulated the establishment of clinical drug registers. Such registers have evaluated a broad spectrum of outcomes in patients exposed to these uniquely designed, potent and expensive drugs. Although the main focus of most drug registers in rheumatology is drug safety, other important issues include drug usage, real-life e...
متن کاملSafety signal detection and evaluation in clinical development programs: A case study of tofacitinib
Adverse events are anticipated during a clinical development program. Tofacitinib is an oral Janus kinase inhibitor for the treatment of rheumatoid arthritis (RA). We describe here the process undertaken by Pfizer to investigate a safety signal for pancreatic cancer with tofacitinib. Potential cases of pancreatic cancer across indications from Pfizer's clinical trials and safety databases were ...
متن کاملذخیره در منابع من
با ذخیره ی این منبع در منابع من، دسترسی به آن را برای استفاده های بعدی آسان تر کنید
عنوان ژورنال:
- Rheumatology
دوره 50 1 شماره
صفحات -
تاریخ انتشار 2011