A retrospective observational study of ibrutinib in chronic lymphocytic leukaemia in a real-life setting in France using the national claims database (OSIRIS).

BACKGROUND: Ibrutinib is a Bruton's tyrosine kinase inhibitor indicated for the first-line treatment and relapse of chronic lymphocytic leukaemia (CLL), Waldenström's macroglobulinemia (WM) and mantle cell lymphoma (MCL). This study aimed to describe the characteristics of CLL patients treated with ibrutinib and its effectiveness, safety, and treatment pattern in real life. METHODS: All patients covered by the general health scheme (approximately 80% of the French population) with a first ibrutinib dispensation from August 1, 2017 (date of reimbursement in France) to December 31, 2020, were identified in the French National Health Insurance database (SNDS). An algorithm was developed to identify the disease (CLL, MCL or WM) for which ibrutinib was prescribed. This article focused on CLL patients. The time to next treatment (TTNT) was plotted using Kaplan‒Meier curves. RESULTS: During this period, 6,083 patients initiated ibrutinib, among whom 2,771 (45.6%) patients had CLL (mean age of 74 years; 61% of men). At ibrutinib initiation, 46.6% of patients had a cardiovascular comorbidity. Most patients (91.7%) were not hospitalized during the exposure period for one of the cardiovascular or bleeding events studied. Hospitalizations were more frequent in patients with a cardiovascular comorbidity (5.9% versus 11.0%, p-value < 0.0001) and aged over 70 (5.9% versus 9.4%, p-value < 0.0001). The median TTNT was not reached. CONCLUSION: This is one of the largest cohorts of ibrutinib-treated patients in the world. The profile of CLL patients treated with ibrutinib was in accordance with the marketing authorization and reimbursement. This study confirmed effectiveness and safety data.

Coverage rates for diphtheria, tetanus, poliomyelitis, and pertussis age-specific booster recommendations in France: 2018 update of the real-world cohort analysis.

The French National Immunization Program was updated in 2013 for vaccination against diphtheria, tetanus, pertussis, and poliomyelitis. Our previous findings on the evolution of age-specific booster vaccination coverage rates (VCRs) up to 2017 suggested suboptimal vaccination coverages due to the pre-2013 recommendation-residual vaccination practices. In the current analysis, we evaluated all age-specific booster VCR and distribution of age at vaccination visits in 2018. In this retrospective observational cohort study, the cumulative booster VCRs were updated at all vaccination visits up to 2018 among the people who were eligible for a booster vaccination, using a 1/97th random sample of French national healthcare reimbursement databases. The cumulative booster VCR for individuals from all age groups increased from 2017 to 2018, except for 85-years-old vaccination visit. Majority of the individuals from all age groups were vaccinated (boosted) with a vaccine containing the pertussis valence. In 2018, sharp peaks corresponding to the recommended ages for booster vaccination visits were observed for individuals aged 6, 11 to 13, 25, 45, and 65 years. Our study reiterates suboptimal coverages in France and implies the need for booster vaccination throughout life for the protection of the population.

Cocooning strategy: Pertussis vaccination coverage rate of parents with a new-born in 2016 and 2017 in France.

Background: The "cocooning" strategy was introduced in 2004 to protect infants too young to be vaccinated against pertussis, by immunizing their parents and close relatives. The study objective was to assess its implementation 12 years after its introduction by estimating the pertussis vaccination coverage rates (VCR) among parents of newborns. Materials and methods: Pertussis VCR were estimated among all women who gave birth and men who took paternity leave, in 2016 or 2017, from a 1/97th random sample of French claims data. Two distinct study periods were defined based on current recommendations for the cocooning strategy: the "common practice" and the "parental project" periods. Results: In 2016, the pertussis VCR of women having given birth and men having taken paternity leave was 47.2 and 47.1%, respectively (46.1 and 45.6% in 2017, respectively). About one quarter of vaccinations were performed during the "parental project" period, with the vaccine most frequently reimbursed during the month of childbirth for women (57.1% in 2016 and 49.4% in 2017) and before or during the month the paternity leave began for men (about 78% in both 2016 and 2017). General practitioners were the main prescribers in private practice, even during the "parental project" period. Conclusion: To optimize the protection for infants, the main objective of the cocooning strategy, pertussis immunization coverage of adults and seniors needs to be improved. Moreover, cocooning vaccination linked to a parental project needs to be performed earlier, during pregnancy (for those around the mother) or in immediate post-partum (e.g., during the maternity stay).

Vaccination coverage rates for Diphtheria, Tetanus, Poliomyelitis and Pertussis booster vaccination in France between 2013 and 2017: Learnings from an analysis of National Health System Real-World Data.

BACKGROUND: Maintaining a high vaccination coverage rate (VCR) throughout the lifetime and complying with the National Immunization Program are essential to optimize the protection of the population. The study objectives were to evaluate the evolution of the VCRs and the compliance with the vaccination visits for the diphtheria, tetanus, poliomyelitis and pertussis boosters in France since the changes implemented in the 2013 National Immunization Program. METHODS: Cumulative booster VCRs were estimated at all vaccination visits, from 2013 to 2017, among persons eligible for a booster vaccination from a 1/97th random sample of French claims data. Broader age groups around the recommended ages by the vaccination schedule (6, 11-13, 25, 45, 65, 75, 85, 95y) were used: all persons aged 5 to 8, 10 to 15, 21 to 29, 41 to 49, 61 to 69, 71 to 79, 81 to 89 and 91 to 99. RESULTS: Over the study period, the diphtheria-tetanus-poliomyelitis booster VCRs increased, reaching in 2017: 73.3% at 8 years old, 75.6% at 15 years old, 46.6% at 29 years old, 38.4% at 49 years old, 36.3% at 69 years old, 30.8% at 79 years old, 22.1% at 89 years old and 11.0% at 99 years old. The pertussis VCRs were also increasing at all vaccination visits, in particular at the vaccination visits at 6 and 11-13 years old (from 16.4% to 63.8% and from 50.3% to 61.2%, respectively). Delayed vaccinations were observed at all vaccination visits. CONCLUSION: VCRs for Diphtheria, Tetanus, Poliomyelitis and Pertussis booster vaccination increased from 2013 to 2017 while remaining suboptimal across all ages and lower in the adult populations. The analysis also shows that the introduction in 2013 of a pertussis vaccination at 6 years of age was relatively well-established in 2017 while other changes in recommendations were slowly or partially implemented.