Non-persistence (treatment discontinuation or switch) with vitamin K antagonists was lower than with rivaroxaban and dabigatran in French primary care; however, non-persistence with the newest drug, apixaban, was similar to vitamin K antagonists. Larger studies with longer follow-up are needed to support these findings. This study is registered on ClinicalTrials.gov (NCT02488421).
Background:Sjögren’s syndrome (SS) is a chronic, systemic autoimmune disorder characterised by oral and ocular dryness related to lymphocytic infiltration of exocrine glands.1–3 Extra-glandular manifestations may include fatigue, musculoskeletal pain and glomerulonephritis.1,3 SS can present as primary SS (pSS) or as SS associated with another autoimmune disorder (SS+AID).1 Reported prevalence of pSS in the French general population is 1.02–1.52 cases/10,000 people.3Objectives:To estimate prevalence, incidence and healthcare costs of SS in France using national health insurance claims data.Methods:Claims from 2011–2018 from the Système National des Données de Santé (SNDS), comprised of data from 99% of the French population, were analysed. Patients (pts) with SS were identified using an algorithm.4 Inclusion criteria: International Classification of Diseases, Tenth Revision code M35.0 (Sicca syndrome [Sjögren]) or M35 (other systemic involvement of connective tissue), and ≥2 drug reimbursements for SS-related treatments. Key exclusion criteria: amyloidosis, sarcoidosis, HIV, and head and neck radiotherapy. Denominators for estimated prevalence rates were derived from French population census data. Healthcare costs were based on Assurance Maladie rates.Results:23,152 pts with pSS and 15,462 with SS+AID were identified during the study period. Estimated prevalence of SS (2011–2018) per 100,000 persons ranged from 22–32 (pSS) and 17–22 (SS+AID) and was stable over time; proportion of female pts was 90–91% (pSS) and 92–93% (SS+AID); mean age ranged from 63–66 (pSS) and 58–63 (SS+AID) years. Estimated incidence of SS (2012–2018) per 100,000 persons ranged from 4.1–0.3 (pSS) and 2.1–0.1 (SS+AID); proportion of female pts was 76–87% (pSS) and 74–90% (SS+AID); mean age ranged from 53–64 (pSS) and 50–62 (SS+AID) years. RA was the most frequently associated autoimmune disorder (32%) in pts with SS+AID. In the first year, artificial tears was the most frequently reimbursed drug (66% [pSS], 55% [SS+AID]), followed by hydroxychloroquine (19% [pSS], 35% [SS+AID]). From 2014–2018, ~30% of men and ~22% of women with pSS reported no drug reimbursement; ~20% of men and ~15% of women with SS+AID reported no drug reimbursement during the same time frame. From 2013–2018, ~50% of all pts had consultations with a dentist or an ophthalmologist. Mean healthcare costs increased over the study period: from €5836 to €9618 (pSS) and €8905 to €13,271 (SS+AID). Pt characteristics and healthcare consumption data are presented (Table 1).Conclusion:Prevalence of pSS in this French claims data study was stable over time and consistent with previous reports.3 Based on these results, SS may be considered an orphan disease. Overall costs for pts with SS were higher than previously estimated.5 Results may help inform and optimise specialist care for pts with SS in France.References:[1]Patel R, Shahane A. Clin Epidemiol 2014;6:247–255.[2]Mariette X, Criswell LA. N Engl J Med 2018;378:931–939.[3]Maldini C, et al. Arthritis Care Res (Hoboken) 2014;66:454–463.[4]Devauchelle Pensec V, et al. Arthritis Rheumatol 2019;71(suppl 10):abstract 1101.[5]l’Assurance Maladie. Améliorer la qualité du système de santé et maîtriser les dépenses. July 2019.Table 1.Characteristics and healthcare consumption data for pts with SS in the SNDS (2011–2018)pSSSS+AIDAge at disease onset, overall and by sexM (n=2515)F (n=20,637)All (n=23,152)M (n=1350)F (n=14,112)All (n=15,462)Mean (SD)62 (15)60 (15)60 (15)59 (14)56 (15)56 (15)Age, yrs, n (%)<50480 (19)4948 (24)5428 (23)328 (24)4507 (32)4835 (31)50–741471 (59)11,567 (56)13,038 (56)852 (63)7887 (56)8739 (57)≥75564 (22)4122 (20)4686 (20)170 (13)1718 (12)1888 (12)Healthcare consumptionMean (IQR) no. prescriptions for treatment of interest37 (9–58)52 (20–78)≥1 Schirmer’s test, n (%)2409 (10)1303 (8)Reimbursement for antinuclear antibody test, n (%)13,312 (58)9587 (62)Mean no. dental reimbursements/yr21Mean no. ophthalmologist reimbursements/yr11F=female; IQR=interquartile range; M=male; yr=year.Acknowledgements:This study was sponsored by Bristol Myers Squibb. Professional medical writing assistance was provided by Lindsay Craik at Caudex and was funded by Bristol Myers Squibb.Disclosure of Interests:Raphaèle Seror Consultant of: Amgen, Boehringer Ingelheim, Bristol Myers Squibb, Fresenius Kabi, GlaxoSmithKline, Janssen, Pfizer, Roche, Laurent Chiche: None declared, Guillaume Desjeux: None declared, Joe Zhuo Shareholder of: Bristol Myers Squibb, Employee of: Bristol Myers Squibb, Bruno Bregman Shareholder of: Bristol Myers Squibb, Employee of: Bristol Myers Squibb, Virginie Vannier-Moreau Shareholder of: Bristol Myers Squibb, Employee of: Bristol Myers Squibb, Valerie Devauchelle-Pensec Consultant of: AbbVie, Bristol Myers Squibb, Novartis, Grant/research support from: Bristol Myers Squibb, Lilly, Roche-Chugai.
Background:Interstitial lung disease (ILD) is a common extra-articular manifestation of RA and is associated with increased morbidity and mortality.1-3 Studies have shown variability in the prevalence and mortality rate of patients with RA-associated ILD (RA-ILD).4 Further studies are needed to better characterise the epidemiology of RA-ILD.Objectives:To estimate the prevalence and incidence of clinical RA-ILD in France and to compare mortality rates between patients with RA-ILD and patients with RA without clinical ILD (RA-noILD).Methods:A historical cohort study was conducted using data from the French national claims database (SNDS) between 1 January 2013 and 31 December 2018. Adults with an RA diagnosis (International Classification of Diseases, Tenth revision [ICD-10] codes M05, M06.0, M06.8 and M06.9) and ≥2 distinct dates of DMARD delivery were included. Onset of RA was defined as the first date of occurrence between RA codes and the first known DMARD reimbursement. ILD diagnosis was defined as having ICD-10 code J84 and ≥1 computed tomography scan after, but within 1 year of, the first date of ILD occurrence. All patients had ≥6 months’ reimbursement after RA-ILD onset. The prevalence and incidence (2014–2018) of RA-ILD were estimated. The mortality rate was calculated, comparing patients with RA-ILD and patients with RA-noILD, matched 1:1 for age, sex, age at RA-ILD onset, duration of RA and presence of diabetes, arterial disease, dyslipidaemia and cardiac disease. Mortality was compared between patients with RA with and without clinical ILD in the matched population using Cox proportional hazards regression.Results:The prevalence of RA-ILD was 6.52 per 100,000 inhabitants (incidence=1.04 per 100,000 person-years). Of the 173,138 patients with RA included in the overall population, 4330 (2.5%) had clinical ILD. Patients with RA-ILD were older at RA diagnosis (mean [SD] age: 63.3 [13.7] vs 56.9 [15.2] years) and were more likely to be male (39.8% vs 27.0%) compared with patients with RA-noILD. Patients with RA-ILD were more likely to have cardiac disease (84.9% vs 63.1%), arterial disease (38.0% vs 19.3%), diabetes (21.4% vs 12.5%) and dyslipidaemia (44.7% vs 32.9%) compared with those with RA-noILD. The mortality rate in patients with clinical RA-ILD was 1.71 per 100,000 inhabitants. The mortality rate increased according to age (0.28 per 100,000 inhabitants for patients aged <65 years, 4.60 per 100,000 inhabitants for patients aged 65–74 years and 11.4 per 100,000 inhabitants for patients aged ≥75 years). After matching, the adjusted mortality risk was three times higher (HR [95% CI]: 3.1 [3.1, 3.9]) in patients with RA-ILD than in those with RA-noILD (Figure 1).Conclusion:This is the largest epidemiological study of RA-ILD in France. The prevalence of clinical RA-ILD in this population was towards the lower end of previous estimates (1–58%),3 possibly due to under-reporting of claims data. However, the occurrence of clinical ILD was associated with a strong increase in mortality compared with patients with RA-noILD.References:[1]Bodolay E, et al. Rheumatology (Oxford) 2005;44:656–661.[2]Duarte AC, et al. Rheumatology (Oxford) 2019;58:2031–2038.[3]Hyldgaard C, et al. Ann Rheum Dis 2017;76:1700–1706.[4]Spagnolo P, et al. Arthritis Rheumatol 2018;70:1544–1554.Acknowledgements:This study was funded by Bristol Myers Squibb. Claire Line, PhD of Caudex provided medical writing support, funded by Bristol Myers Squibb.Disclosure of Interests:Pierre-Antoine Juge Consultant of: Bristol Myers Squibb, Lidwine Wemeau Stervinou Consultant of: Boehringer Ingelheim, Bristol Myers Squibb, Roche, Sanofi, Sebastien Ottaviani Consultant of: AbbVie, Bristol Myers Squibb, Lilly, Merck Sharp & Dohme, Novartis, Roche-Chugai, SOBI, UCB, Guillaume Desjeux: None declared, Joe Zhuo Shareholder of: Bristol Myers Squibb, Employee of: Bristol Myers Squibb, Bruno Bregman Shareholder of: Bristol Myers Squibb, Employee of: Bristol Myers Squibb, Virginie Vannier-Moreau Shareholder of: Bristol Myers Squibb, Employee of: Bristol Myers Squibb, Rene-Marc Flipo Speakers bureau: AbbVie, Bristol Myers Squibb, Janssen, Lilly, Medac, Merck Sharp & Dohme, Novartis, Pfizer, Roche-Chugai, Grant/research support from: Amgen, Janssen, Novartis, Pfizer, Bruno Crestani: None declared, Philippe Dieudé Consultant of: Boehringer Ingelheim, Bristol Myers Squibb, Chugaï, Lilly, Medac, Novartis, Pfizer, Sanofi, Grant/research support from: Bristol Myers Squibb, GlaxoSmithKline, Pfizer
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