Published data on long-term adherence and persistence with adalimumab (Humira® ) in clinical practice are scarce and often limited to selected patient populations. This study assessed adherence with adalimumab across different indications and identified correlates and outcomes of poor adherence.We analysed data originating from the electronic database of Maccabi Healthcare Services (MHS) that includes 2.1 million enrolees. We randomly selected patients with at least one dispense of adalimumab since it was included in the local health basket in Israel in 2008 until the end of 2013. Patients with the following indications (n = 1339) were included: Crohn's disease (CD), ulcerative colitis (UC), rheumatoid arthritis (RA), psoriatic arthritis (PSA), ankylosing spondylitis (AS) and psoriasis. Adherence with therapy was assessed by the medication possession ratio (MPR) during the follow-up period.Good adherence (MPR ≥ 80%) was observed among 80% of study patients and was associated with lower risk for ≥1 hospitalization per year of follow-up (adjusted-OR = 1.94, 95% CI:1.15-3.28). Patients with AS and CD persisted on adalimumab therapy the most, reaching median use of 27.0 and 26.7 months, respectively. Half (52.4%) of the patients discontinued treatment during a mean (SD) follow-up of 3.07 (1.71) years. High socioeconomic status was associated with lower risk for discontinuation (adjusted-HR = 0.74; 0.60-0.91). UC and concomitant prednisolone use were associated with increased risk for treatment discontinuation (HR = 1.31; 1.00-1.72, and HR = 1.40; 1.17-1.68, respectively).Our results indicate encouraging persistence and adherence with adalimumab of patients with inflammatory conditions.
Giant cell arteritis (GCA), also known as temporal arteritis, is a vasculitis of large and medium-sized vessels, which commonly involves the extracranial branches of the carotid artery. There are conflicting evidence regarding the association between GCA and both solid and hematologic malignancies.1–4
Objectives
To assess the coexistence rate of GCA and hematologic malignancies.
Methods
This cross-sectional study was performed utilising the database of Israel's largest healthcare association, Clalit Health Services (CHS). All patients with previously documented diagnosis of GCA were included, as well as age-and sex matched controls without GCA. The proportions of Hodgkin's lymphoma, Non-Hodgkin's lymphoma and multiple myeloma were compared between patients and controls. Univariate analysis was compared using chi-square test for categorical variables and student's t-test for continuous variables. A multivariable logistic regression model was built to assess the covariates associated with each Non-Hodgkin's lymphoma, the hematologic malignancy with the highest number of patients.
Results
The study included 5,663 GCA patients and 28 308 controls with a mean age of 71 and 68.3, respectively. Both groups consisted of 69.8% females. Multiple myeloma was observed in 27 GCA patients (0.48%) and 53 controls (0.19%), crude OR=2.56 p<0.001. Hodgkin's lymphoma was observed in 19 GCA patients (0.34%) and 41 controls (0.14%), crude OR=2.33 p=0.004. Non-Hodgkin's lymphoma was observed in 64 GCA patients (1.13%) and 164 controls (0.58%), crude OR=1.96 p<0.001. Multivariable logistic regression model adjusting for age and gender found GCA as independently associated with Non-Hodgkin's lymphoma (adjusted OR 1.96, p<0.001).
Conclusions
GCA patients have higher rate of hematologic malignancies compared to controls. The association with Non-Hodgkin's lymphoma is the most prominent, and proper screening methods should be applied for early detection and treatment.
References
[1] Askling J. Do steroids increase lymphoma risk? A case-control study of lymphoma risk in polymyalgia rheumatica/giant cell arteritis. Ann Rheum Dis64:1765–1768. doi:10.1136/ard.2005.036459 [2] Liozon E, Loustaud V, Fauchais A-L, et al. Concurrent temporal (giant cell) arteritis and malignancy: report of 20 patients with review of the literature. J Rheumatol2006;33:1606–1614. [3] Kermani TA, Schäfer VS, Crowson CS, et al. Malignancy risk in patients with giant cell arteritis: A population-based cohort study. Arthritis Care Res NA-NA. doi:10.1002/acr.20062 [4] Solans-Laque R, Bosch-Gil JA, Pérez-Bocanegra C, et al. Paraneoplastic vasculitis in patients with solid tumors: report of 15 cases. J Rheumatol35:294–304.
Low-grade inflammation is a risk factor for coronary artery disease. Yet, clinical data on patients with inherited auto-inflammation are limited.
Objectives
To assess the natural progression of cardiovascular and metabolic risk among participants with familial Mediterranean Fever (FMF).
Methods
We performed a cross-sectional study of the prevalence of components of the metabolic syndrome at age 17, from the medical database of the Israeli Defense Force from 1973 through 1997.Included were 745 males with FMF, 902 healthy male siblings and a control group of 787,714 participants. A prospective follow-up (mean follow-up >19 years) study traced the incidence of components of the metabolic syndrome and angiography-proven coronary artery disease (CAD) to age 45 years among 57 FMF and 1,568 control army personnel participants.
Results
In multivariable multinomial regression analysis adjusted for known confounders of obesity, FMF participants had an odds ratio of 0.65 for occurrence of overweight (95%CI=0.44-0.96,p=0.03) and 0.66 (95%CI=0.48-0.92,p=0.012) for hypertension-range blood pressure; their siblings tended to obesity (OR=1.48;95%CI=1.04-2.11,p=0.008). In the follow-up arm, Cox-regression multivariable models adjusted for age, birth year, BMI, education, socioeconomic status, country of origin and physical activity yielded hazard ratios of 0.32 (95%CI=0.10-0.82,p=0.002) for incident obesity, 0.49 (95%CI=0.25-0.95,p=0.037) for incident TG≥150mg/dL, 0.56 (95%CI=0.31-0.98,p=0.048) for LDL≥130mg/dL and 2.14 (1.368-3.359,p=0.001) for HDL<40mg/dL for FMF participants compared to controls. In univariate analysis, incident elevated blood pressure was lower among FMF participants (HR=0.49;95%CI=0.23-1.00,p=0.05), while dysglycemia incidence was comparable. There was no evidence for accelarated CAD among FMF patients.
Conclusions
FMF was associated with lower rates of most components of the metabolic syndrome compared to normal subjects, with no evidence for accelerated CAD.
Background & Objectives: To explore the potential association between positive ANA serology and all-cause mortality in a large cohort of patients, including those with and without rheumatological conditions and other immune-related diseases. Material and Methods: A retrospective cohort study analyzed all-cause mortality among 205,862 patients from Clalit Health Services (CHS), Israel’s largest health maintenance organization (HMO). We compared patients aged 18 and older with positive ANA serology (n = 102,931) to an equal number of ANA-negative controls (n = 102,931). Multivariable Cox regression models were used to assess hazard ratios (HR) for mortality, adjusting for demographic and clinical factors. Results: ANA positivity was strongly associated with increased mortality (adjusted HR [aHR] 4.62; 95% CI 4.5–4.7, p < 0.001). Significant predictors of mortality included male gender (39.2% vs. 24.4%, p < 0.001), older age at testing (72.4 ± 13.0 vs. 50.1 ± 17.3 years, p < 0.001), and Jewish ethnicity (89.6% vs. 83.2%, p < 0.001). Certain ANA patterns, such as mitochondrial (and dense fine speckled (DFS-AC2)), were highly predictive of mortality, with aHRs of 36.14 (95% CI 29.78–43.85) and 29.77 (95% CI 26.58–33.34), respectively. ANA-positive patients with comorbid rheumatological immune-related disorders (RIRDs) demonstrated a higher survival rate compared to those without such a condition (aHR 0.9, 95% CI 0.86–0.95, p < 0.001). This finding remained significant after adjusting for several parameters, including age. Conclusions: ANA positivity is associated with increased all-cause mortality, particularly in individuals without rheumatologic disorders, after adjusting for confounders such as age. This may indicate occult malignancies, cardiovascular pathology, or chronic inflammatory states, necessitating more vigilant surveillance
The association between giant cell arteritis (GCA) and malignancies had been widely investigated with studies reporting conflicting results. Therefore, in this study, we aimed to investigate this association using a large nationwide electronic database.
Ischemic heart disease (IHD) is a well identified cause of mortality in SLE patients due to accelerated premature atherosclerosis attributed to both traditional cardiovascular risk factors and to the inflammatory effect of SLE itself (1,2).
Objectives
To investigate the incidence and prevalence of IHD among Middle Eastern SLE patients derived from a large, national real-life database.
Methods
Using data from the largest HMO in Israel, the Clalit Health Services, we selected for patients with SLE. These patients were compared with age and sex matched controls with regards to the prevalence of IHD in a case-control study. Chi-square and t-tests were used for univariate analysis and a logistic regression model was used for multivariate analysis.
Results
The study included 5,018 patients with SLE and 25,090 age and sex-frequency matched controls. The prevalence of IHD in patients with SLE was increased compared to controls (11.3% and 3.1%, respectively, P<0.001). In a multivariate analysis SLE was associated with IHD (OR 3.77, 95% confidence interval 3.34–4.26).
Conclusions
Our data supports that SLE is an independent risk factor for IHD. When evaluating by gender, the risk seems even more substantial in females.
References
Petri MA, Kiani AN, Post W, Christopher-Stine L, Magder LS. Lupus Atherosclerosis Prevention Study (LAPS).Ann Rheum Dis. 2011;70:760–5 Romero-Díaz J, Vargas-Vόracková F, Kimura-Hayama E, Cortázar-Benítez LF,Gijόn-Mitre R, Criales S, Cabiedes-Contreras J, Iñiguez-Rodríguez Mdel R,Lara-García EA, Núñez-Alvarez C, Llorente L, Aguilar-Salinas C, Sánchez-Guerrero J. Systemic lupus erythematosus risk factors for coronary artery calcifications. Rheumatology (Oxford). 2012;51:110–9.
