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Povzetek: Background: Studies on national policies for biologics are warranted. Objectives: To map and compare national healthcare set-ups for prescription, start, switch, tapering, and discontinuation of biologic/targeted synthetic disease-modifying antirheumatic drugs (DMARDs) in patients with psoriatic arthritis and axial spondyloarthritis across Europe, and assess the healthcare set-ups in relation to countries' socio-economic status. Methods: An electronic survey was developed to collect and compare information on national healthcare systems. The relationship between the cumulative score of biologic/targeted synthetic DMARD regulations, socioeconomic indices, and biologic originator costs were assessed by linear regression. Results: National healthcare set-ups differed considerably across the 15 countries, with significantly fewer regulations with increasing socioeconomic status measured by GDP/current health expenditure/human development index, and with increasing biologic originator costs. In most countries, the biologic/targeted synthetic DMARD prescribing doctor was required to adhere to country and/or hospital recommendations, and about a third of countries had a national/regional tender process. Prescription regulations for biologic/targeted synthetic DMARDs, including pre-treatment and disease activity requirements, varied substantially. Approximately a third of countries had criteria for discontinuation and tapering, whereas only few had for switching. Notably, two countries disallowed biologic/targeted synthetic DMARD retrials, and one imposed limit on the maximum number of biologic/targeted synthetic DMARDs permitted. Conclusion: The findings highlight substantial variability in healthcare set-ups for biologic/targeted synthetic DMARD use in psoriatic arthritis and axial spondyloarthritis across Europe and their association with socioeconomic status and drug costs. These insights provide a basis for rheumatology societies, policymakers, and stakeholders to evaluate and potentially optimize healthcare policies.
Ključne besede: access to health care, axial spondyloarthritis, biologic therapy, health policy, psoriatic arthritis, socioeconomic health disparties
Objavljeno v DiRROS: 27.02.2026; Ogledov: 103; Prenosov: 57
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Povzetek: Background: Observational data on composite scores often comes with missing component information. When a complete-case (CC) analysis of composite scores is unbiased, preferable approaches of dealing with missing component information should also be unbiased and provide a more precise estimate. We assessed the performance of several methods compared to CC analysis in estimating the means of common composite scores used in axial spondyloarthritis research. Methods: Individual mean imputation (IMI), the modified formula method (MF), overall mean imputation (OMI), and multiple imputation of missing component values (MI) were assessed either analytically or by means of simulations from available data collected across Europe. Their performance in estimating the means of the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI), the Bath Ankylosing Spondylitis Functional Index (BASFI), and the Ankylosing Spondylitis Disease Activity Score based on C-reactive protein (ASDAS-CRP) in cases where component information was set missing completely at random was compared to the CC approach based on bias, variance, and coverage. Results: Like the MF method, IMI uses a modified formula for observations with missing components resulting in modified composite scores. In the case of an unbiased CC approach, these two methods yielded representative samples of the distribution arising from a mixture of the original and modified composite scores, which, however, could not be considered the same as the distribution of the original score. The IMI and MF method are, thus, intrinsically biased. OMI provided an unbiased mean but displayed a complex dependence structure among observations that, if not accounted for, resulted in severe coverage issues. MI improved precision compared to CC and gave unbiased means and proper coverage as long as the extent of missingness was not too large. Conclusions: MI of missing component values was the only method found successful in retaining CC's unbiasedness and in providing increased precision for estimating the means of BASDAI, BASFI, and ASDAS-CRP. However, since MI is susceptible to incorrect implementation and its performance may become questionable with increasing missingness, we consider the implementation of an error-free CC approach a valid and valuable option.
Ključne besede: axial spondyloarthritis, complete-case analysis, composite score, missing components, multiple imputation, aksialni spondiloartritis, analiza celotnega primera, sestavljena ocena, manjkajoče komponente, večkratna imputacija
Objavljeno v DiRROS: 26.02.2026; Ogledov: 114; Prenosov: 51
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Povzetek: Background: Efficacy of tumour necrosis factor inhibitors (TNFi) for peripheral arthritis in patients with psoriatic arthritis (PsA) has been established in randomized clinical trials that have used improvement in summated joint counts as an outcome. Whether joints at different anatomical locations might respond differentially to TNFi remains unknown. The aim of the study was to investigate potential variations in the responsiveness to a first tumour necrosis factor inhibitor (TNFi) among joints at distinct locations in patients with psoriatic arthritis (PsA) treated in routine clinical care. Methods: Bionaive PsA patients from nine European countries were included in this observational cohort study if ≥ 1 joint was swollen at the initiation of a first TNFi as monotherapy or added to methotrexate. Only the 28-joint count was available without imaging data confirming the presence of synovitis. The primary outcome was time to first resolution of joint swelling at each joint level. Hazard ratios (HR) for resolution comparing different joint locations were estimated using interval-censored mixed-effects Cox proportional hazards models, including a random effect for country and patient, adjusted for age and sex. Results: A total of 1729 patients with 8397 swollen joints at the start of TNFi were included. Considering the upper extremity, a higher rate of resolution of joint swelling (HR, 95% CI) was observed for the shoulder (1.65, 1.16-2.35) and elbow (1.90, 1.38-2.61), while a lower rate was found for the wrist (0.72, 0.62-0.83) compared to the joints of digit 3. Within fingers, and using the same reference, joint swelling resolved fastest in digit 4 (1.77, 1.49-2.11) and digit 5 (1.88, 1.53-2.31). A lower rate of resolution of joint swelling was found for the knee in comparison to the elbow, the corresponding joint on the upper limb (0.56, 0.40-0.78). Conclusion: The time to resolution of joint swelling upon treatment with TNFi in patients with PsA seems to depend on the localisation of the affected joints.
Ključne besede: TNF inhibitors, joint, psoriatic arthritis
Objavljeno v DiRROS: 26.02.2026; Ogledov: 182; Prenosov: 49
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Povzetek: Objectives: To quantify the influence of lifestyle factors on tumour necrosis factor inhibitor (TNFi) treatment response, in axial spondyloarthritis (axSpA). Methods: Data on biologics-naïve adults with axSpA were captured from European rheumatology registries. Information on lifestyle factors (smoking, overweight/obesity, and/or alcohol consumption) were identified ± 30 days of commencing their first TNFi. Treatment response (BASDAI-50, ASDAS or ASAS response criteria) was determined at 3 and 12 months. In separate models, the relationship between treatment response and baseline smoking, BMI and alcohol was assessed using logistic regression, adjusted for age, sex, country, calendar year of treatment initiation, disease duration and baseline disease activity. Results: From 14 registries, 14,885 patients were included. Of those with available data, 29% were current smokers, 49% current drinkers, 37% were overweight and 21% were obese. At 12 months, smokers were less likely to achieve BASDAI-50 treatment response compared to non-smokers (adjusted odds ratio: 0.77; 95%CI: 0.68-0.86). A similar effect was observed among overweight (0.76; 0.66-0.87) or obese patients (0.53; 0.45-0.63). In contrast, alcohol drinkers experienced a seemingly beneficial effect (1.47; 1.16-1.87). These associations were also observed with other measures of treatment response and were robust to further adjustment for clinical characteristics. Conclusion: Smoking and high BMI decrease the odds of bDMARD treatment success in axSpA. Rheumatologists should consider referral to smoking cessation and/or weight management interventions at the time of commencing therapy, to enhance treatment response. The relationship between alcohol and treatment response is unlikely to be causal and warrants further investigation.
Ključne besede: alcohol, axial spondylarthritis, body mass index, life style, smoking
Objavljeno v DiRROS: 23.02.2026; Ogledov: 187; Prenosov: 57
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Povzetek: Objectives: Recently published 2023 ACR/EULAR APS classification criteria emphasize the importance of quantifying single-, double-, and triple-antiphospholipid antibody positivity, distinguishing between IgG and IgM isotypes, and delineating moderate/high levels of anticardiolipin (aCL) and anti-β2 glycoprotein I (anti-β2GPI) antibodies. We aimed to establish clinically important moderate/high thresholds for aCL and anti-β2GPI IgG/IgM chemiluminescent immunoassays (CLIA), in particular QUANTA Flash, comparable to our in-house ELISAs used for over two decades, and to evaluate their diagnostic performance. Methods: QUANTA Flash CLIA and in-house ELISAs were used to measure aCL and anti-β2GPI IgG/IgM. Moderate thresholds for QUANTA Flash CLIA were determined using a non-parametric approach, calculating a 99th percentile on serum samples from 139 blood donors, and by mirroring the diagnostic performance of in-house ELISA on 159 patient samples. Results: Thresholds for QUANTA Flash CLIA achieving diagnostic performance equivalent to in-house ELISAs were 40 CU for moderate and 80 CU for high levels for aCL and anti-β2GPI IgG and IgM. The assays showed good qualitative agreement, ranging from 76.10 to 91.19 %. When considering in-house ELISA results, 14 out of 80 (17.5 %) patients did not fulfill the new ACR/EULAR laboratory classification criteria, while 27 out of 80 (33.8 %) did not when considering QUANTA Flash CLIA results. Conclusions: We determined moderate and high thresholds for aCL and anti-β2GPI IgG and IgM detected with QUANTA Flash CLIA, aligning with long-established in-house ELISA thresholds. These thresholds are crucial for seamlessly integrating of the new 2023 ACR/EULAR classification criteria into future observational clinical studies and trials.
Ključne besede: anti-β2GPI, anticardiolipin, antiphospholipid syndrome, classification criteria
Objavljeno v DiRROS: 10.11.2025; Ogledov: 323; Prenosov: 175
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