[COVID-19 infections and effectiveness of the vaccination among healthcare workers]. / A COVID­19-fertozés és a védooltások hatásosságának vizsgálata egészségügyi dolgozókon.

INTRODUCTION: New variants of the SARS-CoV-2 coronavirus are constantly appearing, causing the COVID-19 pandemic. From November 2021, most infections were caused by the Omicron coronavirus variant. OBJECTIVE: The aim of this prospective observational cohort study was to estimate the incidence of COVID-19 infections in the high-risk healthcare workers after two BNT162b2 mRNA Pfizer-BioNTech vaccines and the subsequent booster vaccine, as well as the effectiveness, the safety and the humoral immune response of the vaccines. METHOD: We started the two Pfizer-BioNTech ((BNT162b29) vaccinations of healthcare workers of the Polyclinic of the Hospitaller Brothers of St. John between January 07 and March 08, 2021. The choice of the type and timing of the third booster vaccination was voluntary. The workers were followed up between January 07, 2021 and June 29, 2022. The infection rate, adverse events of the vaccination, risk factors to infection and the kinetics of anti-spike (S) antibody and anti-nucleocapsid (N) antibody serum level were evaluated. RESULTS: The data of 294 healthcare workers - 96 medical doctors, 127 nurses and 71 workers in hospital - who had at least three antibody level measurements were analyzed. The third booster vaccine was given to 280 workers, the distribution of the vaccines was the following: Pfizer-BioNTech (BNT162b29) vaccine (n = 210), Moderna COVID-19 (mRNA-1273) vaccine (n = 37), Sinopharm COVID-19 vaccine (n = 21), Janssen COVID-19 (n = 10), AstraZeneca (ChAdOx1 nCoV-19) vaccine (n = 2). Infection occurred in 121 cases (41%) during the observation period. The course of the COVID-19 infections was mostly mild (97%) and recovered within a week. During the observational period, 2 workers died: a 56-year-old woman died after two vaccinations for reason unrelated to COVID-19 infection, and a 58-year-old man died after the booster vaccination, following COVID-19 infection. The incidence of infection did not correlate with age, sex, comorbidities, smoking, occupation and BMI. The median titre of anti-S antibody serum level increased one month after the second vaccination of the basic immunization (1173.0 U/ml) and decreased slowly until the 8th month (678.5-625.8-538.0 U/ml) after the basic vaccination. One month after the booster vaccination, the median titre of anti-S antibody serum level increased significantly (16 535 U/ml), and showed a decreasing trend in the 3rd month after the booster vaccination (9697.7 U/ml). An exceptionally high S antibody serum level increasing after the basic (>10 000 U/mL) and booster (>60 000 U/m) vaccination showed a correlation with prior COVID-19 infection. The median cut-off index (COI) of anti-N antibody was not affected by vaccination, the increasing of the titre is related to the infection. CONCLUSION: The booster vaccination had less effect on the infection caused by Omicron variant, but the course of the infection was milder. Compared to the basic immunisation, the booster vaccination caused a significant increase in the S antibody level. An exceptionally high S antibody level correlated with prior COVID-19 infection. Orv Hetil. 2023; 164(5): 163-171.

ASAS-EULAR recommendations for the management of axial spondyloarthritis: 2022 update.

OBJECTIVES: To update the Assessment of SpondyloArthritis international Society (ASAS)-EULAR recommendations for the management of axial spondyloarthritis (axSpA). METHODS: Following the EULAR Standardised Operating Procedures, two systematic literature reviews were conducted on non-pharmacological and pharmacological treatment of axSpA. In a task force meeting, the evidence was presented, discussed, and overarching principles and recommendations were updated, followed by voting. RESULTS: Five overarching principles and 15 recommendations with a focus on personalised medicine were agreed: eight remained unchanged from the previous recommendations; three with minor edits on nomenclature; two with relevant updates (#9, 12); two newly formulated (#10, 11). The first five recommendations focus on treatment target and monitoring, non-pharmacological management and non-steroidal anti-inflammatory drugs (NSAIDs) as first-choice pharmacological treatment. Recommendations 6-8 deal with analgesics and discourage long-term glucocorticoids and conventional synthetic disease-modifying antirheumatic drugs (DMARDs) for pure axial involvement. Recommendation 9 describes the indication of biological DMARDs (bDMARDs, that is, tumour necrosis factor inhibitors (TNFi), interleukin-17 inhibitors (IL-17i)) and targeted synthetic DMARDs (tsDMARDs, ie, Janus kinase inhibitors) for patients who have Ankylosing Spondylitis Disease Activity Score ≥2.1 and failed ≥2 NSAIDs and also have either elevated C reactive protein, MRI inflammation of sacroiliac joints or radiographic sacroiliitis. Current practice is to start a TNFi or IL-17i. Recommendation 10 addresses extramusculoskeletal manifestations with TNF monoclonal antibodies preferred for recurrent uveitis or inflammatory bowel disease, and IL-17i for significant psoriasis. Treatment failure should prompt re-evaluation of the diagnosis and consideration of the presence of comorbidities (#11). If active axSpA is confirmed, switching to another b/tsDMARD is recommended (#12). Tapering, rather than immediate discontinuation of a bDMARD, can be considered in patients in sustained remission (#13). The last recommendations (#14, 15) deal with surgery and spinal fractures. CONCLUSIONS: The 2022 ASAS-EULAR recommendations provide up-to-date guidance on the management of patients with axSpA.

Long-term clinical results from 10 years follow-up after radiosynoviorthesis: a prospective observational study.

BACKGROUND: The aim of this study was to assess the long-term anti-inflammatory effect and safety of 90-Yttrium and 166-Holmium radiosynoviorthesis (RSO) for treating chronic knee synovitis of various origins. METHODS: A total of 820 patients were included in this study and were followed up to 10 years after the procedure for objective and subjective changes in signs and symptoms of inflammation. RESULTS: Five years after RSO, excellent and good results were seen in 71% (95% CI 67-74%) of patients. Six, seven, eight and nine years following RSO, efficacy did not decrease significantly. Ten years after RSO, the effectiveness of the therapy fell to 65% (95% CI 59-71%). Overall, 64% of patients did not need another joint puncture ten years after RSO. We achieved excellent to good results at 5 years in 79% of patients with rheumatoid arthritis, 59% with ankylosing spondylitis, and 62% with osteoarthritis. Efficacy was mainly affected by the local X-ray stage of the knee joint. A significant association was also found between the diagnosis of the underlying disease and the success of radiosynoviorthesis. Efficacy, however, was not substantially affected by any of the following factors: the duration of synovitis, the number of punctures before radiosynoviorthesis, the number of intraarticular steroid injections before the procedure, or the number of interventions before radiosynoviorthesis (radiotherapy, surgery). CONCLUSIONS: Radiosynoviorthesis is an effective long-term method of treating chronic synovitis. The treatment showed the most favorable effects in patients with rheumatoid arthritis and those with mild to moderate degenerative osseous changes.

Real-world evidence on methotrexate-free subcutaneous tocilizumab therapy in patients with rheumatoid arthritis: 24-week data from the SIMPACT study.

Objectives: The aim of the SIMPACT study was to evaluate the efficacy and safety of MTX-free s.c. tocilizumab (TCZ) therapy in RA patients. Methods: SIMPACT was an open-label, non-controlled, non-randomized, non-interventional study, in which RA patients for whom the treating physicians ordered s.c. TCZ were observed during a 24-week treatment period in Hungarian centres. Although the use of MTX was avoided during the study period, other conventional synthetic DMARDs, oral CSs and NSAIDs were allowed. Study endpoints included the change in DAS28 and clinical activity index (CDAI) scores, the proportion of patients achieving remission in the whole population and in subgroups defined based on prior RA treatment history, and age, weight or biological sex post hoc. The extent of supplementary medication use was monitored. Results: Three hundred and thirty-seven RA patients were enrolled in 18 study centres. TCZ therapy significantly decreased the disease activity measured by both DAS28 (P = 0.0001) and CDAI (P = 0.0001). Clinical response was more pronounced in biologic-naïve patients and was lower in patients >75 years of age. In the whole population, DAS28 ESR or CRP and CDAI remission rates were 70.10%, 78.95% and 33.59%, respectively. In patients <45 years of age, the CDAI remission rate doubled (67.86%). A significant decrease in the frequency of co-administered medication was reported, including oral CSs and DMARDs. Conclusion: Real-world clinical evidence on s.c. TCZ reported here is in line with the efficacy outcomes of randomized clinical trials. Subgroup analysis revealed that TCZ was more effective in biologic-naïve patients and in those <75 years old. Trial registration: ClinicalTrials.gov, http://www.clinicaltrials.gov, NCT02402686.

COVID-19: autoimmunity, multisystemic inflammation and autoimmune rheumatic patients.

Coronavirus disease 2019 (COVID-19) is associated with autoimmunity and systemic inflammation. Patients with autoimmune rheumatic and musculoskeletal disease (RMD) may be at high risk for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection. In this review, based on evidence from the literature, as well as international scientific recommendations, we review the relationships between COVID-19, autoimmunity and patients with autoimmune RMDs, as well as the basics of a multisystemic inflammatory syndrome associated with COVID-19. We discuss the repurposing of pharmaceutics used to treat RMDs, the principles for the treatment of patients with autoimmune RMDs during the pandemic and the main aspects of vaccination against SARS-CoV-2 in autoimmune RMD patients.

Development of an environmental contextual factor item set relevant to global functioning and health in patients with axial spondyloarthritis.

OBJECTIVE: To describe the development of an Environmental contextual factors (EF) Item Set (EFIS) accompanying the disease specific Assessment of SpondyloArthritis international Society Health Index (ASAS HI). METHOD: First, a candidate item pool was developed by linking items from existing questionnaires to 13 EF previously selected for the International Classification of Functioning, Disability and Health (ICF) /ASAS Core Set. Second, using data from two international surveys, which contained the EF item pool as well as the items from the ASAS HI, the number of EF items was reduced based on the correlation between the item and the ASAS HI sum score combined with expert opinion. Third, the final English EFIS was translated into 15 languages and cross-culturally validated. RESULTS: The initial item pool contained 53 EF addressing four ICF EF chapters: products and technology (e1), support and relationship (e3), attitudes (e4) and health services (e5). Based on 1754 responses of axial spondyloarthritis patients in an international survey, 44 of 53 initial items were removed based on low correlations to the ASAS HI or redundancy combined with expert opinion. Nine items of the initial item pool (range correlation 0.21-0.49) form the final EFIS. The EFIS was translated into 15 languages and field tested in 24 countries. CONCLUSIONS: An EFIS is available complementing the ASAS HI and helps to interpret the ASAS HI results by gaining an understanding of the interaction between a health condition and contextual factors. The EFIS emphasizes the importance of support and relationships, as well as attitudes of the patient and health services in relation to self-reported health.

Identification of clinical phenotypes of peripheral involvement in patients with spondyloarthritis, including psoriatic arthritis: a cluster analysis in the worldwide ASAS-PerSpA study.

OBJECTIVE: To identify clusters of peripheral involvement according to the specific location of peripheral manifestations (ie, arthritis, enthesitis and dactylitis) in patients with spondyloarthritis (SpA) including psoriatic arthritis (PsA), and to evaluate whether these clusters correspond with the clinical diagnosis of a rheumatologist. METHODS: Cross-sectional study with 24 participating countries. Consecutive patients diagnosed by their rheumatologist as PsA, axial SpA or peripheral SpA were enrolled. Four different cluster analyses were conducted: one using information on the specific location from all the peripheral manifestations, and a cluster analysis for each peripheral manifestation, separately. Multiple correspondence analyses and k-means clustering methods were used. Distribution of peripheral manifestations and clinical characteristics were compared across the different clusters. RESULTS: The different cluster analyses performed in the 4465 patients clearly distinguished a predominantly axial phenotype (cluster 1) and a predominantly peripheral phenotype (cluster 2). In the predominantly axial phenotype, hip involvement and lower limb large joint arthritis, heel enthesitis and lack of dactylitis were more prevalent. In the predominantly peripheral phenotype, different subgroups were distinguished based on the type and location of peripheral involvement: a predominantly involvement of upper versus lower limbs joints, a predominantly axial enthesitis versus peripheral enthesitis, and predominantly finger versus toe involvement in dactylitis. A poor agreement between the clusters and the rheumatologist's diagnosis as well as with the classification criteria was found. CONCLUSION: These results suggest the presence of two main phenotypes (predominantly axial and predominantly peripheral) based on the presence and location of the peripheral manifestations.

Immunogenicity and safety of the BNT162b2 mRNA COVID-19 vaccine in healthcare workers / A BNT162b2 mRNS-Pfizer-BioNTech-védooltás hatásosságának és immunogenitásának monitorozása egészségügyben dolgozókon.

Összefoglaló. Bevezetés: A SARS-CoV-2 koronavírus okozta COVID-19 általános egészségügyi és gazdasági krízist idézett elo. Célkituzés: A megfigyeléses vizsgálat célja a BNT162b2 mRNS-Pfizer-BioNTech-vakcina hatásosságának, biztonságosságának és immunogenitásának igazolása a Budai Irgalmasrendi Kórház dolgozóin. Módszer: A vakcina adása után elemeztük a COVID-19-fertozés elofordulását, az oltások utáni reakciókat, valamint a "spike" (S-) protein és a nukleokapszid (N)-protein elleni ellenanyag szintjének változását. Eredmények: A felmérésben részt vevo 295 dolgozó közül az oltást megelozoen 36 dolgozó esett át COVID-19-fertozésen (COVID-19-pozitív csoport). A második oltás után a megfigyelési idoszak három hónapjában COVID-19-fertozés nem alakult ki a felmérésben részt vevo oltott dolgozók körében. Az oltási reakciók enyhék voltak. A COVID-19-pozitív csoportban az N-antitestek medián küszöbértékindexe az elso vakcina után 4 héttel mérve szignifikánsan magasabb volt (28,37), mint a COVID-19-negatív (0,085) csoportban (p<0,0001). Az elso vakcina után 4 héttel az S-antitestek medián értéke (8015 U/ml) a COVID-19-pozitív csoportban szignifikánsan magasabb volt (p<0,0001), mint a COVID-19-negatív csoportban (23,18 U/ml). A COVID-19-negatív csoport S-antitest-középértéke a második vakcina után szignifikáns (p<0,0001), mintegy 500×-os emelkedést mutatott (23,18 U/ml rol 1173 U/ml-re). Egy vakcina hatásosságát a fertozések terjedésének megakadályozása igazolja. Következtetések: A második vakcina utáni megfigyelési idoszakban új COVID-19-fertozés nem volt az oltott dolgozók körében. A fertozésen át nem esett COVID-19-negatív egyének esetén az S-antitest emelkedése mérsékelt az elso oltás után, míg a második oltás után lényegesen emelkedik. A COVID-19-fertozésen átesett egyének csoportjában már az elso vakcina is jelentos S-antitest-termelodést vált ki. Orv Hetil. 2021; 162(39): 1551-1557. INTRODUCTION: The coronavirus disease 2019 (COVID-19) pandemic caused global public health and economic crises. OBJECTIVE: The aim of this observation study was to estimate the effectiveness, safety and elicited immune response of the BNT162b2 mRNA Pfizer-BioNTech vaccine in healthcare workers of the Buda Hospital of the Hospitaller Order of St. John of God. METHOD: After vaccination, the infection rate, adverse events and the kinetics of anti-SARS-CoV-2 spike (S) protein and anti-SARS-CoV-2 nucleocapsid (N) protein antibodies were evaluated. RESULTS: Before vaccination, from the 295 healthcare workers 36 recovered from prior COVID-19 infection (COVID-19-positive group). After the second vaccination, there was no COVID-19 infection during the three-month follow-up period. The adverse events were mild. In the COVID-19-positive group, the median cut-off index of anti-N antibodies measured at 4 weeks after the first vaccination were significantly (p<0.0001) higher (28.37) than in the COVID-19-negative group (0.085). After the first vaccine, the median titer of anti-S antibodies was significantly higher (p<0.0001) in the COVID-19-positive group (8015 U/ml) compared to the COVID-19-negative group (23.18 U/ml). In the COVID-19-negative group, the median titer of anti-S antibodies increased significantly (p<0.0001) after the second vaccine (from 23.18 U/ml to 1173 U/ml), showing an increase of 500×. CONCLUSIONS: After the second vaccination, there was no COVID-19 infection during the follow-up. In the COVID-19-negative group, the anti-S antibody titer is moderate after the first vaccination and increases significantly after the second vaccine. In the COVID-19-positive group, the first vaccine induces significant anti-S antibody production. Orv Hetil. 2021; 162(39): 1551-1557.

Assessing the risk of rapid radiographic progression in Hungarian rheumatoid arthritis patients.

BACKGROUND: The outcome of rheumatoid arthritis (RA) should be determined early. Rapid radiological progression (RRP) is > or = 5 units increase according to the van der Heijde-Sharp score within a year. The risk of RRP can be estimated by a matrix model using non-radiographic indicators, such as C-reactive protein (CRP), rheumatoid factor (RF) and swollen joint count (SJC). PATIENTS AND METHODS: A non-interventional, cross-sectional, retrospective study was conducted in eleven Hungarian arthritis centres. We assessed RRP risk in biologic-naïve RA patients with the prevalence of high RRP risk as primary endpoint. RRP was calculated according to this matrix model. As a secondary endpoint, we compared RRP in methotrexate (MTX) responders vs non-responders. RESULTS: We analyzed data from 1356 patients. Mean CRP was 17.7 mg/l, RF was 139.3 IU/ml, mean 28-joint disease activity score (DAS28) was 5.00 and mean SJC was 6.56. Altogether 18.2% of patients had high risk (≥40%) of RRP. RA patients with high RRP risk of RRP (n = 247) had significantly lower age compared to those with RRP < 40% (n = 1109). MTX non-response (OR: 16.84), male gender (OR: 1.67), erosions at baseline (OR: 1.50) and ACPA seropositivity (OR: 2.18) were independent predictors of high-risk RRP. Male gender (OR: 5.20), ACPA seropositivity (OR: 4.67) and erosions (OR: 7.98) were independent predictors of high RRP risk in MTX responders. CONCLUSIONS: In this Hungarian study, high RRP risk occurred in 18% of RA patients. These patients differ from others in various parameters. RRP was associated with non-response to MTX.

Prevalence and distribution of peripheral musculoskeletal manifestations in spondyloarthritis including psoriatic arthritis: results of the worldwide, cross-sectional ASAS-PerSpA study.

OBJECTIVES: To characterise peripheral musculoskeletal involvement in patients with spondyloarthritis (SpA) including psoriatic arthritis (PsA), across the world. METHODS: Cross-sectional study with 24 participating countries. Patients with a diagnosis of axial SpA (axSpA), peripheral SpA (pSpA) or PsA according to their rheumatologist were included. The investigators were asked which diagnosis out of a list of six (axSpA, PsA, pSpA, inflammatory bowel disease-associated SpA, reactive arthritis or juvenile SpA (Juv-SpA)) fitted the patient best. Peripheral manifestations (ie, peripheral joint disease, enthesitis, dactylitis and root joint disease), their localisation and treatments were evaluated. RESULTS: A total of 4465 patients were included (61% men, mean age 44.5 years) from four geographic areas: Latin America (n=538), Europe plus North America (n=1677), Asia (n=975) and the Middle East plus North Africa (n=1275). Of those, 78% had ever suffered from at least one peripheral musculoskeletal manifestation; 57% had peripheral joint disease, 44% had enthesitis and 15% had dactylitis. Latin American had far more often peripheral joint disease (80%) than patients from other areas. Patients with PsA had predominantly upper limb and small joint involvement (52%).Hip and shoulder involvement was found in 34% of patients. The prevalence of enthesitis ranged between 41% in patients with axSpA and 65% in patients with Juv-SpA. Dactylitis was most frequent among patients with PsA (37%). CONCLUSION: These results suggest that all peripheral features can be found in all subtypes of SpA, and that differences are quantitative rather than qualitative. In a high proportion of patients, axial and peripheral manifestations coincided. These findings reconfirm SpA clinical subtypes are descendants of the same underlying disease, called SpA.

A prospective observational study on the long-term results of 90Yttrium citrate radiosynoviorthesis of synovitis in osteoarthritis of the knee joint.

OBJECTIVES: Radiosynoviorthesis (RSO) is used for the treatment of inflammatory joint diseases. However, there are no long-term results published comparing it to conservative therapy. Therefore, the aim of this prospective observational study was to evaluate response rates after radionuclide therapy in patients suffering from knee osteoarthritis over a time period of 10 years. METHODS: Radionuclide therapy with intra-articular administration of colloidal 90Yttrium citrate was performed in osteoarthritic patients [Kellgren-Lawrence grades I/II (n = 69) and Kellgren-Lawrence grade III (n = 72)]. RESULTS: In patients with early-stage disease, an excellent/good response with respect to pain, joint mobility, and function was observed in 82.5% for 1 year and in 73.7% for 8 years after therapy. Responses declined to 50% at 10 years post treatment. In grade III patients, an excellent/good response was observed in 45.9%; a decline to 41.2% was observed in the first 8 years. In this group, the number of patients available for follow-up after 9 and 10 years dropped significantly from 51 patients after 8 years to only 30 patients after 9 years, and to nine patients after 10 years. As a result, these response rates were not appraisable. CONCLUSION: Long-term results of radiosynoviorthesis in knee osteoarthritis are excellent/good in many patients. The response rate depends on Kellgren-Lawrence stages, and early-stage radionuclide therapy for osteoarthritis is suggested.

Intercentre variance in patient reported outcomes is lower than objective rheumatoid arthritis activity measures: a cross-sectional study.

Objective: To assess intercentre variability in the ACR core set measures, DAS28 based on three variables (DAS28v3) and Routine Assessment of Patient Index Data 3 in a multinational study. Methods: Seven thousand and twenty-three patients were recruited (84 centres; 30 countries) using a standard protocol in the Quantitative Standard Monitoring of Patients with RA study. Analysis of variance (ANOVA) and mixed-effect analysis of covariance models were used to model the relationship between study centre and different patient-reported and physician-reported RA activity measures. These models were built to adjust for the remaining ACR core set measure (for each ACR core set measure or each composite index), socio-demographics and medical characteristics. ANOVA and analysis of covariance models yielded similar results, and ANOVA tables were used to present variance attributable to recruiting centre. Results: The proportion of variances attributable to recruiting centre was lower for patient reported outcomes (PROs: pain, HAQ, patient global) compared with objective measures (joint counts, ESR, physician global) in all models. In the full model, variance in PROs attributable to recruiting centre ranged from 1.53% for patient global to 3.71% for HAQ compared with objective measures that ranged from 5.92% for physician global to 9.25% for ESR; and was lower for Routine Assessment of Patient Index Data 3 (2.6%) compared with DAS28v3 (11.75%). Conclusion: Intercentre variability in PROs is lower than objective measures of RA activity demonstrating that PROs may be more comparable across centres, and the need for standardization of objective measures.

[Initial experiences with VATS lobectomy]. / VATS-lobectomiák kezdeti tapasztalatai.

OBJECTIVE: The authors analyse the experience of videothoracoscopic (VATS) lung lobectomies performed since December 2010 at the Thoracic Surgery Department of Markusovszky University Teaching Hospital. PATIENTS AND METHOD: 78 patients (44 men and 34 women) underwent VATS lobectomy. The average age was 61.2 years ranging from 30 to 80. The indications were peripheral malignancy (35 cases) or the suspicion of that (43 cases), presence of curable distant metastasis was not considered as contraindication. RESULTS: In the initial period the operation time was quite long, but shortly after the duration of surgery became almost similar to lobectomies via thoracotomy. Late reoperation was performed in two cases, one for chronic pneumothorax and one for port-site metastasis. 10 vessel and two bronchial injuries occurred, eight of them needed conversion into axillary thoracotomy (conversion rate 10.26%). The postoperative pain was significantly less than after thoracotomy. CONCLUSION: VATS lobectomy is a safe procedure with less surgical stress and without oncological compromise.

Adaptation of the osteoarthritis-specific quality of life scale (the OAQoL) for use in Germany, Hungary, Italy, Spain and Turkey.

The Osteoarthritis Quality of Life scale (OAQoL) is specific to individuals with osteoarthritis. The present study describes the adaptation of the OAQoL for use in the following five European languages: German, Hungarian, Italian, Spanish and Turkish. The study involved three stages in each language; translation, cognitive debriefing (face and content validity) and validation. The validation stage assessed internal consistency (Cronbach's alpha), reproducibility (test-retest reliability using Spearman's rank correlations), convergent and divergent validity (correlations with the Health Assessment Questionnaire, The Western Ontario and McMaster Universities Index of osteoarthritis and Nottingham Health Profile) and known group validity. The OAQoL was successfully translated into the target languages with minimal problems. Cognitive debriefing interviewees found the measures easy to complete and identified few problems with content. Internal consistency ranged from 0.94 to 0.97 and test-retest reliability (reproducibility) from 0.87 to 0.98. These values indicate that the new language versions produce very low levels of measurement error. Median OAQoL scores were higher for patients reporting a current flare of osteoarthritis in all countries. Scores were also related, as expected, to perceived severity of osteoarthritis. The OAQoL was successfully adapted for use in Germany, Hungary, Italy, Spain and Turkey. The addition of these new language versions will prove valuable to multinational clinical trials and to clinical practice in the respective countries.

2016 update of the ASAS-EULAR management recommendations for axial spondyloarthritis.

To update and integrate the recommendations for ankylosing spondylitis and the recommendations for the use of tumour necrosis factor inhibitors (TNFi) in axial spondyloarthritis (axSpA) into one set applicable to the full spectrum of patients with axSpA. Following the latest version of the European League Against Rheumatism (EULAR) Standardised Operating Procedures, two systematic literature reviews first collected the evidence regarding all treatment options (pharmacological and non-pharmacological) that were published since 2009. After a discussion of the results in the steering group and presentation to the task force, overarching principles and recommendations were formulated, and consensus was obtained by informal voting. A total of 5 overarching principles and 13 recommendations were agreed on. The first three recommendations deal with personalised medicine including treatment target and monitoring. Recommendation 4 covers non-pharmacological management. Recommendation 5 describes the central role of non-steroidal anti-inflammatory drugs (NSAIDs) as first-choice drug treatment. Recommendations 6-8 define the rather modest role of analgesics, and disprove glucocorticoids and conventional synthetic disease-modifying antirheumatic drugs (DMARDs) for axSpA patents with predominant axial involvement. Recommendation 9 refers to biological DMARDs (bDMARDs) including TNFi and IL-17 inhibitors (IL-17i) for patients with high disease activity despite the use (or intolerance/contraindication) of at least two NSAIDs. In addition, they should either have an elevated C reactive protein and/or definite inflammation on MRI and/or radiographic evidence of sacroiliitis. Current practice is to start with a TNFi. Switching to another TNFi or an IL-17i is recommended in case TNFi fails (recommendation 10). Tapering, but not stopping a bDMARD, can be considered in patients in sustained remission (recommendation 11). The final two recommendations (12, 13) deal with surgery and spinal fractures. The 2016 Assessment of SpondyloArthritis international Society-EULAR recommendations provide up-to-date guidance on the management of patients with axSpA.

[Peroral and transdermal application of non-steroidal anti-inflammatory drugs (NSAIDs) for the treatment of regional musculoskeletal pain syndromes]. / Nem szteroid gyulladáscsökkentok peroralis és transdermalis alkalmazása regionális mozgásszervi fájdalmi szindrómákban.

In this review the available evidences regarding the most frequently applied medication (peroral and transdermal non-steroidal anti-inflammatory agents) for the most frequent musculoskeletal complaints (regional pain syndromes) have been collected for the appropriate medical professionals who are most frequently faced with these conditions (general practitioners, rheumatologists, orthopedics, occupational and sports medicine experts). The special population at risk (with repeated and high energy overuse because of occupational or sport activities) and the pathology of their syndromes are identified. Mode of action, pharmacological properties of the non-steroidal anti-inflammatory drugs and the unwanted effects of their application especially in infants and elderly are highlighted. Recommendations of the general and specific pain management guidelines have been selected and listed in the review. Orv Hetil. 2017; 158(Suppl. 3): 3-30.

Improved clinical, functional and work outcomes in spondyloarthritides during real-life adalimumab treatment in central-eastern Europe.

AIM: Adalimumab effectiveness on clinical, functional and work-related outcomes was evaluated in patients with active ankylosing spondylitis or psoriatic arthritis treated in routine clinical practice in central-eastern Europe. METHODS: Patients (n = 555) were followed for 12 months. Primary end point was percentage of patients with a treatment response (≥50% decrease from baseline in Bath Ankylosing Spondylitis Disease Activity Index or ≥1.2 point decrease from baseline in Disease Activity Index-28 joint for axial or peripheral symptoms, respectively). Functional status was evaluated by the Bath Ankylosing Spondylitis Functional Index and Health Assessment Questionnaire Disability Index. Working ability was evaluated by the Work Productivity and Activity Impairment Questionnaire - Specific Health Problem. RESULTS: 76.1% of patients with axial symptoms and 83.5% with peripheral symptoms achieved a treatment response. Frequency of extra-articular manifestations decreased. Improvements were observed in functional status and workability. No new safety signals were observed. CONCLUSION: Adalimumab was effective and well tolerated during real-world use in central-eastern Europe.

Comparative efficacy and safety of biosimilar infliximab and other biological treatments in ankylosing spondylitis: systematic literature review and meta-analysis.

OBJECTIVES: To compare the efficacy and safety of infliximab-biosimilar with other biological drugs for the treatment of active ankylosing spondylitis (AS). METHODS: Systematic literature review for randomized controlled trials (RCTs) with adalimumab, etanercept, golimumab, infliximab and infliximab-biosimilar in AS was performed and indirect meta-analysis (Bayesian mixed treatment comparison) was carried out. The proportion of patients reaching 20% improvement by the assessment of Spondyloarthritis International Society response criteria (ASAS20) at weeks 12 and 24 was used as efficacy endpoints, and the occurrence of serious adverse events at week 24 was applied to compare the safety of the biologicals. RESULTS: Altogether, 13 RCTs, identified by the systematic literature search, were included in the analysis. Results on the ASAS20 efficacy endpoint were reported for week 12 in 12 RCTs involving 2,395 patients, and for week 24 in 5 RCTs comprising 1,337 patients. All the five biological agents proved to be significantly superior to placebo. Infliximab showed the highest odds ratio (OR) of 7.2 (95% CI 3.68-13.19) compared to placebo, followed by infliximab-biosimilar with OR 6.25 (95% CI 2.55-13.14), both assessed at week 24. No significant difference was found between infliximab-biosimilar and other biological treatments regarding their efficacy and safety. CONCLUSIONS: This is the first study which includes a biosimilar drug in the meta-analysis of biological treatments in AS. The results have proven the similar efficacy and safety profile of infliximab-biosimilar treatment compared to other biologicals.