Health-Related Quality of Life, Costs and Treatment of Inflammatory Rheumatic Diseases in Routine Practice : With special emphasis on biological drugs

Rheumatoid arthritis (RA) and other chronic inflammatory joint diseases already begin to affect patients health-related quality of life (HRQoL) in the earliest phases of these diseases. In treatment of inflammatory joint diseases, the last two decades have seen new strategies and treatment options introduced. Treatment is started at an earlier phase; combinations of disease-modifying anti-rheumatic drugs (DMARDs) and corticosteroids are used; and in refractory cases new drugs such as tumour necrosis factor (TNF) inhibitors or other biologicals can be started. In patients with new referrals to the Department of Rheumatology of the Helsinki University Central Hospital, we evaluated the 15D and the Stanford Health Assessment Questionnaire (HAQ) results at baseline and approximately 8 months after their first visit. Altogether the analysis included 295 patients with various rheumatic diseases. The mean baseline 15D score (0.822, SD 0.114) was significantly lower than for the age-matched general population (0.903, SD 0.098). Patients with osteoarthritis (OA) and spondyloarthropathies (SPA) reported the poorest HRQoL. In patients with RA and reactive arthritis (ReA) the HRQoL improved in a statistically significant manner during the 8-month follow-up. In addition, a clinically important change appeared in patients with systemic rheumatic diseases. HAQ score improved significantly in patients with RA, arthralgia and fibromyalgia, and ReA. In a study of 97 RA patients treated either with etanercept or adalimumab, we assessed their HRQoL with the RAND 36-Item Health Survey 1.0 (RAND-36) questionnaire. We also analysed changes in clinical parameters and the HAQ. With etanercept and adalimumab, the values of all domains in the RAND-36 questionnaire increased during the first 3 months. The efficacy of each in improving HRQoL was statistically significant, and the drug effects were comparable. Compared to Finnish age- and sex-matched general population values, the HRQoL of the RA patients was significantly lower at baseline and, despite the improvement, remained lower also at follow-up. Our RA patients had long-standing and severe disease that can explain the low HRQoL also at follow-up. In a pharmacoeconomic study of patients treated with infliximab we evaluated medical and work disability costs for patients with chronic inflammatory joint disease during one year before and one year after institution of infliximab treatment. Clinical and economic data for 96 patients with different arthritis diagnoses showed, in all patients, significantly improved clinical and laboratory variables. However, the medical costs increased significantly during the second period by 12 015 (95% confidence interval, 6 496 to 18 076). Only a minimal decrease in work disability costs occurred mean decrease 130 (-1 268 to 1 072). In a study involving a switch from infliximab to etanercept, we investigated the clinical outcome in 49 patients with RA. Reasons for switching were in 42% failure to respond by American College of Rheumatology (ACR) 50% criteria; in 12% adverse event; and in 46% non-medical reasons although the patients had responded to infliximab. The Disease Activity Score with 28 joints examined (DAS28) allowed us to measure patients disease activity and compare outcome between groups based on the reason for switching. In the patients in whom infliximab was switched to etanercept for nonmedical reasons, etanercept continued to suppress disease activity effectively, and 1-year drug survival for etanercept was 77% (95% CI, 62 to 97). In patients in the infliximab failure and adverse event groups, DAS28 values improved significantly during etanercept therapy. However, the 1-year drug survival of etanercept was only 43% (95% CI, 26 to 70) and 50% (95% CI, 33 to 100), respectively. Although the HRQoL of patients with inflammatory joint diseases is significantly lower than that of the general population, use of early and aggressive treatment strategies including TNF-inhibitors can improve patients HRQoL effectively. Further research is needed in finding new treatment strategies for those patients who fail to respond or lose their response to TNF-inhibitors.Tulehduksellisten nivelsairauksien hoidon kustannukset, biologisten lääkkeiden teho ja vaikutus elämänlaatuun Nivelreumalla ja muilla tulehduksellisilla nivelsairauksilla on selkeä vaikutus potilaiden elämänlaatuun heti sairauden alkuvaiheessa. Lisäksi nivelsairaus aiheuttaa huomattavia kustannuksia sekä potilaalle että yhteiskunnalle. Viimeisen parinkymmenen vuoden aikana on tapahtunut merkittäviä muutoksia tulehduksellisten nivelsairauksien lääkityksessä ja myös hoitoperiaatteissa. Erittäin tärkeä on hoidon aloitus sairauden alkuvaiheessa; antireumaattisten lääkkeiden yhdistelmähoitojen käyttö; ja ns. biologisten täsmälääkkeiden, mm. tulehduksen välittäjäaineiden (TNF-α) vaikutusta estävien lääkkeiden käyttö. Elämänlaatua selvittävässä tutkimuksessa 295 reumapotilaalla mitattiin ennen ensimmäistä käyntiä Helsingin Yliopistollisen Keskussairaalan Reumapoliklinikalla elämänlaatua (15D-kyselykaavake) ja toimintakykyä (HAQ-kyselykaavake). Toisen kerran kerättiin samoja tietoja 8 kuukautta myöhemmin. Kaikilla potilailla oli matalampi elämänlaatu samanikäisiin väestöverrokkeihin verrattuina. Huonoimmat tulokset oli nivelrikkoa ja selkärankareumaa sairastavilla potilailla. Nivelreumaa ja reaktiivista niveltulehdusta sairastavilla potilailla parantui elämänlaatu 8 kuukauden aikana huomattavasti. Biologisten lääkkeiden vaikutusta elämänlaatuun mittasimme 97 nivelreumapotilaalla 3 kuukauden etanerseptin tai adalimumabin hoidon aikana RAND-36 mittarilla. Molemmat biologiset lääkkeet korjasivat elämänlaatua huomattavasti. Nivelsairauden hoidon kustannuksia 1 vuoden perinteisen reumalääkityksen ja 1 vuoden infliksimabihoidon aikana mittasimme 96 potilaalla. Suorat reumalääkityksestä, sairaalahoitojaksoista ja poliklinikkakäynneistä kertyvät kustannukset nousivat infliksimabihoidon aikana huomattavasti. Epäsuorat kustannukset jäivät infliksimabihoidon aikana samalle tasolle kuin perinteisen reumalääkityksen aikana ja säästöä ei tapahtunut. Jos yksi TNF-salpaaja toimii huonosti, on hyvin usein tapana vaihtaa se toiseen TNF-salpaajaan. Infliksimabista etanerseptiin vaihdon kliinistä vaikutusta tutkimme 49 nivelreumapotilaalla. Vaihdon syy oli huono teho infliksimabille (42%); sivuvaikutus (12%) tai muu syy (46%). Muu syy tarkoitti että näillä potilailla infliksimabi oli tehokas mutta lääkitys vaihdettiin etanerseptiin koska tällöin ei tarvita yhtä usein sairaalakäyntejä. Etanerseptin potilas pistää kotona ihon alle, mutta infliksimabi annetaan suonensisäisenä infuusiona päiväsairaalassa. Paras tulos infliksimabista etanerseptiin vaihdon jälkeen oli näillä muusta syystä hoitovaihdon läpikäyneillä potilailla joista 77% jatkoi etanerseptiä vielä 1 vuoden jälkeen. Muissa ryhmissä oli myös hyvä kliininen tulos, mutta 1-vuoden jälkeen lääkitystä jatkoi alle 50% potilaista. Tulehduksellisia nivelsairauksia sairastavilla potilailla on huomattavasti huonompi elämänlaatu verrattuina samanikäisiin väestöverrokkeihin. Varhain aloitettu ja tehokas hoito pystyy parantamaan erityisesti nivelreumapotilaiden elämänlaatua

Reumatoidartriidi patsientide haigestumus tuberkuloosi enne ja pärast bioloogilise ravi kasutuselevõttu Eestis: kahe perioodi võrdlus

Taust. Bioloogilise ravi (BR) kasutuselevõtt reumaatiliste haiguste korral on võimaldanud saavutada oluliselt paremaid ravitulemusi. BRi probleemiks on patsientide suurenenud vastuvõtlikkus infektsioonidele ja sagenenud haigestumine tuberkuloosi (TB). Eesmärgid. Võrrelda TB-haigestumust reumatoidartriidi (RA) haigetel enne ja pärast BRi kasutuselevõttu Eestis; kirjeldada TB esinemist BRi saavatel RA-patsientidel. Meetodid. Eesti Haigekassa andmete alusel koostati valim isikutest, kellel aastatel 2004–2017 oli diagnoositud RA koodidega M05 ja M06.0. RA-patsientidel registreeritud TB-juhud leiti linkimisel tuberkuloosiregistriga. Üldrahvastiku TB-haigestumuse hindamiseks kasutati tuberkuloosiregistrit ja Eesti Statistikaameti andmebaasi. Leiti RA-patsientide TB-haigestumus ajavahemikul 2000–2007 ja 2008–2016. Arvutati RA-patsientide vanuse ja soo järgi standarditud TB-haigestumusmäär võrreldavatel perioodidel. Bioloogilise ravi registrist saadi teave TBsse haigestunud RA-patsientide BRi kohta. Tulemused. RA-patsientide üldarv haigekassa andmebaasis oli 5040. Ühe aasta keskmine TB-haigestumus 100 000 RA-patsiendi kohta oli 24,8 perioodil 2000–2007 ja 30,9 perioodil 2008–2016. RA-patsientide standarditud haigestumusmäär (võrreldes üldrahvastikuga) oli 77% (95% usaldusvahemik 41–143) perioodil 2000–2007 ja 200% (95% usaldusvahemik 118–338) perioodil 2008–2016. Bioloogilist ravi sai kolm TBsse haigestunud RA-patsienti. Järeldused. Üldrahvastiku TB-haigestumuse vähenemise foonil on TB-haigestumus RA-patsientidel perioodide 2000–2007 ja 2008–2016 võrdluses suurenenud. Perioodil 2008–2016 oli RA-patsientide TB-haigestumus suurem üldrahvastiku TB-haigestumusest. RA-patsientide TB-haigestumuse suurenemine võib olla seotud BRi kasutuselevõtuga

Differences and similarities between the EULAR/ASAS-EULAR and national recommendations for treatment of patients with psoriatic arthritis and axial spondyloarthritis across Europe

This is the first report comparing EULAR and national treatment recommendations for PsA patients across Europe, and the first this decade to compare ASAS-EULAR and national treatment recommendations in axSpA patients. An electronic survey was completed from October 2021-April 2022 by rheumatologists in 15 European countries. One and four countries followed all EULAR and ASAS-EULAR recommendations, respectively. Five countries had no national treatment recommendations for PsA and/or axSpA, but followed other regulations. In several countries, national treatment recommendations predated the most recent EULAR/ASAS-EULAR recommendations. Entry criteria for starting biologic/targeted synthetic disease-modifying anti-rheumatic drugs varied considerably. In several countries, for PsA patients with significant skin involvement, interleukin-17 inhibitors were not given preference. The positioning of Janus Kinase inhibitors differed and Phosphodiesterase-4 inhibitors were not in use/reimbursed in most countries. This study may motivate European countries to update their national treatment recommendations, to align them better with the latest international recommendations

Commonalities and differences in set-up and data collection across European spondyloarthritis registries : results from the EuroSpA collaboration

Funding Open access funding provided by Royal Library, Copenhagen University Library The EuroSpA Research Collaboration Network was financially supported by Novartis Pharma AG. Novartis had no influence on the data collection, statistical analyses, manuscript preparation or decision to submit the manuscript.Peer reviewedPublisher PD

Predictors of ASDAS-CRP inactive disease in axial spondyloarthritis during treatment with TNF-inhibitors : Data from the EuroSpA collaboration

Correction: Volume 58, Article Number 152141 DOI: 10.1016/j.semarthrit.2022.152141 Published: FEB 2023Objectives: In patients with axial spondyloarthritis (axSpA) initiating their first tumor necrosis factor alpha-inhibitor (TNFi), we aimed to identify common baseline predictors of Ankylosing Spondylitis Disease Activity Score (ASDAS-CRP) inactive disease (primary objective) and clinically important improvement (CII) at 6 months, and drug retention at 12-months across 15 European registries. Methods: Baseline demographic and clinical characteristics were collected. Outcomes were investigated per registry and in pooled data using logistic regression analyses on multiply imputed data. Results: The consistency of baseline predictors in individual registries justified pooling the data. In the pooled dataset (n = 21,196), the 6-month rates for ASDAS inactive disease and ASDAS CII were 26% and 51%, and the 12-month drug retention rate 65% in patients with available data (n = 9,845, n = 6,948 and n = 21,196, respectively). Nine common baseline predictors of ASDAS inactive disease, ASDAS CII and 12-month drug retention were identified, and the odds ratios (95%-confidence interval) for ASDAS inactive disease were: age, per year: 0.97 (0.97-0.98), men vs. women: 1.88 (1.60-2.22), current vs. non-smoking: 0.76 (0.63-0.91), HLA-B27 positive vs. negative: 1.51 (1.20-1.91), TNF start year 2015-2018 vs. 2009-2014: 1.24 (1.06-1.45), CRP > 10 vs.Peer reviewe

Predictors of DAPSA28 remission in patients with psoriatic arthritis initiating a first TNF-inhibitor: results from 13 European registries.

OBJECTIVES In bio-naïve patients with Psoriatic arthritis (PsA) initiating a Tumour Necrosis Factor inhibitor (TNFi), we aimed to identify baseline predictors of Disease Activity index for PsA in 28 joints (DAPSA28) remission (primary objective) and DAPSA28 moderate response at 6 months, as well as drug retention at 12 months across 13 European registries. METHODS Baseline demographic and clinical characteristics were retrieved and the three outcomes investigated per registry and in pooled data, using logistic regression analyses on multiply imputed data. In the pooled cohort, selected predictors that were either consistently positive or negative across all three outcomes, were defined as common predictors. RESULTS In the pooled cohort (n = 13 369), six-month proportions of remission, moderate response and 12-month drug retention were 25%, 34% and 63% in patients with available data (n = 6,954, n = 5,275 and n = 13 369, respectively). Baseline predictors of remission, moderate response and 12-month drug retention were identified, five common across all three outcomes. Odds ratios (95% confidence interval) for DAPSA28 remission were: age, per year: 0.97 (0.96-0.98); disease duration, years (10 vs ≤ 10 mg/l: 1.52 (1.22-1.89) and one mm increase in patient fatigue score: 0.99 (0.98-0.99). CONCLUSION Baseline predictors of remission, response and adherence to TNFi were identified, of which five were common for all three outcomes, indicating that the predictors emerging from our pooled cohort may be considered generalisable from the country- to disease-level

Patient-reported outcomes in axial spondyloarthritis and psoriatic arthritis patients treated with secukinumab for 24 months in daily clinical practice

On behalf of the EuroSpA Scientific Committee, the authors acknowledge Novartis Pharma AG for supporting the EuroSpA collaboration.Peer reviewe

Predictors of ASDAS-CRP inactive disease in axial spondyloarthritis during treatment with TNF-inhibitors: Data from the EuroSpA collaboration

ObjectivesIn patients with axial spondyloarthritis (axSpA) initiating their first tumor necrosis factor alpha-inhibitor (TNFi), we aimed to identify common baseline predictors of Ankylosing Spondylitis Disease Activity Score (ASDAS-CRP) inactive disease (primary objective) and clinically important improvement (CII) at 6 months, and drug retention at 12-months across 15 European registries.MethodsBaseline demographic and clinical characteristics were collected. Outcomes were investigated per registry and in pooled data using logistic regression analyses on multiply imputed data.ResultsThe consistency of baseline predictors in individual registries justified pooling the data. In the pooled dataset (n = 21,196), the 6-month rates for ASDAS inactive disease and ASDAS CII were 26% and 51%, and the 12-month drug retention rate 65% in patients with available data (n = 9,845, n = 6,948 and n = 21,196, respectively). Nine common baseline predictors of ASDAS inactive disease, ASDAS CII and 12-month drug retention were identified, and the odds ratios (95%-confidence interval) for ASDAS inactive disease were: age, per year: 0.97 (0.97–0.98), men vs. women: 1.88 (1.60–2.22), current vs. non-smoking: 0.76 (0.63–0.91), HLA-B27 positive vs. negative: 1.51 (1.20–1.91), TNF start year 2015–2018 vs. 2009–2014: 1.24 (1.06–1.45), CRP>10 vs. ≤10 mg/l: 1.49 (1.25–1.77), one unit increase in health assessment questionnaire (HAQ): 0.77 (0.58–1.03), one-millimeter (mm) increase in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) fatigue and spinal pain: 0.99 (0.99–1.00) and 0.99 (0.99–1.99), respectivelyConclusionCommon baseline predictors of treatment response and adherence to TNFi could be identified across data from 15 European registries, indicating that they may be universal across different axSpA populations.</p

Predictors of ASDAS-CRP inactive disease in axial spondyloarthritis during treatment with TNF-inhibitors: Data from the EuroSpA collaboration

OBJECTIVES: In patients with axial spondyloarthritis (axSpA) initiating their first tumor necrosis factor alpha-inhibitor (TNFi), we aimed to identify common baseline predictors of Ankylosing Spondylitis Disease Activity Score (ASDAS-CRP) inactive disease (primary objective) and clinically important improvement (CII) at 6 months, and drug retention at 12-months across 15 European registries. METHODS: Baseline demographic and clinical characteristics were collected. Outcomes were investigated per registry and in pooled data using logistic regression analyses on multiply imputed data. RESULTS: The consistency of baseline predictors in individual registries justified pooling the data. In the pooled dataset (n = 21,196), the 6-month rates for ASDAS inactive disease and ASDAS CII were 26% and 51%, and the 12-month drug retention rate 65% in patients with available data (n = 9,845, n = 6,948 and n = 21,196, respectively). Nine common baseline predictors of ASDAS inactive disease, ASDAS CII and 12-month drug retention were identified, and the odds ratios (95%-confidence interval) for ASDAS inactive disease were: age, per year: 0.97 (0.97-0.98), men vs. women: 1.88 (1.60-2.22), current vs. non-smoking: 0.76 (0.63-0.91), HLA-B27 positive vs. negative: 1.51 (1.20-1.91), TNF start year 2015-2018 vs. 2009-2014: 1.24 (1.06-1.45), CRP>10 vs. ≤10 mg/l: 1.49 (1.25-1.77), one unit increase in health assessment questionnaire (HAQ): 0.77 (0.58-1.03), one-millimeter (mm) increase in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) fatigue and spinal pain: 0.99 (0.99-1.00) and 0.99 (0.99-1.99), respectively CONCLUSION: Common baseline predictors of treatment response and adherence to TNFi could be identified across data from 15 European registries, indicating that they may be universal across different axSpA populations

data from the EuroSpA collaboration’ [Seminars in Arthritis and Rheumatism 56 (2022) 1-13/152081] (Seminars in Arthritis and Rheumatism (2022) 56, (S0049017222001329), (10.1016/j.semarthrit.2022.152081))

The authors regret that the following incorrect values have been published in the original paper: In the abstract: Line 11-12: “age, per year: 0.97 (0.97-0.98)” should be “age, per year: 0.98 (0.97-0.99)” Line 12: “men vs. women: 1.88 (1.60-2.22)” should be “men vs. women: 1.79 (1.51-2.12)” Line 12: “current vs. non-smoking: 0.76 (0.63-0.91)” should be “current vs. non-smoking: 0.72 (0.59-0.87)” Line 12-13: “HLA-B27 positive vs. negative: 1.51 (1.20-1.91)” should be “HLA-B27 positive vs. negative: 1.65 (1.27-2.15)” Line 14: “CRP>10 vs. ≤10 mg/l: 1.49 (1.25-1.77)” should be “CRP>10 vs. ≤10 mg/l: 1.36 (1.14-1.62)” Line 15-16: “fatigue and spinal pain: 0.99 (0.99-1.00) and 0.99 (0.99-1.99)” should be “fatigue and spinal pain: 0.99 (0.99-0.99) and 0.99 (0.99-1.00)” In Table 3, row with EPV (row 3 after header/subheader): Column with header/subheader “Czech Republic/ATTRA”: EPV 15.9 should be 13.2 Column with header/subheader “Netherlands/ARC”: EPV 1 should be 1.0 Column with header/subheader “Portugal/Reuma.pt”: EPV 14.7 should be 13.1 Column with header/subheader “Romania/RRBR”: EPV 2.8 should be 2.4 Column with header/subheader “Turkey/TURKBIO”: EPV 12.9 should be 11.8 In Table 5, row with “Patient global score, mm” (row 10 counting from row with “Age at treatment start, years”): In the column with header: “Analysis of 12-month drug retention” and subheader: “Univariate”, the value for the odds ratio (OR) is missing. The OR should be 0.99. The authors would like to apologise for any inconvenience caused.publishersversionpublishe