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13XPHMATC^OTOYMENO ПPQTOKOЛЛO АПО THN EPE-EnEPE ERE-EPERE-SUPPORTED PROTOCOL
noA^ev^^ MeÀéiri KaiGYpai^Q Aööevuv pe Pe^aioe^ ApBpÍiióa ötov EЛЛпvlкô Xúpo
ЛпмпФ^ BQölЛóпouЛoç, MD, PhD
(вк pépouç тпс 0|j06qq EpyQölQQ PeupiQToetôoÙQ Ap9píti6qq Tr|Q EPE - EnEPE)
mediterranean journal 26
of RHEUMATOLOGY i
E Л Л H N I К H PEYMAÏOAOriA 2015
EPEYNHTIKO ПРПТОКОЛАО Eioaywyn
H peupaToetóñQ gp9píti6g (PA) eÍvai п пю öuxvq фЛeY-povшбпQ gp9píti6g pe eпíптwöп ötov eЛЛпvlкó пЛп9и-0pó пou кupaÍveтal peia^ú 0.35-0.68 %. H пpÓYVWöП кal oi eпlпЛoкéQ ttiq vóöou e^apiüviai öe peYáXo ßa9-pó aпó ^v evepYÓтптa (DAS2B), ßapúтптa (пapouöÍa aктlvoÀoYlкшv aAAoiwöewv), ЛelтoupYlкóтптa (HAQ), opoЛoYlкó пpoфÍÀ (RF, anti-CCP), тп xopПYOÚpevп avTi-peupaTiraí aY^Yñ кal tiq öuvuпápxouöeç öuvvoöПpó-irçieQ. EпlпЛéov, oi aö9eveiQ pe PA epфavÍZouv au^-pévп 9vпölpóтптa öe öxéöп pe tov Yevlкó пЛп9uöpó, elбlкá auToÍ pe ифп^п evepYÓтптa тпQ vóöou. H eiöa-YШYñ öтп кЛlVlкñ пpá^п тп TeAeuTaÍa 15eTÍa twv ßioXo-Y^wv Tpo™™^™^ тпQ vóöOu фappáкwv (biologic DMARDs - bDMARDs), ши xopпYOÚvтal öuvñ9wQ peTá aпó i^v aпoтuxÍa twv öupßaтlкwv öuv9eтlкwv TpoTO-ТО1Пик^ тпQ vóöOu фappáкwv (csDMARDs) öúpфwva pe tiq пpóöфaтeQ E^v^eq кal Лle9veÍQ OбпYÍeQ, éxei aAAá^ei öпpavтlкá to 9epaпeuтlкó тoпÍo сттт| PA. Ta бeбopéva öxeтlкá pe ^v evepYÓтптa, ßapúтптa, öÚYXPOVп 9epaпeuтlкñ aYWYñ кal tiq öuvvoöПPÓтптeQ i^Q PA öтп x^pa paQ eÍvai пeploplöpéva кal пpoépxo-vTai ^pÍwQ aпó peYáXa Tplтoßá9pla KévTpa Avaфo-páQ TПQ vóöou.
AoGeveiç Kai m¿0o6oi
H peЛéтп 9a pia пoЛuкevтplкñ, öUYXPOVlкñ (cross-sectional study) peXé^, pe катаYpафñ twv aö9evwv pe PA пou пapaкoЛou9oúvтal evepYá öe Noöoкopelaкá KévTpa, ^iwTirá iaTpeÍa п iaTpeÍa tou EIY Yia бláöтп-pa 6 pпvшv rai pe öкoпó va eпavaЛпф9eÍ peTá ará пápoбo 3 eTúv, wöie va uпoЛoYlöтoúv бláфopol 6bí-i<TeQ éкßaöПQ тпQ vóöOu óпwQ п V0öпpóтптa ^uxvó-
тпта öoßapwv ÀoipwÇewv, voöпЛelwv, op9oпalбlкwv eпepßáöewv) кal 9vпölpóтптa (aiTÍeQ 9aváTou). Ta öToixeia twv aö9evwv 9a кaтaYpáфovтal pEöw piaQ aпЛñQ фóppaQ кaтaYpaфñQ, П oraÍa 9a бlaтí9eтal öe вк^п^^ rai öe пAeктpovlкñ popфñ (кaтaxwpпöп pEöw пpóößaöПQ öe öUYкeкplpévo löтóтoпo). Ká9e aö9evñQ 9a uпoYpáфel evtu™ пЛпpoфopпpévпQ öu-Yкaтá9eöПQ кal 9a rataxwpeítai pe та apxlкá tou ovopaтeпwvupoú tou, та oпoÍa öe öuvбuaöpó pe to éTOQ YévvпöñQ tou rai tov кшб^ tou tóvipou пapa-кoЛoú9пöñQ tou 9a öxпpaтÍZouv éva povaбlкó шбито avá aö9evñ. £та tóvipa пou 9a öuppeтáöxouv, 9a aпoöтaЛeÍ uЛlкó pe avaXuTiraQ oбпYÍeQ öxeтlкá pe тп öupпЛñpшöп twv бráфopwv to6íwv тпQ фóppaQ ката-YpaфñQ, wöTe va eraTeux9ei п кaЛúтepп бuvaтñ opoio-Yéveia öтп öuЛЛoYñ twv 6b6opevwv. H aváЛuöп twv öioixeiwv 9a YÍvei pe пeplYpaфlкñ öia-тlöтlкñ, uTOÁoYopó Xóywv öxernüv кlvбúvwv кal pe кaтaYpaфñ twv бlaxpovlкwv тáöewv отп бlápкela tou бlaöтñpaтoQ тпQ peXé^Q. ПapáЛЛпAa öTa пЛaÍöla тпQ peXé^Q, 9a eпlxelpп9eÍ eпlкúpwöп tou uraÁoYopoú tou eтпöÍou кlvбúvou Yia öoßapñ Aoipw^ öe aö9eveiQ pe PA. TéXoQ, 9a eпlxelpп9eÍ eпlкúpwöп tou utoàoyi-öpoú tou бeкaeтoúQ кapбlaYYelaкoú кlvбúvou, óпwQ auTÓQ пpoтeÍveтal аш тпv Eupwпaïкñ KapбloЛoYlкñ ETaipeÍa.
ITÓXOI THQ ме^ётп^
H кaтaYpaфñ:
1. twv бпpoYpaфlкwv xapaктпplöтlкwv twv aö9evwv pe PA öтпv EЛЛáбa öñpepa
2. тпQ evepYÓтптaQ кal ЛelтoupYlкóтптaQ тпQ vóö0u, óпwQ auтñ e^páZeTai aпó touq бeÍктeQ DAS2B, HAQ, CDAI, SDAI
3. ^Q voöПPÓтптaQ кal em^o^v тпQ vóö0u óпwQ
Лé^elQ-KЛelбlá: QuioavoöiQ, QuтoávoöQ voöñpQTQ, peupaioe^Q qp9píti6q
B0
nOAYKENTRIKH MEAETH KATARPAOHX AX0ENQN ME REYMATOEIAH AP0RITIAA HON EAAHNIKO XQRO MULTiCENTER ERiDEMiOLOGiCAL STUDY OF RHEUMATOiD ARTHRiTiS iN GREECE
EK0päZeTai anö Tn ouxvöTnTa twv op9onai5iKwv enejßäoewv, voonAeiwv Kai ooßapwv Aoijw^ewv
4. twv aKoAou9oujevwv oÜYXpovwv 9epaneuTi-kwv npaKTiKwv (Ai^n Kai SoooAoYia csDMARDs, bDMARDs, KopTiKooTepoeiSwv)
5. twv ouwoonpoTHTwv (KapSiaweiarä vooqjaTa, XpöviEQ nveujovona9eieQ, ooTeonöpwon, veo-nAaojaTiKeQ na9iioeiQ)
6. TnQ eninTwonQ Kai tou eninoAaojou Aoijw^ewv, önwQ oi lOYeveiQ nnaTiTiSeQ (HBV, HCV), o epnn-TaQ ZwoTnpaQ Kai n 0ujaTiwon
7. TnQ E|jßoAiaoTiKnQ KäAu^nQ evavTi ouxvwv na-
9oYÖVWV, ÖnWQ O nVEUJOViöKOKKOQ Kai o iöQ TnQ
YpinnQ. AvapevÖMeva o^eAn
H jeAeTn auTq nou xpnjaToSoTeiTai oAoKAqpou anö Tnv EAAnviKq PeujaToAoYiKii ETaipeia & EnaY-YeAjaTiKq 'Evwon PeujaToAÖYWV EAAqsoq (EPE&E-nEPE) Kai npaYjaTonoieiTai jeow TnQ OjaSaQ Ep-YaoiaQ TnQ PA, 9a eivai n npwTn jeAeTn nou 9a nepi-Aäßei eva jeYäAo SeiYja ao9evwv avTinpoowneuTiKö tou YeviKoü nAn9uojou TnQ PA otov EAAnviKö x^po Kai avajeveTai va:
- KaTaSei^ei to aKpißeQ 0opTio TnQ vöoou oqjepa (evepYÖTnTa, ßapüTnTa)
- eKTijnoei tiq oüYxpoveQ 9epaneuTiKeQ oTpaTnYiKeQ oTn PeujaToAoYiKq KoivöTnTa Kai Tnv oujjöp0won touq je tiq unäpxouoeQ EAAnviKeQ Kai Aie9veiQ 9e-paneuTiKeQ ouoTäoeiQ Kai va
- KaTaYpä^ei Yia npüTn 0opä je aKpißeia tiq ooßa-peQ eninAoKeQ Kai ouvoonpöTnTeQ TnQ vöoou.
BIBAIOrPAOIA
1. Drosos AA, Alamanos I, Voulgari PV, Psychos DN, Katsaraki A, Papadopoulos I, et al. Epidemiology of adult rheumatoid arthritis in northwest Greece 1987-1995. J Rheumatol 1997; 24;2129-2133.
2. Andrianakos A, Trontzas P, Christoyannis F, Kaskani E, Nikolia Z, Tavaniotou E, et al . Prevalence and management of rheumatoid arthritis in the general population of Greece--the ESORDIG study. Rheumatology (Oxford) 2006; 45;1549-1554.
3. Anagnostopoulos I, Zinzaras E, Alexiou I, Papathanasiou AA, Davas E, Koutroumpas A, et al . The prevalence of rheumatic diseases in central Greece: a population survey. BMC Musculoskelet Disord 2010; 11;98.
4. Flouri I, Markatseli TE, Voulgari PV, Boki KA, Papadopoulos I, Settas L, et al . Comparative effectiveness and survival of infliximab, adalimumab, and etanercept for rheumatoid arthritis patients in the Hellenic Registry of Biologics: Low rates of remission and 5-year drug survival. Semin Arthritis Rheum 2014; 43;447-457.
5. Smolen JS, Landewe R, Breedveld FC, Buch M, Burmester G, Dougados M, et al . EULAR recommendations for the management of rheumatoid arthritis with synthetic and biological disease-modifying antirheumatic drugs: 2013 update. Ann Rheum Dis 2014; 73;492-509.
6. Singh JA, Furst DE, Bharat A, Curtis JR, Kavanaugh AF, Kremer JM, et al . 2012 update of the 2008 American College of Rheumatology recommendations for the use of disease-modifying antirheumatic drugs and biologic agents in the treatment of rheumatoid arthritis. Arthritis Care Res (Hoboken ) 2012; 64;625-639.
7. Conroy RM et al. Estimation of ten-year risk of fatal cardiovascular disease in Europe: the SCORE project. European Heart Journal 2003; 24, 987- 1003
8. Panagiotakos DB, Fitzgerald AP, Pitsavos C, Pipilis A, Graham I, Stefanadis C. Statistical modelling of 10-year fatal cardiovascular disease risk in Greece: the HellenicSCORE (a calibration of the ESC SCORE project). Hellenic J Cardiol. 2007;48:55-63.
9. Crowson CS, Hoganson DD, Fitz-Gibbon PD, Matteson EL. Development and validation of a risk score for serious infection in patients with rheumatoid arthritis. Arthritis Rheum. 2012; 64:2847-55.
Multicenter Epidemiological Study of Rheumatoid Arthritis in Greece
Dimitrios Vassilopoulos, MD,PhD, on behalf of the ERE Rheumatoid Arthritis Study Group
mediterranean journal 26
of RHEUMATOLOGY 1
EAAHNIKH PEYMATOAOriA 2015
Introduction
Rheumatoid arthritis is the most common form of inflammatory arthritis with an incidence ranging between 0.35-0.68% in Greece. The prognosis and complications of the disease depend on disease activity (DAS28), severity (presence of radiologic lesions), functional status (HAQ), serology profile (RF, anti-CCP), treatment and co-morbidities. In addition, patients with RA show increased mortality compared to the general population, especially those with high disease activity. Introduction of biologic DMARDs (bDMARDs) in clinical practice in the last 15 years which, are usually used after conventional synthetic DLARDs (csDMARDs) have failed (according to most recent Greek and International guidelines), have substantially changed the therapeutic field of RA. Data regarding the activity, severity, contemporary therapy and comorbidities of RA in Greece are limited and are derived mainly from tertiary referral centers.
Patients and Methods
This is a multicenter, cross-sectional study of consecutive RA patients who are actively followed up in outpatient hospital clinics and private offices will be included during a 6-month period. The same recording will be repeated after 3 years in order to calculate disease outcomes such as morbidity (incidence of serious infections, hospitalization rates, orthopedic surgeries) and mortality (causes of death).
Patient data will be entered using a simple registry form, available both in printed and electronic version (via access to a specific web site). Every patient will sign an informed consent and will be registered with his/her name and surname initials which, combined with his/ her year of birth and treating center code, will produce a unique patient code. Participating centers will receive printed material with detailed instructions for the filling of the form, in order to obtain maximum homogeneity in data collection.
Data analysis will be performed with descriptive statistics,
incidence and odds ratio calculation and description of longitudinal changes during the observational period. In addition, validation of the 1-year risk for serious infection and the 10-year risk for cardiovascular event will be attempted as proposed.
Aims of the study
To record:
1. The demographics of patients with RA in Greece
2. The activity and severity of the disease (as expressed by DAS28, HAQ, CDAI, SDAI)
3. The morbidity and complications of the disease (as expressed by the rates of orthopedic surgeries, hospitalizations and serious infections).
4. The current treatment practice (use and dosage of csDMARDs, bDMARDs and corticosteroids)
5. The comorbidities (cardiovascular, chronic lung disease, osteoporosis, neoplasms)
6. The incidence and prevalence or exposure to infections (such as hepatitis B and C, herpes zoster and tuberculosis).
7. The vaccination coverage against common pathogens, such as pneumococcus and influenza virus.
Anticipated benefits
The study, which will be funded by the Greek Society of Rheumatology and run by the RA Study Group, will be the first to include such a large sample of patients representative of the general population with RA in Greece and is expected to:
- determine the exact burden of the disease (activity, severity)
- document the current therapeutic strategies of Greek rheumatologists and the compliance to the existing Greek and International treatment recommendations or guidelines
- record for the first time the rate of serious complications and co-morbidities of the disease.
Keywords: Autoimmunity, autoimmune diseases, rheumatoid arthritis
