BackgroundThe Austrian BioReg registry () was initiated in 2009. Patients treated with one of the nine biologics (abatacept, adalimumab, anakinra, certolizumab, etanercept, golimumab, infliximab, rituximab, tocilizumab) approved in Austria can be included. Patients with ongoing biologic therapy as well as biologic-naïve patients starting biologic therapy can be included. Further documentation is recommended about every six months. Meanwhile, 1493 patients (rheumatoid arthritis (RA) n=857, ankylosing spondylitis (SpA) n=362, psoriatic arthritis (PsA) n=239, treatments out of label n=35) have been documented. Most biologics are approved for treatment of RA only in combination with methotrexate (MTX).ObjectivesThe aim of this evaluation was to elucidate the percentage of RA patients treated with biologic monotherapy at baseline and at control visits one, two and three years after inclusion in BioReg.MethodsThree different patient groups were defined. Patients with data at baseline and control visit after one or two or three years ±3 months were evaluated for drug therapy at the time of inclusion and at control visit. 411 RA patients with data at baseline and after one year, 186 with data after two years and 98 with data after three years were analyzed.Results155/411 had a biologic as monotherapy at baseline, after one year 165/411; 62/186 at baseline, 71/186 after two years; 40/98 at baseline, 43/98 after three years. At baseline 39.7% of patients received a biologic as monotherapy. The percentage of RA patients (40.1; 38.2; 43.9%) on biologic monotherapy seems to increase with time of treatment.ConclusionsAbout forty percent of RA patients treated with a biologic receive biologics as monotherapy and not in combination with a conventional disease-modifying drug (DMARD). These data are in agreement with observations from other registries (1, 2).ReferencesEmery P et al. Ann Rheum Dis. 2013;72:1897-904Zhang J et al. Arthritis Care Res 2014 doi: 10.1002/acr.22510AcknowledgementsBioReg is supported by an unlimited industrial grant.Disclosure of InterestNone declared
Background:Gender differences in prevalence and disease course are known in various rheumatic diseases; however, investigations of gender difference concerning therapeutical response have yielded variable results.Objectives:The aim of this retrospective study was to investigate, whether a gender difference in response rate to biological disease-modifying antirheumatic drugs (bDMARDs) and apremilast in bDMARD-naïve patients could be observed across the three most prevalent inflammatory arthritis diseases: rheumatoid arthritis (RA), spondylarthritis (SpA) and psoriatic arthritis (PsA). Additionally, a response to individual TNF blockers was investigated in this respect.Methods:Data from bDMARD-naïve RA-, SpA- and PsA-patients from Bioreg, the Austrian registry for biological DMARDs in rheumatic diseases, were used. Patients with a baseline (Visit 1=V1) and follow-up visits at 6 months (Visit 2=V2) and 12 months (Visit 3=V3) were included and response to therapy with TNF-inhibitors (TNFi), furthermore to therapy with rituximab, tocilizumab and apremilast was analyzed according to gender. The remaining bDMARDs were not analyzed due to small numbers. Key response-parameter for RA was disease activity score (DAS28), whereas for PsoA the Stockerau Activity Score for Psoriatic Arthritis (SASPA) and for SpA the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) were employed; in addition, the Health assessment Questionnaire (HAQ) was used. Data were analyzed in R Statistic stratified by gender using Kruskal-Wallis and Wilcoxon tests.Results:354 women and 123 men with RA (n=477), 81 women and 69 men with PsA (n=150), 121 women and 191 men with SpA (n=312) were included. No significant differences in biometrics was seen between female and male patients at baseline in all diseases.In RA patients overall DAS28 decreased from baseline (V1) to V2 and V3 (DAS28: V1: male: 4.38 [3.66, 5.11], female: 4.30 [3.68, 5.03], p(m/f) = 0.905; V2: male: 2.66 [1.73, 3.63], female: 3.10 [2.17, 3.98], p(m/f) = 0.015; V3: male: 2.25 [1.39, 3.36], female: 3.01 [1.87, 3.87], p(m/f) = 0.002). For TNF inhibitors (n=311), there was a significant difference between genders at V2 (Fig.1a). Patients receiving Rituximab (n=41) displayed a significantly higher DAS28 at baseline in females, which diminished in the follow up: V1: (p(m/f) p=0.002; V2: p=0.019; V3: p=0.13); response to tocilizumab (n=63) did not show any gender differences.In PsA patients overall SASPA decreased from baseline (V1) to V2 and V3 (SASPA: V1: male: 4.00 [2.80, 5.20], female: 4.40 [2.80, 5.80], p(m/f) = 0.399; V2: male: 2.20 [1.20, 3.50], female: 3.40 [2.00, 5.00], p(m/f) = 0.071; V3: male: 1.80 [0.80, 2.70], female: 3.01 [2.35, 4.80], p(m/f) = 0.001). For TNF inhibitors (n=79), there was a significant difference between genders at V3 (Fig 1a). For Apremilast (n=39), there was a significant difference between genders at V2 (Fig.1c).In SpA patients overall BASDAI decreased from baseline (V1) to V2 and V3 (BASDAI: V1: male: 4.70 [2.88, 6.18], female: 4.80 [3.30, 6.20], p(m/f) = 0.463; V2: male: 3.05 [2.00, 4.60], female: 3.64 [2.62, 5.41], p(m/f) = 0.039; V3: male: 3.02 [1.67, 4.20], female: 3.65 [2.18, 5.47], p(m/f) = 0.016). In V3 a differential BASDAI in response to TNFi (n=299) was observed (Fig.1a).Possible differences of response to individual TNFi (etanercept, infliximab, other TNFi) measured by HAQ were investigated in all diseases together. The difference between male and females was significant at baseline for all 3 TNFi; whereas with the use of ETA the significant difference was carried through to V2 and V3, it was lost with the use of IFX and was variable with the other TNFi (Fig.1b)Figure 1.Conclusion:Female patients showed a statistically lower response to TNFi in all three disease entities (RA, SpA and PsoA) to a variable degree in our homogenous central european population. Interestingly, the difference was not uniform across individual TNFi when measured by HAQ. Gender differences were also seen in response to Apremilast.Disclosure of Interests:Elisabeth Loibner: None declared, Valentin Ritschl: None declared, Burkhard Leeb Speakers bureau: AbbVie, Roche, MSD, Pfizer, Actiopharm, Boehringer-Ingelheim, Kwizda, Celgene, Sandoz, Grünenthal, Eli-Lilly, Grant/research support from: TRB, Roche, Consultancies: AbbVie, Amgen, Roche, MSD, Pfizer, Celgene, Grünenthal, Kwizda, Eli-Lilly, Novartis, Sandoz;, Peter Spellitz: None declared, Gabriela Eichbauer-Sturm: None declared, Jochen Zwerina: None declared, Manfred Herold: None declared, Miriam Stetter: None declared, Rudolf Puchner Speakers bureau: AbbVie, BMS, Janssen, Kwizda, MSD, Pfizer, Celgene, Grünenthal, Eli-Lilly, Consultant of: AbbVie, Amgen, Pfizer, Celgene, Grünenthal, Eli-Lilly, Franz Singer: None declared, Ruth Fritsch-Stork: None declared
BackgroundRemission or at last low disease activity is the aim of drug therapy in patients with chronic inflammatory rheumatic diseases. We evaluated disease activity in patients treated with biologics and using data of the Austrian biologic registry.ObjectivesThe aim of this evaluation was to elucidate disease activity in patients with rheumatoid arthritis (RA), spondyloarthritis (SpA) and psoriatic arthritis (PsA) at baseline and at control-visits every six months after inclusion in BioReg.MethodsData were extracted from the Austrian BioReg registry (bioreg.at) which was initiated in 2009 to document patients treated with one of the biologics approved in Austria. Patients with ongoing biologic therapy as well as biologic-naïve patients starting biologic therapy can be included (baseline, BL). Further documentation is recommended about every six months (V1,V2 up to V11). Meanwhile, 1877 patients (rheumatoid arthritis (RA) n=1046, ankylosing spondylitis (SpA) n=446, psoriatic arthritis (PsA) n=322, other disease n=63) have been documented. Estimation of disease activity is done using DAS-28 as well as RADAI-5 in RA, SASPA in PsA, and BASDAI in SpA.ResultsDAS-28 (median values of BL; V1; V2; V9; V10) of patients with RA are 3,30; 2,51; 2,58; 2,52; 2,49, the respective RADAI-5 values are 3,2; 2,4; 2,2; 2.0; 2,3. BASDAI in patients with SpA were 3,60; 2,61; 2,45; 2,63; 2,20. Median values of inflammation's laboratory markers (ESR in mm/1st hour and CRP in mg/l) were always within the normal range (ESR and CRP in RA 15; 12; 12; 12,5; 14 and 2,0; 2,0; 2,0; 2,0; 2,0; in SpA: 8; 6; 7; 8; 8; and 2,0; 1,4; 1,4; 1,1; 1,0 in PsA 9; 8; 9; 7 (V7); 6 (V8); and 1,6; 1,5; 1,4; 1,9 (V7); 0,8 (V8)).ConclusionsOur data confirm the efficiency of therapy with biologicals. During 5 years of continuous treatment more than half of patients with RA reach and keep remission with a DAS-28 below 2,6 and normal values of ESR and CRP. Also patients with SpA and PsA show similar successful therapeutic response.AcknowledgementsBIOREG is supported by an unlimited industrial grantDisclosure of InterestNone declared
BackgroundBIOREG, the Austrian registry for patients (pts) with chronic rheumatic diseases treated with biologic DMARD's, includes pts with rheumatoid arthritis (RA), spondylarthritis (SPA), psoriatic arthritis (PSA) and other diseases since 2010. Patients on biologic treatment are included irrespective of treatment duration and history. The primary interest of BIOREG is safety; aside disease activity and socioeconomic data are also documented.ObjectivesThe aim of this evaluation was to figure out eventual differences with respect to safety and disease activity in SPA and PSA pts on long term-treatment or beginners on biologic DMARDs after one year of treatment.MethodsSPA and PSA pts starting their first biologic treatment (NEW) and pts treated with biologics for a longer time (LS) were compared with respect to demographic aspects, disease activity (DA) (BASDAI in SPA; total TJC, total SJC and number of dactylitides (DAC) in PSA). Safety concerns were recorded. If not otherwise indicated median values (first and third quartile) are given.ResultsSPA: One-hundred-seventy pts (146 LS, 24 NEW) of a total of 362 SPA pts were included into this evaluation as a full dataset was available. Disease duration amounted to 7.0 years (4.0, 15.0) for LS and 3.0 years (1.0, 8.5) for NEW SPA pts. For LS 75.4% were male, the age was 45.0 years (36.0, 52.0), for NEW pts 79.2% and 40.5 (33.5, 49.5) respectively. LS were on biologic DMARDs since 4.21 years (2.17, 5.91). A slight difference in DA can be observed after 1 year according to the BASDAI in favor of NEW (LS 2.45 (1.23, 3.88) and NEW 1.93 (1.20, 3.10).PSA: One-hundred-four pts (85 LS, 19 NEW) out of 239 PSA pts were included into this evaluation as a full dataset was available. Disease duration amounted to 8.0 years (4.0, 14.0) for LS and 3.0 years (1.0, 10.0) for NEW pts, 60.7% were male, 57.9% respectively, the age was 53.0 years (45.0, 59.0) and 47.0 (39.0, 54.0) respectively. LS were on biologic DMARDs since 3.75 years (1.77, 5.74). No difference in DA can be observed after 1 year according to TJC (LS as well as NEW 0.0 (0.0, 1.0)), to SJC (LS as well as NEW 0.0 (0.0, 0.0)) and to dactylitis (LS in 11.8%, NEW 10.5%).In both groups, 63 adverse events had to be noticed in the LS pats (27%) and 10 in the NEW pats (30%) most likely infections.ConclusionsAfter 1 year of biologic treatment, all pts achieve a comparable level of disease activity control. Adverse events occur in both groups in around 30% with no difference in LS and NEW.Disclosure of InterestB. Rintelen Grant/research support from: BIOREG is supported by an unrestricted industrial grant, M. Herold Grant/research support from: BIOREG is supported by an unrestricted industrial grant, F. Singer Grant/research support from: BIOREG is supported by an unrestricted industrial grant, J. Hitzelhammer Grant/research support from: BIOREG is supported by an unrestricted industrial grant, J. Zwerina Grant/research support from: BIOREG is supported by an unrestricted industrial grant, W. Halder Grant/research support from: BIO...
BackgroundThe discordance between patients and physicians in estimation of patients' global health is well known especially from RA patients. We tried to find out whether differences in global health estimation are the same in patients with different diseases using data of the Austrian biologic registry.ObjectivesThe aim of this evaluation was to elucidate the amount of differences between PGA (Patient Global disease Activity) and EGA (Evaluator's Global disease Activity) in patients with rheumatoid arthritis (RA), spondylarthritis (SpA) and psoriatic arthritis (PsA) at baseline and at control visits every six months after inclusion in BioReg.MethodsData were extracted from the Austrian BioReg registry (which was initiated in 2009 to document patients treated with one of the nine biologics (abatacept, adalimumab, anakinra, certolizumab, etanercept, golimumab, infliximab, rituximab, tocilizumab) approved in Austria. Patients with ongoing biologic therapy as well as biologic-naïve patients starting biologic therapy can be included (baseline, BL). Further documentation is recommended about every six months (V1, V2 up to V11). Meanwhile, 1663 patients (rheumatoid arthritis (RA) n=948, ankylosing spondylitis (SpA) n=400, psoriatic arthritis (PsA) n=267, other disease n=48) have been documented. Estimation of global health is done using a visual analogue scale (VAS with 100 mm, 0 = no disease) by patients (PGA) and by physicians (EGA) at every visit.ResultsVAS (median values of BL; V1; V2; V3; V4; V5) of patients with RA showed differences between PGA (30; 20; 22; 20; 20; 20) and EGA (15; 7; 10; 10; 10) as well as in SpA (PGA 39; 30; 26; 30; 30; 20 and EGA 20; 10; 10; 10; 10; 10) and in PSA (PGA 30; 10; 12; 20; 20; 10 and EGA 20; 10; 5; 10; 10; 10). Median values of inflammation's laboratory markers (ESR in mm/1st hour and CRP in mg/l) were always within the normal range (ESR and CRP in RA 5; 12; 14; 12; 14; 14 and 2,0; 2,0; 2,2; 2,0; 2,0; 2,0; in SpA: 7; 7; 7; 8; 7; 7 and 1,5; 1, 5; 1,7; 1,4; 1,2; 1,1 and in PsA 8; 8,5; 9; 9; 10; 10 and2,0; 1,7; 1,4; 1,0; 1,0; 1,0).ConclusionsAs described for RA we also saw in patients with RA but also in SpA and PsA, that physicians' estimation of global health is always better than patients' values at all visits. We suppose that physicians focus primarily on signs of active inflammation and less on general feeling. The normal values of ESR and CRP support this assumption.ReferencesIsabel Castrejon et al. Discordance of Global Estimates by Patients and Their Physicians in Usual Care of Many Rheumatic Diseases: Association With 5 Scores on a Multidimensional Health Assessment Questionnaire (MDHAQ) That Are Not Found on the Health Assessment Questionnaire (HAQ). Arthritis Care Res 2014;66:934–42Furu M et al. Discordance and accordance between patient's and physician's assessments in rheumatoid arthritis. Scand J Rheumatol 2014;43:291–5AcknowledgementBIOREG is supported by an unlimited industrial grant.Disclosure of InterestNone declared
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