All previously published data on gene frequencies of the ADA and SOD systems are compiled in this paper.

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Background The ICHIBAN study collects clinical routine data to evaluate the efficacy and safety of tocilizumab (TCZ) in pat. with rheumatoid arthritis (RA) over a period of 2 years. Methods The start of this prospective, non-interventional study, being intended to include 4000 pat., was in Feb. 2010. Clinical data of RA pat., their therapies, therapeutic responses, pat. related outcomes and adverse events are collected “on the fly” using an online database with structured web forms. Results On 18th December 2011 as reference date, baseline data of 1036 pat. were available. In 343 pat. observation period was already at least 52 weeks or discontinuation or change of a treatment was documented. 75.4% of the 1036 pat. were female, the mean age was 56.0 years. Pat. suffered from RA since 10.1 years in mean and the baseline DAS28 was 5.4. 73.3% of the pat. had concomitant diseases. 74.4% were pretreated with TNF-alpha inhibitors, 23.9% exclusively with synthetic DMARDs. In week 52 (LOCF) 31.1% of the pat. (N=97/312) showed a remission of DAS28 (<2,6). A moderate or good EULAR response was seen in 32.3% or 42.2% of the pat., respectively. The mean number of tender joints decreased from 10.1 to 4.4, the mean number of swollen joints from 7.3 to 2.5. The mean ESR decreased from 35.4 to 13.7 mm/1h and the CRP from 3.3 to 0.8 mg/dl. Data on pat. reported outcomes (PRO) and functional status at week 52 are shown in Tab. 1. In 21.9% of the pat. (N=75/343) treatment was changed during the observational period of 52 weeks. The total TCZ exposition was 910.1 pat. years. 781 adverse events were reported (in 339 of the 1036 pat.; 85.8/100 pat. years). 147 of these events were infections (16.2/100 pat. years). 160 serious adverse events were reported (in 95 pat.; 17.6/100 pat. years), 110 of which included an at least improbable causal relationship with TCZ (12.1/100 pat. years). Table 1. Means of VAS scales (mm), FFbH and HAQ Week 0 (Baseline)Week 52 (LOCF)N Disease activity (100 = strongest possible activity)65.240.4249 Health state (100 = very bad)63.041.0248 Exhaustion/fatigue (100 = very strong)60.543.8246 Pain intensity (100 = intolerable pain)65.141.5247 Sleep disturbances (100 = very strong)49.739.8245 FFbH (%)58.664.4249 HAQ1.41.2221 Conclusions The results of this “real life study” represent a severely diseased RA population showing significant impairments. The first 343 patients having completed the first observation period of at least one year show clear improvements in all recorded RA parameters. These data confirm the results of previous real life studies with TCZ such as ROUTINE and TAMARA. The safety results correspond to the expectations. Disclosure of Interest C. Specker Grant/Research support from: Has received honoraria from Chugai for advising in study design and conduction and fees for talks, in summary less than €10.000/year, J. Kaufmann: None Declared, M. Vollmer: None Declared, H. Kellner: None Declared, M. Bohl-Bühler: None Declared, M. Aringer: None Declared, A. Alberding: None Declared, H. Schwenke:...

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Background The ICHIBAN study collects routine clinical data to evaluate the effectiveness and safety of tocilizumab (TCZ) in patients with rheumatoid arthritis (RA) in real world practice over a period of 2 years. Methods The start of this prospective, non-interventional study was in February 2010. The target recruitment is 4000 patients. Clinical data of RA patients, their therapies, therapeutic responses, patient reported outcomes and adverse events are collected in the process of normal practice using an online database with structured web forms. Results As of 1st December 2012, baseline data for 1895 patients were available. In 490 of these patients the observation period was at least 76 weeks under TCZ treatment, or treatment was interrupted or changed (analysis was performed according to LOCF method). The total TCZ exposure was 2299.8 patient years. 74.9% of the 1895 patients were female, the mean age was 56.3 years. Mean duration of RA was 10.0 years and baseline DAS28 was 5.1. 72.0% of the patients had concomitant diseases. 69.8% were pre-treated with TNF-alpha inhibitors, 28.0% exclusively with synthetic DMARDs. At baseline 40.1% of TCZ-treated patients did not receive any additional DMARD, while 46.0% were treated in combination with MTX. At W76, 34.0% of the patients (n=149/438) achieved DAS28 remission (<2.6). A moderate or good EULAR response was seen in 29.1% or 56.9% of the patients, respectively. The mean tender joint count (TJC) decreased from 9.6 to 3.5, the mean swollen joint count from 6.9 to 2.1. Mean ESR decreased from 35.5 to 10.6 mm/1h and CRP from 3.5 to 0.6 mg/dl. Data on patient reported outcomes (PRO) at week 76 are shown in Tab. 1. In 12.0% of the initially TCZ-treated patients (n=59/490) treatment was changed during the observational period. 1916 adverse events were reported (in 751/1895 patients; 83.3/100 patient years). 404 of these events were infections (17.6/100 patient years). 370 serious adverse events were reported (in 222 patients; 16.1/100 patient years), 219 of which (59.2%) were judged at least “unlikely” in relation to TCZ. Conclusions In daily practice TCZ treatment of patients with moderate to severe RA demonstrates good efficacy also in monotherapy and confirms the known safety profile. The first 490 patients having completed the observational period of at least one and a half years show clear improvements in all recorded RA parameters, as well as further improvements compared to the results after the first year of treatment. Disclosure of Interest C. Specker Grant/research support from: Has received honoraria from Chugai for advising in study design and conduction and fees for talks, in summary less than €10.000/year, J. Kaufmann: None Declared, H. Kellner: None Declared, M. Bohl-Bühler: None Declared, H. Schwenke: None Declared, M. Vollmer: None Declared, A. Kapelle: None Declared, S. Zinke: None Declared, M. Hofmann: None Declared, P. Hellmann: None Declared, G. Fliedner Grant/research support from: Has received honoraria from Chugai for advising in study de...

Phenotypes and gene frequencies of the erythrocyte enzyme adenosine deaminase were determined in samples from Schleswig-Holstein, Portugal, Brazil, and South Africa (Bantu-Xhosa and White). In the Portugal population the phenotypes ADA 5-1 and ADA 5-2 were found.Zusammenfassung. In einer populationsgenetischen Studie wurden die Ph/~notypen und Genfrequenzen ftir das Erythrozytenenzym Adenosindesaminase in Bev61kerungsgruppen aus Schleswig-Holstein, Portugal, Brasilien und Stidafrika (Bantu-Xhosa und Weige) ermittelt. In der portugiesischen Population fanden sich die Phfinotypen ADA 5-1 und ADA 5-2.

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