Rheumatoid Arthritis: Thon A

Horneff G, Schmeling H, Biedermann T, Foeldvari I, Ganser G, Girschick HJ, Hospach T, Huppertz HI, Keitzer R, Küster RM, Michels H, Moebius D, Rogalski B, Thon A, Anonymous00374. · Department of Paediatrics, University Medical Centre, Martin Luther University, Halle-Wittenberg, Germany. · Ann Rheum Dis. · Pubmed #15115709 links to  free full text

Abstract: OBJECTIVE: To describe a registry set up to monitor children treated with etanercept in Germany and Austria. METHODS: Giannini's criteria, duration of morning stiffness, number of swollen, tender and contracted joints, adverse events, and reasons for discontinuation were assessed. RESULTS: 322 patients with juvenile idiopathic arthritis (JIA) and 12 additional patients with non-JIA rheumatic diagnoses were included. Therapeutic efficacy was observed from one month after treatment was started. The number of patients with significant improvement and the degree of improvement increased during the first year. The mean (SD) number of tender and swollen joints decreased from 9 (9) and 8.4 (9) to 3.0 (6.5) and 4.5 (7) after one month, and to 2.2 (5.5) and 3.3 (5.5) after three months; morning stiffness decreased from 45 (65) minutes to 12 (30) and 7 (19) after one and three months (p<0.001 for all). Using Gianinni's criteria of 30%, 50%, and 70% improvement, a therapeutic response in JIA patients was achieved in, respectively, 66%, 54%, and 30% after one month, 78%, 61%, and 38% after three months, and 83%, 72%, and 52% after six months. Therapeutic efficacy was lower in patients with systemic onset arthritis. Overall tolerability was good: in 592 patient treatment-years there were 69 reports of adverse events in 56 patients, including one CNS demyelination. There were no opportunistic infections or lupus-like reactions. Treatment was discontinued in 53 JIA patients, in 25 because of lack of efficacy. CONCLUSION: Etanercept treatment was safe and led to a significant improvement in most JIA patients resistant to conventional treatment.

Burgos-Vargas R, Foeldvari I, Thon A, Linke R, Tuerck D. · Department of Rheumatology, Hospital General de Mexico, Mexico. · J Clin Pharmacol. · Pubmed #15286090 No free full text.

Abstract: The pharmacokinetics of a meloxicam suspension were studied in 18 children with juvenile rheumatoid arthritis. Children received a single 0.25-mg/kg dose up to a maximum of 15 mg. Pharmacokinetic parameters after the first dose were calculated by noncompartmental methods. Geometric mean (percent coefficient of variation for geometric mean [gCV]) C(max), AUC(0- infinity ), apparent clearance, apparent volume of distribution, and elimination half-life values were 1.24 microg/mL (47% gCV), 25.6 microg x h/mL (81% gCV), 0.17 mL/min/kg (83% gCV), 0.19 L/kg (63% gCV), and 13.4 hours (54% gCV) in the younger group and 1.89 microg/mL (25% gCV), 35.8 microg x h/mL (21% gCV), 0.12 mL/min/kg (23% gCV), 0.13 L/kg (22% gCV), and 12.7 hours (21% gCV) for the older group, respectively. Area under the curve, volume of distribution, and clearance tended to be higher in the younger group, whereas elimination half-lives were similar. A post hoc comparison to pharmacokinetic data in adults revealed no relevant differences. Thus, a common body weight-normalized dose is considered appropriate for children older than 2 years.

Foeldvari I, Burgos-Vargas R, Thon A, Tuerck D. · Pediatric Rheumatology Clinic, Am Allgemeinen Krankenhaus Eilbek, Hamburg, Germany. · J Rheumatol. · Pubmed #12022326 No free full text.

Abstract: OBJECTIVE: Use of meloxicam as a selective COX-2 inhibitor for treatment of adult rheumatic diseases decreases the frequency of gastrointestinal (GI) side effects in comparison with nonselective COX inhibitors. Up to 50% of children with juvenile rheumatoid arthritis (JRA) also develop GI side effects through nonselective COX inhibitors. In this 12 week Phase I/II study, with an additional open extension lasting up to 52 weeks, the safety, efficacy, and pharmacokinetics of meloxicam in JRA were investigated. METHODS: Meloxicam suspension 0.25 mg/kg once daily was given to 36 patients with JRA who required a nonsteroidal antiinflammatory drug. Safety evaluation and periodic measurement of efficacy were carried out using the Pediatric Rheumatology International Trials Organisation (PRINTO) criteria. Eighteen patients underwent pharmacokinetic (PK) evaluation. RESULTS: Thirty-one patients completed the study. Four were dropped due to administrative reasons. One patient, who found the drug ineffective, discontinued participation. A response was seen according to PRINTO outcome criteria in 44% of the patients at Week 4, 62% at Week 12, and 74% at Week 52. Drug related adverse events were observed in 5 patients. PK evaluation showed that the maximum plasma concentration Cmax of -34% and AUC(0-infinity) of -28% tended to be lower in younger children (2-6 years) versus older children. Plasma elimination half-life (13 h) was similar in all patients. CONCLUSION: Meloxicam suspension 0.25 mg/kg once daily seems to be effective and safe for treating active JRA over a period of 52 weeks.

Heiligenhaus A, Niewerth M, Mingels A, Ganser G, Thon A, Pleyer U, Greiner K, Minden K. · Augenabteilung am St.-Franziskus-Hospital, Münster. · Klin Monatsbl Augenheilkd. · Pubmed #16418970 No free full text.

Abstract: BACKGROUND: Uveitis is a frequent and potentially vision-threatening manifestation of juvenile idiopathic arthritis (JIA). There are only a few population-based studies providing data on the frequency and severity of uveitis. METHODS: Documentation of patients with JIA was collected in a national database. An analysis of the paediatric rheumatologic and ophthalmologic data collected from all patients that were included in 2002 was performed. RESULTS: Uveitis was documented in 12 % of a total of 3271 JIA patients: extended oligoarthritis (25 %), persistent oligoarthritis (16 %), seronegative polyarthritis (4 %), seropositive polyarthritis (2 %), psoriatic arthritis (10 %), enthesitis-related arthritis (ERA) (7 %), systemic arthritis (1 %), other arthritis forms (11 %). Ophthalmologic data were available from 115 uveitis patients (28 %). Mean age at onset of uveitis was 5.2 (SD 3.2) years. JIA patients with uveitis were significantly younger at onset of arthritis (3.8 vs. 7.0 years), and were more often girls (74 vs. 63 %) or ANA-positive (86 vs. 42 %) than the patients without uveitis. Uveitis complications were present in 45 % at initial presentation of uveitis. After a mean duration of 5.6 years, complications were noted in 56 %, and included band keratopathy (29 %), posterior synechiae (27 %), cataract (26 %), glaucoma (8 %), and macula oedema (6 %). Final visual acuity was less than 20/50 in 31 % and less than 20/200 in 12 % of eyes. In patients with uveitis, immunosuppressive or immunomodulatory drugs were used significantly more often than in patients without uveitis (75 % vs. 43 %). CONCLUSIONS: The nationwide data documents the spectrum of uveitis in patients with JIA, the complications and the therapy for uveitis. The high rate of uveitis complications at the time of diagnosis points out the need for early ophthalmologic screening and therapy, and for a close collaboration between ophthalmologist and paediatric rheumatologist.

Ullrich G, Mattussek S, Dressler F, Thon A. · Kinderklinik der MHH, Hannover Medical School, Carl-Neuberg-Str.1, D-30623 Hannover, Germany. · Eur J Med Res. · Pubmed #11827835 No free full text.

Abstract: AIMS: To explore the information needs of adolescents with juvenile chronic arthritis (JCA) with respect to patient education and other measures to promote self-management. METHODS: Standardized cross-sectional inquiry concerning disease-related knowledge, perceived importance of information giving, unmet needs as well as perceived attractiveness of a range of services (lecture, structured patient education, support group, self-help group) to promote self-management. SAMPLE: N = 48 adolescents (68% of all adolescents with JCA of our outpatient clinic); mean age x = 14.9 (+/- 2.1) years; 56% female; 17% had the oligoarthritis form of JCA, 40% juvenile spondylarthritis, 25% polyarthritis and systemic form, 19% other rheumatic diseases. RESULTS: The majority of adolescents considered themselves as sufficiently well-informed and voted in favour of detailed information giving. However, 30% were unsatisfied with their current information and knowledge. Information needs predominantly related to the prognosis, course, and treatment of JCA, whereas the psychosocial impact (except sports and job matters) were judged as less important. Adolescents with a lower level of education were generally more interested than those with a high level of education. As for the attractiveness of services nearly half of the adolescents judged all of them as not very attractive. CONCLUSIONS: The majority of adolescents is interested in detailed information giving and some of them point to unmet needs, but nearly half of them is hesitant towards services which are delivered in a group format (such as structured patient education or support groups).