Session Information
Session Type: Abstract Submissions (ACR)
Background/Purpose: To assess the efficacy and safety of rituximab (RT) treatment in long-term follow-up of children with systemic juvenile idiopathic arthritis (sJIA).
Methods:
The results of the treatment of 60 children with sJIA (33 girls and 27 boys) aged from 1 year to 18 years (mean – 8.7 y) were analyzed. Duration of disease at the time of RT prescription was 5.3 y on average. At the start of RT treatment, all children had arthritis and severe systemic manifestations. Previously 32 patients were treated with MT, 28 with MT+CsA, 56 with GK i/v, 32 with GK i/a, 36 with oral prednisolon, 19 with TNF blockers 5 with tocilizumab. ACRpedi criteria and criteria of inactive disease and remission (Wallace) were used. The dose of RT was 375 mg/m2 per infusion, weekly, 4 sequential weeks. One course of RT treatment was performed to 60 patients; two courses – to 36 patients, three courses – to 19 patients; 4 courses – to 5 patients, 5 courses – to 3 patients. The effect of therapy was assessed in 60 patients after 6 months, in 45 after 1 y, in 39 after 2 y, in 32 after 3 y; in 27 after 4 y; in 9 patients after 5 y.
Results:
after 6 months of follow up remission of systemic manifestations was documented in 45 (75%) patients. Improvement by ACRpedi30/50/70 was achieved by 65, 40 and 35% of patients, respectively; inactive disease by 15 (25%) patients. By month 12 (n=45) improvement by ACRpedi30/50/70 was achieved by 80, 55, 45% of patients, respectively; inactive disease by 18 (30%) patients. After 2 (n=39), 3 (n=32), 4 (n=27) years of follow up improvement by ACRpedi30/50/70/90 was observed in 90, 80, 75, 70%; 90, 85, 80 and 75% and 98, 95, 95 and 93% of patients, respectively; inactive disease and remission in 43, 33, 33% of patients. In all patients (n=9) who was followed up 5 years remission of disease was documented. Within all period of observation disease remission was documented in 26 (43%) patients, remission of systemic manifestations in 45 (75%) patients. Mean duration – 18 (6;32) and 25 (6; 41) months, respectively.
The second course of RT was made within 18 (6; 32) months in 36 patients after documentation of inactive disease, the third course – within 26 (6; 32) months, the forth course – within 38 (8; 42) months.
RT was discontinued in 39 (65%) patients within 18 (6;32) months due to primary inefficacy in 15 (25%) patients, partial efficacy 8 (13%) (active arthritis), flare of arthritis in 4 (7%) patients, flare of systemic manifestations in 7 (12%). Other patients turned 18 years old and were lost for follow-up.
Within all period of observation the following were reported: infusion reactions 0,8 AE/100 patient years; 0,7 infectious AE/100 patient year; 0,34 Infectious SAE/100 patient year (pneumonia pneumocystic carini); neutropenia 0,35 AE/100 patient year, decrease in serum concentrations Ig 0,25 AE/100 patient years.
Conclusion: RT may be effective in very severe course of sJIA resistant to immunosuppressive drugs, GK and other biologics. RT induced disease remission in 43% of patients and remission of systemic manifestations in 75% of patients. Infectious AEs and SAEs are controlled by antibiotics, non- infectious AEs by IVIG, and GM-CSF.
Disclosure:
E. Alexeeva,
Roche, Abbott, Pfizer, BMS, Centocor, Novartis,
2,
Roche, Merck, Abbott, BMS, Medac, Novartis, Pfizer,
8;
A. Baranov,
None;
S. Valieva,
None;
T. Bzarova,
None;
R. Denisova,
None;
K. Isayeva,
None;
T. Sleptsova,
None;
E. Mitenko,
None;
E. Chistyakova,
None;
A. Fetisova,
None;
E. Semikina,
None;
S. Akulova,
None.
« Back to ACR/ARHP Annual Meeting 2013
ACR Meeting Abstracts - https://acrabstracts.org/abstract/efficacy-and-safety-of-long-term-rituximab-use-in-patients-with-systemic-juvenile-idiopathic-arthritis-the-results-of-5-year-follow-up-in-real-clinical-practice/