This study will provide evidence-based medical evidence in the application of infliximab for pediatric rheumatology.
Methods
The 45 cases of this study were allocated to treatment group and control group. The treatment group was divided into JIA and JAS subgroup. the disease of them were all in active stage.If the patients took methotrexate (MTX) before enrolling group, the dose must be stabile in 10-15mg/m2 per week for at least 3 months. A small dose of non-steroidal anti-inflammatory drugs (NSAID) was allowed. The test group received MTX combined with infliximab intravenous infusion (JIA group: 3 mg kg–1; JAS group: 5 mg kg–1); the control group received MTX combined an equal volume of placebo intravenous infusion. The cases of JIA group were injected at 0 weeks, 2 weeks, 6 weeks, 14 weeks, 22 weeks, 30 weeks, and the JAS group were injected at 0 weeks, 2 weeks, 6 weeks, 12 weeks, 18 weeks, 24 weeks. Observe the efficacy at each time point and evaluate whether there were significant differences between treatment and control groups so as to judge whether infliximab could reduce disease activity more effectively and durably.
Results
The treatment groups included 12 JIA cases and 7 JAS cases while the control group included 18 JIA cases and 8 JAS cases. A total number of 45 cases achieved the injection. The ACR30 improvement rate of JIA treatment group after two weeks was 66.7%, while the control group was 27.7% (P=0.035). The ACR30 and ACR50 improvement rate of JIA treatment group after 30 weeks were 91.7% and 75%; while the control group was 61.1% (P=0.099) and 22.2% (P=0.004). The ASAS 20 response rate of JAS treatment group after two weeks was 85.7%, which was far higher than 25%, the rate of the control group (P=0.04). The ASAS 20 response rate in the treatment group at the endpoint was 100%, while the rate of control group was 37.5% (P=0.07). The recorded adverse reaction in the process of drug use was visible. 3 children merged with respiratory tract infection. An old JIA children merged with chest distress and polypnea 5 minutes later after the second time intravenous infliximab and the symptoms were disappeared after drug withdrawal. One JIA case of penicillin anaphylaxis appeared with systemic wheal -like rash during the 4th injection, and the rash subsided one hour later with the oral phenergan treatment. Tuberculosis, severe infections and tumors were not found in the Short-term observation.
Conclusions
This study shows that MTX combined with infliximab can quickly alleviate joint pain and reduce inflammatory markers compared with single MTX in the treatment of juvenile idiopathic arthritis and juvenile ankylosing spondylitis. The significant difference is more obvious in juvenile ankylosing spondylitis treatment. This study also provides data to support the point that the use of infliximab in children is of good safety. The allergy incidence is even lower than the same type of adult reports. The statistically significant differences did not appear in part of the control study considering that it needed a larger sample to support. The long-term efficacy and safety of infliximab require a large sample and long-term follow-up study.
Using the ACR Ped-30, 50, 70 to assess the clinical efficacy of tumor necrosis factor antagonist in refractory systemic juvenile idiopathic arthritis (So-JIA).
Methods
Evaluate the 30 refractory SO-JIA patients that achieved TNF antagonists using ACR Ped-30, 50, 70. The evaluation will carry out after treatment of 1 month, 3 months and 6 months. Several indicators will be evulate, insist: (1) the dosage of the hormone; (2) the body temperature; (3) count of active inflammatory joint; (4) blood sedimentation (ESR) or c-reactive protein (CRP); (5) the doctors 9s overall evaluation. If there are at least 3 items that with an improvement between 30% and 49%, it will be regarded that the cases9 30% clinical symptoms alleviate. If there are at least 3 items that with an improvement between 50% and 69%, the cases9 50% clinical symptoms alleviate. If there are at least 3 items that with an improvement above 70%, the cases9 70% clinical symptoms alleviate. It will be treated as poor efficacy or invalid if there are more than 3 items that with an improvement less than 29%. The occurrence of adverse reactions are monitored and recorded at the same time.
Results
After 1 month9s treatment, only 40% (12/30) of children achieved more than 30% of the clinical symptoms alleviated. Among them, 13.3% (4/30) achieved more than 50% of the clinical symptoms alleviated, 10% (3/30) reached more than 70% of the clinical symptoms eased. 2 cases merged with muscular stiffness, so the biological agent9s treatment was stopped. After 3 month9s treatment, 63% (17/27) cases achieved more than 30% of the clinical symptoms alleviated. Among them, 44.4% (12/27) achieved more than 50% of the clinical symptoms alleviated, 22.2% (6/27) reached more than 70% of the clinical symptoms eased 5 cases discontinued because of recurrent infections or the ineffective treatment; 16 cases continued treatment to 6 months Among them, 55.6% (15/27) cases achieved more than 30% clinical symptoms alleviated, 40.7% (11/27) achieved more than 50% clinical symptoms alleviated, 29.6% (8/27) reached more than 70% of the clinical symptoms eased. After 6 month, 3 cases that had more than 70% symptom in remission were recurrent because of repeated infection. 4 cases maintain biological preparation treatment up to two years, 3 of them were in stable condition, and 1 switch to other biological agents because that his bone destruction continued.
Conclusions
The ACR Ped-30, 50, 70 can evaluate the clinical efficacy of tumor necrosis factor antagonists in the treatment of refractory systemic juvenile idiopathic arthritis.
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