STRATEGY TO PREVENT TUBERCULOSIS DURING ANTI TNF THERAPY IN JUVENILE ANKYLOSING - SPONDYLITIS WITH LOW DOSE INFLIXIMAB WITHOUT LOADING SCHEDULE : A ONE YEAR OPEN LABEL STUDY OF TOXICITY AND EFFICACY IN 15 PATIENTS
Shalini Singh*, VK Singal**, Ved Chaturvedi ***
Dept of Rheumatology Army Hospital (RR), Delhi Cantt-10.*, Dept of Rheumatology Army Hospital (RR), Delhi Cantt-10.**, Dept of Rheumatology Army Hospital (RR), Delhi Cantt-10.***
Aim
Anti TNF Alpha therapy, although effective in adult Ankylosing spondylitis (AS) is feared with increase incidence of infections, e.g., tuberculosis, especially in Indian population. The experience of this therapy in juvenile AS is scanty. This retrospective study was done to investigate the toxicity and efficacy of Infliximab (IFX) in active Juvenile AS during low dose without loading schedule.
Materials and Methods
15 patients with active Juvenile AS, who met the selection criteria and gave their written consent were included in this open label study in which patients received a 3 mg/kg IFX infusion at every 8 week and were followed through 52 week. Loading dose of IFX was not used. Demographic data, medical history, physical examination and relevant lab investigations including HLA B27 were performed at screening visit. Patients included in this study had a pelvic X-ray showing bilateral Sacroiliitis, a bath AS disease activity index (BASDAI)> 4 and a spinal pain score> 40 despite adequate trial of Sulfasalazine and NSAIDS. Follow-up visit were scheduled at week every 8 week to assess the efficacy and safety of IFX. Assessment of pain on a 0-100 mm visual analog scale (VAS), BASDAI and patient global assessment were the primary endpoints.
Results
15 male patients with mean age group 13.4 years (11-17) and mean disease duration ranging from 1 to 3 years were included in this study. 3 patients were treated with one infusion, 6 patients were treated with two infusions, 5 patients were treated with three infusions.

1 patient was treated with four infusions. Most patients showed clinically significant improvements in assessment of pain, BASDAI, and duration of morning stiffness as compared with baseline. (Table 1)

Table 1. Efficacy of Infliximab in Juvenile AS patients

Primary endpoints (Mean) Baseline Week 8 Week 24 Week 52
VAS (0-100) 69.2

48.3

37.3 36.7
BASDAI 58

31

20 18
PGA (0-100 mm) 72 44 40 24


Safety: No case of tuberculosis was observed during study period in spite of objectively searching for it. Other side effects are depicted in (Table 2)

Table 2. Toxicity of Infliximab in juvenile AS patients.

Tuberculosis Nil
Infusion reaction
Superficial fungal infection
Upper resp tract infection
Jaundice
1
1
1
1
Conclusions
Conclusions: In this group of active Juvenile AS patients, IFX has resulted in a clinically significant improvement in most efficacy parameters. We have not seen any case of Tuberculosis during study period. It seems 3 mg/kg given every eight week without loading dose is safe and efficacious in this group of patients.
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