Better understanding of pathogenesis of juvenile idiopathic arthritis (JIA) have led to the use of a number of biological agents in last two decades [1]. Their high cost and potential adverse effects preclude them from being used as first-line agents in developing countries. Their most important adverse effect is infection, and in India, tuberculosis is of particular concern [2]. Aim of the present study was to evaluate the adverse events and response to biological agents in patients with JIA, and to provide description of challenges in way of treatment of JIA with biological agents.

We conducted chart review of all patients diagnosed to have JIA and treated with biological agents in our center. Diagnosis of JIA was based on International League of Associations for Rheumatology Criteria [3]. They were treated as per guidelines of American College of Rheumatology [4]. Selected patients who were refractory or had responded inadequately to conventional therapy, were explained the need of biological therapy. It was prescribed on an individual basis to those who could afford it. Screening for tuberculosis was done before the initiation of therapy. Patients were followed up every 4-12 weeks and the following information was extracted from their records: demographic profile, clinical phenotype, laboratory results, therapy, response and side effects. As available data might not suffice for standard outcome criteria [5,6], response to treatment was defined as complete response (no or minimal residual symptoms, with no requirement for supplementary agents to maintain clinical remission and normal laboratory study findings), no response (no or minimal clinical benefit), and partial response (intermediate between remission and absent response) [7].

Biological agents were given in 14 patients between March 2012 – July 2015. Four patients were excluded because total duration of follow up was less than 12 weeks in two, and discontinuation of therapy (because of financial constraints) in two patients. Before commencing biological agent, all 10 patients (7 males) were on disease modifying antirheumatoid drugs (DMARDS), and 7 were on systemic steroids. Mean (SD) age of study population at onset of disease and at commencing biological agents was 4.8 (2.7) and 7.3 (3.6) years, respectively. Median (range) duration of follow up following initiation of biological agents was 11 (range 4-41) months. Clinical profile of the patients who received biological agents are summarized in Table I.

TABLE I Clinical Profile of Patients with Juvenile Idiopathic Arthritis  Who Received Biological Agents

Clinical response was seen in nine out of 10 patients. Eight patients achieved complete response, while one had partial response. Median (IQR) time to show response for systemic features was 15 (15,20) days, and for articular disease was 40 (30,75) days. Five out of 7 patients were free of steroids by three months. One patient suffered from bronchopneumonia necessitating systemic antibiotics, and another had minor reactions related to tocilizumab infusion. No case of tuberculosis, malignancy or death occurred while on treatment.

Experience with these agents in Indian patients is scant. With biological agents, substantial proportion of patients were able to discontinue systemic steroids. Efficacy to the biological agents in published literature (75-85%) is comparable to the present study [8-10]. Limitation of present set of data includes small number of patients, lack of standardized outcome criteria due to retrospective study design and use of biological agents in only those who could afford. Two patients had to stop treatment due to high cost. We conclude that biological agents can be used in children who fail conventional treatment without risk of increased incidence of infection.

Contributors: IS: Data collection, analysis and manuscript writing; LD: data collection and manuscript writing; NG: data collection and manuscript writing; SKK: data collection, analysis, manuscript writing, and will act as guarantor for the study

Funding: None; Competing Interests: None stated

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