Background/Purpose: Biological agents licensed in JIA have demonstrated a favourable benefit-to-risk profile. Nevertheless, intolerance, loss and lack of efficacy or adverse events have led to try other therapeutic options. Ultrasound can help in the assessment of active synovitis. The purpose of this study was to evaluate efficacy and safety of Golimumab in young adults affected by JIA with active polyarthritis (with or without uveitis), non responders to MTX, antiCD20 and anti-IL-1 and intolerant to the first generation of antiTNF (Infliximab, Etanercept and Adalimumab) by EULAR criteria and power Doppler ultrasound (PDUS).

Methods:

In our Centre, since november ‘99 to  dicembre 2011, 288 patients affected by refractory JIA were treated with TNF inhibitors and since May 2011, 25 patients (16 F, 9 M) affected by refractory JIA, non responders  to other biologic agents, were enrolled in  Golimumab (Simponi).

Patients had failed MTX as monotherapy, previous TNF inhibitors, Rituximab and anti-IL1 therapy. Two patients had been treated with 8 different biologic agents, 1 patient with 7, 2 patients with 6, 5 patients with 5, 3 with 3, 7 with 2 and 3 patients with just one previous biologic agent. 

Two patients had a Systemic onset of JIA, 4 polyarthritis RF negative,  3 enthesitis related arthritis, 1 psoriatic arthritis, 6 oligoarthritis persistent and 9 oligoarthritis extended. Median age was of 28.7 years, median onset age 7.3 years, median disease duration  19.8 years. All patients had active disease according to EULAR criteria, 8 patients had a previous history of chronic Iridocyclitis. Patients received Golimumab at the dose of 50 mg subcutaneously every month, as in RA. Fifteen patients receive Golimumab in association with MTX. All patients underwent basal assessment of DAS 28 and after 4 months DAS 28 and PDUS assessment of the same 28 joints. Presence of synovitis at PDUS examination was considered in presence of at least one between joint effusion, synovial thickening and power Doppler signal detected in accordance to OMERACT criteria.

Results: Seventeen patients (68%) were responders according both to DAS 28 and PDUS, 5 patients were not evaluable because of follow-up less than 12 weeks and 3 patients were non responders (1 of these 3 pts dropped-out). In non responder patients PDUS showed a higher number of joints involved. No adverse events were observed. No adverse events occured.

Conclusion: Golimumab seems to be effective and well tolerated and could be a good treatment of long lasting refractory JIA in young adults who failed other biologics. Data found are confirmed by PDUS examination. This study seem to be one of the first experiences in the use of Golimumab in young adults affected by JIA.

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ACR Meeting Abstracts - https://acrabstracts.org/abstract/golimumab-in-25-young-adults-affected-by-juvenile-idiopathic-arthritis-non-responders-to-other-biological-agents-preliminary-data/