FRI0543 EFFICACY AND SAFETY OF INTRAVENOUS GOLIMUMAB IN PATIENTS WITH JUVENILE IDIOPATHIC ARTHRITIS: RESULTS FROM A PHASE 3 OPEN-LABEL STUDY
Authors: Nicolino Ruperto, Alberto Spindler, Cesar Francisco Pacheco Tena, Ingrid Louw, Gabriel Vega Cornejo, Daniel Kingsbury, Michael Clark, Karen Bensley, LI Xiaoming, Hermine Brunner
Journal: Annals of the Rheumatic Diseases (2019)

<h3>Objectives</h3> To assess efficacy &amp; safety of intravenous golimumab in pediatric patients with active polyarticular course juvenile idiopathic arthritis despite methotrexate therapy through 28 weeks of treatment. <h3>Methods</h3> A multicenter, Phase 3, single arm, open-label trial was conducted using intravenous golimumab at a dose of 80mg/m<sup>2</sup> given at weeks 0 &amp; 4, then every 8 weeks thereafter, in pediatric patients ages 2-17 years old with active polyarticular course juvenile idiopathic arthritis despite methotrexate therapy. Patients received commercial MTX weekly at same BSA-based dose as at time of study entry. All the results below are based on full analysis set which includes all patients who received at least 1 dose of study agent. <h3>Results</h3> 180 patients were screened (130 enrolled, 127 treated) with the first patient screened on 22Dec2014; last patient first treated 26Dec2017, &amp; last patient’s Wk28 visit was 09Jul2018. Proportion of JIA ACR 30,50,70, &amp; 90 responders at Wk28 was 83.5%,79.5%,70.1%, &amp; 46.5%, respectively. 29.1% of patients met criteria for inactive disease at Wk28. Median change from baseline for JASDAS 10, 27, &amp; 71 was -14.20, -16.60, &amp; -20.32, respectively at Wk28. JADAS 10, 27, &amp; 71 minimal disease activity was met by 15% of patients at Wk28. Proportion of patients experiencing at least 1 treatment-emergent AE through Wk28 was 77.2%. MedDRA system organ class with highest incidence of AEs was Infections &amp; infestations (57.5%);most commonly reported AE upper respiratory tract infection(17.3%), then nasopharyngitis(15.0%).Six patients experienced serious AEs through Wk28: Herpes zoster disseminated, Infective exacerbation of bronchiectasis, Sepsis, Varicella, Mycosis fungoides, &amp; Suicidal ideation. These events resulted in permanent discontinuation of intravenous golimumab, except for Varicella. <h3>Conclusion</h3> Intravenous golimumab delivered at a dose of 80mg/m2 at weeks 0 &amp; 4, then every 8 weeks thereafter and appears to be effective in these patients with a safety profile similar to other TNF inhibitor therapies. <h3>Disclosure of Interests</h3> Nicolino Ruperto Grant/research support from: The Gaslini Hospital, where NR works as full-time public employee, has received contributions (&gt; 10.000 USD each) from the following industries in the last 3 years: BMS, Eli-Lilly, GlaxoSmithKline, F Hoffmann-La Roche, Janssen, Novartis, Pfizer, Sobi. This funding has been reinvested for the research activities of the hospital in a fully independent manner, without any commitment with third parties., Consultant for: Received honoraria for consultancies or speaker bureaus (&lt; 10.000 USD each) from the following pharmaceutical companies in the past 3 years: Ablynx, AbbVie, Astrazeneca-Medimmune, Biogen, Boehringer, Bristol-Myers Squibb, Eli-Lilly, EMD Serono, GlaxoSmithKline, Hoffmann-La Roche, Janssen, Merck, Novartis, Pfizer, R-Pharma, SanofiServier, Sinergie, Sobi and Takeda., Speakers bureau: Received honoraria for consultancies or speaker bureaus (&lt; 10.000 USD each) from the following pharmaceutical companies in the past 3 years: Ablynx, AbbVie, Astrazeneca-Medimmune, Biogen, Boehringer, Bristol-Myers Squibb, Eli-Lilly, EMD Serono, GlaxoSmithKline, Hoffmann-La Roche, Janssen, Merck, Novartis, Pfizer, R-Pharma, SanofiServier, Sinergie, Sobi and Takeda., Alberto Spindler: None declared, Cesar Francisco Pacheco Tena Grant/research support from: Janssen Research &amp; Development, LLC, Ingrid Louw Consultant for: Advisory committee: Roche, Novartis, Pfizer, Gabriel Vega Cornejo Grant/research support from: I currently have no conflicts of interest, I am only setting protocols for the pharmaceutical industry with Parexel, Sanofi and Bristol-Myers Squibb., Daniel Kingsbury Grant/research support from: Clinical trial support from Bristol-Myers Squibb, Michael Clark Shareholder of: Johnson &amp; Johnson, Employee of: Janssen Research &amp; Development, LLC, Karen Bensley Shareholder of: Johnson &amp; Johnson, Employee of: Janssen Research &amp; Devvelopment, LLC, Xiaoming Li Shareholder of: Johnson &amp; Johnson, Employee of: Janssen Research &amp; Development, LLC, Hermine Brunner Grant/research support from: Bristol-Myers Squibb, Pfizer, Consultant for: Pfizer, Bristol-Myers Squibb, Janssen, Novartis, Lilly, Roche, GlaxoSmithKline, Sanofi, Speakers bureau: Novartis, Roche