Results Of a 24 Month Extension Study In Patients Who Participated In The Trial Of Early Aggressive Therapy In Polyarticular Juvenile Idiopathic Arthritis

Carol A. Wallace¹, John Bonsack², Steven J. Spalding³, Hermine Brunner⁴, Kathleen M. O'Neil⁵, Diana Milojevic⁶, Sarah Ringold⁷, Laura E. Schanberg⁸, Gloria C. Higgins⁹, Beth S. Gottlieb¹⁰, Joyce J. Hsu¹¹, Marilynn G. Punaro¹², Yukiko Kimura¹³ and Audrey F. Hendrickson¹⁴, ¹University of Washington School of Medicine and Seattle Children's Hospital, Seattle, WA, ²Pediatrics, University of Utah Health Sciences Center, Salt Lake City, UT, ³Pediatric Institute, Department of Pediatric Rheumatology, The Cleveland Clinic, Cleveland, OH, ⁴Division of Rheumatology, Cincinnati Children's Hospital Medical Center, Cincinnati, OH, ⁵Pediatric Rheumatology, Riley Hospital for Children, Indianapolis, IN, ⁶Dept of Pediatric Rheumatology, University of California, San Francisco, San Francisco, CA, ⁷Pediatrics, Seattle Children's Hospital/Univ of Washington, Seattle, WA, ⁸Pediatrics, Duke University Medical Center, Durham, NC, ⁹Pediatric Rheumatology Ohio State University, Nationwide Childrens Hosp, Columbus, OH, ¹⁰Pediatric Rheumatology, Cohen Children's Medical Center of New York, New Hyde Park, NY, ¹¹Pediatric Rheumatology, Stanford University, Palo Alto, CA, ¹²Pediatric Rheumatology, Texas Scottish Rite Hospital, Dallas, TX, ¹³Pediatric Rheumatology, Joseph M Sanzari Children’s Hospital, Hackensack University Medical Center, Hackensack, NJ, ¹⁴Rheumatology, Seattle Children's Research Institute, Seattle, WA

Meeting: 2013 ACR/ARHP Annual Meeting

Keywords: clinical trials

Session Information

Title: Pediatric Rheumatology - Clinical and Therapeutic Aspects I: Juvenile Idiopathic Arthritis

Session Type: Abstract Submissions (ACR)

Background/Purpose:

The Trial of Early Aggressive Therapy in Polyarticular Juvenile Idiopathic Arthritis (TREAT-JIA) was a double-blind, randomized, placebo-controlled trial in 85 patients with onset of polyarticular JIA < 12 mos to determine if clinical inactive disease (CID) could be achieved by 6 months. Two aggressive treatment arms were used; (i) (MTX arm) SQ methotrexate (MTX; 0.5 mg/kg/wk) or (ii) (M-E-P arm ) etanercept (ETN 0.8 mg/kg/wk), prednisolone (0.5 mg/kg/d tapered to zero by 17 wks) and MTX at the dose above. The purpose of this investigation was to follow these children beyond the original study for 2 additional years to understand the longer-term outcomes.

Methods:

Patients who completed a minimum of 6 mos in the TREAT study were eligible to enroll in this extension study, regardless of response during the original trial and whether or not they continued to receive the same medications. Patients were treated as per standard of care. Physician, patient/parent and laboratory reported measures of disease status and safety information were collected at clinic visits every 3 mos for up to 2 years. Information regarding disease status and safety during the time period between studies was collected from chart review. Adverse events grade 3 and higher as well as infections requiring systemic therapy were reported.

Results:

Twelve of the 15 original TREAT study sites participated and enrolled 52 of 77 (67.5%) eligible patients, 48 of whom returned for follow-up visits. TREAT baseline demographic and disease characteristics as well as disease state at the end of the TREAT trial did not differ between those who participated in the extension and those who did not. At enrollment into the extension study, 21 (44%) were receiving ETN and MTX, 13 (27%) MTX alone, 6 (12%) ETN alone, 7 (15%) no meds or NSAIDs alone, 1 patient each on prednisone, adalimumab and abatacept. Twenty-five (52%) entered the extension study in CID, while 23 (48%) had active disease. Patients were followed for a mean of 21.4 mos (range 9 to 24) and 27 (56%) patients spent more than 50% of their follow up time in CID. Eight patients were in CID >12 months and 2 were in CID off meds for the entire study. Disease activity during periods of AD tended to be low with means of MD global of 2.4; active joint count of 3.5; parent global evaluation of 2.4; CHAQ of 0.32; ESR 19; and morning stiffness of 23 minutes. Patients who were RF(-) tended to spend more study time in CID than RF(+) patients (52% vs 43%), as did patients who were ANA (-) 58% vs 47% ANA (+). Patients who achieved CID at 6 months in the TREAT study tended to spend more time in CID (58% vs 45%) than did those who ended the TREAT study in AD (55% vs 43%). There were no serious adverse events or adverse events grade 3 or higher reported. Four patients had 6 infections requiring systemic antibiotics.

Conclusion:

Early aggressive therapy in this group of polyarticular JIA patients, with high initial disease activity and proportion with RF positivity, was associated with prolonged periods of CID in the majority of patients during this 24 month extension study. Those not in CID had low levels of disease activity.

Disclosure:

C. A. Wallace,

Amgen,

Pfizer Inc,

Novartis Pharmaceutical Corporation,

J. Bonsack,

Novartis Pharmaceutical Corporation,

S. J. Spalding,
None;

H. Brunner,

Novartis, Genentech, Medimmune, EMD, Serono, AMS, Pfizer, UCB, Janssen,

Genentech and Biogen IDEC Inc.,

K. M. O’Neil,

UCB,

D. Milojevic,
None;

S. Ringold,
None;

L. E. Schanberg,

Novartis Pharmaceutical Corporation,

Lilly,

UCB,

Amgen,

BMS,

SOBI,

Pfizer Inc,

G. C. Higgins,
None;

B. S. Gottlieb,
None;

J. J. Hsu,
None;

M. G. Punaro,
None;

Y. Kimura,
None;

A. F. Hendrickson,
None.

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