Session Information
Session Type: Late-Breaking Abstracts
Background/Purpose:
BeSt for Kids compares 3 Disease Modifying Anti Rheumatic Drug (DMARD) strategies in juvenile idiopathic arthritis (JIA) patients, for time to inactive disease, time to flare after DMARD discontinuation, ACRpedi scores, functional ability, safety, and radiological damage. Follow up will be 2 years. Here we present the 3 months clinical outcome of the initial treatments.
Methods:
Recent onset, DMARD naïve JIA patients (Rheumatoid Factor-negative polyarticular, oligoarticular or with psoriasis (ILAR-criteria), < 18 months symptom duration) were randomized (per center, variable blocks) to 3 treatment strategies: 1. sequential DMARD-monotherapy (starting with sulfasalazine (SSZ) 50mg/kg/day or methotrexate (MTX) 10mg/m2/week, based on physician’s preference), 2. combination therapy: MTX 10mg/m2/week and 4 weeks prednisolone-bridging 0.5mg/kg/day, in 2 weeks tapered to nil, and 3. combination therapy with MTX 10mg/m2/week and etanercept 0.8mg/kg/wk.
MTX was combined with folic acid 5mg/week. NSAIDs and intra-articular steroids are permitted in all patients. Treatment adjustments were made every 3 months after assessment by a trained examiner who remained unaware of allocated treatment group. Target was ACRpedi50 after 3 months and from 6 months of follow-up and onwards the treatment target was inactive disease.
Results:
From October 2009 to April 2014, 95 children, of which 33% boys, were enrolled: 32 in arm 1, 32 in arm 2 and 31 in arm 3. Baseline median (IQR) age was 9.1 (4.7-12,9) years. 38% were ANA positive, 12 patients had oligoarticular disease, 68 patients oligoextended/polyarticular JIA and 15 patients had JIA with psoriasis. Baseline median (IQR) ACRpedi scores: VAS physician 49 (40-58) mm, VAS patient 54 (37-70) mm, ESR 6,5 (2-14,8) mm/hr, number of active joints 8 (5-12), number of joints with limited range of motion 3 (1-5), CHAQ score 0,88 (0,63-1,5). In arm 1, 18/32 had started with MTX, the others with SSZ. One patient in arm 1 (lost to FU) and 1 in arm 3 (uveitis) dropped out before 3 months. Complete visits were included for analysis.
By 3 months ACRpedi30 was reached by 14/31 (45%), 15/31 (48%), 20/29 (69%) of patients in arms 1-3, respectively (p=0.14). ACRpedi50 was reached by 7/31 (23%), 12/31 (39%) and 15/29 (52%) (p=0.065, arm 1 vs 2 p=0.17, 2 vs 3 p=0.31, 1 vs 3 p=0.019) and ACRpedi70 was reached by 3/31 (10%), 5/31 (16%) and 10/29 (34%) in arms 1-3, respectively (p=0.045, arm 1 vs 2 p=0.45, 2 vs 3 p=0.10, 1 vs 3 p=0.020).
Toxicity (mainly gastrointestinal complaints) was similar in the treatment arms. No serious adverse events were reported. In 2/32, 1/32 and 2/31 patients MTX dose was reduced or switched to subcutaneous and 3/18 patients stopped SSZ after 6 weeks because of nausea, malaise and headache.
Conclusion:
After 3 months of initial treatment in a three-armed strategy trial, patients with recent onset JIA achieve more clinical improvement (significantly more ACRpedi50 and 70) on initial combination therapy with MTX and etanercept than on initial MTX or SSZ monotherapy. Numerically, response to initial treatment with MTX and prednisolone bridging seems more effective than monotherapy and less effective than combination with etanercept, but these differences were not statistically significant.
Disclosure:
P. C. E. Hissink Muller,
Pfizer Inc,
3;
D. M. C. Brinkman,
None;
D. Schonenberg,
None;
Y. Koopman-Keemink,
None;
J. M. Van den Berg,
None;
W. P. Bekkering,
None;
M. van Rossum,
Pfizer Inc,
2,
Pfizer Inc,
9;
L. W. van Suijlekom-Smit,
Dutch Arthritis Association,
2,
Pfizer, Roche, Novartis,
5,
Pfizer Inc, Bristol-Myers Squibb,
9;
C. F. Allaart,
None;
R. ten Cate,
Pfizer Inc,
2.
« Back to ACR/ARHP Annual Meeting 2014
ACR Meeting Abstracts - https://acrabstracts.org/abstract/a-comparison-of-three-treatment-strategies-in-recent-onset-dmard-naive-juvenile-idiopathic-arthritis-3-months-results-of-the-best-for-kids-study/