Arthritis & Rheumatism, Volume 60,
October 2009 Abstract Supplement
The 2009 ACR/ARHP Annual Scientific Meeting
Philadelphia October 16-21, 2009.
Aggressive Combination Drug Therapy in Very Early Polyarticular Juvenile Idiopathic Arthritis (A-CUTE-JIA): A Multicenter Randomized Clinical Trial
Tynjala1, Pirjo, Vahasalo2, Paula, Tarkiainen1, Maarit, Aalto1, Kristiina, Kroger3, Liisa, Malin4, Merja, Putto-Laurila5, Anne
Helsinki University Central Hospital, Helsinki, Finland,
Oulu University Hospital,
Kuopio University Hospital,
Tampere University Hospital,
Turku University Hospital,
Rheumatism Foundation Hospital, Heinola
We compared the efficacy of two combination treatment strategies, methotrexate with infliximab (TNF) and synthetic DMARD combination therapy with methotrexate, sulfasalazine and hydroxychloroquine (COMBO) on methotrexate alone (MTX) in early polyarticular juvenile idiopathic arthritis (JIA). The protocol did not include the use of systemic steroids.
We performed multicenter randomized clinical trial in 60 patients with polyarticular JIA aged 416 years with the duration of JIA less than 6 months. Primary endpoint was American College of Rheumatology Pediatric (ACR Pedi) 75 response at 54 weeks. Secondary endpoints included inactive disease at 54 weeks and the time spent in the state of an inactive disease. Outcome was illustrated by Kaplan-Meier analysis and comparison of therapies was performed by Mantel-Cox test, or Kruskall-Wallis and Dunn's test.
Of the 60 patients, 59 completed the trial (64% females). Twenty-two (37%) had ANA, 13 (22%) were HLA-B27 positive, and one (2%) RF positive. At baseline their mean (± SE) duration of JIA was 0.10 ± 0.02 years, age 9.6 ± 0.4 years, ESR 36 ± 4 mm/hr, active joints 18 ± 1, physician's global 55 ± 2 mm, and CHAQ 0.763 ± 0.082.
Primary endpoint: 42 patients (71%) had ACR Pedi 75 response; 19 (100%) receiving TNF, 13 (65%) COMBO and 10 (50%) MTX (p<0.0001). The difference was significant between TNF and MTX (p<0.0001), and TNF and COMBO (p=0.0005), but not between COMBO and MTX.
Secondary endpoint: At 54 weeks, 13 patients (68%) receiving TNF, 8 (40%) receiving COMBO and 5 (25%) receiving MTX (p=0.002) had inactive state of the disease. Those on TNF reached inactive disease more often than those on MTX (p=0.02), but the response between COMBO and TNF (p=0.050), or COMBO and MTX (p=0.220) was not significant. During the 54-week follow-up, those on TNF spent a mean of 26 weeks (95% CI 1834) in inactive state of disease. This was longer than those on COMBO (13 weeks, 95% CI 620; p=0.044 compared with TNF), or those on MTX (6 weeks, 95% CI 210; p=0.001 compared with TNF), but the difference between COMBO and MTX was not statistically significant.
When the target was ACR Pedi 75 response within the first year of therapy in early polyarticular JIA, infliximab plus methotrexate turned out to be superior to synthetic DMARD combination, and even more clearly, superior to MTX monotherapy.
To cite this abstract, please use the following information:
Tynjala, Pirjo, Vahasalo, Paula, Tarkiainen, Maarit, Aalto, Kristiina, Kroger, Liisa, Malin, Merja, et al; Aggressive Combination Drug Therapy in Very Early Polyarticular Juvenile Idiopathic Arthritis (A-CUTE-JIA): A Multicenter Randomized Clinical Trial [abstract]. Arthritis Rheum 2009;60 Suppl 10 :2051