Session Information
Session Type: Abstract Submissions (ACR)
Background/Purpose: Juvenile idiopathic arthritis (JIA) is one of the most common rheumatic diseases of childhood and adolescents, and improvement in health-related quality of life and functional disability is an important therapeutic goal in the treatment of patients (pts) with JIA. The objective was to evaluate pt-reported outcomes (PROs) in pts with moderately to severely active polyarticular or polyarticular-course JIA (pJIA) who are prescribed and treated with adalimumab (ADA) ± methotrexate (MTX) in routine clinical practice.
Methods: This is an ongoing, multicenter, non-interventional, observational registry of pts diagnosed with moderately to severely active pJIA that are prescribed and treated in a routine clinical setting with either ADA±MTX or MTX alone. Pts with resistant disease, that had received prior MTX treatment, were prescribed and treated with ADA as second line therapy. A cohort of pts with prescribed MTX, naïve to biologics, served as controls. Physical function was measured by the Disability Index of Childhood Health Assessment Questionnaire (DICHAQ), which ranges from 0 (no disability) to 3 (worst disability), and the minimal clinically important difference for improvement is -0.188. Quality of life was assessed by the Child Health Questionnaire-Parent Form (CHQ-PF50), with a scale of 0 (worst possible health state) to 100 (best possible health state). The currently study is limited using data up to 12 months, and all data are as observed.
Results: 842 pts (540 in ADA arm/302 in MTX arm) were enrolled and treated in the registry. The majority of the pts were female (76% and 69% for MTX and ADA, respectively). The mean age at baseline was 9.6 and 12.2 yrs and the mean pJIA disease duration at baseline was 1.3 and 3.7 yrs for MTX and ADA arms, respectively. At baseline mean DICHAQ was 0.62 for both MTX and ADA treatment arms. For those pts with data at both baseline and 12 months, the mean change in DICHAQ was -0.24 and -0.22 for the MTX and ADA arms, respectively, indicating a clinically meaningful difference. From baseline to 12 months, the scores of the individual health concepts in the CHQ-PF50 increased for both the MTX and ADA treatment arms, with the exception of Family Cohesion, as the scores had little change over time (Table). Parental emotional impact had a substantial increase as mean scores changed from 57.8 to 73.0 and 57.0 to 68.8 in the MTX and ADA treatment arms from baseline to 12 months, respectively.
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Table. Summary of Child Health Questionnaire Parent Form (CHQ-PF50) |
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Baseline |
Month 12 |
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MTX |
ADA ± MTX |
MTX |
ADA ± MTX |
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Global Health Mean (SD) n |
73.1 (22.7) 287 |
63.1 (25.6) 466 |
80.8 (17.6) 158 |
73.5 (21.4) 282 |
|
Physical Functioning Mean (SD) n |
73.1 (27.5) 295 |
71.8 (28.2) 473 |
86.1 (21.1) 171 |
81.8 (25.9) 297 |
|
Role/Social Limitations – Emotional/Behavioral Mean (SD) n |
84.7 (26.1) 293 |
79.9 (27.9) 472 |
92.3 (17.7) 170 |
89.8 (20.1) 296 |
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Role/Social Limitations – Physical Mean (SD) n |
78.9 (29.7) 292 |
75.0 (30.3) 472 |
90.7 (20.6) 170 |
86.9 (25.9) 295 |
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Bodily Pain/Discomfort Mean (SD) n |
54.8 (26.4) 295 |
53.3 (28.3) 473 |
75.1 (24.2) 171 |
70.2 (27.0) 296 |
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Behavior Mean (SD) n |
75.3 (17.2) 293 |
77.2 (16.3) 472 |
80.5 (14.7) 170 |
80.4 (17.2) 296 |
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Global Behavior Mean (SD) n |
80.3 (19.6) 276 |
79.6 (19.8) 441 |
81.9 (18.8) 140 |
80.9 (19.7) 263 |
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Mental Health Mean (SD) n |
74.8 (16.3) 293 |
74.7 (17.6) 470 |
79.6 (15.1) 171 |
78.8 (16.6) 295 |
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Self Esteem Mean (SD) n |
78.6 (19.9) 290 |
75.5 (20.9) 470 |
84.7 (17.2) 169 |
79.5 (20.8) 294 |
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General Health Perceptions Mean (SD) n |
60.0 (18.1) 295 |
53.0 (17.4) 471 |
61.2 (17.7) 171 |
55.5 (18.1) 294 |
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Change in Health Mean (SD) n |
2.8 (1.3) 291 |
3.3 (1.4) 463 |
4.3 (0.9) 166 |
4.2 (1.0) 280 |
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Parental Impact – Emotional Mean (SD) n |
57.8 (26.3) 294 |
57.0 (26.9) 472 |
73.0 (21.5) 169 |
68.8 (25.6) 295 |
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Parental Impact – Time Mean (SD) n |
77.5 (25.6) 294 |
76.6 (27.2) 472 |
87.1 (19.9) 169 |
83.7 (22.1) 293 |
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Family Activities Mean (SD) n |
77.6 (22.0) 294 |
78.6 (21.7) 472 |
86.8 (16.4) 169 |
85.0 (18.9) 295 |
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Family Cohesion Mean (SD) n |
80.7 (19.4) 293 |
76.8 (20.9) 469 |
79.5 (21.3) 169 |
77.4 (22.1) 291 |
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Conclusion: Over the course of 12 months of treatment, pts with pJIA in the ADA treatment arm demonstrated clinically meaningful improvements in functional disability as well as an increase in the scores of the individual health concepts, indicating an improvement in health-related quality of life. The extent of improvement was comparable to that in the MTX treatment arm.
Disclosure:
G. Horneff,
AbbVie, Pfizer, and Roche ,
2,
AbbVie, Novartis, Pfizer, and Roche,
8;
C. A. Wallace,
Pfizer and Amgen ,
2,
Amgen and Novartis,
5;
P. Quartier,
AbbVie, Novartis, Pfizer, BMS, Chugai-Roche, Medimmune, Servier, and Swedish Orphan Biovitrum,
2,
AbbVie, Novartis, Pfizer, BMS, Chugai-Roche, Medimmune, Servier, and Swedish Orphan Biovitrum,
5;
D. J. Kingsbury,
AbbVie,
9;
K. Minden,
Pfizer and Abbvie,
2,
Pfizer, Abbvie, Roche/Chugai, Novartis, Medac and Pharm-Allergan,
5;
M. Bereswill,
AbbVie,
1,
AbbVie,
3;
V. Garg,
AbbVie,
1,
AbbVie,
3;
H. Kupper,
AbbVie,
1,
AbbVie,
3;
J. Kalabic,
AbbVie,
1,
AbbVie,
3.
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ACR Meeting Abstracts - https://acrabstracts.org/abstract/patient-reported-outcomes-in-children-with-moderately-to-severely-active-polyarticular-or-polyarticular-course-juvenile-idiopathic-arthritis-who-are-prescribed-and-treated-with-adalimumab/