Session Information
Session Type: Abstract Submissions (ACR)
Background/Purpose:
Children with enthesitis-related arthritis (ERA) require medical therapy to control inflammation and restore normal function; however, the use of multiple medications and for longer periods than needed is of special concern in the pediatric population. The objective of this analysis is to evaluate the proportion of patients (pts) who discontinued one or more concomitant medications for pediatric ERA during the first 52 weeks (wk) of adalimumab (ADA) treatment.
Methods:
This is a phase 3, multicenter, randomized, double-blind study in pts aged ≥6 to <18 years (yr) with active ERA not responsive to ≥1 NSAID and ≥1 DMARD. Pts were randomized 2:1 to receive blinded ADA (24 mg/m2BSA up to 40 mg every other wk) or placebo (PBO) for 12 wks followed by open-label (OL) ADA up to 144 wks. Active disease was defined as: ≥3 active joints (AJC; swelling not due to deformity or joints with loss of motion plus pain and/or tenderness) and evidence of enthesitis in ≥1 location (documented in the past or present at baseline [BL]). Pts could enter the study on stable doses of concomitant NSAIDs, DMARDs (methotrexate [MTX] or sulfasalazine [SSZ]), and corticosteroids (CSs); doses remained stable during the first 12 wks except as medically required due to adverse event (AE). Dose adjustment or treatment induction with these agents was permitted after wk 12. Discontinuation of concomitant ERA medications was not required in the protocol and was at the discretion of the treating physician. Concomitant use was defined as use of the drug at any time during the study through wk 52.
Results:
46 pts were randomized (PBO 15, ADA 31). At BL, mean duration of ERA symptoms was 2.6 yrs; mean AJC was 7.8, and mean enthesitis count was 8.1. Mean % change from BL to wk 12 in AJC (primary endpoint) was greater in the ADA group vs. PBO (-63% vs -12%, P=0.039), with 89% overall reduction in AJC from BL through wk 52. Prior use of NSAIDs, DMARDs, and CSs was reported in 100%, 91%, and 57% of pts, respectively. Concomitant use of ERA drugs at BL is shown in the table. 16 pts (35%) stopped NSAIDs, 5 pts (11%) stopped DMARDS (2 SSZ, 3 MTX), and 7 pts (15%) stopped CSs without restarting prior to wk 52; NSAIDs were stopped in 3 pts due to AEs. 3 pts discontinued the study due to AE (2) or inefficacy (1) during OL period. Of those remaining in the study at wk 52, 8/43 (19%) were completely off concomitant ERA drugs. At wk 52 mean % change from BL in AJC was -81.8% in pts who stopped NSAIDs, -72.4% in pts who stopped DMARDs, -97.1% in pts who stopped CSs, and -82.9% in pts who stopped all NSAIDs and DMARDs.
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Table. Concomitant Medications for Enthesitis-Related Arthritis |
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Placebo/Adalimumab N = 15 n (%) |
Adalimumab/Adalimumab N = 31 n (%) |
Total N = 46 n (%) |
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NSAIDs |
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At baseline |
13 (87) |
24 (77) |
37 (80) |
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At week 52a |
8 (57) |
14 (48) |
22 (51) |
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DMARDs |
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At baseline |
11 (73) |
21 (68) |
32 (70) |
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At week 52a |
9 (64) |
18 (62) |
27 (63) |
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Corticosteroids |
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At baseline |
4 (27) |
8 (26) |
12 (26) |
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At week 52a |
3 (21) |
4 (14) |
7 (16) |
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NSAID +DMARD |
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At baseline |
10 (67) |
15 (48) |
25 (54) |
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At week 52a |
5 (36) |
7 (24) |
12 (28) |
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ADA Monotherapyb |
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At baseline |
0 |
1 (3) |
1 (2) |
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At week 52a |
3 (21) |
5 (17) |
8 (19) |
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aObserved data; includes pts who started ERA concomitant medication after the double-blind period; includes 3 pts who discontinued the study after week 12 and prior to week 52; N=14/29/43, PBO/ADA/total. bADA monotherapy = no concomitant NSAID, DMARD, or corticosteroid. ADA, adalimumab; DMARD, disease-modifying antirheumatic drug; NSAID, nonsteroidal anti-inflammatory drug. |
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Conclusion:
Clinical improvement with ADA through 52 wks allowed some pts to discontinue concomitant NSAIDs, DMARDs, or CSs for ERA at the investigator’s discretion. Clinical response was generally maintained in pts who stopped 1 or more concomitant medications. Standardized discontinuation of concomitant ERA medications in ADA responders may have resulted in a higher number of pts able to discontinue concomitant ERA therapies.
Disclosure:
S. M. Tse,
AbbVie,
2,
AbbVie, Pfizer,
5;
R. Burgos-Vargas,
AbbVie,
2,
AbbVie, BMS, Janssen, Pfizer, and Roche,
5,
AbbVie, BMS, Janssen, Pfizer, and Roche,
8;
G. Horneff,
AbbVie, Pfizer, and Roche ,
2,
AbbVie, Novartis, Pfizer, and Roche,
8;
A. L. Pangan,
AbbVie,
1,
AbbVie,
3;
J. Kalabic,
AbbVie,
1,
AbbVie,
3;
K. Unnebrink,
AbbVie ,
1,
AbbVie ,
3;
J. K. Anderson,
AbbVie,
1,
AbbVie,
3.
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ACR Meeting Abstracts - https://acrabstracts.org/abstract/discontinuation-of-concomitant-medication-for-enthesitis-related-arthritis-during-52-weeks-of-treatment-with-adalimumab/