Session Information
Date: Tuesday, November 7, 2017
Title: Pediatric Rheumatology – Clinical and Therapeutic Aspects Poster III: Juvenile Arthritis
Session Type: ACR Poster Session C
Session Time: 9:00AM-11:00AM
Background/Purpose: A Phase 3b, open-label (OL), multicenter study (CLIPPER) has shown the safety of etanercept (ETN) in pediatric patients (pts) with extended oligoarticular (eo) juvenile idiopathic arthritis (JIA), enthesitis-related arthritis (ERA), and psoriatic arthritis (PsA). CLIPPER2 is an ongoing OL extension study assessing long-term safety and clinical benefits of ETN in this population. The objective of the current study was to describe the safety of 6 years (y) of ETN treatment in the CLIPPER (2-y) and CLIPPER2 (4-y) studies.
Methods: 127 pts with eoJIA (2-17 y), ERA, or PsA (each 12-17 y) who received ≥1 ETN dose (0.8 mg/kg QW [max, 50 mg]) in CLIPPER were eligible to enter CLIPPER2. Long-term safety of ETN treatment was assessed as the total incidence of events from CLIPPER baseline (BL) to month (m) 72, frequency of events per 100 patient-years (EP100PY), and frequency of events in each study year.
Results: 109/127 (86%) pts entered CLIPPER2. At m72, 39/127 (31%) were actively taking ETN, 6 (5%) had withdrawn from treatment due to low/inactive disease, 7 (6%) had re-started ETN following an earlier withdrawal from treatment, 36 (28%) had stopped ETN (but remained in the study under observation), and 37 (29%) had permanently discontinued from the CLIPPER studies. The safety of ETN treatment from BL to m72, including incidence of treatment-emergent adverse events (TEAEs) and infections, and patient withdrawals owing to these, is shown in Table 1. From BL to m72, the most frequently reported TEAEs were (N [EP100PY]), headache (28 [5.34]), arthralgia (24 [4.58]), pyrexia (20 [3.81]), diarrhea, and leukopenia (both 12 [2.29]). All 32 serious TEAEs occurred at a rate of ≤3 events each. In this study, only 1 case of malignancy (Hodgkin’s lymphoma) was reported (1 patient with eoJIA in y3 of the study). There were no cases of active tuberculosis or demyelinating disorders, and no deaths. The number and frequency (N [EP100PY]) of TEAEs (excluding infections/ISRs) decreased over the 6-y study period from 193 [173.81] in y1 to 37 [61.34] in y6 (Table 2). The number and frequency of TE infections and serious TE infections also decreased over the 6-y study period. The incidence of serious TEAEs, however, varied from a high of 10 [9.61] in y2 to a low of 0 in y4 with no clear trend of decrease with time.
Conclusion: OL ETN treatment to m72 was well tolerated. Frequency of TEAEs and TE infections decreased over time. Trial Registration: NCT00962741/NCT01421069
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Table 1. ETN safety summary (from CLIPPER BL to m72) N (EP100PY) unless otherwise stated |
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|
eoJIA EXP=245.607 PY |
ERA EXP=158.888 PY |
PsA EXP=119.945 PY |
Total EXP=524.441 PY |
|
|
TEAEs* |
244 (99.35) |
151 (95.04) |
90 (75.03) |
485 (92.48) |
|
Serious TEAEs* |
11 (4.48) |
17 (10.70) |
4 (3.33) |
32 (6.10) |
|
TE infections |
351 (142.91) |
93 (58.53) |
117 (97.54) |
561 (106.97) |
|
Serious TE infections |
5 (2.04) |
4 (2.52) |
4 (3.33) |
13 (2.48) |
|
Opportunistic infections† |
0 |
1 (0.63) |
1 (0.83) |
2 (0.38) |
|
TEAEs* causing withdrawal, n (%) |
5 (2.04) |
8 (5.03) |
0 |
13 (2.48) |
|
TE infections causing withdrawal, n (%) |
2 (0.81) |
0 |
1 (0.83) |
3 (0.57) |
|
Data from patients taking ETN (FAS) *Excluding infections/ISRs †All herpes zoster EXP, exposure to ETN; FAS, full analysis set; ISRs, injection-site reactions; PY, patient-years; TE, treatment-emergent |
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Table 1. ETN safety summary (from CLIPPER BL to m72) N (EP100PY) unless otherwise stated |
||||
|
eoJIA EXP=245.607 PY |
ERA EXP=158.888 PY |
PsA EXP=119.945 PY |
Total EXP=524.441 PY |
|
|
TEAEs* |
244 (99.35) |
151 (95.04) |
90 (75.03) |
485 (92.48) |
|
Serious TEAEs* |
11 (4.48) |
17 (10.70) |
4 (3.33) |
32 (6.10) |
|
TE infections |
351 (142.91) |
93 (58.53) |
117 (97.54) |
561 (106.97) |
|
Serious TE infections |
5 (2.04) |
4 (2.52) |
4 (3.33) |
13 (2.48) |
|
Opportunistic infections† |
0 |
1 (0.63) |
1 (0.83) |
2 (0.38) |
|
TEAEs* causing withdrawal, n (%) |
5 (2.04) |
8 (5.03) |
0 |
13 (2.48) |
|
TE infections causing withdrawal, n (%) |
2 (0.81) |
0 |
1 (0.83) |
3 (0.57) |
|
Data from patients taking ETN (FAS) *Excluding infections/ISRs †All herpes zoster EXP, exposure to ETN; FAS, full analysis set; ISRs, injection-site reactions; PY, patient-years; TE, treatment-emergent |
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To cite this abstract in AMA style:
Foeldvari I, Constantin T, Vojinovic J, Horneff G, Dehoorne J, Susic G, Kobusinska K, Panaviene VV, Zuber Z, Stanevicha V, Chasnyk V, Pedersen R, Bukowski JF, Hinnershitz T, Vlahos B, Martini A, Ruperto N. An Open-Label Extension Study to Assess the Long-Term Safety of Etanercept in Pediatric Patients with Extended Oligo, Enthesitis Related, and Psoriatic Juvenile Idiopathic Arthritis: 6-Year Data from the Clipper Studies [abstract]. Arthritis Rheumatol. 2017; 69 (suppl 10). https://acrabstracts.org/abstract/an-open-label-extension-study-to-assess-the-long-term-safety-of-etanercept-in-pediatric-patients-with-extended-oligo-enthesitis-related-and-psoriatic-juvenile-idiopathic-arthritis-6-year-data-from/. Accessed .« Back to 2017 ACR/ARHP Annual Meeting
ACR Meeting Abstracts - https://acrabstracts.org/abstract/an-open-label-extension-study-to-assess-the-long-term-safety-of-etanercept-in-pediatric-patients-with-extended-oligo-enthesitis-related-and-psoriatic-juvenile-idiopathic-arthritis-6-year-data-from/