TY - JOUR
T1 - Ten-year safety and clinical benefit from open-label etanercept treatment in children and young adults with juvenile idiopathic arthritis
AU - Vojinović, Jelena
AU - Foeldvari, Ivan
AU - Dehoorne, Joke
AU - Panaviene, Violeta
AU - Susic, Gordana
AU - Horneff, Gerd
AU - Stanevicha, Valda
AU - Kobusinska, Katarzyna
AU - Zuber, Zbigniew
AU - Dobrzyniecka, Bogna
AU - Akikusa, Jonathan
AU - Avcin, Tadej
AU - Borlenghi, Cecilia
AU - Arthur, Edmund
AU - Tatulych, Svitlana Y
AU - Zang, Chuanbo
AU - Tsekouras, Vassilis
AU - Vlahos, Bonnie
AU - Martini, Alberto
AU - Ruperto, Nicolino
AU - Paediatric Rheumatology International Trials Organisation (PRINTO)
N1 - © The Author(s) 2023. Published by Oxford University Press on behalf of the British Society for Rheumatology.
PY - 2023/5/4
Y1 - 2023/5/4
N2 - OBJECTIVES: CLIPPER2 was an 8-year, open-label extension of the phase 3 b, 2-year CLIPPER study on the safety and efficacy of etanercept in patients with juvenile idiopathic arthritis (JIA), categorized as extended oligoarticular arthritis (eoJIA), enthesitis-related arthritis (ERA), or psoriatic arthritis (PsA).METHODS: Participants with eoJIA (2-17 years old), ERA, or PsA (each 12-17 years old) who received ≥1 etanercept dose (0.8 mg/kg weekly; maximum 50 mg) in CLIPPER could enter CLIPPER2. Primary end point was occurrence of malignancy. Efficacy assessments included proportions achieving JIA American College of Rheumatology (ACR) 30/50/70/90/100 criteriaand ACR inactive disease criteria, and clinical remission (ACR criteria) or Juvenile Arthritis Disease Activity Score (JADAS) ≤1.RESULTS: Overall, 109/127 (86%) CLIPPER participants entered CLIPPER2 (n = 55 eoJIA, n = 31 ERA, n = 23 PsA; 99 [78%] on active treatment); 84 (66%) completed 120 months' follow-up (32 [25%] on active treatment). One malignancy (Hodgkin's disease in 18-year-old patient with eoJIA treated with methotrexate for 8 years) was reported; there were no cases of active tuberculosis or deaths. Numbers and incidence rates [events per 100 patient-years] of TEAEs (excluding infections/ISRs) decreased from 193 [173.81] in Year 1-9 [27.15] in Year 10; TE infections and serious infections also decreased. Over 45% of participants (N = 127) achieved JIA ACR50 responses from Month 2 onwards; 42 (33%) and 17 34 (27%) participants achieved JADAS and ACR clinical remission, respectively.CONCLUSIONS: Etanercept treatment up to 10 years was well tolerated, consistent with the known safety profile, with durable response in the participants still on active treatment. The benefit-risk assessment of etanercept in these JIA categories remains favorable.CLINICALTRIALS.GOV IDS: CLIPPER (NCT00962741); CLIPPER2 (NCT01421069).
AB - OBJECTIVES: CLIPPER2 was an 8-year, open-label extension of the phase 3 b, 2-year CLIPPER study on the safety and efficacy of etanercept in patients with juvenile idiopathic arthritis (JIA), categorized as extended oligoarticular arthritis (eoJIA), enthesitis-related arthritis (ERA), or psoriatic arthritis (PsA).METHODS: Participants with eoJIA (2-17 years old), ERA, or PsA (each 12-17 years old) who received ≥1 etanercept dose (0.8 mg/kg weekly; maximum 50 mg) in CLIPPER could enter CLIPPER2. Primary end point was occurrence of malignancy. Efficacy assessments included proportions achieving JIA American College of Rheumatology (ACR) 30/50/70/90/100 criteriaand ACR inactive disease criteria, and clinical remission (ACR criteria) or Juvenile Arthritis Disease Activity Score (JADAS) ≤1.RESULTS: Overall, 109/127 (86%) CLIPPER participants entered CLIPPER2 (n = 55 eoJIA, n = 31 ERA, n = 23 PsA; 99 [78%] on active treatment); 84 (66%) completed 120 months' follow-up (32 [25%] on active treatment). One malignancy (Hodgkin's disease in 18-year-old patient with eoJIA treated with methotrexate for 8 years) was reported; there were no cases of active tuberculosis or deaths. Numbers and incidence rates [events per 100 patient-years] of TEAEs (excluding infections/ISRs) decreased from 193 [173.81] in Year 1-9 [27.15] in Year 10; TE infections and serious infections also decreased. Over 45% of participants (N = 127) achieved JIA ACR50 responses from Month 2 onwards; 42 (33%) and 17 34 (27%) participants achieved JADAS and ACR clinical remission, respectively.CONCLUSIONS: Etanercept treatment up to 10 years was well tolerated, consistent with the known safety profile, with durable response in the participants still on active treatment. The benefit-risk assessment of etanercept in these JIA categories remains favorable.CLINICALTRIALS.GOV IDS: CLIPPER (NCT00962741); CLIPPER2 (NCT01421069).
KW - TNF inhibitor
KW - enthesitis-related arthritis
KW - etanercept
KW - extended oligoarticular arthritis
KW - juvenile idiopathic arthritis
KW - psoriatic arthritis
UR - http://www.ncbi.nlm.nih.gov/pubmed/37140539
UR - https://www.mendeley.com/catalogue/f127f65a-98e1-3847-92d6-4b9e317f7b6c/
U2 - 10.1093/rheumatology/kead183
DO - 10.1093/rheumatology/kead183
M3 - Article
C2 - 37140539
SN - 1462-0324
JO - Rheumatology
JF - Rheumatology
ER -
