Abstract
Original language | English |
---|---|
Journal | Pediatric Rheumatology |
Volume | 14 |
Issue number | 1 |
DOIs | |
Publication status | Published - 2016 |
Keywords
- Biologic therapies
- Etanercept
- Juvenile idiopathic arthritis
- Pediatric rheumatology
- TNF inhibitors
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Disease status, reasons for discontinuation and adverse events in 1038 Italian children with juvenile idiopathic arthritis treated with etanercept. / Verazza, Sara; Davì, S.; Consolaro, A. et al.
In: Pediatric Rheumatology, Vol. 14, No. 1, 2016.Research output: Contribution to journal › Article › peer-review
}
TY - JOUR
T1 - Disease status, reasons for discontinuation and adverse events in 1038 Italian children with juvenile idiopathic arthritis treated with etanercept
AU - Verazza, Sara
AU - Davì, S.
AU - Consolaro, A.
AU - Bovis, F.
AU - Insalaco, A.
AU - Magni-Manzoni, S.
AU - Nicolai, R.
AU - Marafon, D. Pires
AU - De Benedetti, F.
AU - Gerloni, V.
AU - Pontikaki, Irene
AU - Rovelli, F.
AU - Cimaz, Rolando
AU - Marino, A. A.
AU - Zulian, F.
AU - Martini, G.
AU - Pastore, S.
AU - Sandrin, Chiara
AU - Corona, F.
AU - Torcoletti, Marta
AU - Conti, G.
AU - Fede, Carmelo
AU - Barone, Paolo
AU - Cattalini, Marco
AU - Cortis, E.
AU - Breda, L.
AU - Olivieri, A.N.
AU - Civino, A.
AU - Podda, R.
AU - Rigante, D.
AU - Torre, F.
AU - D'Angelo, G.
AU - Jorini, M.
AU - Gallizzi, Romina
AU - Maggio, M. C.
AU - Consolini, R.
AU - Fanti, A.
AU - Muratore, Valentina
AU - Alpigiani, M.G.
AU - Ruperto, N.
AU - Martini, Alberto
AU - Ravelli, A.
N1 - Export Date: 30 March 2017 Correspondence Address: Ravelli, A.; Università degli Studi di GenovaItaly; email: angeloravelli@gaslini.org References: Lovell, D.J., Giannini, E.H., Reiff, A., Cawkwell, G.D., Silverman, E.D., Nocton, J.J., Etanercept in children with polyarticular juvenile rheumatoid arthritis. 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Lovell, D.J., Reiff, A., Ilowite, N.T., Wallace, C.A., Chon, Y., Lin, S.-L., Safety and efficacy of up to eight years of continuous etanercept therapy in patients with juvenile rheumatoid arthritis (2008) Arthritis Rheum, 58, pp. 1496-1504; Lomholt, J.J., Thastum, M., Herlin, T., Pain experience in children with juvenile idiopathic arthritis treated with anti-TNF agents compared to non-biologic standard treatment (2013) Pediatr Rheumatol Online J, 11, p. 21; Consolaro, A., Ravelli, A., Paediatric rheumatology: Juvenile idiopathic arthritis--are biologic agents effective for pain (2013) Nat Rev Rheumatol, 9, pp. 447-448; Lovell, D.J., Reiff, A., Jones, O.Y., Schneider, R., Nocton, J., Stein, L.D., Long-term safety and efficacy of etanercept in children with polyarticular-course juvenile rheumatoid arthritis (2006) Arthritis Rheum, 54, pp. 1987-1994; Horneff, G., De Bock, F., Foeldvari, I., Girschick, H.J., Michels, H., Moebius, D., Safety and efficacy of combination of etanercept and methotrexate compared to treatment with etanercept only in patients with juvenile idiopathic arthritis (JIA): preliminary data from the German JIA Registry (2009) Ann Rheum Dis, 68, pp. 519-525; 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Kostik, M.M., Gaidar, E.V., Hynnes, A.Y., Dubko, M.F., Masalova, V.V., Snegireva, L.S., Methotrexate treatment may prevent uveitis onset in patients with juvenile idiopathic arthritis: experiences and subgroup analysis in a cohort with frequent methotrexate use (2016) Clin Exp Rheumatol, 34, pp. 714-718; Levy-Clarke, G., Jabs, D.A., Read, R.W., Rosenbaum, J.T., Vitale, A., Gelder, R.N., Expert panel recommendations for the use of anti-tumor necrosis factor biologic agents in patients with ocular inflammatory disorders (2014) Ophthalmol, 121, pp. 785-796; Davies, R., Southwood, T.R., Kearsley-Fleet, L., Lunt, M., Hyrich, K.L., Medically significant infections are increased in patients with juvenile idiopathic arthritis treated with etanercept: results from the British Society for Paediatric and Adolescent Rheumatology Etanercept Cohort Study (2015) Arthritis Rheumatol, 67, pp. 2487-2494; Beukelman, T., Xie, F., Baddley, J.W., Chen, L., Delzell, E., Grijalva, C.G., Brief report: incidence of selected opportunistic infections among children with juvenile idiopathic arthritis (2013) Arthritis Rheum, 65, pp. 1384-1389; Renaud, C., Ovetchkine, P., Bortolozzi, P., Saint-Cyr, C., Tapiero, B., Fatal group A Streptococcus purpura fulminans in a child receiving TNF-alpha blocker (2011) Eur J Pediatr, 170, pp. 657-660; Dijkhuizen, E.H., Pouw, J.N., Scheuern, A., Hugle, B., Hardt, S., Ganser, G., Methotrexate intolerance in oral and subcutaneous administration in patients with juvenile idiopathic arthritis: a cross-sectional, observational study (2016) Clin Exp Rheumatol, 34, pp. 148-154; Wiegering, V., Morbach, H., Dick, A., Girschick, H.J., Crohn's disease during etanercept therapy in juvenile idiopathic arthritis: a case report and review of the literature (2010) Rheumatol Int, 30, pp. 801-804; Dijken, T.D., Vastert, S.J., Gerloni, V.M., Pontikaki, I., Linnemann, K., Girschick, H., Development of inflammatory bowel disease in patients with juvenile idiopathic arthritis treated with etanercept (2011) J Rheumatol, 38, pp. 1441-1446; Dallocchio, A., Canioni, D., Ruemmele, F., Duquesne, A., Scoazec, J.Y., Bouvier, R., Occurrence of inflammatory bowel disease during treatment of juvenile idiopathic arthritis with etanercept: a French retrospective study (2010) Rheumatology (Oxford), 49, pp. 1694-1698; 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PY - 2016
Y1 - 2016
N2 - Background: Data from routine clinical practice are needed to further define the efficacy and safety of biologic medications in children with juvenile idiopathic arthritis (JIA). The aim of this analysis was to investigate the disease status, reasons for discontinuation and adverse events in Italian JIA patients treated with etanercept (ETN). Methods: In 2013, all centers of the Italian Pediatric Rheumatology Study Group were asked to make a census of patients given ETN after January 2000. Patients were classified in three groups: group 1 = patients still taking ETN; group 2 = patients discontinued from ETN for any reasons; group 3 = patients lost to follow-up while receiving ETN. All three groups received a retrospective assessment; patients in group 1 also underwent a cross-sectional assessment. Results: 1038 patients were enrolled by 23 centers: 422 (40.7%) were in group 1, 462 (44.5%) in group 2, and 154 (14.8%) in group 3. Median duration of ETN therapy was 2.5 years. At cross-sectional assessment, 41.8% to 48.6% of patients in group 1 met formal criteria for inactive disease, whereas 52.4% of patients in group 2 and 55.8% of patients in group 3 were judged in clinical remission by their caring physician at last visit. A relatively greater proportion of patients with systemic arthritis were discontinued or lost to follow-up. Parent evaluations at cross-sectional visit in group 1 showed that 52.4% of patients had normal physical function, very few had impairment in quality of life, 51.2% had no pain, 76% had no morning stiffness, and 82.7% of parents were satisfied with their child's illness outcome. Clinically significant adverse events were reported for 27.8% of patients and ETN was discontinued for side effects in 9.5%. The most common adverse events were new onset or recurrent uveitis (10.2%), infections (6.6%), injection site reactions (4.4%), and neuropsychiatric (3.1%), gastrointestinal (2.4%), and hematological disorders (2.1%). Ten patients developed an inflammatory bowel disease and 2 had a malignancy. One patient died of a fulminant streptococcal sepsis. Conclusions: Around half of the patients achieved complete disease quiescence under treatment with ETN. The medication was overall well tolerated, as only one quarter of patients experienced clinically significant adverse events and less than 10% had treatment discontinued for toxicity. © 2016 The Author(s).
AB - Background: Data from routine clinical practice are needed to further define the efficacy and safety of biologic medications in children with juvenile idiopathic arthritis (JIA). The aim of this analysis was to investigate the disease status, reasons for discontinuation and adverse events in Italian JIA patients treated with etanercept (ETN). Methods: In 2013, all centers of the Italian Pediatric Rheumatology Study Group were asked to make a census of patients given ETN after January 2000. Patients were classified in three groups: group 1 = patients still taking ETN; group 2 = patients discontinued from ETN for any reasons; group 3 = patients lost to follow-up while receiving ETN. All three groups received a retrospective assessment; patients in group 1 also underwent a cross-sectional assessment. Results: 1038 patients were enrolled by 23 centers: 422 (40.7%) were in group 1, 462 (44.5%) in group 2, and 154 (14.8%) in group 3. Median duration of ETN therapy was 2.5 years. At cross-sectional assessment, 41.8% to 48.6% of patients in group 1 met formal criteria for inactive disease, whereas 52.4% of patients in group 2 and 55.8% of patients in group 3 were judged in clinical remission by their caring physician at last visit. A relatively greater proportion of patients with systemic arthritis were discontinued or lost to follow-up. Parent evaluations at cross-sectional visit in group 1 showed that 52.4% of patients had normal physical function, very few had impairment in quality of life, 51.2% had no pain, 76% had no morning stiffness, and 82.7% of parents were satisfied with their child's illness outcome. Clinically significant adverse events were reported for 27.8% of patients and ETN was discontinued for side effects in 9.5%. The most common adverse events were new onset or recurrent uveitis (10.2%), infections (6.6%), injection site reactions (4.4%), and neuropsychiatric (3.1%), gastrointestinal (2.4%), and hematological disorders (2.1%). Ten patients developed an inflammatory bowel disease and 2 had a malignancy. One patient died of a fulminant streptococcal sepsis. Conclusions: Around half of the patients achieved complete disease quiescence under treatment with ETN. The medication was overall well tolerated, as only one quarter of patients experienced clinically significant adverse events and less than 10% had treatment discontinued for toxicity. © 2016 The Author(s).
KW - Biologic therapies
KW - Etanercept
KW - Juvenile idiopathic arthritis
KW - Pediatric rheumatology
KW - TNF inhibitors
U2 - 10.1186/s12969-016-0126-0
DO - 10.1186/s12969-016-0126-0
M3 - Article
VL - 14
JO - Pediatric Rheumatology
JF - Pediatric Rheumatology
SN - 1546-0096
IS - 1
ER -