170 Safety and efficacy of subcutaneous tocilizumab in patients with systemic and polyarticular juvenile idiopathic arthritis
Notice bibliographique
Résumé
Background: As intravenous (IV) tocilizumab (TCZ) has been shown to improve disease symptoms in patients with polyarticular (p)JIA/systemic (s)JIA, an ongoing 5-year, long-term extension (LTE) (NCT02165345) of two 52-week, open-label studies (NCT01904279/NCT01904292) will evaluate long-term safety and efficacy of subcutaneous (SC) TCZ. Methods: PJIA patients aged 1-17 years received TCZ 162 mg every 3 weeks (Q3W) for body weight (BW) <30 kg or every 2 weeks (Q2W) for BW ⩾ 30 kg; sJIA patients received TCZ 162 mg Q2W for BW < 30 kg (or every 10 days (Q10D)) or weekly (QW) for BW ⩾ 30 kg. pJIA patients had failed or could not tolerate MTX treatment and sJIA patients had inadequate response to NSAIDs and glucocorticoids. All patients had to discontinue biologic DMARDs (except TCZ IV, which was switched to SC). After 52 weeks, eligible patients continued TCZ treatment according to BW in the LTE; we report LTE safety data for pJIA/sJIA. Results: Adverse event (AE) rates (Table 1) were similar regardless of BW. Most AEs were grade 1/2; grade ⩾3 AEs were reported by 10/44 (20.8%) pJIA patients and 4/38 (10.5%) sJIA patients. The most common AE was nasopharyngitis in both pJIA (17/44 [38.6%]) and sJIA (11/38 [28.9%]). Other AEs reported in ⩾ 15% of patients were arthralgia, gastroenteritis, cough, vomiting, diarrhoea, pyrexia, headache, and oropharyngeal pain in pJIA, and upper respiratory tract infection, cough, pyrexia, arthralgia, and rash in sJIA. AEs of special interest (AESIs) were consistent with the 52-week data, and no opportunistic infections developed. Neutropaenia AEs were reported by 6 pJIA patients (13.6%) and 7 sJIA patients (18.4%). Of pJIA patents, 5/44 (11.4%) experienced SAEs (furuncle, appendicitis, pneumonia, eye pain/headache, infectious mononucleosis); only pneumonia was considered treatment related. Of sJIA patients, 2/38 (5.3%) experienced SAEs (pneumonia, craniocerebral injury from a fall); neither was considered treatment related. Neutralising anti-TCZ antibodies developed in 2 pJIA patients (4.7%) and 0 sJIA patients. No deaths were reported in the LTE to the data cutoff. Conclusion: In this long-term extension study of SC TCZ in children with pJIA or sJIA, TCZ continues to have an acceptable tolerability profile with no new safety concerns. Safety summary AEs, adverse events; CI, confidence interval; pJIA, polyarticular juvenile idiopathic arthritis; PY, patient-years; Q2W, every 2 weeks; Q3W, every 3 weeks; Q10D, every 10 days; SAEs, serious adverse events; SC, subcutaneous; sJIA, systemic juvenile idiopathic arthritis; TCZ, tocilizumab. Disclosures: A.V. Ramanan: Member of speakers’ bureau; AbbVie, UCB, SOBI, Lily. H.I. Brunner: Consultancies; Roche, BMS, Novartis, Pfizer, R-Pharm, Celgene, AstraZeneca, Jannsen, Ablynx, GSK, Takeda, Sanofi. Member of speakers’ bureau; Roche, Novartis, Pfizer. Other; Roche, Novartis, Pfizer, BMS. N. Ruperto: Consultancies; Abbott, AbbVie, Amgen, Biogenidec, Astellas, Alter, AstraZeneca, Baxalta Biosimilars, Boehringer, BMS, CD-Pharma, Celgene, CrescendoBio, EMD Serono, Hoffmann-La Roche, Italfarmaco, Janssen, MedImmune, Medac, Novartis, NovoNordisk, Pfizer, Rewind Arms, R-Ph. Grants/research support; Abbott, BMS. A. Martini: None. R.J. Cuttica: None. J.E. Weiss: None. M. Henrickson: None. H. Schmeling: Grants/research support; Roche. J. Antón: Consultancies; AbbVie, Alexion, BMS, Gebro, Novartis, Pfizer, Roche, Sobi. Honoraria; AbbVie, Alexion, BMS, Gebro, Novartis, Pfizer, Roche, Sobi. Member of speakers’ bureau; AbbVie, Alexion, BMS, Gebro, Novartis, Pfizer, Roche, Sobi. Grants/research support; AbbVie, Alexion, Amgen, BMS, ChemoCentryx, Novartis, Novimmune, Roche, Sanofi, Pfizer. K. Minden: Consultancies; AbbVie, Sanofi, Medac, MedCon. Grants/research support; Pfizer, AbbVie, Roche. G. Horneff: Consultancies; Abbvie, Chugai, Roche, BMS, Novartis, Pfizer, Celgene, MSD, Ablynx. M. Gámir-Gámir: None. M. Hufnagel: None. W. Douglass: Corporate appointments; Roche. Shareholder/stock ownership; Roche. C. Wells: Corporate appointments; Roche. S. Wimalasundera: Corporate appointments; Roche. Shareholder/stock ownership; Roche. N.L. Mallalieu: Corporate appointments; Roche. Shareholder/stock ownership; Roche. D.J. Lovell: Consultancies; AstraZeneca, Amgen, Abbott, Pfizer. Member of speakers’ bureau; Wyeth. F. De Benedetti: Grants/research support; Abbvie, Sobi, Novimmune, Roche, Novartis, Sanofi, UCB, Pzifer.
Récupéré en direct depuis OpenAlex et désinversé. Les résumés ne sont pas conservés dans cette base de données : les index inversés représentent 8,6 Go des 9,3 Go de texte de la base, et le serveur dispose de 13 Go libres.
Comment cette classification a été obtenuedéplier
Prédiction machine sur la base complète
Imitation des enseignantsNi prévalence calibrée, ni vérité terrain. Validation humaine à venir. Le volet Gemma est une étiquette directe du modèle pour chaque travail de la base, lue sur la notice réduite au titre. Le volet Codex est un classifieur appris des 10 348 étiquettes directes de Codex et calibré sur les taux pondérés de l'échantillon; les champs sans appui suffisant ne portent aucun appel Codex. Le mode candidate est l'union des deux volets; le consensus est leur intersection. Ces sorties portent le statut machine_predicted_unvalidated et ne sont pas des étiquettes humaines.
Scores du classifieur distillé par catégorie (deux têtes)
| Catégorie | Codex | Gemma |
|---|---|---|
| Métarecherche | 0,001 | 0,001 |
| Méta-épidémiologie (sens strict) | 0,000 | 0,000 |
| Méta-épidémiologie (sens large) | 0,001 | 0,000 |
| Bibliométrie | 0,000 | 0,000 |
| Études des sciences et des technologies | 0,000 | 0,000 |
| Communication savante | 0,000 | 0,000 |
| Science ouverte | 0,000 | 0,000 |
| Intégrité de la recherche | 0,000 | 0,001 |
| Charge utile insuffisante (le modèle a refusé de juger) | 0,001 | 0,000 |
Scores machine (provisoires)
Les deux têtes enseignantes du modèle étudiant, lues sur ce travail. Un score ordonne la base pour la relecture; il n'affirme jamais une catégorie, et le statut de validation accompagne chaque rangée tel quel.
Scores de référence d'un modèle non mature (critères de maturité non atteints, 7 itérations). Un score ordonne; il n'affirme jamais une catégorie.
score_only:v0-immature-baseline · tel quel depuis la passe de notation : score_only signifie que le nombre peut ordonner les travaux, et qu'aucune étiquette de catégorie n'en découleClassification
machine, non validéePrédiction automatique; un appel candidat d’une seule source (Gemma direct ou Codex distillé), pas un consensus.
Le détail, modèle par modèle et score par score, se trouve en fin de page sous « Comment cette classification a été obtenue ».