Özet
Amaç
Bu çalışma, romatoid artrit (RA) hastalarının gerçek yaşam koşullarında tedavisinde barisitinibin güvenliliğini, etkililiğini ve tedavide kalıcılığını değerlendirmek; barisitinib içinde ve bir tümör nekroz faktörü inhibitörü (adalimumab) ile karşılaştırmayı amaçlamaktadır.
Yöntem
Haziran 2020 ile Ocak 2023 arasında en az bir doz barisitinib veya adalimumab alan Hacettepe Üniversitesi Biyolojik Prospektif Veritabanı’ndan RA hastaları analiz edildi. İlaç sağkalımı analizi en az bir doz baricitinib ve adalimumab alan hastaları içerirken, etkililik ve güvenlilik analizleri için en az bir takip viziti bulunması gerekiyordu. Advers olaylar, majör olumsuz kardiyovasküler olaylar (MACE), maligniteler ve ilaca uyum değerlendirildi. Avrupa Romatoloji Dernekleri Birliği (EULAR) yanıtı, iyi yanıt verenler veya yanıt vermeyenler olarak sınıflandırdı.
Bulgular
Toplam 280 hasta (86 barisitinib, 194 adalimumab) çalışmaya dahil edildi; ortalama yaş 52,4 (±13,6) yıl olup hastaların %77,5’i kadındı. Barisitinib, hastalık aktivitesi parametrelerini anlamlı düzeyde iyileştirdi. Yüksek hasta global değerlendirmesi iyi yanıtı öngördü [risk oranı (OR): 0,95 (%95 güven aralığı (GA): 0,92-0,98)], RF pozitifliği ise kötü yanıtı işaret etti [OR: 7,66 (%95 GA: 1,46-40,07)]. MACE, barisitinib kullanan 2 hastada (%2,5) ve adalimumab kullanan 4 hastada (%2,5) görüldü; oranlar sırasıyla 1000 hasta-yıl başına 15,3 ve 9,1 idi (p=0,20).
Sonuç
Barisitinib tedavisi hastalık aktivitesi göstergelerinde düzelme sağladı ve yüksek hasta global değerlendirmesi iyi EULAR yanıtının öngördürücüsüydü. MACE sıklığı adalimumab ile benzerdi.
Anahtar Kelimeler:
Romatoid artrit, baricitinib, gerçek yaşam, majör kardiyak olaylar, advers olaylar
Kaynaklar
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