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Todays Berita Pasar Saham Analisa amp Real-Time After Hours Berita Pra-Market Flash Kutipan Kutipan Bagan Interaktif Setelan Bawaan Harap diperhatikan bahwa begitu Anda membuat pilihan Anda, ini akan berlaku untuk semua kunjungan masa depan ke NASDAQ. Jika, sewaktu-waktu, Anda tertarik untuk kembali ke setelan default kami, pilih Setelan Default di atas. Jika Anda memiliki pertanyaan atau mengalami masalah dalam mengubah pengaturan default Anda, silahkan email isfeedbacknasdaq. Harap konfirmasikan pilihan Anda: Anda telah memilih untuk mengubah pengaturan default untuk Pencarian Kutipan. Ini sekarang akan menjadi halaman target default Anda kecuali Anda mengubah konfigurasi Anda lagi, atau Anda menghapus cookies Anda. 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Ini sekarang akan menjadi halaman target default Anda kecuali Anda mengubah konfigurasi Anda lagi, atau Anda menghapus cookies Anda. Yakin ingin mengubah setelan Anda Kami mohon untuk meminta Harap nonaktifkan pemblokir iklan Anda (atau perbarui setelan Anda untuk memastikan javascript dan cookie diaktifkan), sehingga kami dapat terus memberi Anda berita pasar tingkat pertama Dan data yang Anda harapkan dari kami. Rituximab versus Cyclophosphamide pada ANCA-Associated Renal Vasculitis Latar Belakang Rejimen induksi siklofosfamid untuk antigen cytoplasma antibodi antineutrofil (ANCA) terkait efektif pada 70 sampai 90 pasien, namun berhubungan dengan tingkat kematian yang tinggi dan Efek samping Pengobatan dengan rituximab telah menyebabkan tingkat remisi 80 sampai 90 di antara pasien dengan vaskulitis terkait ANCA refraktori dan mungkin lebih aman daripada rejimen siklofosfamid. Kami membandingkan rituximab dengan siklofosfamid sebagai terapi induksi pada vaskulitis terkait ANCA. Kami secara acak, dengan rasio 3: 1, 44 pasien dengan vaskulitis terkait ANCA yang baru didiagnosis dan keterlibatan ginjal terhadap rejimen glukokortikoid standar ditambah dengan rituximab dengan dosis 375 mg per meter persegi luas permukaan tubuh per minggu selama 4 minggu. , Dengan dua pulsa siklofosfamid intravena (33 pasien, kelompok rituximab), atau siklofosfamid intravena selama 3 sampai 6 bulan diikuti dengan azatioprin (11 pasien, kelompok kontrol). Titik akhir primer dipertahankan tingkat remisi pada 12 bulan dan efek samping yang parah. Usia rata-rata adalah 68 tahun, dan tingkat filtrasi glomerulus (GFR) adalah 18 ml per menit per 1,73 m 2 luas permukaan tubuh. Sebanyak 25 pasien dalam kelompok rituximab (76) dan 9 pasien pada kelompok kontrol (82) memiliki remisi berkelanjutan (P0.68). Efek samping berat terjadi pada 14 pasien pada kelompok rituximab (42) dan 4 pasien pada kelompok kontrol (36) (P0.77). Enam dari 33 pasien dalam kelompok rituximab (18) dan 2 dari 11 pasien pada kelompok kontrol (18) meninggal (P1.00). Peningkatan median GFR antara 0 dan 12 bulan adalah 19 ml per menit pada kelompok rituximab dan 15 ml per menit pada kelompok kontrol (P0.14). Kesimpulan Suatu rejimen berbasis rituximab tidak lebih tinggi dari siklosfamidamid intravena standar untuk vaskulitis ANCA yang terkait berat. Tingkat remisi yang dipertahankan tinggi pada kedua kelompok, dan rejimen berbasis rituximab tidak dikaitkan dengan penurunan kejadian buruk parah. (Didanai oleh Cambridge University Hospitals National Health Service Foundation Trust dan F. HoffmannLa Roche Current Controlled Trials number, ISRCTN28528813.) Media dalam Artikel Ini Gambar 1 Randomisasi dan Inklusi dalam Analisis pada 12 Bulan. Pada kelompok kontrol, pasien kedua meninggal pada 20 bulan. Gambar 2 Kejadian Kumulatif Remisi dan Proporsi Kumulatif Pasien dengan Kejadian Merugikan yang parah. Panel A menunjukkan waktu untuk remisi. Waktu remisi adalah waktu di mana Skor Aktivitas Vasculitis Birmingham dari 0 pertama kali dicatat. Data untuk pasien yang meninggal disensor pada saat kematian. Panel B menunjukkan waktu untuk kejadian buruk parah yang parah. Aktivitas Pasal Antitotalomial antibodi sitoplasma (ANCA) terkait, termasuk granulomatosis Wegener dan polangiitis mikroskopis, adalah sindrom autoimun multisistem yang ditandai oleh vaskulitis yang secara dominan mempengaruhi pembuluh mikroskopis dan autoantibodi yang bersirkulasi pada antigen sitoplasma neutrofil. Keterlibatan ginjal terjadi pada 70 pasien yang terkena dan termanifestasi sebagai glomerulonefritis progresif dengan nekrosis nekrosis nekrotikan pauci, glomerulonefritis sianen pada biopsi. Standar perawatan saat ini untuk vaskulitis terkait ANCA adalah siklofosfamid dengan glukokortikoid dosis tinggi 1-4 rejimen semacam itu efektif pada 70 sampai 90 pasien. Namun, siklofosfamid dikaitkan dengan leukopenia, infeksi berat, kanker, dan kegagalan ovarium. 5 Mortalitas pada 1 tahun melebihi 15 infeksi dan vaskulitis aktif adalah penyebab utama kematian dini. Efikasi parsial dan toksisitas berat dari rejimen tersebut mengindikasikan perlunya terapi induksi yang lebih baik pada vaskulitis terkait ANCA. Rituximab adalah antibodi monoklonal anti-CD20 B-celldepleting yang telah disetujui oleh European Medicines Agency dan Administrasi Makanan dan Obat A. S. untuk pengobatan limfoma non-Hodgkins 6 dan rheumatoid arthritis. 7-10 Pada vaskulitis terkait ANCA, aktivasi B-sel dan tingkat faktor pembedahan B berkorelasi dengan aktivitas penyakit. 11,12 CD20-positif, B-cellrich, daerah mirip folikel yang mengandung sel memori autoreactive B dengan afinitas untuk antigen ANCA, proteinase 3, terdapat pada granuloma Wegener. 13,14 ANCAs terlibat dalam patogenesis vaskulitis terkait ANCA. Selanjutnya, siklofosfamid menekan aktivasi, proliferasi, dan diferensiasi sel B autoreaktif. Temuan ini dari peran patogen sel B dan ANCA dalam vaskulitis terkait ANCA memberi dukungan untuk penggunaan terapi berbasis sel B. Remisi berkelanjutan telah dilaporkan pada 80 sampai 90 pasien dengan vaskulitis terkait ANCA refrakter yang diobati dengan rituximab. 17-23 Kami melakukan uji coba acak rituximab versus siklofosfamid dalam vaskulitis terkait ANCA (RITUXVAS). Tujuan dari percobaan ini adalah untuk menilai respons pengobatan dan tingkat kejadian buruk yang terkait dengan rejimen berbasis rituximab, dibandingkan dengan rejimen berbasis siklofamid berdasarkan terapi induksi pada pasien dengan vaskulitis ANCA yang baru didiagnosis dan parah, pada Harapan bahwa rejimen berbasis rituximab mungkin lebih efektif dan aman. Sebuah artikel terkait tentang Rituximab dalam uji coba ANCA-Associated Vasculitis (RAVE) (nomor ClinicalTrials. gov, NCT00104299), yang membandingkan rituximab dengan terapi sitotoksik standar untuk induksi remisi lengkap 6 bulan pada pasien dengan ANA terkait vaskulitis berat, adalah Dilaporkan di tempat lain dalam edisi Journal ini. 24 Desain Studi dan Pasien Penelitian ini merupakan uji coba acak open-label, two-group, parallel-design, yang melibatkan 44 pasien dari delapan pusat di Eropa dan Australia. Semua pasien memberikan informed consent tertulis. Inklusi dalam penelitian ini memerlukan diagnosis baru dari vaskulitis terkait ANCA, 25,26 ANCA positif, dan keterlibatan ginjal, sebagaimana dibuktikan dengan nekrosis glomerulonefritis pada biopsi atau sel darah merah atau hematuria (30 sel merah per medan daya tinggi) pada urinalisis. . Protokol uji coba tersedia dengan teks lengkap artikel ini di NEJM. org dan di vasculitis. org. Pengacakan dilakukan dengan menggunakan algoritma minimisasi komputer untuk menjaga penyembunyian tugas kelompok studi dari para peneliti. Algoritma ini distratifikasi sesuai dengan usia pasien, diagnosis, dan fungsi ginjal awal (lihat rincian dalam Lampiran Tambahan yang tersedia di NEJM. org). Rasio 3: 1 untuk penugasan acak digunakan berdasarkan pengalaman luas kami sebelumnya dengan rejimen kontrol 2 dan kebutuhan yang lebih besar untuk mengkarakterisasi keamanan rituximab. Percobaan ini disponsori oleh Cambridge University Hospitals National Health Service Foundation Trust. F. HoffmannLa Roche menyediakan rituximab dan hibah penelitian yang berkontribusi terhadap biaya percobaan. Uji coba, yang dirancang oleh penulis pertama dan terakhir dan komite pengawas persidangan, mendapat persetujuan etis dari komite etika di setiap pusat yang berpartisipasi dan dilakukan sesuai dengan Petunjuk Uji Klinis Uni Eropa (Directive 2001 EU20EC), 27 (nomor EudraCT , 2005-003610-15). Persetujuan peraturan diperoleh dari otoritas pengatur nasional di masing-masing negara. Data tersebut dipandu oleh penyidik ​​di Rumah Sakit Addenbrookes. Semua penulis memutuskan untuk menyerahkan manuskrip tersebut untuk diterbitkan. Perawatan Sebelum pendaftaran, pasien diijinkan untuk menjalani pertukaran plasma atau menerima maksimal 2 g metilprednisolon intravena, menurut praktik lokal untuk penanganan penyakit berat. Setelah pengacakan, kedua kelompok menerima metilprednisolon intravena (dengan dosis 1 g) dan rejimen glukokortikoid oral yang sama (1 mg per kilogram per hari pada awalnya, dengan pengurangan 5 mg per hari pada akhir 6 bulan). Pasien dalam kelompok rituximab menerima rituximab (MabThera, Roche) dengan dosis 375 mg per meter persegi per minggu, selama 4 minggu berturut-turut, dan siklofosfamid intravena dengan dosis 15 mg per kilogram dengan infus rituximab pertama dan ketiga yang dilakukan pasien ini. Tidak menerima azatioprin untuk menjaga remisi. Untuk pasien dalam kelompok rituximab yang memiliki penyakit progresif dalam 6 bulan pertama, dosis ketiga dari siklosfosfamid intravena (dengan dosis 15 mg per kilogram) diizinkan. Pasien dalam kelompok kontrol menerima rejimen yang divalidasi dari siklofosfamid intravena selama 3 sampai 6 bulan, diikuti dengan azatioprin (lihat Lampiran Tambahan). 2,3 Perlakuan lebih lanjut dengan rituximab atau siklofosfamid diizinkan dalam kasus kambuhan. Relaps yang terjadi sebelum minimal 6 bulan pengampunan berkelanjutan dianggap sebagai kegagalan sehubungan dengan titik akhir kemanjuran utama. Penilaian Penilaian dilakukan pada 0, 1,5, 3, 6, 9, dan 12 bulan dan pada saat kambuh (Lampiran Tambahan). Remisi didefinisikan sebagai tidak adanya aktivitas penyakit klinis, seperti ditunjukkan oleh Skor Aktivitas Vaskulitis Birmingham (BVAS) 28 dari 0 yang dipertahankan selama 2 bulan (skor berkisar antara 0 sampai 63, dengan skor yang lebih tinggi menunjukkan penyakit yang lebih aktif). Remisi berkelanjutan didefinisikan sebagai tidak adanya aktivitas penyakit (BVAS 0) paling sedikit 6 bulan. Kambuh didefinisikan sebagai kekambuhan atau munculnya baru aktivitas penyakit apa pun, yang tercermin dari BVAS, yang disebabkan oleh vaskulitis aktif (Lampiran Tambahan). Penyakit progresif didefinisikan sebagai kegigihan hematuria dan proteinuria, dengan tidak adanya peningkatan laju filtrasi glomerulus (GFR), 29 atau kelanjutan item nonrenal utama, seperti yang ditunjukkan oleh BVAS, pada 6 minggu. Hasil diadili oleh tiga penyidik ​​dan oleh seorang penilai independen yang tidak mengetahui tugas kelompok studi tersebut. Hasil utamanya adalah remisi yang berkelanjutan dan tingkat kejadian buruk yang parah 27 pada 12 bulan. Kematian dan kondisi ganas yang terjadi setelah 12 bulan juga tercatat. Titik akhir kemanjuran sekunder adalah waktu untuk pengampunan, perubahan BVAS antara 0 dan 3 bulan, perubahan dosis GFR, prednisolon, skor pada kuesioner Hasil Penelitian 36-Item Short-item (SF-36), 30 dan skor pada Vasculitis Damage Index (skor untuk indeks ini berkisar antara 0 sampai 64, dengan skor yang lebih tinggi menunjukkan kerusakan yang lebih parah) 31 antara 0 dan 12 bulan. Poin akhir keselamatan sekunder adalah kejadian buruk yang serius, infeksi, dan kematian. Analisis Statistik Kami mengantisipasi tingkat remisi berkelanjutan 95 di antara pasien dalam kelompok rituximab. 19 Di antara pasien dalam kelompok kontrol, kami memperkirakan tingkat remisi 80 dan tingkat remisi yang bertahan 65 karena kambuh. Kami memperkirakan bahwa dengan 44 pasien yang menjalani pengacakan, penelitian ini memiliki kekuatan statistik lebih dari 80, pada tingkat alpha dua sisi 0,05. Perbedaan terkecil dalam risiko bahwa uji coba kami didukung untuk dideteksi adalah kenaikan 33 (95 interval kepercayaan CI, 4 sampai 63) pada tingkat remisi berkelanjutan, sesuai dengan rasio risiko 1,5. Perbedaan ini dianggap penting secara klinis. Analisis dilakukan berdasarkan intention-to-treat. Semua analisis mencakup 44 pasien. Data laboratorium yang hilang (misalnya GFR) untuk pasien yang meninggal diimplikasikan dengan menggunakan metode nilai terakhir yang dibawa ke depan untuk memberikan perkiraan efek konservatif. Hasil dinyatakan sebagai nilai dan persentase untuk variabel kategoris dan median dan rentang interkuartil untuk variabel kontinu (nilai mean diberikan dalam Lampiran Tambahan). Proporsi dibandingkan dengan penggunaan uji chi-kuadrat. Efek samping dinyatakan sebagai tingkat insiden. Analisis time-to-event dilakukan dengan menggunakan uji log-rank. Analisis kovarian digunakan untuk menilai perubahan GFR. Nilai 32 P kurang dari 0,05 dianggap menunjukkan signifikansi statistik. Semua tes statistik dua sisi. Semua analisis dilakukan dengan menggunakan perangkat lunak Stata, versi 10. Antara bulan Juni 2006 dan Juni 2007, sebanyak 44 pasien terdaftar dalam penelitian ini (33 pada kelompok rituximab dan 11 pada kelompok kontrol). Tidak ada pasien yang mangkir. Enam pasien dalam kelompok rituximab dan 1 pasien pada kelompok kontrol meninggal dunia selama 12 bulan (Gambar 1 Gambar 1 Randomisasi dan Inklusi dalam Analisis pada 12 Bulan. Pada kelompok kontrol, pasien kedua meninggal pada usia 20 bulan.). Pasien tambahan di kelompok kontrol meninggal pada usia 19 bulan. Karakteristik pasien ditunjukkan pada Tabel 1 Tabel 1 Karakteristik Demografi dan Klinis Pasien pada Catatan Percobaan. Usia rata-rata pada saat belajar masuk adalah 68 tahun. Penggunaan pertukaran plasma seimbang antar kelompok (Tabel 1). Dua pasien dalam kelompok rituximab menerima dosis ketiga siklofosfamid: seseorang diklasifikasikan memiliki kegagalan pengobatan yang lain, yang mendapat respons terhadap rejimen rituximab dan menerima dosis siklofosfamid ketiga yang melanggar protokol, diklasifikasikan sebagai pengobatan yang berhasil. . Hasil Primer Remisi Berkelanjutan Remisi berkelanjutan terjadi pada 25 dari 33 pasien pada kelompok rituximab (76) dan 9 dari 11 pasien pada kelompok kontrol (82). Perbedaan absolut dalam remisi berkelanjutan dengan rituximab dibandingkan dengan siklofosfamid adalah 6 poin persentase (95 CI, 33 sampai 21 P0.68). Enam pasien dalam kelompok rituximab dan 1 pasien pada kelompok kontrol meninggal dalam 12 bulan pertama. Di antara pasien yang selamat, 93 pasien di kelompok rituximab dan 90 pasien pada kelompok kontrol mengalami remisi berkelanjutan (P0.80). Selain 7 pasien yang meninggal, 3 pasien tidak memiliki remisi yang berkelanjutan: 1 pasien di kelompok rituximab yang menerima rituximab untuk remisi yang tidak sempurna pada 5 bulan (yang kemudian menyebabkan remisi penuh) dan 2 pasien, 1 pada setiap pengobatan Kelompok yang mengalami kambuh dalam waktu 6 bulan setelah remisi telah tercapai. Di antara 9 pasien yang bergantung pada dialisis saat masuk studi, 6 dari 8 pasien dalam kelompok rituximab memiliki remisi berkelanjutan (5 di antaranya tidak memerlukan dialisis lagi), dan 1 pasien dalam kelompok kontrol meninggal sesaat setelah masuk studi. Waktu median untuk remisi adalah 90 hari (kisaran interkuartil, 79 sampai 112) pada kelompok rituximab dan 94 hari (kisaran interkuartil, 91 sampai 100) pada kelompok kontrol (P0.87) (Gambar 2A Gambar 2 Kejadian Kumulatif Remisi dan Proporsi Kumulatif Pasien dengan Kejadian Merugikan yang parah Panel A menunjukkan waktu untuk remisi Remisi waktu adalah waktu di mana Skor Aktivitas Vaskulitis Birmingham dari 0 pertama kali tercatat Data untuk pasien yang meninggal disensor pada saat kematian Panel B menunjukkan waktu untuk kejadian buruk parah pertama). Kejadian Merugikan Sebanyak 31 kejadian buruk berat terjadi pada 14 dari 33 pasien pada kelompok rituximab (42) dan 12 kejadian buruk berat terjadi pada 4 dari 11 pasien pada kelompok kontrol (36) (Tabel 2 Tabel 2 Kejadian Buruk. ). Tingkat kejadian kejadian buruk yang parah adalah 1,00 per tahun pasien pada kelompok rituximab (95 CI, 0,69 sampai 1,44) dan 1,10 per pasien pada kelompok kontrol (95 CI, 0,61 sampai 1,99 P0,77) (Gambar 2B). Sebanyak 19 infeksi terjadi pada 12 dari 33 pasien pada kelompok rituximab (36), dan 7 infeksi terjadi pada 3 dari 11 pasien pada kelompok kontrol (27) (tingkat kejadian, 0,66 per pasien-tahun pada kelompok rituximab Dan 0,60 per pasien-tahun pada kelompok kontrol). Profilaksis antibiotik digunakan pada 22 dari 33 pasien pada kelompok rituximab (67) dan di antara 8 dari 11 pasien pada kelompok kontrol (73). Pneumocystis pneumonia tidak berkembang pada salah satu pasien. Enam dari 33 pasien dalam kelompok rituximab (18) dan 2 dari 11 pasien pada kelompok kontrol (18) meninggal (P1.00). Waktu rata-rata sampai mati adalah 81 hari (kisaran, 22 sampai 330 pada kelompok rituximab dan 2 sampai 601 pada kelompok kontrol). Usia rata-rata saat kematian adalah 76 tahun (kisaran, 63 sampai 84 pada kelompok rituximab dan 76 sampai 82 pada kelompok kontrol), dan GFR pada penelitian di antara pasien yang meninggal adalah 9 ml per menit (kisaran, 0 sampai 29 di Kelompok rituximab dan 0 sampai 9 pada kelompok kontrol). Penyebab kematian adalah infeksi (pada 3 pasien pada kelompok rituximab dan pada 1 pasien pada kelompok kontrol), penyakit kardiovaskular (pada 1 pasien pada kelompok rituximab dan pada 1 pasien pada kelompok kontrol), dan komplikasi tahap akhir Gagal ginjal (pada 2 pasien dalam kelompok rituximab). Kejadian buruk dan parah dan kematian umum terjadi di antara 9 pasien yang bergantung pada dialisis saat masuk studi: 3 pasien (33) meninggal, 6 pasien (67) memiliki setidaknya satu kejadian buruk, dan 7 pasien (78) memiliki Paling tidak satu kejadian buruk yang serius. Hasil Sekunder Aktivitas Data dan Penyakit Laboratorium B-cell deplesi (didefinisikan sebagai lt210 6 sel per liter) terjadi pada 82 pasien dalam kelompok rituximab 6 minggu dan dipertahankan pada 75 pasien dalam kelompok ini pada 12 bulan. Sebanyak 64 pasien dalam kelompok kontrol juga mengalami deplesi B-sel pada beberapa titik selama penelitian. Dosis prednisolon dikurangi pada kedua kelompok sesuai dengan protokol 96 pasien pada kelompok rituximab dan 89 pasien pada kelompok kontrol menerima 5 mg per hari pada 9 bulan. Pada 12 bulan, dosis prednisolon yang disesuaikan dengan berat rata-rata adalah 0,071 mg per kilogram per hari (kisaran interkuartil, 0,062 sampai 0,082) pada kelompok rituximab dan 0,082 mg per kilogram per hari (kisaran interkuartil, 0,071 sampai 0,093) pada kelompok kontrol (P0.78) (Gambar 3A) Gambar 3 Perubahan dalam Prednisolone Dose dan Skor Aktivitas Vaskulitis Birmingham (BVAS), Menurut Kelompok Studi Panel A menunjukkan perubahan dalam dosis prednisolon yang disesuaikan dengan berat badan, dan Panel B menunjukkan perubahan pada BVAS selama 12 bulan follow-up pasien dalam rituximab dan kelompok kontrol Lingkaran menunjukkan outlier. Garis horizontal di dalam kotak mewakili median, batas bawah dan atas kotak mewakili persentil ke 25 dan 75, dan bar saya Mewakili persentil ke-5 dan ke-95.). Remisi (BVAS 0 selama 2 bulan) terjadi pada 30 dari 33 pasien pada kelompok rituximab (91) dan 10 dari 11 pasien pada kelompok kontrol (91). BVAS median menurun dari 19 (kisaran interkuartil, 14 sampai 24) pada saat masuk studi ke 0 (kisaran interkuartil, 0 sampai 1,5) pada 3 bulan pada kelompok rituximab dan dari 18 (kisaran interkuartil, 12 sampai 25) pada saat masuk studi ke 0 (Kisaran interkuartil, 0 sampai 0) pada 3 bulan pada kelompok kontrol (Gambar 3B). Pada kelompok rituximab, perkiraan rata-rata GFR meningkat dari 20 ml per menit per 1,73 m 2 luas permukaan tubuh (kisaran interkuartil, 5 sampai 44) pada saat masuk studi ke 39 ml per menit per 1,73 m 2 (kisaran interkuartil, 20 sampai 45) pada 12 bulan. Pada kelompok kontrol, GFR diperkirakan meningkat dari 12 ml per menit per 1,73 m 2 (kisaran interkuartil, 9 sampai 33) pada saat masuk studi ke 27 ml per menit per 1,73 m 2 (kisaran interkuartil, 12 sampai 47) pada 12 bulan. (P0.14 untuk perbandingan median.) Perubahan rata-rata pada GFR yang diperkirakan adalah 5 ml per menit lebih besar pada kelompok rituximab daripada pada kelompok kontrol (95 CI, 9 sampai 19 P0.49). Pewarnaan Myeloperoxidase dan proteinase 3 spesimen biopsi ginjal untuk pengikatan ANCA menunjukkan penurunan pada kedua kelompok, dengan hasil negatif pada semua pasien pada kelompok rituximab dan pada 8 dari 10 pasien pada kelompok kontrol (80). Pada 12 bulan masa tindak lanjut, 4 dari 27 pasien pada kelompok rituximab (15) dan 1 dari 10 pasien pada kelompok kontrol (10) mengalami kekambuhan (P0.70). Kerusakan Kualitas Kehidupan dan Penyakit Perubahan median skor pada Vasculitis Damage Index tidak berbeda secara signifikan antara kedua kelompok perlakuan. Skor tersebut berubah 2 poin (kisaran interkuartil, 0 sampai 3) pada kelompok rituximab dan 1 poin (interkuartil Kisaran, 0 sampai 2) pada kelompok kontrol (P0.38). Perubahan nilai pada komponen fisik SF-36 juga tidak berbeda secara signifikan antara kedua kelompok (P0.36). Kelompok kontrol memiliki hasil yang jauh lebih baik daripada kelompok rituximab sehubungan dengan perubahan skor pada komponen mental SF-36 (P0.04), namun perbedaan ini dicatat oleh dua pencetus berpengaruh pada kelompok rituximab. Penyensoran data untuk kedua pasien ini menghilangkan hasil yang signifikan (P0.32). Diskusi Ada kebutuhan penting yang tidak terpenuhi untuk terapi yang lebih aman dan lebih efektif pada pasien dengan vaskulitis terkait ANCA, terutama yang berisiko tinggi untuk toksisitas pengobatan dan kematian, seperti pasien lanjut usia dan orang dengan disfungsi ginjal berat. Kami menyelidiki efikasi dan keamanan rejimen berbasis rituximab versus rejimen siklofosfamid konvensional sebagai terapi penginduksi remisi untuk vaskulitis ginjal terkait ANCA. Rejimen berbasis rituximab tidak lebih tinggi dari rejimen siklofosfamid konvensional. Kedua kelompok perlakuan memiliki tingkat remisi berkelanjutan yang tinggi dengan tingkat kejadian buruk yang parah. Tingkat remisi yang dipertahankan tidak lebih baik pada kelompok rituximab. Pada kedua kelompok tersebut, lebih dari 90 korban selamat mendapatkan remisi. Tingkat ini serupa dengan yang dilaporkan dalam penelitian sebelumnya. Sidang kami tidak dibeberkan. Namun, keterlibatan ginjal adalah manifestasi penyakit yang paling umum, dan kami menggunakan pengukuran obyektif (misalnya tingkat kreatinin) untuk menilai fungsi ginjal. Selain itu, tidak ada bukti bias sehubungan dengan perawatan bersamaan, dan kepatuhan terhadap protokol pengurangan kortikosteroid cukup baik. Selain itu, ada putusan independen terhadap hasil. Hanya 2 dari 27 korban yang selamat dalam kelompok rituximab tidak memiliki remisi yang berkelanjutan. Glukokortikoid dosis tinggi dan dua dosis siklofosfamid berkontribusi pada respons awal namun tidak mungkin cukup untuk memperhitungkan pengendalian penyakit yang berkelanjutan yang terlihat pada sebagian besar pasien pada kelompok rituximab. Studi yang tidak terkontrol telah menunjukkan tingkat efikasi 80 sampai 90 dengan pengobatan rituximab pada vaskulitis terkait ANCA refrakter tingkat ini dipertahankan selama 12 bulan rata-rata. 17-23 Dalam percobaan ini, tanggapan yang bertahan pada pasien dalam kelompok rituximab mungkin disebabkan oleh efek pengobatan rituximab awal yang tahan lama. Namun, kami tidak menilai durasi pengampunan melebihi 12 bulan atau nilai pemberian rituximab berulang untuk mempertahankan remisi. Cyclophosphamide adalah komponen terapi induksi yang direkomendasikan untuk vaskulitis terkait ANCA dengan keterlibatan organ utama 1.33 Namun, penggunaannya diperumit oleh infeksi, kanker, dan infertilitas. 5.34 Untuk meminimalkan toksisitas siklofosfamid, rejimen pengobatan telah dioptimalkan dengan beralih ke obat alternatif untuk pemeliharaan remisi atau dengan menggunakan pemberian berdenyut, kedua pendekatan ini mengurangi paparan kumulatif terhadap siklofosfamid. 2,3 Penggunaan rituximab menawarkan kesempatan untuk mengurangi paparan siklofosfamid lebih jauh. Rituximab belum dikaitkan dengan peningkatan komplikasi infeksi yang signifikan bila digunakan bersamaan dengan methotrexate untuk pengobatan rheumatoid arthritis 9 atau dengan kemoterapi untuk pengobatan limfoma non-Hodgkins. Selanjutnya, penggunaan rituximab, tidak seperti siklofosfamid, jarang menghasilkan leukopenia dalam. Namun, dalam uji coba ini, rejimen berbasis rituximab tidak dikaitkan dengan tingkat efek samping parah awal yang lebih rendah daripada rejimen berbasis siklofamid berbasis, dan tidak ada perbedaan dalam keselamatan yang diamati. Usia yang lebih tua dan GFR yang lebih rendah adalah prediktor kematian yang kuat di antara pasien dengan vaskulitis terkait ANCA. Glomerulonefritis progresif cepat paling sering terjadi pada pasien lanjut usia. Uji coba sebelumnya telah menyingkirkan pasien lansia. Pencantuman pasien lansia, tanpa batas usia di atas, memberikan gambaran yang lebih akurat tentang populasi pasien dengan penyakit berat. Kematian sama pada dua kelompok perlakuan dan konsisten dengan 18 tingkat kematian yang dilaporkan dalam sebuah penelitian kohort besar yang melibatkan pasien dengan vaskulitis ginjal terkait ANCA, 36 serta tingkat kematian pada percobaan lain yang melibatkan pasien dengan ANCA-associated Vaskulitis ginjal 2-4 Dalam percobaan ini, 50 kematian disebabkan oleh infeksi, dan sebagian besar kematian terjadi pada awal pengobatan (sebelum 3 bulan). Sampai 6 minggu dari persalinan, kedua kelompok mendapat rejimen glucocorticoid dan cyclophosphamide yang sama dua pulsa siklofosfamid awal diberikan dengan rejimen rituximab karena dimasukkannya pasien dengan glomerulonefritis progresif cepat dan kurangnya pengalaman dengan rituximab sebagai terapi utama pada Pasien. Dengan demikian, keuntungan rituximab dapat dilihat tidak pada periode awal pengelolaan penyakit tetapi dalam tindak lanjut jangka panjang, dengan menghindari dosis kumulatif siklofosfamid dan imunosupresi perawatan yang besar. Rituximab memberikan efeknya terutama melalui deplesi B-sel. Bagian dari efek terapeutik siklofamid dapat dimediasi melalui kontrol autoreaktivitas sel B dengan penekanan sel-B. 37 B-cellderived ANCA terlibat dalam patogenesis vaskulitis, dan negatif ANCA setelah terapi induksi dikaitkan dengan penurunan risiko kambuh. Percobaan ini memberikan dukungan untuk peran sel B dalam patogenesis vaskulitis terkait ANCA, karena deplesi sel B dengan rituximab dikaitkan dengan respons klinis dan semua pasien dalam kelompok rituximab menjadi ANCA-negatif 6 bulan. Tingkat negatif ANCA dalam percobaan ini lebih tinggi daripada yang diamati dengan rejimen siklofosfamid pada penelitian sebelumnya. 2 Namun, gangguan fungsi sel B lainnya, termasuk presentasi antigen dan kestimulasi sel T, juga dapat berkontribusi pada mekanisme terapeutik rituximab. Sebagai kesimpulan, kami menemukan bahwa rejimen berbasis rituximab tidak lebih tinggi daripada rejimen siklofosfamid konvensional bila digunakan sebagai pengobatan induksi pada pasien dengan vaskulitis terkait ANCA. Tingkat remisi tinggi dengan kedua regimen. Namun, rejimen rituximab tidak terkait dengan penurunan kejadian buruk parah, dan kedua rejimen dikaitkan dengan 18 kematian. Penggunaan rituximab memungkinkan pengurangan paparan siklofosfamid dan penghindaran imunosupresi perawatan. Percobaan yang lebih besar diperlukan untuk mengkonfirmasi temuan kami, dan penting untuk menentukan apakah manfaat potensial rituximab diterjemahkan ke dalam peningkatan efikasi dan keamanan dalam jangka panjang. Didukung oleh Cambridge University Hospitals National Health Service Foundation Trust, sebuah hibah penelitian dari F. HoffmannLa Roche, yang juga menyediakan rituximab untuk penelitian ini, sebuah penelitian Core Research Scientist Core Education dan National Training Programme dari Canadian Institute of Health Research, memberikan hibah dari Yayasan Ginjal Kanada dan Canadian Society of Nephrology, dan Clinical Fellowship Award dari Alberta Heritage Foundation for Medical Research (semuanya kepada Dr. M. Walsh). Dr. Jones melaporkan menerima biaya kuliah dari F. HoffmannLa Roche Dr. Jayne, biaya konsultasi dan ceramah dari F. HoffmannLa Roche Dr. Cohen Tervaert, biaya kuliah dan royalti buku dari F. HoffmannLa Roche Dr. Tesar, dukungan perjalanan dari F. HoffmannLa Roche Dr. Luqmani, biaya konsultasi dari Schering-Plough dan F. HoffmannLa Roche dan dukungan perjalanan dari Wyeth, F. HoffmannLa Roche, dan Abbott dan Dr. Savage, biaya konsultasi dari Biogen Idec dan GlaxoSmithKline dan cuti panjang yang dibayarkan di GlaxoSmithKline setelah selesai Dari penelitian ini Addenbrookes Hospital telah menerima dukungan hibah dan biaya kuliah dari F. HoffmannLa Roche untuk layanan yang diberikan oleh Dr. Jayne. University of Birmingham telah menerima dukungan hibah dari Biovitrum dan Talecris untuk layanan yang diberikan oleh Dr. Savage. Tidak ada potensi konflik kepentingan lain yang relevan dengan artikel ini yang dilaporkan. Formulir pengungkapan yang disediakan oleh penulis tersedia dengan teks lengkap artikel ini di NEJM. org. Kami berterima kasih kepada National Institute for Health Research Cambridge Pusat Penelitian Biomedis, Dr. Afzal Chaudhry dari Rumah Sakit Addenbrookes untuk mengembangkan database percobaan, Drs. Annelies Berden dan Ingeborg Bajema dari Leiden University Medical Center untuk meninjau histologis spesimen biopsi ginjal, semua dokter dan staf perawat yang berkontribusi dalam percobaan ini, terutama Denise Brown dari Pusat Ortopedi Nuffield, Jo Gray dan Wellcome Trust Clinical Research Facility di Birmingham, Frances Skilton dari Rumah Sakit Royal Adelaide, Karen Dahlsveen dari Rumah Sakit Addenbrookes, dan dokter perawatan primer dan sekunder yang merujuk pasien untuk persidangan ini. Sumber Informasi Dari Vaskulitis dan Klinik Lupus, Unit Ginjal, Rumah Sakit Addenbrookes, Cambridge (RBJDWMWDRWJ), Departemen Rheumatologi, Pusat Ortopedi Nuffield, Oxford (RL), dan Departemen Imunobiologi Ginjal, Sekolah Imunitas dan Infeksi, Fakultas Kedokteran Dan Ilmu Kesehatan Gigi, Universitas Birmingham, Birmingham (MDMCOS) di Inggris Raya Divisi Imunologi Klinis dan Eksperimental, Departemen Penyakit Dalam, Maastricht University Medical Center, Maastricht, Belanda (JWCTPP) Immunologie-Zentrum Zrich and University Hospital, Zurich, Swiss (TH) Unit Renal, Rumah Sakit Royal Adelaide, Adelaide, Australia (CAP) Departemen Nefrologi di Lund, Rumah Sakit Universitas Skane dan Universitas Lund, Lund (MS), dan Departemen Nefrologi dan Transplantasi di Malm, Rumah Sakit Universitas Skane dan Universitas Lund, Malm (KW) keduanya di Swedia, dan Fakultas Kedokteran Pertama, Ch Arles University, Prague, Republik Cheska (V. T.). 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