¡ã ·¥½Ã¸¶SC ½Å±Ô ±Û·Î¹ú ÀÓ»ó3»ó °á°ú°¡ °ø°³µÈ ECCO ¹ßÇ¥ ÇöÀå |
¼¿Æ®¸®¿ÂÇコÄɾî´Â Áö³ 1ÀϺÎÅÍ 4ÀϱîÁö(ÇöÁö ½Ã°£) ³ªÈê°£ µ§¸¶Å© ÄÚÆæÇÏ°Õ¿¡¼ °³ÃÖµÈ 2023 À¯·´ Å©·Ðº´ ¹× ´ëÀå¿°ÇÐȸ(European Crohn’s and Colitis Organisation, ÀÌÇÏ ECCO)¿¡¼ ¹Ì±¹ Çã°¡¸¦ ¸ñÀûÀ¸·Î ÁøÇàÇÑ ·¥½Ã¸¶SC(¼ººÐ¸í : ÀÎÇø¯½Ã¸¿, ÇÇÇÏÁÖ»çÁ¦Çü)ÀÇ ½Å±Ô ±Û·Î¹ú ÀÓ»ó 3»ó °á°ú¸¦ °ø°³Çϸç ÀÇ·á°ü°èÀÚµé·ÎºÎÅÍ Å« ÁÖ¸ñÀ» ¹Þ¾Ò´Ù.
ù ¹ø° ÀÓ»ó[1]Àº Å©·Ðº´(Crohn’s Disease, ÀÌÇÏ CD) ȯÀÚµéÀ» ´ë»óÀ¸·Î ·¥½Ã¸¶ Åõ¿© ÈÄ À¯Áö Ä¡·á(maintenance therapy) ½Ã À§¾à(Çöó½Ãº¸) ´ëºñ ·¥½Ã¸¶SCÀÇ È¿´É ¹× ¾ÈÀü¼ºÀ» ºÐ¼®ÇÑ °á°ú·Î ¿Â¶óÀο¡¼ ±¸µÎ ¹ßÇ¥(digital oral presentation)·Î °ø°³µÆ´Ù. Áߵ ¹× ÁßÁõÀÇ CD ȯÀÚ 343¸íÀ» ´ë»óÀ¸·Î 10ÁÖÂ÷¿¡ ·¥½Ã¸¶SC Åõ¿©±º°ú À§¾à ´ëÁ¶±ºÀ» 2:1·Î ¹«ÀÛÀ§ ¹èÁ¤ÇÑ µÚ 54ÁÖÂ÷¿¡ ºñ±³ ºÐ¼®Çß´Ù. ±× °á°ú, 1Â÷ Æò°¡ÁöÇ¥ÀÎ ÀÓ»óÀû °üÇØ(clinical remission)[2]´Â ·¥½Ã¸¶SC 62.3%, À§¾à 32.1%·Î ³ªÅ¸³µÀ¸¸ç, ³»½Ã°æÀû ¹ÝÀÀ(endoscopic response)[3]¿¡¼µµ ·¥½Ã¸¶SC 51.1%, À§¾à 17.9%·Î ´ëÁ¶±º ´ëºñ Åë°èÀûÀ¸·Î ³ôÀº À¯È¿¼º °á°ú°¡ È®ÀεƴÙ. ·¥½Ã¸¶SC À¯Áö Ä¡·á¿¡ µû¸¥ »õ·Î¿î ¾ÈÀü¼º ¹®Á¦´Â ¹ß°ßµÇÁö ¾Ê¾Ò´Ù.
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·¥½Ã¸¶SCÀÇ ³ôÀº Ç÷Áß³óµµ(Serum trough concentration)¿Í ³·Àº ¸é¿ª¿ø¼º °£ÀÇ »ó°ü°ü°è¸¦ È®ÀÎÇÏ´Â ÀÓ»ó 1»ó »çÈÄ ºÐ¼® °á°úµµ Æ÷½ºÅÍ·Î °ø°³µÆ´Ù. ‘ÀÎÇø¯½Ã¸¿À¸·Î Ä¡·áÇÑ IBD ȯÀÚÀÇ ¸é¿ª¿ø¼º ¿¹ÃøÀÎÀÚ: CT-P13 SC ÀÓ»ó 1»ó »çÈÄ ºÐ¼®’[5] Á¦ÇÏÀÇ µ¥ÀÌÅÍ ºÐ¼® °á°ú, ·¥½Ã¸¶SC·Î À¯Áö Ä¡·áÇÒ °æ¿ì Ç÷Áß ³óµµ°¡ ƯÁ¤ ÀÓ°èÄ¡ ÀÌ»ó[6]¿¡ µµ´ÞÇϴ ȯÀÚ ºñÀ²ÀÌ Á¤¸ÆÁÖ»ç Åõ¿© ȯÀÚ ´ëºñ ³ôÀº °ÍÀ¸·Î È®ÀεÆÀ¸¸ç, À̸¦ ÅëÇØ ¾à¹°¿¡ ´ëÇÑ Ç×ü(Anti-drug Antibody, ADA) ¹× ¸é¿ª °úÁ¤¿¡ °ü¿©ÇÏ´Â ÁßÈÇ×ü(Neutralizing Antibody, NAb) µîÀÇ ÁöÇ¥´Â ´õ ³·Àº °ÍÀ¸·Î ³ªÅ¸³ª ¸é¿ª¿ø¼º Ãø¸é¿¡¼ ·¥½Ã¸¶SCÀÇ ÀáÀçÀû ÀÌÁ¡À» È®ÀÎÇß´Ù.
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[1] Subcutaneous infliximab (CT-P13 SC) as maintenance therapy for Crohn’s disease: A phase 3, randomised, placebo-
controlled study(LIBERTY-CD)
[2] ÀÓ»óÀû °üÇØ(clinical remission) : ȯÀÚÀÇ Áõ»óÀÌ »ç¶óÁø »óÅÂ
[3] ³»½Ã°æÀû ¹ÝÀÀ(endoscopic response) : ³»½Ã°æ °Ë»ç¿¡¼ Á¡¸· ¿°Áõ °¨¼Ò°¡ º¸ÀÌ´Â »óÅÂ
[4] Subcutaneous infliximab (CT-P13 SC) as maintenance therapy for ulcerative colitis: A phase 3, randomized, placebo-
controlled study: Results of the LIBERTY-UC study
[5] Predictors of immunogenicity in patients with Inflammatory Bowel Disease treated with infliximab: A post hoc analysis of
the randomised phase I CT-P13 SC study
[6] Ctrough ≥4.695 μg/mL
[7] Network meta-analysis to evaluate the comparative efficacy of intravenous and subcutaneous infliximab and vedolizumab
in the maintenance treatment of adult patients with Crohn's Disease and Ulcerative Colitis
[8] Evaluating patient access to infliximab subcutaneous in inflammatory bowel disease
[9] Budget impact analysis of introducing infliximab subcutaneous for the treatment of Inflammatory Bowel Disease in Latvia
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