8b3d0807e97420c501b95f9675b9bf25 jcm-13-00365.pdf cea9505fc67acd9be2824181d5577c4b0e91b88a jcm-13-00365.pdf c00b74385595d4c655fd057fb1bb1827a83bf98f03c6c737982cedaabe465f16 jcm-13-00365.pdf Title: Safety and Effectiveness of Vedolizumab and Ustekinumab in Elderly Patients with Inflammatory Bowel Disease: A Real-Life Multicentric Cohort Study Subject: Background: Data on ustekinumab and vedolizumab in the elderly inflammatory bowel disease (IBD) population are limited. The aim of the current study was to assess the safety and effectiveness of both in an elderly real-life population. Methods: A multicentric retrospective study was performed on IBD patients who started vedolizumab or ustekinumab between 2010 and 2020. Clinical and endoscopic remission rates and (serious) adverse events (AE) were assessed. Results: A total of 911 IBD patients were included, with 171 (19%) aged above 60 (111 VDZ, 60 UST). Elderly patients treated with vedolizumab or ustekinumab had an increased risk for non-IBD hospitalization (10.5% vs. 5.7%, p = 0.021) and malignancy (2.3% vs. 0.5%, p = 0.045) compared to the younger population. Corticosteroid-free clinical (50% vs. 44%; p = 0.201) and endoscopic remission rates (47.9% vs. 31%, p = 0.07) at 1 year were similar. Comparing vedolizumab to ustekinumab in the elderly population, corticosteroid-free (47.9% vs. 31%, p = 0.061) and endoscopic remission rates (66.7% vs. 64.4%, p = 0.981) were similar. Vedolizumab- and ustekinumab-treated patients had comparable infection rates (13.5% vs. 10.0%, p = 0.504), IBD flare-ups (4.5% vs. 5%, p = 1.000), the occurrence of new EIMs (13.5% vs. 10%, p = 0.504), a risk of intestinal surgery (5.4% vs. 6.7%, p = 0.742), malignancy (1.8% vs. 3.3%, p = 0.613), hospitalization (9.9% vs. 11.7%, p = 0.721), and mortality (0.9% vs. 1.7%, p = 1.000). AE risk was associated only with corticosteroid use. Conclusions: Ustekinumab and vedolizumab show comparable effectiveness and safety in the elderly IBD population. Elderly IBD patients have an increased risk for non-IBD hospitalizations and malignancy compared to the younger IBD population, with corticosteroid use as the main risk factor. Keywords: elderly; IBD; vedolizumab; ustekinumab; safety Author: Tom Holvoet, Marie Truyens, Cara De Galan, Harald Peeters, Francisco Mesonero Gismero, Ainara Elorza, Paola Torres, Liv Vandermeulen, Aranzazu Jauregui-Amezaga, Rocio Ferreiro-Iglesias, Yamile Zabana, Laia Peries Reverter, Jeroen Geldof and Triana Lobatón Creator: LaTeX with hyperref Producer: pdfTeX-1.40.25 CreationDate: Tue Jan 9 12:33:39 2024 CET ModDate: Tue Jan 9 12:36:51 2024 CET Custom Metadata: no Metadata Stream: no Tagged: no UserProperties: no Suspects: no Form: none JavaScript: no Pages: 12 Encrypted: no Page size: 595.276 x 841.89 pts (A4) Page rot: 0 File size: 1651505 bytes Optimized: no PDF version: 1.7 name type encoding emb sub uni object ID ------------------------------------ ----------------- ---------------- --- --- --- --------- SOZKOC+VnURWPalladioL-Bold Type 1 Custom yes yes yes 10 0 AZBFJT+VnURWPalladioL Type 1 Custom yes yes yes 16 0 KRLPNI+URWPalladioL-Bold Type 1 Custom yes yes yes 21 0 RNMEKS+URWPalladioL-Roma Type 1 Custom yes yes yes 27 0 NOLTRI+URWPalladioL-Ital Type 1 Custom yes yes yes 32 0 XPUSBJ+TimesNewRomanPS-BoldItalicMT Type 1C WinAnsi yes yes no 48 0 BSDWLC+TimesNewRomanPSMT Type 1C WinAnsi yes yes no 51 0 JGMOZW+CMSY10 Type 1 Builtin yes yes yes 71 0 RIJDHR+CMBSY10 Type 1 Builtin yes yes yes 79 0 WBVKDJ+URWPalladioL-BoldItal Type 1 Custom yes yes yes 84 0 CKBPVA+EURM10 Type 1 Builtin yes yes yes 92 0 FNDALJ+PalatinoLinotype,BoldItalic TrueType WinAnsi yes yes no 110 0 FNCOMN+PalatinoLinotype,Bold TrueType WinAnsi yes yes no 113 0 FNCOMO+PalatinoLinotype CID TrueType Identity-H yes yes yes 116 0 FNCOMP+PalatinoLinotype TrueType WinAnsi yes yes no 122 0 FNCOOA+PalatinoLinotype,Italic TrueType WinAnsi yes yes no 125 0 FNCPFP+PalatinoLinotype TrueType MacRoman yes yes no 128 0 JCHBOF+PalatinoLinotype,BoldItalic TrueType WinAnsi yes yes no 145 0 JCHAIF+PalatinoLinotype,Bold TrueType WinAnsi yes yes no 148 0 JCHAJH+PalatinoLinotype TrueType WinAnsi yes yes no 151 0 JCHAJI+PalatinoLinotype,Italic CID TrueType Identity-H yes yes yes 154 0 JCHAJJ+PalatinoLinotype,Italic TrueType WinAnsi yes yes no 160 0 FNCOMN+PalatinoLinotype,Bold TrueType WinAnsi yes yes no 176 0 FNCOMO+PalatinoLinotype CID TrueType Identity-H yes yes yes 179 0 FNCOMP+PalatinoLinotype TrueType WinAnsi yes yes no 185 0 FNCOOA+PalatinoLinotype,Italic TrueType WinAnsi yes yes no 188 0 FNCPFP+PalatinoLinotype TrueType MacRoman yes yes no 191 0 FNCOMN+PalatinoLinotype,Bold TrueType WinAnsi yes yes no 206 0 FNCOMO+PalatinoLinotype CID TrueType Identity-H yes yes yes 209 0 FNCOMP+PalatinoLinotype TrueType WinAnsi yes yes no 215 0 FNCOOA+PalatinoLinotype,Italic TrueType WinAnsi yes yes no 218 0 FNCPFP+PalatinoLinotype TrueType MacRoman yes yes no 221 0 Jhove (Rel. 1.28.0, 2023-05-18) Date: 2025-07-16 02:40:59 CEST RepresentationInformation: jcm-13-00365.pdf ReportingModule: PDF-hul, Rel. 1.12.4 (2023-03-16) LastModified: 2025-07-15 18:09:08 CEST Size: 1651505 Format: PDF Version: 1.7 Status: Well-Formed and valid SignatureMatches: PDF-hul MIMEtype: application/pdf PDFMetadata: Objects: 362 FreeObjects: 1 IncrementalUpdates: 0 DocumentCatalog: PageLayout: SinglePage PageMode: UseNone Outlines: Item: Title: Introduction Destination: section.1 Item: Title: Methods Destination: section.2 Children: Item: Title: Patient Inclusion and Study Design Destination: subsection.2.1 Item: Title: Data Collection Destination: subsection.2.2 Item: Title: Endpoints Destination: subsection.2.3 Children: Item: Title: Assessment of Effectiveness Destination: subsubsection.2.3.1 Item: Title: Assessment of Safety Destination: subsubsection.2.3.2 Item: Title: Statistical Analyses Destination: subsection.2.4 Item: Title: Ethical Statement Destination: subsection.2.5 Item: Title: Data Availability Statement Destination: subsection.2.6 Item: Title: Results Destination: section.3 Children: Item: Title: Characteristics of the Study Population Destination: subsection.3.1 Item: Title: Safety of Vedolizumab and Ustekinumab Treatment in the Elderly Population Destination: subsection.3.2 Item: Title: Effectiveness of Vedolizumab and Ustekinumab in the Elderly Population Destination: subsection.3.3 Item: Title: Discussion Destination: section.4 Item: Title: References Destination: appendix.A. Info: Title: Safety and Effectiveness of Vedolizumab and Ustekinumab in Elderly Patients with Inflammatory Bowel Disease: A Real-Life Multicentric Cohort Study Author: Tom Holvoet, Marie Truyens, Cara De Galan, Harald Peeters, Francisco Mesonero Gismero, Ainara Elorza, Paola Torres, Liv Vandermeulen, Aranzazu Jauregui-Amezaga, Rocio Ferreiro-Iglesias, Yamile Zabana, Laia Peries Reverter, Jeroen Geldof and Triana Lobatón Subject: Background: Data on ustekinumab and vedolizumab in the elderly inflammatory bowel disease (IBD) population are limited. The aim of the current study was to assess the safety and effectiveness of both in an elderly real-life population. Methods: A multicentric retrospective study was performed on IBD patients who started vedolizumab or ustekinumab between 2010 and 2020. Clinical and endoscopic remission rates and (serious) adverse events (AE) were assessed. Results: A total of 911 IBD patients were included, with 171 (19%) aged above 60 (111 VDZ, 60 UST). Elderly patients treated with vedolizumab or ustekinumab had an increased risk for non-IBD hospitalization (10.5% vs. 5.7%, p = 0.021) and malignancy (2.3% vs. 0.5%, p = 0.045) compared to the younger population. Corticosteroid-free clinical (50% vs. 44%; p = 0.201) and endoscopic remission rates (47.9% vs. 31%, p = 0.07) at 1 year were similar. Comparing vedolizumab to ustekinumab in the elderly population, corticosteroid-free (47.9% vs. 31%, p = 0.061) and endoscopic remission rates (66.7% vs. 64.4%, p = 0.981) were similar. Vedolizumab- and ustekinumab-treated patients had comparable infection rates (13.5% vs. 10.0%, p = 0.504), IBD flare-ups (4.5% vs. 5%, p = 1.000), the occurrence of new EIMs (13.5% vs. 10%, p = 0.504), a risk of intestinal surgery (5.4% vs. 6.7%, p = 0.742), malignancy (1.8% vs. 3.3%, p = 0.613), hospitalization (9.9% vs. 11.7%, p = 0.721), and mortality (0.9% vs. 1.7%, p = 1.000). AE risk was associated only with corticosteroid use. Conclusions: Ustekinumab and vedolizumab show comparable effectiveness and safety in the elderly IBD population. Elderly IBD patients have an increased risk for non-IBD hospitalizations and malignancy compared to the younger IBD population, with corticosteroid use as the main risk factor. Keywords: elderly; IBD; vedolizumab; ustekinumab; safety Creator: LaTeX with hyperref Producer: pdfTeX-1.40.25 CreationDate: Tue Jan 09 12:33:39 CET 2024 ModDate: Tue Jan 09 12:36:51 CET 2024 ID: 0xe133bc54ecc5c2eca10ab6b56225ca7f, 0xe133bc54ecc5c2eca10ab6b56225ca7f Filters: FilterPipeline: FlateDecode Fonts: Type1: Font: BaseFont: AZBFJT+VnURWPalladioL FontSubset: true FirstChar: 161 LastChar: 243 FontDescriptor: FontName: AZBFJT+VnURWPalladioL Flags: Symbolic FontBBox: -166, -283, 1021, 943 FontFile: true EncodingDictionary: Differences: true ToUnicode: true Font: BaseFont: NOLTRI+URWPalladioL-Ital FontSubset: true FirstChar: 3 LastChar: 122 FontDescriptor: FontName: NOLTRI+URWPalladioL-Ital Flags: Symbolic FontBBox: -170, -305, 1010, 941 FontFile: true EncodingDictionary: Differences: true ToUnicode: true Font: BaseFont: WBVKDJ+URWPalladioL-BoldItal FontSubset: true FirstChar: 112 LastChar: 112 FontDescriptor: FontName: WBVKDJ+URWPalladioL-BoldItal Flags: Symbolic FontBBox: -170, -300, 1073, 935 FontFile: true EncodingDictionary: Differences: true ToUnicode: true Font: BaseFont: KRLPNI+URWPalladioL-Bold FontSubset: true FirstChar: 3 LastChar: 134 FontDescriptor: FontName: KRLPNI+URWPalladioL-Bold Flags: Symbolic FontBBox: -152, -301, 1000, 935 FontFile: true EncodingDictionary: Differences: true ToUnicode: true Font: BaseFont: JGMOZW+CMSY10 FontSubset: true FirstChar: 6 LastChar: 21 FontDescriptor: FontName: JGMOZW+CMSY10 Flags: Symbolic FontBBox: -29, -960, 1116, 775 FontFile: true ToUnicode: true Font: BaseFont: SOZKOC+VnURWPalladioL-Bold FontSubset: true FirstChar: 226 LastChar: 226 FontDescriptor: FontName: SOZKOC+VnURWPalladioL-Bold Flags: Symbolic FontBBox: -152, -301, 1000, 935 FontFile: true EncodingDictionary: Differences: true ToUnicode: true Font: BaseFont: RNMEKS+URWPalladioL-Roma FontSubset: true FirstChar: 2 LastChar: 246 FontDescriptor: FontName: RNMEKS+URWPalladioL-Roma Flags: Symbolic FontBBox: -166, -283, 1021, 943 FontFile: true EncodingDictionary: Differences: true ToUnicode: true Font: BaseFont: CKBPVA+EURM10 FontSubset: true FirstChar: 11 LastChar: 11 FontDescriptor: FontName: CKBPVA+EURM10 Flags: Symbolic FontBBox: -32, -243, 1060, 720 FontFile: true ToUnicode: true Font: BaseFont: RIJDHR+CMBSY10 FontSubset: true FirstChar: 21 LastChar: 21 FontDescriptor: FontName: RIJDHR+CMBSY10 Flags: Symbolic FontBBox: -26, -940, 1332, 825 FontFile: true ToUnicode: true Pages: Page: Sequence: 1 Annotations: Annotation: Subtype: Link Rect: 111, 293, 152, 302 Annotation: Subtype: Link Rect: 34, 281, 128, 290 Annotation: Subtype: Link Rect: 34, 164, 96, 186 Annotation: Subtype: Link Rect: 125, 90, 154, 99 Annotation: Subtype: Link Rect: 34, 78, 149, 87 Annotation: Subtype: Link Rect: 34, 756, 176, 792 Annotation: Subtype: Link Rect: 515, 756, 560, 792 Annotation: Subtype: Link Rect: 180, 630, 191, 643 Annotation: Subtype: Link Rect: 397, 617, 408, 630 Annotation: Subtype: Link Rect: 111, 604, 122, 618 Annotation: Subtype: Link Rect: 232, 604, 243, 618 Annotation: Subtype: Link Rect: 126, 17, 263, 28 Annotation: Subtype: Link Rect: 424, 17, 560, 28 Annotation: Subtype: Link Rect: 34, 414, 87, 433 Page: Sequence: 2 Annotations: Annotation: Subtype: Link Rect: 197, 550, 204, 559 ActionDest: 232 Annotation: Subtype: Link Rect: 352, 525, 359, 534 ActionDest: 232 Annotation: Subtype: Link Rect: 232, 475, 239, 484 ActionDest: 232 Annotation: Subtype: Link Rect: 240, 475, 247, 484 ActionDest: 232 Annotation: Subtype: Link Rect: 405, 425, 412, 434 ActionDest: 232 Annotation: Subtype: Link Rect: 415, 425, 422, 434 ActionDest: 232 Annotation: Subtype: Link Rect: 501, 375, 508, 384 ActionDest: 232 Annotation: Subtype: Link Rect: 501, 349, 508, 359 ActionDest: 232 Annotation: Subtype: Link Rect: 509, 350, 516, 359 ActionDest: 232 Annotation: Subtype: Link Rect: 361, 299, 368, 308 ActionDest: 236 Annotation: Subtype: Link Rect: 371, 299, 383, 308 ActionDest: 236 Annotation: Subtype: Link Rect: 310, 262, 322, 271 ActionDest: 236 Annotation: Subtype: Link Rect: 324, 262, 336, 271 ActionDest: 236 Annotation: Subtype: Link Rect: 549, 110, 556, 119 ActionDest: 232 Page: Sequence: 3 Annotations: Annotation: Subtype: Link Rect: 489, 476, 501, 485 ActionDest: 236 Annotation: Subtype: Link Rect: 358, 388, 365, 397 ActionDest: 236 Page: Sequence: 4 Annotations: Annotation: Subtype: Link Rect: 403, 535, 410, 547 ActionDest: 76 Page: Sequence: 5 Annotations: Annotation: Subtype: Link Rect: 306, 350, 313, 362 ActionDest: 89 Page: Sequence: 6 Page: Sequence: 7 Annotations: Annotation: Subtype: Link Rect: 549, 716, 556, 728 ActionDest: 100 Annotation: Subtype: Link Rect: 489, 182, 496, 194 ActionDest: 133 Page: Sequence: 8 Annotations: Annotation: Subtype: Link Rect: 199, 132, 206, 144 ActionDest: 166 Page: Sequence: 9 Annotations: Annotation: Subtype: Link Rect: 501, 367, 508, 379 ActionDest: 166 Annotation: Subtype: Link Rect: 303, 143, 310, 152 ActionDest: 232 Annotation: Subtype: Link Rect: 310, 143, 317, 152 ActionDest: 232 Annotation: Subtype: Link Rect: 318, 143, 325, 152 ActionDest: 232 Annotation: Subtype: Link Rect: 325, 143, 337, 152 ActionDest: 236 Annotation: Subtype: Link Rect: 340, 143, 352, 152 ActionDest: 236 Page: Sequence: 10 Annotations: Annotation: Subtype: Link Rect: 337, 743, 349, 752 ActionDest: 236 Annotation: Subtype: Link Rect: 349, 743, 361, 752 ActionDest: 236 Annotation: Subtype: Link Rect: 361, 706, 368, 715 ActionDest: 232 Annotation: Subtype: Link Rect: 368, 706, 380, 715 ActionDest: 236 Annotation: Subtype: Link Rect: 381, 706, 393, 715 ActionDest: 236 Annotation: Subtype: Link Rect: 347, 656, 359, 665 ActionDest: 236 Annotation: Subtype: Link Rect: 231, 631, 243, 639 ActionDest: 236 Annotation: Subtype: Link Rect: 283, 568, 295, 577 ActionDest: 236 Annotation: Subtype: Link Rect: 483, 530, 495, 539 ActionDest: 236 Annotation: Subtype: Link Rect: 495, 530, 507, 539 ActionDest: 236 Annotation: Subtype: Link Rect: 369, 492, 381, 501 ActionDest: 236 Annotation: Subtype: Link Rect: 317, 467, 329, 476 ActionDest: 236 Annotation: Subtype: Link Rect: 389, 417, 401, 426 ActionDest: 236 Annotation: Subtype: Link Rect: 544, 417, 556, 426 ActionDest: 236 Annotation: Subtype: Link Rect: 511, 392, 523, 401 ActionDest: 236 Annotation: Subtype: Link Rect: 469, 367, 481, 376 ActionDest: 236 Annotation: Subtype: Link Rect: 490, 342, 502, 351 ActionDest: 236 Annotation: Subtype: Link Rect: 359, 216, 371, 225 ActionDest: 236 Page: Sequence: 11 Annotations: Annotation: Subtype: Link Rect: 536, 566, 560, 577 Annotation: Subtype: Link Rect: 165, 554, 379, 565 Annotation: Subtype: Link Rect: 455, 188, 493, 199 Annotation: Subtype: Link Rect: 499, 188, 535, 199 Annotation: Subtype: Link Rect: 328, 165, 365, 176 Annotation: Subtype: Link Rect: 372, 165, 408, 176 Annotation: Subtype: Link Rect: 478, 153, 515, 164 Annotation: Subtype: Link Rect: 521, 153, 557, 164 Annotation: Subtype: Link Rect: 370, 142, 407, 153 Annotation: Subtype: Link Rect: 413, 142, 449, 153 Annotation: Subtype: Link Rect: 181, 96, 219, 107 Annotation: Subtype: Link Rect: 334, 73, 371, 84 Page: Sequence: 12 Annotations: Annotation: Subtype: Link Rect: 500, 741, 538, 752 Annotation: Subtype: Link Rect: 388, 718, 425, 729 Annotation: Subtype: Link Rect: 291, 683, 329, 694 Annotation: Subtype: Link Rect: 390, 660, 427, 671 Annotation: Subtype: Link Rect: 436, 637, 474, 648 Annotation: Subtype: Link Rect: 480, 637, 516, 648 Annotation: Subtype: Link Rect: 432, 614, 470, 625 Annotation: Subtype: Link Rect: 476, 614, 512, 625 Annotation: Subtype: Link Rect: 338, 591, 375, 602 Annotation: Subtype: Link Rect: 158, 569, 195, 579 Annotation: Subtype: Link Rect: 59, 512, 96, 522 Annotation: Subtype: Link Rect: 102, 512, 138, 522 Annotation: Subtype: Link Rect: 104, 489, 142, 499 Annotation: Subtype: Link Rect: 437, 476, 475, 487 Annotation: Subtype: Link Rect: 371, 442, 409, 453 Annotation: Subtype: Link Rect: 394, 407, 432, 418 Annotation: Subtype: Link Rect: 438, 407, 474, 418 Annotation: Subtype: Link Rect: 95, 374, 133, 384 Annotation: Subtype: Link Rect: 139, 374, 175, 384 Annotation: Subtype: Link Rect: 467, 350, 504, 361 Annotation: Subtype: Link Rect: 510, 350, 546, 361 Annotation: Subtype: Link Rect: 151, 316, 188, 326 Annotation: Subtype: Link Rect: 195, 316, 231, 326 Annotation: Subtype: Link Rect: 469, 292, 507, 303 Annotation: Subtype: Link Rect: 513, 292, 549, 303 Annotation: Subtype: Link Rect: 519, 269, 557, 280 Annotation: Subtype: Link Rect: 59, 259, 95, 269 Annotation: Subtype: Link Rect: 59, 224, 96, 234 Annotation: Subtype: Link Rect: 102, 224, 138, 234 Annotation: Subtype: Link Rect: 234, 189, 271, 200 Annotation: Subtype: Link Rect: 323, 120, 361, 131 Checksum: e5cccb4f Type: CRC32 Checksum: 8b3d0807e97420c501b95f9675b9bf25 Type: MD5 Checksum: cea9505fc67acd9be2824181d5577c4b0e91b88a Type: SHA-1 Checksum: c00b74385595d4c655fd057fb1bb1827a83bf98f03c6c737982cedaabe465f16 Type: SHA-256