However, this effect was no longer statistically significant in the corrected multivariable analysis. influence of patient sex on adverse events. PHA690509 Studies were included in the assessment regardless of study type or setting. Results The search yielded 19,461 citations; after review, 55 studies were included in the study, involving 28,465 patients treated with adalimumab, certolizumab pegol, infliximab, or vedolizumab. There was no significant association between patient sex and endoscopic efficacy in 41 relevant studies. Increased adverse events were associated with female sex in 7 out of 14 relevant studies. Conclusions There is no evidence for a sex difference in endoscopically measured response to biological therapies in IBD patients. However, there is an influence of sex around the occurrence of adverse events. Electronic supplementary material The online version of this article (10.1007/s00384-020-03663-2) contains supplementary material, which is available to authorized users. values and/or confidence intervals. If only proportions were reported, the OR was calculated. For meta-analysis, where applicable, studies were pooled using a random-effects model, regardless of statistical heterogeneity. Heterogeneity was tested using the Chi-squared test, the em I /em -squared test and visual inspection of forest plots. If heterogeneity was present, we attempted to investigate the cause thereof (such as methodological factors or the outcome assessment). In the case of high heterogeneity ( em I /em 2? ?75%), studies were pooled only if the direction of their results was consistent. Subgroup analysis or meta-regression would be performed post hoc, if sufficient studies were included for meta-analysis. Results Results of the search The literature search performed on 08 April 2019 identified 19,461 citations, of which 11,049 remained after automatic removal of double entries (Fig.?1). After reviewing title and abstracts, 10,771 manuscripts were considered irrelevant (e.g. did not study biological, case reports, abstract format only, in vitro study, see also Supplemental Table 1). This resulted in 278 potentially relevant studies. Examining the reference lists did not yield additional potentially useful manuscripts. In total, 273 manuscripts were assessed completely for eligibility as 5 manuscripts could not be retrieved (Fig. ?(Fig.1,1, flowchart). Of these 273 studies, 217 were excluded for various PHA690509 reasons (Supplemental Table 2). The remaining 55 studies were included in this review (Tables?1 and ?and2)2) [7, 9, 15C67]. Open in a PHA690509 separate window Fig. 1 PRISMA flowchart of identification and selection of studies Table 1 Characteristics of included studies concerning patient sex and endoscopic efficacy thead th rowspan=”1″ colspan=”1″ Biological /th th rowspan=”1″ colspan=”1″ Study type /th th rowspan=”1″ colspan=”1″ Patients /th th rowspan=”1″ colspan=”1″ Author (ref) /th th rowspan=”1″ colspan=”1″ Outcome, measurement time point /th th rowspan=”1″ colspan=”1″ Patient sex associated with outcome? /th /thead ADA, induction of remissionProspective43 CDHall [37]CECDAI, 52?weeksNot associatedRetrospective201 UCKiss [43]MH, 12?monthsNot associatedRetrospective43 UCPapamichael [7]MH, 8C14?weeksNot associatedRetrospective77 CDRismo [58]MH, variable time-pointNot associatedRCT post-hoc135 CDWatanabe [65]MH, 26 and 52?weeksNot associatedADA, maintenance of remissionCross-sectional98 IBDJuncadella [40]CD: MH; UC: endoscopic Mayo ?1Not associatedCross-sectional40 IBDRoblin [59]CD: MH; UC: endoscopic Mayo ?1Not associatedCross-sectional60 CDZittan [67]MHNot associatedADA, post-operativeRCT post-hoc101 CDde Cruz [26]Disease recurrence, 6?monthsNot associatedRCT post-hoc84 CDTaxonera [5]Disease recurrence, 52?weeksNot associatedIFX, induction of remissionProspective285 UCArias [15]MH, 10C14?weeksNot associatedCombineda126 UCArmuzzi [17]MH, 12?weeks and 12?monthsNot associatedRCT post-hoc508 CDBouguen [19]MH, 26?weeksNot associatedProspective30 UCBrandse [20]Endoscopic Mayo decrease ?1 and 8?weeksNot associatedProspective63 UCFarkas [30]MH, 14?weeksNot associatedProspective44 UCHassan [38]MH, 12?weeksNot associatedRetrospective42 UCKelly [41]MH, 48?weeksNot associatedRetrospective101 UCPapamichael [7]MH, 10C14?weeksNot associatedRetrospective49 UCRibaldone [56]Total Mayo decrease ?3, 6?monthsNot associatedRetrospective49 UCRismo [57]Endoscopic Mayo ?1, 8C12?weeksNot associatedRetrospective97 CDShen [61]MH, 10?weeksNot associatedRetrospective126 CDThomas [63]Complete/near-complete MH, 12C20?weeksNot associatedIFX, maintenance of remissionRetrospective271 IBDKelly [42]CD: SES-CD? ?3; UC: endoscopic Mayo ?1Not associatedProspective35 CDKoga [44]MHNot associatedRetrospective110 CDPapamichael [53]MHNot associatedProspective54 IBDPaul [54]MHNot associatedVED, induction of remissionRetrospective48 CDCrowell [24]Undefined endoscopic improvement, 45?weeksNot associatedRetrospective179 IBDDreesen [27]CD: MH, 22?weeks; UC: endoscopic Mayo ?1, 14?weeksNot associatedRetrospective212 CDDulai [29]MH, 6 and 12?monthsNot associatedRetrospective222 IBDKotze [45]CD: MH or radiographic remission, 3, 6 and 12?months; UC: endoscopic Mayo?=?0, 3, 6 and 12?monthsNot associatedRetrospective321 UCNarula [50]Endoscopic Mayo?=?0 and 12?monthsNot associatedProspective82 IBDYacoub [66]CD: MH or radiographic remission, 12?months; UC: endoscopic Lysipressin Acetate Mayo ?1, 12?monthsNot associatedADA, IFX, remission inductionRetrospective248 IBDBeigel [18]CD: SES-CD?=?0; UC: endoscopic Mayo?=?0; for both groups after median 11C25?monthsNot associatedRetrospective48 UCDahlen [25]Total Mayo decrease ?3, 14?weeksNot associatedProspective50 CDKuzela [46]Normal mucosal appearance.
