Table 4 Reported relative risk estimates and key findings in studies of biological treatment
Author and year | Country and study period | Definition of outcome | Reported relative risk estimates (95% CI)a | Key findings | |||
|---|---|---|---|---|---|---|---|
IBD | CD | UC | Estimate type | ||||
Lie 2017 [45] | Netherlands Mar/2006—Feb/2011 | Discontinuation |  | 1.81 p-value = 0.02 |  | HR | Males significantly more likely to continue ADA treatment (HR = 1.807, P = 0.020) |
Rundquist 2018 [93] | Sweden 2005—2017 | Discontinuation of golimumab treatment |  | 0.15 [0.02;0.96] / 0.45 [0.24;0.84] Reported for at 12 weeks / at most recent foloow-up |  | HR | Male sex was associated with decreased risk of discontinuing golimumab treatment at 12 weeks adjusted HR = 0.15, 95% CI: 0.02;0.96;p = 0.05) and at the most recent follow-up (adjusted HR = 0.45, 95% CI: 0.24;0.84;p = 0.01) |
Schultheiss 2019 [94] | The Netherlands Jan/2011—Dec/2017 | All TNF-alfa inhibitor drug persistence | 0.70 [0.57;0.86] |  |  | HR | Male sex was significantly associated with a lower risk of discontinuation of TNF-alfa inhibitor therapy in multivariate Cox proportional hazards regression (HR 0.70, 95% CI 0.57;0.86) |
Tanaka 2018 [95] | Japan Between Oct/2010 and Dec/2013 | Retention of adalimumab treatment defined as the incidence of the discontinuation of adalimumab treatment | Â | 0.73 [0.56;0.94] | Â | HR | Female sex was identified as independent predictor for the discontinuation of adalimumab |
Heath | Canada Mar/2012—Sept/2019 | Biologics drug exposure |  | Males: 11 (3.8%) Females: 18 (4.5%) p-value = ns | Males: 28 (14.8%) Females: 14 (8.0%) p-value = 0.049 | N (%) | Females with UC are significantly more likely than males to have been exposed to biologics |
Herzog 2014 [42] | Switzerland 2008—Sep/2012 | Anti-TNF therapy |  | Males: 6 (33.3) / 11(22.5) Females: 4 (57.1) / 13 (41.9) p-value = 0.20 / 0.14 Reported for < 10 years / >  = 10 years | Males: 6 (35.3) / 4 (14.4) Females: 3 (12) / 1 (3.8) p-value = 0.45 / 0.17 Reported for < 10 years / >  = 10 years | N (%) | Gender was not associated with use of anti-TNF therapy |
Lagana 2019 [96] | Italy Before 2019 | Discontinuation of adalimumab or inflimax | Males: 8 (9%) / 30 (27.5%) Females: 17 (22%) / 25 (32%) p-value = 0.03 / 0.52 Reported for adalimumab / infliximab |  |  | N (%) | The overall rate of female patients discontinuing ADA (17/77, 22%) was significantly (p = 0.03) higher than that of male patients (8/85, 9%) No significant differences between female and male patients were detected for IFX discontinuation |
Liu 2022 [70] | China Jan/2000 – Dec/2020 | Use of biologic therapy |  | Males: 122 (29.0) Females: 47 (24.6) p-value = 0.255 |  | N (%) | No difference was observed in use of biologics at diagnosis between female and male patients |
Severs 2018 [26] | The Netherlands, 2010—? | Anti-TNF, Adalimumab, Infliximab |  | Males: 81 (22%) / 35 (10%) / 47 (13%) Females: 118 (21%) / 67 (12%) / 51 (9%) p-value = 0.63 / 0.28 / 0.06 Reported for Anti-TNF/Adalimumab/Infliximab | Males: 18 (3%) / 8 (2%) / 10 (2%) Females: 21 (4%) / 5 (1%) 16 / (3%) p-value = 0.37 / 0.54 / 0.13 Reported for Anti-TNF/Adalimumab/Infliximab | N (%) | No differences regarding the use of biologics were observed between men and women |
Dotson 2015 [36] | USA Apr/2004—Jun/2012 | Use of biological agent |  | Males: 444 (15%) Females: 460 (16%) p-value = 1 |  | N(%) | Female rates for biological agents (n = 460, 16%), were not statistically different from those for males (n = 444, 15%,P = 1) [adjusted based on Bonferroni correction] |
Khalili 2020 [90] | Sweden Jan/2014—Dec/2014 | Anti-TNF treatment | Females: 1016 (42.5%) | Females: 674 (44%) | Females: 342 (39.7%) | N (%) | No description |
McKenna 2018 [87] | USA Jan/2002—Aug/2013 | Preoperative use of biologics |  | Males: 71 (20.2%) Females: 48 (22.1%) p-value = 0.58 |  | N(%) | Gender was not associated with preoperative use of biologics |
Calvo-Arbeloa 2020 [97] | Spain Jan/2019—Jun/2019 | Adherence to treatment with adalimumab, golimumab and ustekinumab | 2.28 [1.13;4.63] |  |  | OR | Female sex was associated with lower adherence levels/male patients had higher odds for being adherent to biologics; No statistical significant association between educational status and adherence was found |
Lee 2012 [86] | USA May/2007—May/2010 | Medication use with biologics therapy (Infliximab) |  | 0.96 [0.72;1.27] | 0.71 [0.38;1.30] | OR | No sex differences in the use of infliximab in the study population as a whole or when stratified by age |
Lin 2013 [91] | USA 1998—2010 | Use of anti-TNF therapy | 0.85 [0.35;2.08] |  |  | OR | Gender was not associated with anti-TNF therapy |
Mahlich 2018 [92] | Japan Survey data collected in Feb/2016 | Biological treatment not further specified | 1.30 [0.78;2.17] | 3.33 [1.27;9.09] | 1.49 [0.28;1.30] | OR | In Crohn’s disease, female IBD patients had lower probability of using biologic agents than men. No statistically significant associations were found in UC patients Annual income did not play a role in selecting biologic treatment in Japan The highest level of education (masters degree or higher) was associated with lower risk of biological treatment compared to the lowest education (college or less) in Crohns disease patients and overall |
Timmer 2017 [60] | Germany 2011/2012 and 2013 | Use of biologics (ever) | 0.83 [0.62;1.10] | Â | Â | OR | Sex: No difference in use of biologicals between males and females; SES: no difference in use of biologicals between the middle income tertile and the high and low tertile, respectively |
Bernstein 2020 [72] | Canada Apr/1995—Mar/2018 | Biologic therapy |  |  |  |  | No difference for biologic therapy across socioeconomic status; p-values not reported |