Table 2.
IBD treatments that have been shown to improve HRQoL.
| Treatment | Study | Measurement Tool(s) | No. Patients | HRQoL: Primary Outcome | Results |
|---|---|---|---|---|---|
| 5-ASA | Robinson et al. [27] | 5 disease-specific and 7 general items | 374 UC | Yes | Mesalamine 2 g and 4 g daily was significantly superior to placebo in improving each of the 12 HRQoL parameters. |
| Probert et al. [28] | EQ-5D-3L | 115 UC | No | The combined (oral + rectal) therapy group reported a significant improvement in the ‘mobility’, ‘usual activity’ and ‘anxiety/depression’ domains at week 4. | |
| Thiopurines | Alruthia et al. [32] | EQ-5D-3L EQ-5D-VAS |
160 IBD (56% CD, 44% UC) | Yes | Patients on AZA presented higher HRQoL at six-month follow-up compared with patients on other treatments (β = 9.35; 95% CI: 0.486–18.22; p = 0.003). |
| Bastida et al. [49] | SF-36 IBDQ |
92 IBD (68 CD, 24 UC) | Yes | Compared with baseline, 68 and 64% patients’ scores improved at 6 and 12 months, respectively (ΔIBDQ was 0.86 and 1.05, respectively). SF-36 showed a similar improvement. | |
| Calvet et al. [50] | SF-36 | 33 RCD a, 14 ACD b, 66 HC c |
Yes | SF-36 were 85 in RCD, 85 in HC (p = 1), and 58.6 in ACD (p < 0.001 for comparison with RCD and HC). | |
| Infliximab | Feagan et al. [33] | IBDQ SF-36 |
728 UC | No | IBDQ score improvement was significantly greater in the IFX 5 and 10 mg/kg groups (40 and 36, respectively p < 0.001) vs. placebo (28). |
| Silva et al. [34] | IBDQ | 31 UC | Yes | In IFX group (n = 21), the IBDQ scores ranges from 116.2 at baseline to 170.75 and 176.62 at week 30 and 54, respectively (p ≤ 0.02) | |
| Feagan et al. [51] | IBDQ SF-36 |
335 CD | No | The mean change in the IBDQ at week 54 compared to baseline was 22.1 in the 5 mg/kg and 30.2 in 10 mg/kg IFX maintenance group while it was 8.9 in the placebo group (p ≤ 0.05). SF-36 changed in the same line. | |
| Adalimumab | Travis et al. [36] | SIBDQ EQ-5D-5L EQ-5D-VAS |
463 UC | Yes | Significant improvements from baseline to week 26 were detected on SIBDQ (mean change 17.4) and EQ5D (index: 0.1 ± 0.2; VAS: 19.5). |
| Louis et al. [56] | SIBDQ | 945 CD | No | 60% of IFX-naïve patients and 47% of IFX primary non-responders reported clinically significant improvements (≥9 points) on SIBDQ. | |
| Saro et al. [58] | IBDQ EQ-5D EQ-5D-VAS |
126 CD | Yes | It has been shown a significant improvement on the EQ5D from 0.735 to 0.797, the EQ5D VAS from 50.0 to 80.0, and the IBDQ from 56.7 to 67.5 (p < 0.05 for all comparisons). | |
| Golimumab | Feagan et al. [37] | IBDQ SF-36 |
1064 UC | No | It was determined a significantly greater improvement from baseline to week 6 in GLM vs. placebo groups in IBDQ (27.2 vs. 14.6), SF-36 PCS (4.14 vs. 2.46) and MCS (4.89 vs. 1.60, p < 0.01 for all comparisons). |
| Vedolizumab | Feagan et al. [38] | IBDQ SF-36 EQ-5D-3L ED-5D-VAS |
373 UC | No | Patients on VDZ reported significantly greater improvements in IBDQ and EQ5D-VAS scores. For EQ-5D utility score, only the VDZ every 4 weeks group showed a significant difference from placebo. At week 52, more patients on VDZ met the minimal clinically meaningful difference thresholds for IBDQ, SF-36 physical component and EQ5D-VAS scores. |
| Loftus et al. [39] | IBDQ | 769 UC (383 VDZ, 386 ADA) | No | At week 52, clinically important IBDQ improvement was detected in a greater proportion of VDZ treated patients compared with ADA treated ones (52.0% vs. 42.2%). Likewise, 50.1% (VDZ) vs. 40.4% (ADA) of patients achieved IBDQ remission. | |
| Vermiere et al. [59] | IBDQ EQ5D-VAS SF-36 |
1349 CD | No | At week 80, the mean changes from baseline HRQL scores were >51 for IBDQ, >23 for EQ-5D VAS, >9 for SF-36 PCS and >10 for SF-36 MCS. | |
| Parkes et al. [60] | SIBDQ | 61 IBD (21 CD, 40 UC) |
No | SIBDQ score increased by 8.5 and 10.2 points in CD and UC patients, respectively, at week 14. | |
| Eriksson et al. [61] | SHS | 169 CD | No | It has been seen a significant decreased of the SHS score at week 52 (n = 68; p < 0.001) | |
| Ustekinumab | Sandborn et al. [41] | IBDQ SF-36 |
284 UC | No | 55.6% of patients who had been treated with USK were in IBDQ remission. Regarding the SF-36, 50.0% and 45.1% of patients had a clinically meaningful improvement in the PCS and the MCS, respectively. |
| Sands et al. [62] | IBDQ SF-36 |
1368 CD | No | A clinically meaningful improvement in IBDQ score at week 8 was achieved in 68.1% of anti-TNF naïve patients and 54.8% of patients with previous failure to antiTNF. Similarly, greater improvements in SF-36 in the USK group have been determined. | |
| Marquès et al. [63] | IBDQ | 33 CD | Yes | 18% achieved IBDQ normalization at week 52. | |
| Tofacitinib | Panés et al. [42] | IBDQ SF-36 |
1161 UC (induction) 593 UC (sustain) |
No | In OCTAVE induction 1 and 2, mean IBDQ changes from baseline to week 8 was 40.7 and 44.6 with TFC 10mg twice daily versus 21 and 25 with placebo, respectively (p < 0.001). Mean SF-36 changes were comparable with the IBDQ changes and both were sustained at week 52 |
| Surgery (intestinal resection) | Wright et al. [64] | IBDQ SF-36 |
174 CD | No | A significant improvement has been observed at 6 months postoperatively compared to preoperatively in PCS (68 vs. 40), MCS (68 vs. 44) and IBDQ (171 vs. 125; p < 0.001 for all comparisons). |
| Ha et al. [65] | 5 generic tools 3 disease-specific tools |
1108 CD | Yes | Both generic and disease-specific tools showed an improvement in HRQoL from 2 weeks after intestinal resection for up to 5 years. |
AZA: azathioprine. IFX: infliximab. GLM: golimumab. VDZ: vedolizumab. ADA: adalimumab. USK: ustekinumab. TFC: tofacitinib.a Remission Crohn’s disease. b Active Crohn’s disease. c Healthy controls.