Table 3.
Studies and pruritus efficacy measures by medication
| Class | Intervention | N studies (n RCT) | N patients treated (n PBC) | Pruritus efficacy assessment (N studies) | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| NRS | Pruritus reduction | VAS | PBC-40 / 27 itch | 5-D itch scale | Scratching activity | Sleep interference | N studies with any significant improvement1 (RCTs) | ||||
| Anion-exchange resins | Cholestyramine2 | 5 (2) | 59 (56) | 3 | 3 | 1 | 3 (2) | ||||
| Colesevelam2 | 1 (1) | 17 (4) | 1 | 1 | |||||||
| Colestilan | 1 (1) | 5 (5) | 1 | 1 (1) | |||||||
| DEAE-Dextran | 2 (1) | 31 (31) | 1 | 2 | 1 (1) | ||||||
| Antibiotics | Rifampicin2 | 7 (43) | 191 (110) | 2 | 4 | 3 | 4 (4) | ||||
| Rifaximin | 1 (0) | 16 (0) | 1 | ||||||||
| Opiate agents | Naloxone2 | 2 (1) | 28 (> 8) | 2 | 2 | ||||||
| Naltrexone2 | 3 (23) | 28 (23) | 1 | 2 | 1 | 2 (2) | |||||
| Nalmefene2 | 1 (0) | 9 (9) | 1 | 1 (0) | |||||||
| Nalfurafine4 | 1 (0) | 44 (44) | 1 | 1 | 1 (0) | ||||||
| Selective serotonin reuptake inhibitors | Sertraline1 | 2 (2) | 30 (16) | 1 | 2 | 1 | 1 (1) | ||||
| Fibrates | Bezafibrate | 5 (3) | 167 (120) | 1 | 3 | 2 | 1 | 3 (3) | |||
| Fenofibrate | 2 (0) | 40 (20) | 1 | 2 | 1 (0) | ||||||
| IBAT inhibitors | Maralixibat | 1 (1) | 42 (42) | 1 | 1 | 1 | 1 | ||||
| Linerixibat | 1 (1) | 21 (21) | 1 | 1 | 1 | 1 | 1 (1) | ||||
| A4250/odevixibat | 1 (0) | 10 (10) | 1 | ||||||||
| Other | Lidocaine | 1 (1) | 12 (9) | 1 | 1 (1) | ||||||
| Terfenadine | 1 (1) | 8 (7) | 1 | 1 (1) | |||||||
| Phenobarbital1 | 2 (1) | 31 (29) | 2 | 1 | |||||||
| NGM282 | 2 (2) | 72 (30) | 1 | 1 | 1 | 2 | |||||
| Flumecinol | 3 (3) | 55 (> 51) | 2 | 3 | 2 (2) | ||||||
| Ondansetron | 1 (1) | 9 (> 7) | 1 | 1 | 1 | ||||||
| Chlorpheniramine | 1 (1) | 8 (7) | 1 | ||||||||
1Studies reporting significant improvement in pruritus as defined by the authors of the studies; values in parentheses represent number of RCTs. Blank cells reflect significantly worse, not significant, or not reported
2Recommended treatment included in AASLD guidelines [14]
3One RCT includes an open-label extension reported in the same publication and not counted as a separate study
4A large Phase 3 trial was not included as it did not meet the 75% PBC/PSC inclusion criteria (n = 90/317)
> implies that the number was reported as total and not by study arm and/or studies did not report number of PBC patients
NOTE: table reports available data on all treatments; therefore, the same study may be included more than once
The number of patients refers to the number of patients treated with the specified medication
AASLD American Association for the Study of Liver Diseases, DEAE diethylaminoethyl, NRS numerical rating scale, PBC primary biliary cholangitis, RCT randomised controlled trial, VAS visual analogue scale