In patients with CKD-associated pruritus on haemodialysis treated with difelikefalin in Study 3105 (post hoc analysis), mean SQ-NRS change was -5.2 (95% CI -5.6, -4.8) with ≥3-point WI-NRS improvement versus -1.5 (-2.0, -1.0) with <3-point improvement.
In plain wordsIn difelikefalin-treated patients, greater itch improvement was linked to greater sleep improvement than lesser itch improvement.
- Peptide
- Difelikefalin
- Outcome
- DecreaseSQ-NRS change by itch response
- Study
n: not reported in source
- Comparator
- <3-point WI-NRS improvement
- Outcome group
- Sleep · Sleep
- Studied dose
- 0.5 µg/kg three times weekly · intravenous · 12 weeksAs given in this study (human).
Measurements
- Mean SQ-NRS change
- −5.2 points
- Study 3105; ≥3-point WI-NRS improvement
- 95% CI of mean SQ-NRS change
- −5.6 to −4.8 points
- Study 3105; ≥3-point WI-NRS improvement
- Mean SQ-NRS change
- −1.5 points
- Study 3105; <3-point WI-NRS improvement
- 95% CI of mean SQ-NRS change
- −2 to −1 points
- Study 3105; <3-point WI-NRS improvement
Source sentences
Greater improvements in sleep quality were observed in patients with ≥3-point versus <3-point WI-NRS improvement using SQ-NRS in Study 3105 [mean (95% confidence interval) -5.2 (-5.6, -4.8) vs -1.5 (-2.0, -1.0)] and 5-D SDQ in KALM-1 and -2 [-1.8 (-2.1, -1.6) vs -0.8 (-1.1, -0.4)].
2 context sentences(design, population, supporting numbers)
This post hoc analysis of the Phase 3 difelikefalin studies (Study 3105 and the pooled dataset from KALM-1 and KALM-2) evaluated whether itch reduction in individuals with CKD-aP improved sleep quality.
Sleep quality was assessed using the sleep disability question of the 5-D Itch Scale (5-D SDQ) in all studies and, in Study 3105, with the Sleep Quality Numeric Rating Scale (SQ-NRS).