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Patient-reported Outcomes for Multicentric Castleman's Disease in a Randomized, Placebo-controlled Study of Siltuximab.

van Rhee F, Rothman M, Ho KF, Fleming S, Wong RS, Fosså A, Dispenzieri A, Cavet J, Munshi N, Vermeulen J, Casper C - Patient (2015)

Bottom Line: Siltuximab-treated subjects reported early improvements in symptoms compared with subjects in the placebo arm on both the MCD-SS and FACIT-Fatigue scale.Statistically significant improvements in five SF-36 domains were observed in siltuximab-treated patients, namely role physical, role emotional, vitality, bodily pain, and mental health.Siltuximab-treated patients reported significant improvements in these outcomes after treatment.

View Article: PubMed Central - PubMed

Affiliation: Myeloma Institute for Research and Therapy, University of Arkansas for Medical Sciences, Little Rock, AR, 72205, USA, vanrheefrits@uams.edu.

ABSTRACT

Background: Multicentric Castleman's disease (MCD) is a rare lymphoproliferative disorder driven by dysregulated interleukin-6 production. MCD has a poor prognosis, and treatment is generally noncurative and aimed at symptom relief. Siltuximab is a novel, monoclonal interleukin-6 antibody recently shown to be effective in a registration clinical trial. MCD symptoms, such as fatigue, pain, and weakness, are most appropriately quantified using patient-reported outcome (PRO) measures. We assessed the effect of siltuximab on patient perception of symptoms, functional status, and wellbeing using PRO instruments.

Methods: We analyzed results of a randomized, double-blind trial comparing siltuximab 11 mg/kg every 3 weeks with placebo to treat MCD. Subjects (N = 79) completed the recently developed MCD-Symptom Scale (MCD-SS), the Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue) scale, and the Short Form (SF)-36 at predetermined time points throughout the treatment period. Scores were compared at baseline and over time between the treatment arms and PRO instruments.

Results: At baseline, the mean number of symptoms reported was 9.2 (standard deviation 3.76) out of 16 total, as measured by the MCD-SS. Fatigue was a key symptom across all PRO instruments. Siltuximab-treated subjects reported early improvements in symptoms compared with subjects in the placebo arm on both the MCD-SS and FACIT-Fatigue scale. Statistically significant improvements in five SF-36 domains were observed in siltuximab-treated patients, namely role physical, role emotional, vitality, bodily pain, and mental health.

Conclusions: Patients with MCD commonly report impairments in functioning, wellbeing, and fatigue at baseline. Siltuximab-treated patients reported significant improvements in these outcomes after treatment.

No MeSH data available.


Related in: MedlinePlus

(a) Cycle 1 Day 1 means and box plots of MCD–SS domains and total score. Light shading indicates median to third quartile and dark shading indicates median to first quartile. (b) Cycle 1 Day 1 frequency distributions of MCD–SS individual items. The mean (SD) number of symptoms reported per patient was 9.2 (3.76). MCD–SS ranges from 0 to 10, higher scores represent greater symptom severity. LN lymph node, MCD–SS Multicentric Castleman’s Disease–Symptom Scale, SD standard deviation
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Fig1: (a) Cycle 1 Day 1 means and box plots of MCD–SS domains and total score. Light shading indicates median to third quartile and dark shading indicates median to first quartile. (b) Cycle 1 Day 1 frequency distributions of MCD–SS individual items. The mean (SD) number of symptoms reported per patient was 9.2 (3.76). MCD–SS ranges from 0 to 10, higher scores represent greater symptom severity. LN lymph node, MCD–SS Multicentric Castleman’s Disease–Symptom Scale, SD standard deviation

Mentions: At baseline, the mean (SD) number of symptoms reported per subject on the MCD–SS was 9.2 (3.76) out of 16 total (Fig. 1). The total score was 2.53 (on a scale of 0–10, from very mild to very severe), indicating that symptom severity at the start of the study was generally mild; however, the Fatigue domain had a mean score of 4.23, suggesting higher severity. Approximately 50 % of scores in the Fatigue domain were moderate or higher.Fig. 1


Patient-reported Outcomes for Multicentric Castleman's Disease in a Randomized, Placebo-controlled Study of Siltuximab.

van Rhee F, Rothman M, Ho KF, Fleming S, Wong RS, Fosså A, Dispenzieri A, Cavet J, Munshi N, Vermeulen J, Casper C - Patient (2015)

(a) Cycle 1 Day 1 means and box plots of MCD–SS domains and total score. Light shading indicates median to third quartile and dark shading indicates median to first quartile. (b) Cycle 1 Day 1 frequency distributions of MCD–SS individual items. The mean (SD) number of symptoms reported per patient was 9.2 (3.76). MCD–SS ranges from 0 to 10, higher scores represent greater symptom severity. LN lymph node, MCD–SS Multicentric Castleman’s Disease–Symptom Scale, SD standard deviation
© Copyright Policy - OpenAccess
Related In: Results  -  Collection

Show All Figures
getmorefigures.php?uid=PMC4383814&req=5

Fig1: (a) Cycle 1 Day 1 means and box plots of MCD–SS domains and total score. Light shading indicates median to third quartile and dark shading indicates median to first quartile. (b) Cycle 1 Day 1 frequency distributions of MCD–SS individual items. The mean (SD) number of symptoms reported per patient was 9.2 (3.76). MCD–SS ranges from 0 to 10, higher scores represent greater symptom severity. LN lymph node, MCD–SS Multicentric Castleman’s Disease–Symptom Scale, SD standard deviation
Mentions: At baseline, the mean (SD) number of symptoms reported per subject on the MCD–SS was 9.2 (3.76) out of 16 total (Fig. 1). The total score was 2.53 (on a scale of 0–10, from very mild to very severe), indicating that symptom severity at the start of the study was generally mild; however, the Fatigue domain had a mean score of 4.23, suggesting higher severity. Approximately 50 % of scores in the Fatigue domain were moderate or higher.Fig. 1

Bottom Line: Siltuximab-treated subjects reported early improvements in symptoms compared with subjects in the placebo arm on both the MCD-SS and FACIT-Fatigue scale.Statistically significant improvements in five SF-36 domains were observed in siltuximab-treated patients, namely role physical, role emotional, vitality, bodily pain, and mental health.Siltuximab-treated patients reported significant improvements in these outcomes after treatment.

View Article: PubMed Central - PubMed

Affiliation: Myeloma Institute for Research and Therapy, University of Arkansas for Medical Sciences, Little Rock, AR, 72205, USA, vanrheefrits@uams.edu.

ABSTRACT

Background: Multicentric Castleman's disease (MCD) is a rare lymphoproliferative disorder driven by dysregulated interleukin-6 production. MCD has a poor prognosis, and treatment is generally noncurative and aimed at symptom relief. Siltuximab is a novel, monoclonal interleukin-6 antibody recently shown to be effective in a registration clinical trial. MCD symptoms, such as fatigue, pain, and weakness, are most appropriately quantified using patient-reported outcome (PRO) measures. We assessed the effect of siltuximab on patient perception of symptoms, functional status, and wellbeing using PRO instruments.

Methods: We analyzed results of a randomized, double-blind trial comparing siltuximab 11 mg/kg every 3 weeks with placebo to treat MCD. Subjects (N = 79) completed the recently developed MCD-Symptom Scale (MCD-SS), the Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue) scale, and the Short Form (SF)-36 at predetermined time points throughout the treatment period. Scores were compared at baseline and over time between the treatment arms and PRO instruments.

Results: At baseline, the mean number of symptoms reported was 9.2 (standard deviation 3.76) out of 16 total, as measured by the MCD-SS. Fatigue was a key symptom across all PRO instruments. Siltuximab-treated subjects reported early improvements in symptoms compared with subjects in the placebo arm on both the MCD-SS and FACIT-Fatigue scale. Statistically significant improvements in five SF-36 domains were observed in siltuximab-treated patients, namely role physical, role emotional, vitality, bodily pain, and mental health.

Conclusions: Patients with MCD commonly report impairments in functioning, wellbeing, and fatigue at baseline. Siltuximab-treated patients reported significant improvements in these outcomes after treatment.

No MeSH data available.


Related in: MedlinePlus