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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

Time to improvement of Short Form (SF)-36 mental component summary (MCS) score during the blinded treatment period. Median time to improvement: 104 days with siltuximab compared with 302 days with placebo [hazard ratio (HR) = 2.412; p = 0.0173]. BSC best supportive care
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Fig4: Time to improvement of Short Form (SF)-36 mental component summary (MCS) score during the blinded treatment period. Median time to improvement: 104 days with siltuximab compared with 302 days with placebo [hazard ratio (HR) = 2.412; p = 0.0173]. BSC best supportive care

Mentions: Overall, during the blinded treatment period, 24 patients (48 %) in the siltuximab group and 8 patients (31 %) in the placebo group achieved a ≥5-point improvement in the SF-36 PCS score. In the siltuximab group, the median time to improvement in the SF-36 PCS score was 420 days. The median time to improvement was not reached in the placebo group [hazard ratio (HR) = 1.421; p = 0.3941]. A ≥5-point improvement in SF-36 MCS score was achieved by 34 (68 %) patients in the siltuximab group and 9 (35 %) patients in the placebo group (p = 0.0074). Median time to improvement of the SF-36 MCS score was significantly faster (104 days) with siltuximab than with placebo (302 days; HR = 2.412; p = 0.0173; Fig. 4).Fig. 4


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)

Time to improvement of Short Form (SF)-36 mental component summary (MCS) score during the blinded treatment period. Median time to improvement: 104 days with siltuximab compared with 302 days with placebo [hazard ratio (HR) = 2.412; p = 0.0173]. BSC best supportive care
© Copyright Policy - OpenAccess
Related In: Results  -  Collection

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

Fig4: Time to improvement of Short Form (SF)-36 mental component summary (MCS) score during the blinded treatment period. Median time to improvement: 104 days with siltuximab compared with 302 days with placebo [hazard ratio (HR) = 2.412; p = 0.0173]. BSC best supportive care
Mentions: Overall, during the blinded treatment period, 24 patients (48 %) in the siltuximab group and 8 patients (31 %) in the placebo group achieved a ≥5-point improvement in the SF-36 PCS score. In the siltuximab group, the median time to improvement in the SF-36 PCS score was 420 days. The median time to improvement was not reached in the placebo group [hazard ratio (HR) = 1.421; p = 0.3941]. A ≥5-point improvement in SF-36 MCS score was achieved by 34 (68 %) patients in the siltuximab group and 9 (35 %) patients in the placebo group (p = 0.0074). Median time to improvement of the SF-36 MCS score was significantly faster (104 days) with siltuximab than with placebo (302 days; HR = 2.412; p = 0.0173; Fig. 4).Fig. 4

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