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Oral fingolimod (FTY720) in relapsing multiple sclerosis: impact on health-related quality of life in a phase II study.
Mult Scler. 2011 Nov; 17(11):1341-50.MS

Abstract

BACKGROUND

Health-related quality of life (HRQoL) worsens with multiple sclerosis (MS) relapses and disease progression. Common symptoms including depression and fatigue may contribute to poor HRQoL.

OBJECTIVES

To report exploratory analyses assessing the impact of fingolimod (FTY720) on HRQoL and depression in a phase II study of relapsing MS.

METHODS

The Hamburg Quality of Life Questionnaire in MS (HAQUAMS) and Beck Depression Inventory second edition (BDI-II) scores were assessed during a 6-month, placebo-controlled study and optional extension.

RESULTS

HAQUAMS total score improved with fingolimod and worsened with placebo. Mean score change from baseline to month 6 was -0.02 with fingolimod 1.25 mg (p < 0.05 versus placebo), -0.01 with fingolimod 5.0 mg and + 0.12 with placebo. Categorical data supported a clinically important effect of fingolimod on HRQoL. Fingolimod 1.25 mg was also beneficial over placebo in the fatigue/thinking HAQUAMS sub-domain (p < 0.05 versus placebo). Change in mean BDI-II scores from baseline to month 6 and the proportion of patients with BDI-II scores indicative of clinical depression favored fingolimod 1.25 mg over placebo (p < 0.05 for both). At month 4, mean BDI-II and HAQUAMS total scores appeared to be maintained in fingolimod-treated patients.

CONCLUSION

Fingolimod 1.25 mg may improve HRQoL and depression at 6 months compared with placebo in patients with relapsing MS.

Authors+Show Affiliations

Unitat de Neuroimmunologia Clinica, Vall d'Hebron University Hospital, Barcelona, Spain. xavier.montalban@unic-em.comNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Clinical Trial, Phase II
Journal Article
Multicenter Study
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

21727148

Citation

Montalban, X, et al. "Oral Fingolimod (FTY720) in Relapsing Multiple Sclerosis: Impact On Health-related Quality of Life in a Phase II Study." Multiple Sclerosis (Houndmills, Basingstoke, England), vol. 17, no. 11, 2011, pp. 1341-50.
Montalban X, Comi G, O'Connor P, et al. Oral fingolimod (FTY720) in relapsing multiple sclerosis: impact on health-related quality of life in a phase II study. Mult Scler. 2011;17(11):1341-50.
Montalban, X., Comi, G., O'Connor, P., Gold, S., de Vera, A., Eckert, B., & Kappos, L. (2011). Oral fingolimod (FTY720) in relapsing multiple sclerosis: impact on health-related quality of life in a phase II study. Multiple Sclerosis (Houndmills, Basingstoke, England), 17(11), 1341-50. https://doi.org/10.1177/1352458511411061
Montalban X, et al. Oral Fingolimod (FTY720) in Relapsing Multiple Sclerosis: Impact On Health-related Quality of Life in a Phase II Study. Mult Scler. 2011;17(11):1341-50. PubMed PMID: 21727148.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Oral fingolimod (FTY720) in relapsing multiple sclerosis: impact on health-related quality of life in a phase II study. AU - Montalban,X, AU - Comi,G, AU - O'Connor,P, AU - Gold,Sm, AU - de Vera,A, AU - Eckert,B, AU - Kappos,L, Y1 - 2011/07/04/ PY - 2011/7/6/entrez PY - 2011/7/6/pubmed PY - 2012/3/2/medline SP - 1341 EP - 50 JF - Multiple sclerosis (Houndmills, Basingstoke, England) JO - Mult. Scler. VL - 17 IS - 11 N2 - BACKGROUND: Health-related quality of life (HRQoL) worsens with multiple sclerosis (MS) relapses and disease progression. Common symptoms including depression and fatigue may contribute to poor HRQoL. OBJECTIVES: To report exploratory analyses assessing the impact of fingolimod (FTY720) on HRQoL and depression in a phase II study of relapsing MS. METHODS: The Hamburg Quality of Life Questionnaire in MS (HAQUAMS) and Beck Depression Inventory second edition (BDI-II) scores were assessed during a 6-month, placebo-controlled study and optional extension. RESULTS: HAQUAMS total score improved with fingolimod and worsened with placebo. Mean score change from baseline to month 6 was -0.02 with fingolimod 1.25 mg (p < 0.05 versus placebo), -0.01 with fingolimod 5.0 mg and + 0.12 with placebo. Categorical data supported a clinically important effect of fingolimod on HRQoL. Fingolimod 1.25 mg was also beneficial over placebo in the fatigue/thinking HAQUAMS sub-domain (p < 0.05 versus placebo). Change in mean BDI-II scores from baseline to month 6 and the proportion of patients with BDI-II scores indicative of clinical depression favored fingolimod 1.25 mg over placebo (p < 0.05 for both). At month 4, mean BDI-II and HAQUAMS total scores appeared to be maintained in fingolimod-treated patients. CONCLUSION: Fingolimod 1.25 mg may improve HRQoL and depression at 6 months compared with placebo in patients with relapsing MS. SN - 1477-0970 UR - https://www.unboundmedicine.com/medline/citation/21727148/Oral_fingolimod__FTY720__in_relapsing_multiple_sclerosis:_impact_on_health_related_quality_of_life_in_a_phase_II_study_ L2 - http://journals.sagepub.com/doi/full/10.1177/1352458511411061?url_ver=Z39.88-2003&amp;rfr_id=ori:rid:crossref.org&amp;rfr_dat=cr_pub=pubmed DB - PRIME DP - Unbound Medicine ER -