Abstract: P1278
Type: Poster
Abstract Category: Therapy - disease modifying - Treatment of progressive MS
Background: Multiple sclerosis (MS) is a chronic disease, resulting in long-term accumulation of physical and cognitive disability that negatively impacts patients" quality of life (QoL). Patient-reported outcomes provide insight into the humanistic burden of diseases. Limited patient-reported data are available in primary progressive MS (PPMS), highlighting the need to understand the patient"s perception of their disease.
Objective: To assess baseline fatigue and health-related QoL in patients enrolled in ORATORIO, a Phase III, randomised, double-blind, placebo-controlled study of ocrelizumab in PPMS.
Methods: The Modified Fatigue Impact Scale (MFIS) assesses the effects of fatigue on physical, cognitive and psychosocial functioning. The MFIS is scored on a 0-84 scale and scores ≥38 indicate a clinically important level of fatigue. The Short Form-36 (SF-36) assesses patients" perception of health and well-being across 8 health concepts: 1) general health perceptions; 2) physical functioning; 3) role limitations due to physical problems; 4) bodily pain; 5) mental health; 6) role limitations due to emotional problems; 7) vitality; 8) social functioning. A Physical Component Summary (PCS) and Mental Component Summary (MCS) score can also be calculated. The SF-36 is scored on a 0-100 scale, and lower scores reflect poorer QoL. T scores for SF-36 were calculated using the 2009 US Normative data; a mean (SD) score of 50 (10) corresponds to that of the general US population. MFIS and SF-36 were assessed at baseline in ORATORIO patients.
Results: In ORATORIO, the mean (SD) MFIS score was 41.6 (17.2) at baseline, with 62.7% of patients scoring above the threshold for clinically important symptoms. Baseline mean (SD) SF-36 PCS and MCS were 37.9 (8.6) and 44.2 (11.2), respectively, indicating their HRQoL was below that of the general US population. The baseline mean (SD) SF-36 subscale scores were as follows: general health perceptions, 40.8 (9.4); physical functioning, 34.6 (9.4); role limitations due to physical problems, 35.6 (10.2); bodily pain, 45.4 (11.3); mental health 43.9 (10.6); role-limitations due to emotional problems, 39.7 (12.8); vitality, 42.5 (9.4); and social functioning, 40.7 (10.5).
Conclusion: In ORATORIO, a high prevalence of fatigue and diminished HRQoL were reported at baseline by patients with PPMS, highlighting the unmet need for treatments that improve QoL and fatigue in this chronic, disabling disease.
Sponsored by F. Hoffmann-La Roche Ltd.
Disclosure: Xavier Montalban has received speaking honoraria and travel expense reimbursement for participation in scientific meetings, has been a steering committee member of clinical trials or participated in advisory boards of clinical trials in the past years with Actelion, Almirall, Bayer, Biogen, Genzyme, Merck, Novartis, Octapharma, Receptos, F. Hoffmann-La Roche Ltd., Sanofi, Teva and Trophos.
Fiona McDougall is an employee of F. Hoffmann-La Roche Ltd.
Ellen Lentz is an employee of Genentech, Inc.
Gurpreet Deol-Bhullar is an employee of F. Hoffmann-La Roche Ltd.
Jerry Wolinsky in the last 3 years has received compensation for service on steering committees or data monitoring boards for F. Hoffmann-La Roche Ltd., Medday Pharmaceuticals, Novartis, Sanofi Genzyme and Teva Pharmaceuticals; consultant fees from AbbVie, Actelion, Alkermes, EMD Serono, Forward Pharma, Genentech, Inc., F. Hoffmann-La Roche Ltd., Novartis, Sanofi Genzyme, Takeda, Teva, and XenoPort; research support from, Sanofi Genzyme, the NIH and the NMSS through the University of Texas Health Science Center at Houston (UTHSCH) and royalties for monoclonal antibodies out-licensed to Chemicon International through UTHSCH.
Abstract: P1278
Type: Poster
Abstract Category: Therapy - disease modifying - Treatment of progressive MS
Background: Multiple sclerosis (MS) is a chronic disease, resulting in long-term accumulation of physical and cognitive disability that negatively impacts patients" quality of life (QoL). Patient-reported outcomes provide insight into the humanistic burden of diseases. Limited patient-reported data are available in primary progressive MS (PPMS), highlighting the need to understand the patient"s perception of their disease.
Objective: To assess baseline fatigue and health-related QoL in patients enrolled in ORATORIO, a Phase III, randomised, double-blind, placebo-controlled study of ocrelizumab in PPMS.
Methods: The Modified Fatigue Impact Scale (MFIS) assesses the effects of fatigue on physical, cognitive and psychosocial functioning. The MFIS is scored on a 0-84 scale and scores ≥38 indicate a clinically important level of fatigue. The Short Form-36 (SF-36) assesses patients" perception of health and well-being across 8 health concepts: 1) general health perceptions; 2) physical functioning; 3) role limitations due to physical problems; 4) bodily pain; 5) mental health; 6) role limitations due to emotional problems; 7) vitality; 8) social functioning. A Physical Component Summary (PCS) and Mental Component Summary (MCS) score can also be calculated. The SF-36 is scored on a 0-100 scale, and lower scores reflect poorer QoL. T scores for SF-36 were calculated using the 2009 US Normative data; a mean (SD) score of 50 (10) corresponds to that of the general US population. MFIS and SF-36 were assessed at baseline in ORATORIO patients.
Results: In ORATORIO, the mean (SD) MFIS score was 41.6 (17.2) at baseline, with 62.7% of patients scoring above the threshold for clinically important symptoms. Baseline mean (SD) SF-36 PCS and MCS were 37.9 (8.6) and 44.2 (11.2), respectively, indicating their HRQoL was below that of the general US population. The baseline mean (SD) SF-36 subscale scores were as follows: general health perceptions, 40.8 (9.4); physical functioning, 34.6 (9.4); role limitations due to physical problems, 35.6 (10.2); bodily pain, 45.4 (11.3); mental health 43.9 (10.6); role-limitations due to emotional problems, 39.7 (12.8); vitality, 42.5 (9.4); and social functioning, 40.7 (10.5).
Conclusion: In ORATORIO, a high prevalence of fatigue and diminished HRQoL were reported at baseline by patients with PPMS, highlighting the unmet need for treatments that improve QoL and fatigue in this chronic, disabling disease.
Sponsored by F. Hoffmann-La Roche Ltd.
Disclosure: Xavier Montalban has received speaking honoraria and travel expense reimbursement for participation in scientific meetings, has been a steering committee member of clinical trials or participated in advisory boards of clinical trials in the past years with Actelion, Almirall, Bayer, Biogen, Genzyme, Merck, Novartis, Octapharma, Receptos, F. Hoffmann-La Roche Ltd., Sanofi, Teva and Trophos.
Fiona McDougall is an employee of F. Hoffmann-La Roche Ltd.
Ellen Lentz is an employee of Genentech, Inc.
Gurpreet Deol-Bhullar is an employee of F. Hoffmann-La Roche Ltd.
Jerry Wolinsky in the last 3 years has received compensation for service on steering committees or data monitoring boards for F. Hoffmann-La Roche Ltd., Medday Pharmaceuticals, Novartis, Sanofi Genzyme and Teva Pharmaceuticals; consultant fees from AbbVie, Actelion, Alkermes, EMD Serono, Forward Pharma, Genentech, Inc., F. Hoffmann-La Roche Ltd., Novartis, Sanofi Genzyme, Takeda, Teva, and XenoPort; research support from, Sanofi Genzyme, the NIH and the NMSS through the University of Texas Health Science Center at Houston (UTHSCH) and royalties for monoclonal antibodies out-licensed to Chemicon International through UTHSCH.