Relapsing Multiple Sclerosis
Conditions
Keywords
flu-like symptoms
Brief summary
The primary objective of this study is to determine the proportion of participants with relapsing multiple sclerosis who experience new and/or increased flu-like symptoms (FLS) after transitioning from nonpegylated IFN-β therapies to peginterferon beta-1a (BIIB017). Secondary objectives are: to determine the severity and frequency (measured by flu-like symptom score \[FLS-S\]) of FLS in these participants; to determine the duration (measured in number of hours) of FLS in these participants; to determine the effect of BIIB017 on other participant-reported outcomes, including treatment satisfaction (measured with the Treatment Satisfaction Questionnaire for Medication \[TSQM\]) and disability status (measured with the Patient Determined Disease Steps \[PDDS\]) over a 56-week period; to determine whether interferon-related FLS result in missed days of work/daily activities (e.g., absenteeism); to assess the use of additional medications (in addition to current medications used to treat FLS) to relieve BIIB017-related FLS; to determine the incidence of adverse events throughout the study period; to characterize the immunogenicity profiles of participants switching from prior IFN-β therapy to BIIB017.
Interventions
DRUGBIIB017
DRUGnaproxen
Sponsors
Biogen
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
Key Inclusion Criteria: * Must have a confirmed diagnosis of relapsing forms of multiple sclerosis (MS), as defined by McDonald criteria #1-4 \[Polman 2005\] * Must have neurological findings consistent with an Expanded Disability Status Scale (EDSS) score of 0.0 - 5.0 * Must be treated with IFN-β and must be receiving a stable dose of IFN-β for at least 4 months immediately prior to screening * All male patients and female patients of childbearing potential must practice effective contraception during the study and be willing and able to continue contraception for 3 months after their last dose of study treatment. Key
Exclusion criteria
* Primary progressive, secondary progressive, or progressive relapsing MS \[Lublin and Reingold 1996\]. These conditions require the presence of continuous clinical disease worsening over a period of at least 3 months. Patients with these conditions may also have superimposed relapse but are distinguished from patients with relapsing MS by the lack of clinically stable periods or clinical improvement * History of severe allergic or anaphylactic reactions or known hypersensitivity to medication which might suggest potential for a reaction to IFN β-1a or polyethylene glycol * History of malignant disease, including solid tumors and hematologic malignancies (with the exception of basal cell and squamous cell carcinomas of the skin that have been completely excised and are considered cured) * History of seizure disorder or unexplained blackouts OR history of a seizure within 3 months prior to Baseline * Known allergy to any component of the BIIB017 formulation * An MS relapse that has occurred within the 50 days prior to Baseline (Day 1) and/or lack of stabilization from a previous relapse prior to Baseline. NOTE: Other protocol defined Inclusion/
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants Experiencing New or Increased FLS During the First 8 Weeks: Overall Population | during the first 8 weeks of treatment | The total Flu-like Symptoms Score (FLS-S) is the sum of all 4 symptom scores (muscle aches, chills, fatigue and fever), each rated from 0 (absent) to 3 (severe), with a range of 0-12 with 0 indicating no FLS and 12 indicating severe FLS. New or increased FLS is defined as an FLS overall score of 2 points or greater over Screening. Pre-dose data were not used; up to 48-hour data after dosing were used. Overall score was imputed as the average score after dose. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With Any FLS in the 4-Week Run-In Period, During the First 8 Weeks of Treatment, and During 48 Weeks of Treatment | 4-week run-in period, first 8 weeks of treatment, 48 weeks of treatment | Any FLS is defined as an FLS-S total score \> 0. The total FLS-S is the sum of all 4 symptom scores (muscle aches, chills, fatigue and fever), each rated from 0 (absent) to 3 (severe), with a range of 0-12 with 0 indicating no FLS and 12 indicating severe FLS. 4WRI=4-week run-in; F8W=first 8 weeks; 48W=48 weeks. |
| Shift in Percentage of Participants With Any FLS From 4-Week Run-In Period to the First 8 Weeks | 4-week run-in period, first 8 weeks of treatment | Any FLS is defined as an FLS-S total score \> 0. The total FLS-S is the sum of all 4 symptom scores (muscle aches, chills, fatigue and fever), each rated from 0 (absent) to 3 (severe), with a range of 0-12 with 0 indicating no FLS and 12 indicating severe FLS. Pre-dose data not were used. Data up to 48-hours after dosing were used. Total score was imputed as the highest score after dose. 4WRI=4-week run-in period; F8W=first 8 weeks. |
| Shift in Percentage of Participants With Any FLS From 4-Week Run-In Period to 48 Weeks | 4-week run-in period, 48 weeks of treatment | Any FLS is defined as an FLS-S total score \> 0. The total FLS-S is the sum of all 4 symptom scores (muscle aches, chills, fatigue and fever), each rated from 0 (absent) to 3 (severe), with a range of 0-12 with 0 indicating no FLS and 12 indicating severe FLS. Pre-dose data not were used. Data up to 48-hours after dosing were used. Total score was imputed as the highest score after dose. 4WRI=4-week run-in period; 48W=48 weeks. |
| Summary of Severity of FLS (Per FLS-S) in the First 8 Weeks Compared to 4-Week Run-In Period Between Arms | 4-week run-in period, first 8 weeks of treatment | The total FLS-S is the sum of all 4 symptom scores (muscle aches, chills, fatigue and fever), each rated from 0 (absent) to 3 (severe), with a range of 0-12 with 0 indicating no FLS and 12 indicating severe FLS. 4WRI=4-week run-in period; F8W=first 8 weeks. |
| Summary of Severity of FLS (Per FLS-S) in the 48 Weeks of Treatment Compared to 4-Week Run-In Period Between Arms | 4-week run-in period, 48 weeks of treatment | The total FLS-S is the sum of all 4 symptom scores (muscle aches, chills, fatigue and fever), each rated from 0 (absent) to 3 (severe), with a range of 0-12 with 0 indicating no FLS and 12 indicating severe FLS. 4WRI=4-week run-in period; 48W=48 weeks. |
| Summary of Average Duration of FLS in the First 8 Weeks of Treatment | 4-week run-in period, first 8 weeks of treatment | Duration of FLS for a treatment was defined as the sum of hours from the time of treatment to 48 hours with an FLS-S score \> 0. The total FLS-S is the sum of all 4 symptom scores (muscle aches, chills, fatigue and fever), each rated from 0 (absent) to 3 (severe), with a range of 0-12 with 0 indicating no FLS and 12 indicating severe FLS. If an FLS is \> 0 at an evaluation time, 6 hours were counted as the duration assuming the event started from previous evaluation time. Average duration of FLS for the first 8 weeks was defined as the mean duration from Weeks 0, 2, 4, 6, and 8. 4WRI=4-week run-in period; F8W=first 8 weeks. |
| Summary of Average Duration of FLS in the 48 Weeks of Treatment | 4-week run-in period, 48 weeks of treatment | Duration of FLS for a treatment was defined as the sum of hours from the time of treatment to 48 hours with a FLS-S score \> 0. The total FLS-S is the sum of all 4 symptom scores (muscle aches, chills, fatigue and fever), each rated from 0 (absent) to 3 (severe), with a range of 0-12 with 0 indicating no FLS and 12 indicating severe FLS. If a FLS is \> 0 at an evaluation time, 6 hours were counted as the duration assuming the event started from previous evaluation time. Average duration of FLS for the first 8 weeks was defined as the mean duration from Weeks 0, 2, 4, 6, and 8. 4WRI=4-week run-in period; 48W=48 weeks. |
| Summary of FLS-Visual Analogue Scale (VAS) During the First 8 Weeks of Treatment Compared to 4-Week Run-In Period: Effectiveness of FLS Treatment | 4-week run-in period, first 8 weeks of treatment | Participants reported the effectiveness of their FLS management regimen on a 100-mm VAS between not effective (0) and very effective (100). 4WRI=4-week run-in period; F8W=first 8 weeks. |
| Summary of FLS-VAS During the First 8 Weeks of Treatment Compared to 4-Week Run-In Period: Satisfaction With FLS Treatment | 4-week run-in period, first 8 weeks of treatment | Participants reported their satisfaction with the effectiveness of their FLS management regimen on a 100-mm VAS between not satisfied (0) and very satisfied (100). 4WRI=4-week run-in period; F8W=first 8 weeks. |
| Summary of FLS-VAS During the 48 Weeks of Treatment Compared to 4-Week Run-In Period: Effectiveness of FLS Treatment | 4-week run-in period, 48 weeks of treatment | Participants reported the effectiveness of their FLS management regimen on a 100-mm VAS between not effective (0) and very effective (100). 4WRI=4-week run-in period; 48W=48 weeks. |
| Summary of FLS-VAS During the 48 Weeks of Treatment Compared to 4-Week Run-In Period: Satisfaction With FLS Treatment | 4-week run-in period, 48 weeks of treatment | Participants reported their satisfaction with the effectiveness of their FLS management regimen on a 100-mm VAS between not satisfied (0) and very satisfied (100). 4WRI=4-week run-in period; 48W=48 weeks. |
| Percentage of Participants Requiring Additional FLS Management Regimen to Relieve BIIB017-related FLS | during the first 8 weeks of treatment | — |
| Mean Change From 4-Week Run-In Period at Each Visit for Treatment Satisfaction Questionnaire for Medication (TSQM), Effectiveness Scale Factor: Overall Population | 4-week run-in period, Weeks 4, 12, 24, 36, 48 (or Early Termination) | The TSQM assessed participants' global satisfaction with treatment and captured information on treatment side effects, effectiveness, and convenience. Changes from the 4-week run-in period to each visit using transformed scores between 0 and 100 for effectiveness (with higher scores indicating greater satisfaction) are presented. 4WRI=4-week run-in. |
| Mean Change From 4-Week Run-In Period at Each Visit for TSQM, Side-Effects Scale Factor: Overall Population | 4-week run-in period, Weeks 4, 12, 24, 36, 48 (or Early Termination) | The TSQM assessed participants' global satisfaction with treatment and captured information on treatment side effects, effectiveness, and convenience. Changes from the 4-week run-in period to each visit using transformed scores between 0 and 100 for side effects (with higher scores indicating greater satisfaction) are presented. 4WRI=4-week run-in. |
| Percentage of Participants Experiencing New or Increased FLS During the First 8 Weeks: Between FLS Management Arms | during the first 8 weeks of treatment | The total FLS-S is the sum of all 4 symptom scores (muscle aches, chills, fatigue and fever), each rated from 0 (absent) to 3 (severe), with a range of 0-12 with 0 indicating no FLS and 12 indicating severe FLS. New or increased FLS is defined as an FLS overall score of 2 points or greater over Screening. Pre-dose data were not used; up to 48-hour data after dosing were used. Overall score was imputed as the average score after dose. |
| Mean Change From 4-Week Run-In Period at Each Visit for TSQM, Global Satisfaction Scale Factor: Overall Population | 4-week run-in period, Weeks 4, 12, 24, 36, 48 (or Early Termination) | The TSQM assessed participants' global satisfaction with treatment and captured information on treatment side effects, effectiveness, and convenience. Changes from the 4-week run-in period to each visit using transformed scores between 0 and 100 for global satisfaction (with higher scores indicating greater satisfaction) are presented. 4WRI=4-week run-in. |
| Mean Change From 4-Week Run-In Period at Week 4 for TSQM, Effectiveness Scale Factor: Between FLS Management Arms | 4-week run-in period, Week 4 | The TSQM assessed participants' global satisfaction with treatment and captured information on treatment side effects, effectiveness, and convenience. Changes from the 4-week run-in period to Week 4 using transformed scores between 0 and 100 for effectiveness (with higher scores indicating greater satisfaction) are presented. This secondary endpoint was targeted for Week 4 only. 4WRI=4-week run-in. |
| Mean Change From 4-Week Run-In Period at Week 4 for TSQM, Side Effects Scale Factor: Between FLS Management Arms | 4-week run-in period, Week 4 | The TSQM assessed participants' global satisfaction with treatment and captured information on treatment side effects, effectiveness, and convenience. Changes from the 4-week run-in period to Week 4 using transformed scores between 0 and 100 for side effects (with higher scores indicating greater satisfaction) are presented. This secondary endpoint was targeted for Week 4 only. 4WRI=4-week run-in. |
| Mean Change From 4-Week Run-In Period at Week 4 for TSQM, Convenience Scale Factor: Between FLS Management Arms | 4-week run-in period, Week 4 | The TSQM assessed participants' global satisfaction with treatment and captured information on treatment side effects, effectiveness, and convenience. Changes from the 4-week run-in period to Week 4 using transformed scores between 0 and 100 for convenience (with higher scores indicating greater satisfaction) are presented. This secondary endpoint was targeted for Week 4 only. 4WRI=4-week run-in. |
| Mean Change From 4-Week Run-In Period at Week 4 for TSQM, Global Satisfaction Scale Factor: Between FLS Management Arms | 4-week run-in period, Week 4 | The TSQM assessed participants' global satisfaction with treatment and captured information on treatment side effects, effectiveness, and convenience. Changes from the 4-week run-in period to Week 4 using transformed scores between 0 and 100 for global satisfaction (with higher scores indicating greater satisfaction) are presented. This secondary endpoint was targeted for Week 4 only. 4WRI=4-week run-in. |
| Mean Change From Screening at Each Visit in Absenteeism Questionnaire, Usual Work Days Per Week: Overall Population | Week -4 (screening), Week 12, Week 24, Week 36, Week 48, Early Termination | Categorical questions in the Absenteeism Questionnaire asked participants to report the number of usual work days per week, the number of days missed in 2 weeks from multiple sclerosis (MS) symptoms, and the number of days missed in 2 weeks from MS treatment. This secondary endpoint was targeted to analyze the Overall Population only. 4WRI=4-week run-in. |
| Mean Change From Screening at Each Visit in Absenteeism Questionnaire, Days Missed in 2 Weeks From MS Symptoms: Overall Population | Week -4 (screening), Week 12, Week 24, Week 36, Week 48, Early Termination | Categorical questions in the Absenteeism Questionnaire asked participants to report the number of usual work days per week, the number of days missed in 2 weeks from MS symptoms, and the number of days missed in 2 weeks from MS treatment. This secondary endpoint was targeted to analyze the Overall Population only. 4WRI=4-week run-in. |
| Mean Change From Screening at Each Visit in Absenteeism Questionnaire, Days Missed in 2 Weeks From MS Treatment: Overall Population | Week -4 (screening), Week 12, Week 24, Week 36, Week 48, Early Termination | Categorical questions in the Absenteeism Questionnaire asked participants to report the number of usual work days per week, the number of days missed in 2 weeks from MS symptoms, and the number of days missed in 2 weeks from MS treatment. This secondary endpoint was targeted to analyze the Overall Population only. 4WRI=4-week run-in. |
| Change From Baseline Visit (Day 1) to Week 48 in Walking Disability Status as Measured by Patient Determined Disease Steps (PDDS): Overall Population | Day 1 (Baseline, pre-dose), Week 12, Week 48, Early Termination | Subjects rated their perceived walking disability on a scale of 0 to 8 using the PDDS, with higher scores indicating more severe disability. This secondary endpoint was targeted to analyze the Overall Population only. |
| Summary of Adverse Events (AEs), Serious AEs (SAEs), and Discontinuations Due to AEs | Day 1 to Week 52 | An AE was any untoward medical occurrence that did not necessarily have a causal relationship with this treatment. An SAE was any untoward medical occurrence that at any dose: resulted in death; in the view of the Investigator, placed the subject at immediate risk of death (a life-threatening event); required inpatient hospitalization or prolongation of existing hospitalization; resulted in persistent or significant disability/incapacity; resulted in a congenital anomaly/birth defect; any other medically important event that, in the opinion of the Investigator, could jeopardize the subject or could require intervention to prevent one of the other outcomes listed in the definition above. ISR=injection site reactions. |
| Summary of Average Duration of FLS Within the Last 4 Weeks of the BIIB017 Treatment Period Compared With the Duration of FLS in the 4-Week Run-In Period | Weeks -4 to -1 (Screening), Weeks 45-48 (last 4 weeks of study) | Average duration of FLS for the last 4 weeks (L4W) is defined as the mean duration of last 4 weeks. Duration of FLS for a treatment is defined as the sum of hours from the treatment to 48 hours with a FLS-S score \> 0. The total FLS-S is the sum of all 4 symptom scores (muscle aches, chills, fatigue and fever), each rated from 0 (absent) to 3 (severe), with a range of 0-12 with 0 indicating no FLS and 12 indicating severe FLS. If a FLS is \> 0 at an evaluation time, 6 hours were counted as the duration assuming the event started from previous evaluation time. 4WRI=4-week run-in. |
| Antibody Data in the Overall Population: IFN β-1a Antibody Screening | Baseline (BL; Day 1), Week 12, Week 24, Week 36, Week 48 or early withdrawal (EW) | The number of participants who tested positive for IFN β-1a binding antibodies (BAbs). Value was coded as 'positive' if observed value \> 0 or coded as 'negative' if observed value \< 0. This secondary endpoint was targeted to analyze the Overall Population only. |
| Antibody Data in the Overall Population: IFN β-1a Anti-Pegylated (PEG) Antibody Testing | Baseline (BL; Day 1), Week 12, Week 24, Week 36, Week 48 or early withdrawal (EW) | The number of participants who tested positive or negative for IFN β-1a anti-PEG antibodies. Value was coded as 'positive' if observed value \> 0 or coded as 'negative' if observed value \< 0. This secondary endpoint was targeted to analyze the Overall Population only. |
| Antibody Data in the Overall Population: IFN β-1a Neutralizing Antibodies (Nabs) Testing | Baseline (Day 1), Week 12, Week 24, Week 36, Week 48 or early withdrawal (EW) | The number of participants who tested positive for IFN β-1a Nabs. Value was coded as 'positive' if observed value \> 0 or coded as 'negative' if observed value \< 0. This secondary endpoint was targeted to analyze the Overall Population only. |
| Mean Change From 4-Week Run-In Period at Each Visit for TSQM, Convenience Scale Factor: Overall Population | 4-week run-in period, Weeks 4, 12, 24, 36, 48 (or Early Termination) | The TSQM assessed participants' global satisfaction with treatment and captured information on treatment side effects, effectiveness, and convenience. Changes from the 4-week run-in period to each visit using transformed scores between 0 and 100 for convenience (with higher scores indicating greater satisfaction) are presented. 4WRI=4-week run-in. |
Countries
United States
Participant flow
Pre-assignment details
Of the 251 participants who entered into the run-in period of non-pegylated interferon (IFN) therapy, a total of 201 were randomized.
Participants by arm
| Arm | Count |
|---|---|
| BIIB017 Plus Current FLS Therapy Following a 4-week run-in period (starting 1 day after the Screening Visit) in which participants administered non-pegylated IFN therapy, participants received BIIB017 at an initial dose of 63 μg followed by 94 μg dose at Week 2 and 125 μg every 2 weeks from Week 4 to Week 46, plus current FLS management regimen as determined by the clinician. | 103 |
| BIIB017 Plus Naproxen Following a 4-week run-in period (starting 1 day after the Screening Visit) in which participants administered non-pegylated IFN therapy, participants received BIIB017 at an initial dose of 63 μg followed by 94 μg dose at Week 2 and 125 μg every 2 weeks from Week 4 to Week 46, plus 500 mg naproxen administered twice daily up to 24 hours prior to BIIB017 treatment and continuing for 48 hours following the BIIB017 injection for the first 8 weeks of treatment, and as recommended by the treating physician subsequently. | 98 |
| Total | 201 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 13 | 13 |
| Overall Study | Other | 1 | 2 |
| Overall Study | Withdrawal by Subject | 5 | 3 |
Baseline characteristics
| Characteristic | BIIB017 Plus Current FLS Therapy | BIIB017 Plus Naproxen | Total |
|---|---|---|---|
| Age, Continuous | 49.76 years STANDARD_DEVIATION 10.32 | 49.88 years STANDARD_DEVIATION 9.45 | 49.82 years STANDARD_DEVIATION 9.88 |
| Gender Female | 84 Participants | 79 Participants | 163 Participants |
| Gender Male | 19 Participants | 19 Participants | 38 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 92 / 103 | 90 / 98 |
| serious Total, serious adverse events | 4 / 103 | 6 / 98 |
Outcome results
Primary
Percentage of Participants Experiencing New or Increased FLS During the First 8 Weeks: Overall Population
The total Flu-like Symptoms Score (FLS-S) is the sum of all 4 symptom scores (muscle aches, chills, fatigue and fever), each rated from 0 (absent) to 3 (severe), with a range of 0-12 with 0 indicating no FLS and 12 indicating severe FLS. New or increased FLS is defined as an FLS overall score of 2 points or greater over Screening. Pre-dose data were not used; up to 48-hour data after dosing were used. Overall score was imputed as the average score after dose.
Time frame: during the first 8 weeks of treatment
Population: Efficacy population: randomized participants who received at least 1 dose of study treatment and had efficacy data in both the 4-week run-in period and the post-baseline treatment period.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Overall Population | Percentage of Participants Experiencing New or Increased FLS During the First 8 Weeks: Overall Population | 10.3 percentage of participants |
p-value: <0.0001Chi-squared
Secondary
Antibody Data in the Overall Population: IFN β-1a Antibody Screening
The number of participants who tested positive for IFN β-1a binding antibodies (BAbs). Value was coded as 'positive' if observed value \> 0 or coded as 'negative' if observed value \< 0. This secondary endpoint was targeted to analyze the Overall Population only.
Time frame: Baseline (BL; Day 1), Week 12, Week 24, Week 36, Week 48 or early withdrawal (EW)
Population: Safety population: participants who received at least 1 injection of study treatment and had an assessment; n=number of participants with an assessment at given timepoint.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Overall Population | Antibody Data in the Overall Population: IFN β-1a Antibody Screening | Baseline: Positive; n=199 | 22 participants |
| Overall Population | Antibody Data in the Overall Population: IFN β-1a Antibody Screening | Baseline: Negative; n=199 | 177 participants |
| Overall Population | Antibody Data in the Overall Population: IFN β-1a Antibody Screening | Any post-baseline visit: Positive; n=198 | 35 participants |
| Overall Population | Antibody Data in the Overall Population: IFN β-1a Antibody Screening | Any post-baseline visit: Negative; n=198 | 178 participants |
| Overall Population | Antibody Data in the Overall Population: IFN β-1a Antibody Screening | Week 12: Positive; n=183 | 26 participants |
| Overall Population | Antibody Data in the Overall Population: IFN β-1a Antibody Screening | Week 12: Negative; n=183 | 157 participants |
| Overall Population | Antibody Data in the Overall Population: IFN β-1a Antibody Screening | Week 24: Positive; n=171 | 22 participants |
| Overall Population | Antibody Data in the Overall Population: IFN β-1a Antibody Screening | Week 24: Negative; n=171 | 149 participants |
| Overall Population | Antibody Data in the Overall Population: IFN β-1a Antibody Screening | Week 36: Positive; n=167 | 18 participants |
| Overall Population | Antibody Data in the Overall Population: IFN β-1a Antibody Screening | Week 36: Negative; n=167 | 149 participants |
| Overall Population | Antibody Data in the Overall Population: IFN β-1a Antibody Screening | Week 48/EW: Positive; n=193 | 25 participants |
| Overall Population | Antibody Data in the Overall Population: IFN β-1a Antibody Screening | Week 48/EW: Negative; n=193 | 168 participants |
| Overall Population | Antibody Data in the Overall Population: IFN β-1a Antibody Screening | Negative at BL with ≥ 1 positive post-BL; n=174 | 13 participants |
Secondary
Antibody Data in the Overall Population: IFN β-1a Anti-Pegylated (PEG) Antibody Testing
The number of participants who tested positive or negative for IFN β-1a anti-PEG antibodies. Value was coded as 'positive' if observed value \> 0 or coded as 'negative' if observed value \< 0. This secondary endpoint was targeted to analyze the Overall Population only.
Time frame: Baseline (BL; Day 1), Week 12, Week 24, Week 36, Week 48 or early withdrawal (EW)
Population: Safety population: participants who received at least 1 injection of study treatment and had an assessment; n=number of participants with an assessment at given timepoint.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Overall Population | Antibody Data in the Overall Population: IFN β-1a Anti-Pegylated (PEG) Antibody Testing | Baseline: Positive; n=201 | 7 participants |
| Overall Population | Antibody Data in the Overall Population: IFN β-1a Anti-Pegylated (PEG) Antibody Testing | Baseline: Negative; n=201 | 194 participants |
| Overall Population | Antibody Data in the Overall Population: IFN β-1a Anti-Pegylated (PEG) Antibody Testing | Any post-baseline visit: Positive; n=198 | 8 participants |
| Overall Population | Antibody Data in the Overall Population: IFN β-1a Anti-Pegylated (PEG) Antibody Testing | Any post-baseline visit: Negative; n=198 | 196 participants |
| Overall Population | Antibody Data in the Overall Population: IFN β-1a Anti-Pegylated (PEG) Antibody Testing | Week 12: Positive; n=182 | 6 participants |
| Overall Population | Antibody Data in the Overall Population: IFN β-1a Anti-Pegylated (PEG) Antibody Testing | Week 12: Negative; n=182 | 176 participants |
| Overall Population | Antibody Data in the Overall Population: IFN β-1a Anti-Pegylated (PEG) Antibody Testing | Week 24: Positive; n=173 | 3 participants |
| Overall Population | Antibody Data in the Overall Population: IFN β-1a Anti-Pegylated (PEG) Antibody Testing | Week 24: Negative; n=173 | 170 participants |
| Overall Population | Antibody Data in the Overall Population: IFN β-1a Anti-Pegylated (PEG) Antibody Testing | Week 36: Positive; n=168 | 1 participants |
| Overall Population | Antibody Data in the Overall Population: IFN β-1a Anti-Pegylated (PEG) Antibody Testing | Week 36: Negative; n=168 | 167 participants |
| Overall Population | Antibody Data in the Overall Population: IFN β-1a Anti-Pegylated (PEG) Antibody Testing | Week 48/EW: Positive; n=193 | 3 participants |
| Overall Population | Antibody Data in the Overall Population: IFN β-1a Anti-Pegylated (PEG) Antibody Testing | Week 48/EW: Negative; n=193 | 190 participants |
| Overall Population | Antibody Data in the Overall Population: IFN β-1a Anti-Pegylated (PEG) Antibody Testing | Negative at BL with ≥ 1 positive post-BL; n=192 | 4 participants |
Secondary
Antibody Data in the Overall Population: IFN β-1a Neutralizing Antibodies (Nabs) Testing
The number of participants who tested positive for IFN β-1a Nabs. Value was coded as 'positive' if observed value \> 0 or coded as 'negative' if observed value \< 0. This secondary endpoint was targeted to analyze the Overall Population only.
Time frame: Baseline (Day 1), Week 12, Week 24, Week 36, Week 48 or early withdrawal (EW)
Population: Safety population: participants who received at least 1 injection of study treatment and had an assessment; n=number of participants with an assessment at given timepoint.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Overall Population | Antibody Data in the Overall Population: IFN β-1a Neutralizing Antibodies (Nabs) Testing | Week 48/EW: Negative; n=25 | 13 participants |
| Overall Population | Antibody Data in the Overall Population: IFN β-1a Neutralizing Antibodies (Nabs) Testing | Negative at BL with ≥ 1 positive post-BL; n=7 | 1 participants |
| Overall Population | Antibody Data in the Overall Population: IFN β-1a Neutralizing Antibodies (Nabs) Testing | Baseline: Positive; n=22 | 14 participants |
| Overall Population | Antibody Data in the Overall Population: IFN β-1a Neutralizing Antibodies (Nabs) Testing | Baseline: Negative; n=22 | 8 participants |
| Overall Population | Antibody Data in the Overall Population: IFN β-1a Neutralizing Antibodies (Nabs) Testing | Any post-baseline visit: Positive; n=35 | 17 participants |
| Overall Population | Antibody Data in the Overall Population: IFN β-1a Neutralizing Antibodies (Nabs) Testing | Any post-baseline visit: Negative; n=35 | 20 participants |
| Overall Population | Antibody Data in the Overall Population: IFN β-1a Neutralizing Antibodies (Nabs) Testing | Week 12: Positive; n=26 | 15 participants |
| Overall Population | Antibody Data in the Overall Population: IFN β-1a Neutralizing Antibodies (Nabs) Testing | Week 12: Negative; n=26 | 11 participants |
| Overall Population | Antibody Data in the Overall Population: IFN β-1a Neutralizing Antibodies (Nabs) Testing | Week 24: Positive; n=22 | 11 participants |
| Overall Population | Antibody Data in the Overall Population: IFN β-1a Neutralizing Antibodies (Nabs) Testing | Week 24: Negative; n=22 | 11 participants |
| Overall Population | Antibody Data in the Overall Population: IFN β-1a Neutralizing Antibodies (Nabs) Testing | Week 36: Positive; n=18 | 11 participants |
| Overall Population | Antibody Data in the Overall Population: IFN β-1a Neutralizing Antibodies (Nabs) Testing | Week 36: Negative; n=18 | 7 participants |
| Overall Population | Antibody Data in the Overall Population: IFN β-1a Neutralizing Antibodies (Nabs) Testing | Week 48/EW: Positive; n=25 | 12 participants |
Secondary
Change From Baseline Visit (Day 1) to Week 48 in Walking Disability Status as Measured by Patient Determined Disease Steps (PDDS): Overall Population
Subjects rated their perceived walking disability on a scale of 0 to 8 using the PDDS, with higher scores indicating more severe disability. This secondary endpoint was targeted to analyze the Overall Population only.
Time frame: Day 1 (Baseline, pre-dose), Week 12, Week 48, Early Termination
Population: Efficacy population: randomized participants who received at least 1 dose of study treatment and had efficacy data in both the 4-week run-in period and the post-baseline treatment period; n=number of participants assessed at the given timepoint.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Overall Population | Change From Baseline Visit (Day 1) to Week 48 in Walking Disability Status as Measured by Patient Determined Disease Steps (PDDS): Overall Population | Baseline; n=194 | 0.83 units on a scale | Standard Deviation 1.258 |
| Overall Population | Change From Baseline Visit (Day 1) to Week 48 in Walking Disability Status as Measured by Patient Determined Disease Steps (PDDS): Overall Population | Change at Week 12; n=174 | 0.029 units on a scale | Standard Deviation 0.836 |
| Overall Population | Change From Baseline Visit (Day 1) to Week 48 in Walking Disability Status as Measured by Patient Determined Disease Steps (PDDS): Overall Population | Change at Week 48; n=153 | 0.15 units on a scale | Standard Deviation 0.857 |
| Overall Population | Change From Baseline Visit (Day 1) to Week 48 in Walking Disability Status as Measured by Patient Determined Disease Steps (PDDS): Overall Population | Change Early Termination; n=26 | 0.346 units on a scale | Standard Deviation 1.093 |
Comparison: change at Week 12p-value: 0.6508paired t-test within 1 arm
Comparison: change at Week 48p-value: 0.0315paired t-test within 1 arm
Comparison: change at Early Terminationp-value: 0.119paired t-test within 1 arm
p-value: 0.152general linear model
Secondary
Mean Change From 4-Week Run-In Period at Each Visit for Treatment Satisfaction Questionnaire for Medication (TSQM), Effectiveness Scale Factor: Overall Population
The TSQM assessed participants' global satisfaction with treatment and captured information on treatment side effects, effectiveness, and convenience. Changes from the 4-week run-in period to each visit using transformed scores between 0 and 100 for effectiveness (with higher scores indicating greater satisfaction) are presented. 4WRI=4-week run-in.
Time frame: 4-week run-in period, Weeks 4, 12, 24, 36, 48 (or Early Termination)
Population: Efficacy population: randomized participants who received at least 1 dose of study treatment and had efficacy data in both the 4-week run-in period and the post-baseline treatment period; n=number of participants assessed at the given timepoint.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Overall Population | Mean Change From 4-Week Run-In Period at Each Visit for Treatment Satisfaction Questionnaire for Medication (TSQM), Effectiveness Scale Factor: Overall Population | Effectiveness at 4WRI; n=194 | 73.871 units on a scale | Standard Deviation 20.131 |
| Overall Population | Mean Change From 4-Week Run-In Period at Each Visit for Treatment Satisfaction Questionnaire for Medication (TSQM), Effectiveness Scale Factor: Overall Population | Change at Week 4; n=185 | -2.589 units on a scale | Standard Deviation 28.139 |
| Overall Population | Mean Change From 4-Week Run-In Period at Each Visit for Treatment Satisfaction Questionnaire for Medication (TSQM), Effectiveness Scale Factor: Overall Population | Change at Week 12; n=175 | -1.274 units on a scale | Standard Deviation 30.682 |
| Overall Population | Mean Change From 4-Week Run-In Period at Each Visit for Treatment Satisfaction Questionnaire for Medication (TSQM), Effectiveness Scale Factor: Overall Population | Change at Week 24; n=167 | 0.341 units on a scale | Standard Deviation 27.401 |
| Overall Population | Mean Change From 4-Week Run-In Period at Each Visit for Treatment Satisfaction Questionnaire for Medication (TSQM), Effectiveness Scale Factor: Overall Population | Change at Week 36; n =162 | 1.864 units on a scale | Standard Deviation 29.175 |
| Overall Population | Mean Change From 4-Week Run-In Period at Each Visit for Treatment Satisfaction Questionnaire for Medication (TSQM), Effectiveness Scale Factor: Overall Population | Change at Week 48; n=153 | 2.863 units on a scale | Standard Deviation 29.172 |
| Overall Population | Mean Change From 4-Week Run-In Period at Each Visit for Treatment Satisfaction Questionnaire for Medication (TSQM), Effectiveness Scale Factor: Overall Population | Change at Early Termination; n=26 | -17.308 units on a scale | Standard Deviation 34.534 |
Comparison: change at Week 4p-value: 0.2123paired t-test within 1 arm
Comparison: change at Week 12p-value: 0.5834paired t-test within 1 arm
Comparison: change at Week 24p-value: 0.8723paired t-test within 1 arm
Comparison: change at Week 36p-value: 0.4173paired t-test within 1 arm
Comparison: change at Week 48p-value: 0.2267paired t-test within 1 arm
Comparison: change at Early Termp-value: 0.0171paired t-test within 1 arm
Secondary
Mean Change From 4-Week Run-In Period at Each Visit for TSQM, Convenience Scale Factor: Overall Population
The TSQM assessed participants' global satisfaction with treatment and captured information on treatment side effects, effectiveness, and convenience. Changes from the 4-week run-in period to each visit using transformed scores between 0 and 100 for convenience (with higher scores indicating greater satisfaction) are presented. 4WRI=4-week run-in.
Time frame: 4-week run-in period, Weeks 4, 12, 24, 36, 48 (or Early Termination)
Population: Efficacy population: randomized participants who received at least 1 dose of study treatment and had efficacy data in both the 4-week run-in period and the post-baseline treatment period; n=number of participants assessed at the given timepoint.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Overall Population | Mean Change From 4-Week Run-In Period at Each Visit for TSQM, Convenience Scale Factor: Overall Population | Convenience at 4WRI; n=194 | 66.665 units on a scale | Standard Deviation 16.588 |
| Overall Population | Mean Change From 4-Week Run-In Period at Each Visit for TSQM, Convenience Scale Factor: Overall Population | Change at Week 4; n=185 | 18.703 units on a scale | Standard Deviation 21.864 |
| Overall Population | Mean Change From 4-Week Run-In Period at Each Visit for TSQM, Convenience Scale Factor: Overall Population | Change at Week 12; n=175 | 18.12 units on a scale | Standard Deviation 20.588 |
| Overall Population | Mean Change From 4-Week Run-In Period at Each Visit for TSQM, Convenience Scale Factor: Overall Population | Change at Week 24; n=167 | 18.419 units on a scale | Standard Deviation 20.804 |
| Overall Population | Mean Change From 4-Week Run-In Period at Each Visit for TSQM, Convenience Scale Factor: Overall Population | Change at Week 36; n =162 | 18.704 units on a scale | Standard Deviation 21.258 |
| Overall Population | Mean Change From 4-Week Run-In Period at Each Visit for TSQM, Convenience Scale Factor: Overall Population | Change at Week 48; n=153 | 19.588 units on a scale | Standard Deviation 20.912 |
| Overall Population | Mean Change From 4-Week Run-In Period at Each Visit for TSQM, Convenience Scale Factor: Overall Population | Change at Early Termination; n=26 | 7.808 units on a scale | Standard Deviation 28.788 |
Comparison: change at Week 4p-value: <0.0001paired t-test within 1 arm
Comparison: change at Week 12p-value: <0.0001paired t-test within 1 arm
Comparison: change at Week 24p-value: <0.0001paired t-test within 1 arm
Comparison: change at Week 36p-value: <0.0001paired t-test within 1 arm
Comparison: change at Week 48p-value: <0.0001paired t-test within 1 arm
Comparison: change at Early Terminationp-value: 0.1789paired t-test within 1 arm
p-value: 0.2248general linear model
Secondary
Mean Change From 4-Week Run-In Period at Each Visit for TSQM, Global Satisfaction Scale Factor: Overall Population
The TSQM assessed participants' global satisfaction with treatment and captured information on treatment side effects, effectiveness, and convenience. Changes from the 4-week run-in period to each visit using transformed scores between 0 and 100 for global satisfaction (with higher scores indicating greater satisfaction) are presented. 4WRI=4-week run-in.
Time frame: 4-week run-in period, Weeks 4, 12, 24, 36, 48 (or Early Termination)
Population: Efficacy population: randomized participants who received at least 1 dose of study treatment and had efficacy data in both the 4-week run-in period and the post-baseline treatment period; n=number of participants assessed at the given timepoint.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Overall Population | Mean Change From 4-Week Run-In Period at Each Visit for TSQM, Global Satisfaction Scale Factor: Overall Population | Global Satisfaction at 4WRI; n=194 | 75.985 units on a scale | Standard Deviation 15.137 |
| Overall Population | Mean Change From 4-Week Run-In Period at Each Visit for TSQM, Global Satisfaction Scale Factor: Overall Population | Change at Week 4; n=185 | 6.789 units on a scale | Standard Deviation 19.8 |
| Overall Population | Mean Change From 4-Week Run-In Period at Each Visit for TSQM, Global Satisfaction Scale Factor: Overall Population | Change at Week 12; n=175 | 7.354 units on a scale | Standard Deviation 20.296 |
| Overall Population | Mean Change From 4-Week Run-In Period at Each Visit for TSQM, Global Satisfaction Scale Factor: Overall Population | Change at Week 24; n=167 | 7.575 units on a scale | Standard Deviation 19.91 |
| Overall Population | Mean Change From 4-Week Run-In Period at Each Visit for TSQM, Global Satisfaction Scale Factor: Overall Population | Change at Week 36; n =162 | 9.179 units on a scale | Standard Deviation 19.215 |
| Overall Population | Mean Change From 4-Week Run-In Period at Each Visit for TSQM, Global Satisfaction Scale Factor: Overall Population | Change at Week 48; n=153 | 8.556 units on a scale | Standard Deviation 23.389 |
| Overall Population | Mean Change From 4-Week Run-In Period at Each Visit for TSQM, Global Satisfaction Scale Factor: Overall Population | Change at Early Termination; n=26 | -38.538 units on a scale | Standard Deviation 26.224 |
Comparison: change at Week 4p-value: <0.0001paired t-test within 1 arm
Comparison: change at Week 12p-value: <0.0001paired t-test within 1 arm
Comparison: change at Week 24p-value: <0.0001paired t-test within 1 arm
Comparison: change at Week 36p-value: <0.0001paired t-test within 1 arm
Comparison: change at Week 48p-value: <0.0001paired t-test within 1 arm
Comparison: change at Early Terminationp-value: <0.0001paired t-test within 1 arm
p-value: <0.0001general linear model
Secondary
Mean Change From 4-Week Run-In Period at Each Visit for TSQM, Side-Effects Scale Factor: Overall Population
The TSQM assessed participants' global satisfaction with treatment and captured information on treatment side effects, effectiveness, and convenience. Changes from the 4-week run-in period to each visit using transformed scores between 0 and 100 for side effects (with higher scores indicating greater satisfaction) are presented. 4WRI=4-week run-in.
Time frame: 4-week run-in period, Weeks 4, 12, 24, 36, 48 (or Early Termination)
Population: Efficacy population: randomized participants who received at least 1 dose of study treatment and had efficacy data in both the 4-week run-in period and the post-baseline treatment period; n=number of participants assessed at the given timepoint.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Overall Population | Mean Change From 4-Week Run-In Period at Each Visit for TSQM, Side-Effects Scale Factor: Overall Population | Side Effects at 4WRI; n=194 | 85.17 units on a scale | Standard Deviation 18.136 |
| Overall Population | Mean Change From 4-Week Run-In Period at Each Visit for TSQM, Side-Effects Scale Factor: Overall Population | Change at Week 4; n=185 | 6.065 units on a scale | Standard Deviation 21.243 |
| Overall Population | Mean Change From 4-Week Run-In Period at Each Visit for TSQM, Side-Effects Scale Factor: Overall Population | Change at Week 12; n=175 | 5.109 units on a scale | Standard Deviation 19.67 |
| Overall Population | Mean Change From 4-Week Run-In Period at Each Visit for TSQM, Side-Effects Scale Factor: Overall Population | Change at Week 24; n=167 | 2.958 units on a scale | Standard Deviation 18.131 |
| Overall Population | Mean Change From 4-Week Run-In Period at Each Visit for TSQM, Side-Effects Scale Factor: Overall Population | Change at Week 36; n=162 | 3.37 units on a scale | Standard Deviation 18.207 |
| Overall Population | Mean Change From 4-Week Run-In Period at Each Visit for TSQM, Side-Effects Scale Factor: Overall Population | Change at Week 48; n=153 | 1.418 units on a scale | Standard Deviation 20.922 |
| Overall Population | Mean Change From 4-Week Run-In Period at Each Visit for TSQM, Side-Effects Scale Factor: Overall Population | Change at Early Termination; n=26 | -18.731 units on a scale | Standard Deviation 31.776 |
Comparison: change at Week 4p-value: 0.0001paired t-test within 1 arm
Comparison: change at Week 12p-value: 0.0007paired t-test within 1 arm
Comparison: change at Week 24p-value: 0.0365paired t-test within 1 arm
Comparison: change at Week 36p-value: 0.0197paired t-test within 1 arm
Comparison: change at Week 48p-value: 0.4031paired t-test within 1 arm
Comparison: change at Early Terminationp-value: 0.006paired t-test within 1 arm
Secondary
Mean Change From 4-Week Run-In Period at Week 4 for TSQM, Convenience Scale Factor: Between FLS Management Arms
The TSQM assessed participants' global satisfaction with treatment and captured information on treatment side effects, effectiveness, and convenience. Changes from the 4-week run-in period to Week 4 using transformed scores between 0 and 100 for convenience (with higher scores indicating greater satisfaction) are presented. This secondary endpoint was targeted for Week 4 only. 4WRI=4-week run-in.
Time frame: 4-week run-in period, Week 4
Population: Efficacy population: randomized participants who received at least 1 dose of study treatment and had efficacy data in both the 4-week run-in period and the post-baseline treatment period; n=number of participants assessed at the given timepoint.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Overall Population | Mean Change From 4-Week Run-In Period at Week 4 for TSQM, Convenience Scale Factor: Between FLS Management Arms | Convenience at 4WRI; n=100, 94 | 65.94 units on a scale | Standard Deviation 15.878 |
| Overall Population | Mean Change From 4-Week Run-In Period at Week 4 for TSQM, Convenience Scale Factor: Between FLS Management Arms | Change at Week 4; n=95, 90 | 19.768 units on a scale | Standard Deviation 22.403 |
| BIIB017 Plus Naproxen | Mean Change From 4-Week Run-In Period at Week 4 for TSQM, Convenience Scale Factor: Between FLS Management Arms | Convenience at 4WRI; n=100, 94 | 67.436 units on a scale | Standard Deviation 17.365 |
| BIIB017 Plus Naproxen | Mean Change From 4-Week Run-In Period at Week 4 for TSQM, Convenience Scale Factor: Between FLS Management Arms | Change at Week 4; n=95, 90 | 17.578 units on a scale | Standard Deviation 21.347 |
Comparison: change at Week 4p-value: <0.0001paired t-test within 1 arm
Comparison: change at Week 4p-value: <0.0001paired t-test within 1 arm
Comparison: change at Week 4p-value: 0.49732-sample t-test between 2 arms
Secondary
Mean Change From 4-Week Run-In Period at Week 4 for TSQM, Effectiveness Scale Factor: Between FLS Management Arms
The TSQM assessed participants' global satisfaction with treatment and captured information on treatment side effects, effectiveness, and convenience. Changes from the 4-week run-in period to Week 4 using transformed scores between 0 and 100 for effectiveness (with higher scores indicating greater satisfaction) are presented. This secondary endpoint was targeted for Week 4 only. 4WRI=4-week run-in.
Time frame: 4-week run-in period, Week 4
Population: Efficacy population: randomized participants who received at least 1 dose of study treatment and had efficacy data in both the 4-week run-in period and the post-baseline treatment period; n=number of participants assessed at the given timepoint.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Overall Population | Mean Change From 4-Week Run-In Period at Week 4 for TSQM, Effectiveness Scale Factor: Between FLS Management Arms | Effectiveness at 4WRI; n=100, 94 | 75.16 units on a scale | Standard Deviation 19.431 |
| Overall Population | Mean Change From 4-Week Run-In Period at Week 4 for TSQM, Effectiveness Scale Factor: Between FLS Management Arms | Change at Week 4; n=95, 90 | 0.979 units on a scale | Standard Deviation 24.793 |
| BIIB017 Plus Naproxen | Mean Change From 4-Week Run-In Period at Week 4 for TSQM, Effectiveness Scale Factor: Between FLS Management Arms | Effectiveness at 4WRI; n=100, 94 | 72.5 units on a scale | Standard Deviation 20.866 |
| BIIB017 Plus Naproxen | Mean Change From 4-Week Run-In Period at Week 4 for TSQM, Effectiveness Scale Factor: Between FLS Management Arms | Change at Week 4; n=95, 90 | -6.356 units on a scale | Standard Deviation 30.982 |
Comparison: change at Week 4p-value: 0.7012paired t-test within 1 arm
Comparison: change at Week 4p-value: 0.0548paired t-test within 1 arm
Comparison: change at Week 4p-value: 0.07822-sample t-test between 2 arms
Secondary
Mean Change From 4-Week Run-In Period at Week 4 for TSQM, Global Satisfaction Scale Factor: Between FLS Management Arms
The TSQM assessed participants' global satisfaction with treatment and captured information on treatment side effects, effectiveness, and convenience. Changes from the 4-week run-in period to Week 4 using transformed scores between 0 and 100 for global satisfaction (with higher scores indicating greater satisfaction) are presented. This secondary endpoint was targeted for Week 4 only. 4WRI=4-week run-in.
Time frame: 4-week run-in period, Week 4
Population: Efficacy population: randomized participants who received at least 1 dose of study treatment and had efficacy data in both the 4-week run-in period and the post-baseline treatment period; n=number of participants assessed at the given timepoint.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Overall Population | Mean Change From 4-Week Run-In Period at Week 4 for TSQM, Global Satisfaction Scale Factor: Between FLS Management Arms | Global Satisfaction at 4WRI; n=100, 94 | 75.86 units on a scale | Standard Deviation 14.001 |
| Overall Population | Mean Change From 4-Week Run-In Period at Week 4 for TSQM, Global Satisfaction Scale Factor: Between FLS Management Arms | Change at Week 4; n=95, 90 | 8.663 units on a scale | Standard Deviation 16.633 |
| BIIB017 Plus Naproxen | Mean Change From 4-Week Run-In Period at Week 4 for TSQM, Global Satisfaction Scale Factor: Between FLS Management Arms | Global Satisfaction at 4WRI; n=100, 94 | 76.117 units on a scale | Standard Deviation 16.334 |
| BIIB017 Plus Naproxen | Mean Change From 4-Week Run-In Period at Week 4 for TSQM, Global Satisfaction Scale Factor: Between FLS Management Arms | Change at Week 4; n=95, 90 | 4.811 units on a scale | Standard Deviation 22.596 |
Comparison: change at Week 4p-value: <0.0001paired t-test within 1 arm
Comparison: change at Week 4p-value: 0.0464paired t-test within 1 arm
Comparison: change at Week 4p-value: 0.19052-sample t-test between 2 arms
Secondary
Mean Change From 4-Week Run-In Period at Week 4 for TSQM, Side Effects Scale Factor: Between FLS Management Arms
The TSQM assessed participants' global satisfaction with treatment and captured information on treatment side effects, effectiveness, and convenience. Changes from the 4-week run-in period to Week 4 using transformed scores between 0 and 100 for side effects (with higher scores indicating greater satisfaction) are presented. This secondary endpoint was targeted for Week 4 only. 4WRI=4-week run-in.
Time frame: 4-week run-in period, Week 4
Population: Efficacy population: randomized participants who received at least 1 dose of study treatment and had efficacy data in both the 4-week run-in period and the post-baseline treatment period; n=number of participants assessed at the given timepoint.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Overall Population | Mean Change From 4-Week Run-In Period at Week 4 for TSQM, Side Effects Scale Factor: Between FLS Management Arms | Side Effects at 4WRI; n=100, 94 | 83.78 units on a scale | Standard Deviation 20.074 |
| Overall Population | Mean Change From 4-Week Run-In Period at Week 4 for TSQM, Side Effects Scale Factor: Between FLS Management Arms | Change at Week 4; n=95, 90 | 8.579 units on a scale | Standard Deviation 23.576 |
| BIIB017 Plus Naproxen | Mean Change From 4-Week Run-In Period at Week 4 for TSQM, Side Effects Scale Factor: Between FLS Management Arms | Side Effects at 4WRI; n=100, 94 | 86.649 units on a scale | Standard Deviation 15.789 |
| BIIB017 Plus Naproxen | Mean Change From 4-Week Run-In Period at Week 4 for TSQM, Side Effects Scale Factor: Between FLS Management Arms | Change at Week 4; n=95, 90 | 3.411 units on a scale | Standard Deviation 18.222 |
Comparison: change at Week 4p-value: 0.0006paired t-test within 1 arm
Comparison: change at Week 4p-value: 0.0792paired t-test within 1 arm
Comparison: change at Week 4p-value: 0.09612-sample t-test between 2 arms
Secondary
Mean Change From Screening at Each Visit in Absenteeism Questionnaire, Days Missed in 2 Weeks From MS Symptoms: Overall Population
Categorical questions in the Absenteeism Questionnaire asked participants to report the number of usual work days per week, the number of days missed in 2 weeks from MS symptoms, and the number of days missed in 2 weeks from MS treatment. This secondary endpoint was targeted to analyze the Overall Population only. 4WRI=4-week run-in.
Time frame: Week -4 (screening), Week 12, Week 24, Week 36, Week 48, Early Termination
Population: Efficacy population: randomized participants who received at least 1 dose of study treatment, had efficacy data in both the 4-week run-in period and the post-baseline treatment period, and were employed; n=number of participants assessed at the given timepoint.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Overall Population | Mean Change From Screening at Each Visit in Absenteeism Questionnaire, Days Missed in 2 Weeks From MS Symptoms: Overall Population | Days in 4WRI; n=123 | 0.016 days | Standard Deviation 0.127 |
| Overall Population | Mean Change From Screening at Each Visit in Absenteeism Questionnaire, Days Missed in 2 Weeks From MS Symptoms: Overall Population | Change at Week 12; n=106 | 0.057 days | Standard Deviation 0.513 |
| Overall Population | Mean Change From Screening at Each Visit in Absenteeism Questionnaire, Days Missed in 2 Weeks From MS Symptoms: Overall Population | Change at Week 24; n=99 | 0.061 days | Standard Deviation 0.373 |
| Overall Population | Mean Change From Screening at Each Visit in Absenteeism Questionnaire, Days Missed in 2 Weeks From MS Symptoms: Overall Population | Change at Week 36; n=96 | 0 days | Standard Deviation 0.205 |
| Overall Population | Mean Change From Screening at Each Visit in Absenteeism Questionnaire, Days Missed in 2 Weeks From MS Symptoms: Overall Population | Change at Week 48; n =95 | 0.137 days | Standard Deviation 1.078 |
| Overall Population | Mean Change From Screening at Each Visit in Absenteeism Questionnaire, Days Missed in 2 Weeks From MS Symptoms: Overall Population | Change at Early Termination; n=15 | 0 days | Standard Deviation 0 |
Comparison: change at Week 12p-value: 0.2588paired t-test within 1 arm
Comparison: change at Week 24p-value: 0.1092paired t-test within 1 arm
Comparison: change at Week 36p-value: 1paired t-test within 1 arm
Comparison: change at Week 48p-value: 0.219paired t-test within 1 arm
p-value: 0.6402general linear model
Secondary
Mean Change From Screening at Each Visit in Absenteeism Questionnaire, Days Missed in 2 Weeks From MS Treatment: Overall Population
Categorical questions in the Absenteeism Questionnaire asked participants to report the number of usual work days per week, the number of days missed in 2 weeks from MS symptoms, and the number of days missed in 2 weeks from MS treatment. This secondary endpoint was targeted to analyze the Overall Population only. 4WRI=4-week run-in.
Time frame: Week -4 (screening), Week 12, Week 24, Week 36, Week 48, Early Termination
Population: Efficacy population: randomized participants who received at least 1 dose of study treatment, had efficacy data in both the 4-week run-in period and the post-baseline treatment period, and were employed; n=number of participants assessed at the given timepoint.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Overall Population | Mean Change From Screening at Each Visit in Absenteeism Questionnaire, Days Missed in 2 Weeks From MS Treatment: Overall Population | Days in 4WRI; n=123 | 0.016 days | Standard Deviation 0.127 |
| Overall Population | Mean Change From Screening at Each Visit in Absenteeism Questionnaire, Days Missed in 2 Weeks From MS Treatment: Overall Population | Change at Week 12; n=106 | 0.019 days | Standard Deviation 0.275 |
| Overall Population | Mean Change From Screening at Each Visit in Absenteeism Questionnaire, Days Missed in 2 Weeks From MS Treatment: Overall Population | Change at Week 24; n=99 | 0.02 days | Standard Deviation 0.319 |
| Overall Population | Mean Change From Screening at Each Visit in Absenteeism Questionnaire, Days Missed in 2 Weeks From MS Treatment: Overall Population | Change at Week 36; n=96 | -0.021 days | Standard Deviation 0.144 |
| Overall Population | Mean Change From Screening at Each Visit in Absenteeism Questionnaire, Days Missed in 2 Weeks From MS Treatment: Overall Population | Change at Week 48; n =95 | 0.126 days | Standard Deviation 1.074 |
| Overall Population | Mean Change From Screening at Each Visit in Absenteeism Questionnaire, Days Missed in 2 Weeks From MS Treatment: Overall Population | Change at Early Termination; n=15 | 0.2 days | Standard Deviation 0.414 |
Comparison: change at Week 12p-value: 0.4821paired t-test within 1 arm
Comparison: change at Week 24p-value: 0.5298paired t-test within 1 arm
Comparison: change at Week 36p-value: 0.1584paired t-test within 1 arm
Comparison: change at Week 48p-value: 0.2547paired t-test within 1 arm
Comparison: change at Early Terminationp-value: 0.0824paired t-test within 1 arm
p-value: 0.3148general linear model
Secondary
Mean Change From Screening at Each Visit in Absenteeism Questionnaire, Usual Work Days Per Week: Overall Population
Categorical questions in the Absenteeism Questionnaire asked participants to report the number of usual work days per week, the number of days missed in 2 weeks from multiple sclerosis (MS) symptoms, and the number of days missed in 2 weeks from MS treatment. This secondary endpoint was targeted to analyze the Overall Population only. 4WRI=4-week run-in.
Time frame: Week -4 (screening), Week 12, Week 24, Week 36, Week 48, Early Termination
Population: Efficacy population: randomized participants who received at least 1 dose of study treatment, had efficacy data in both the 4-week run-in period and the post-baseline treatment period, and were employed; n=number of participants assessed at the given timepoint.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Overall Population | Mean Change From Screening at Each Visit in Absenteeism Questionnaire, Usual Work Days Per Week: Overall Population | Change at Week 12; n=106 | -0.019 days | Standard Deviation 0.436 |
| Overall Population | Mean Change From Screening at Each Visit in Absenteeism Questionnaire, Usual Work Days Per Week: Overall Population | Days in 4WRI; n=123 | 4.691 days | Standard Deviation 1.033 |
| Overall Population | Mean Change From Screening at Each Visit in Absenteeism Questionnaire, Usual Work Days Per Week: Overall Population | Change at Week 24; n=99 | -0.081 days | Standard Deviation 0.566 |
| Overall Population | Mean Change From Screening at Each Visit in Absenteeism Questionnaire, Usual Work Days Per Week: Overall Population | Change at Week 36; n=96 | -0.052 days | Standard Deviation 0.773 |
| Overall Population | Mean Change From Screening at Each Visit in Absenteeism Questionnaire, Usual Work Days Per Week: Overall Population | Change at Week 48; n=95 | 0.032 days | Standard Deviation 0.573 |
| Overall Population | Mean Change From Screening at Each Visit in Absenteeism Questionnaire, Usual Work Days Per Week: Overall Population | Change at Early Termination; n=15 | 0.2 days | Standard Deviation 0.862 |
Comparison: change at Week 12p-value: 0.6569paired t-test within 1 arm
Comparison: change at Week 24p-value: 0.1584paired t-test within 1 arm
Comparison: change at Week 36p-value: 0.5106paired t-test within 1 arm
Comparison: change at Week 48p-value: 0.5927paired t-test within 1 arm
Comparison: change at Early Terminationp-value: 0.384paired t-test within 1 arm
p-value: 0.4182general linear model
Secondary
Percentage of Participants Experiencing New or Increased FLS During the First 8 Weeks: Between FLS Management Arms
The total FLS-S is the sum of all 4 symptom scores (muscle aches, chills, fatigue and fever), each rated from 0 (absent) to 3 (severe), with a range of 0-12 with 0 indicating no FLS and 12 indicating severe FLS. New or increased FLS is defined as an FLS overall score of 2 points or greater over Screening. Pre-dose data were not used; up to 48-hour data after dosing were used. Overall score was imputed as the average score after dose.
Time frame: during the first 8 weeks of treatment
Population: Efficacy population: randomized participants who received at least 1 dose of study treatment and had efficacy data in both the 4-week run-in period and the post-baseline treatment period.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Overall Population | Percentage of Participants Experiencing New or Increased FLS During the First 8 Weeks: Between FLS Management Arms | 13 percentage of participants |
| BIIB017 Plus Naproxen | Percentage of Participants Experiencing New or Increased FLS During the First 8 Weeks: Between FLS Management Arms | 7.4 percentage of participants |
p-value: 0.2037Chi-squared
Secondary
Percentage of Participants Requiring Additional FLS Management Regimen to Relieve BIIB017-related FLS
Time frame: during the first 8 weeks of treatment
Population: Efficacy population: randomized participants who received at least 1 dose of study treatment and had efficacy data in both the 4-week run-in period and the post-baseline treatment period; n=number of subjects assessed at the given timepoint.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Overall Population | Percentage of Participants Requiring Additional FLS Management Regimen to Relieve BIIB017-related FLS | Used additional regimen, first 8 weeks; n=78, 85 | 6.4 percentage of participants |
| Overall Population | Percentage of Participants Requiring Additional FLS Management Regimen to Relieve BIIB017-related FLS | No additional regimen, first 8 weeks; n=78, 85 | 93.6 percentage of participants |
| Overall Population | Percentage of Participants Requiring Additional FLS Management Regimen to Relieve BIIB017-related FLS | Used additional regimen, Weeks 0-2; n=57, 73 | 1.8 percentage of participants |
| Overall Population | Percentage of Participants Requiring Additional FLS Management Regimen to Relieve BIIB017-related FLS | No additional regimen, Weeks 0-2; n=57, 73 | 98.2 percentage of participants |
| Overall Population | Percentage of Participants Requiring Additional FLS Management Regimen to Relieve BIIB017-related FLS | Used additional regimen, Weeks 3-4; n=61, 77 | 6.6 percentage of participants |
| Overall Population | Percentage of Participants Requiring Additional FLS Management Regimen to Relieve BIIB017-related FLS | No additional regimen, Weeks 3-4; n=61, 77 | 93.4 percentage of participants |
| Overall Population | Percentage of Participants Requiring Additional FLS Management Regimen to Relieve BIIB017-related FLS | Used additional regimen, Weeks 5-6; n=63, 76 | 0 percentage of participants |
| Overall Population | Percentage of Participants Requiring Additional FLS Management Regimen to Relieve BIIB017-related FLS | No additional regimen, Weeks 5-6; n=63, 76 | 100 percentage of participants |
| Overall Population | Percentage of Participants Requiring Additional FLS Management Regimen to Relieve BIIB017-related FLS | Used additional regimen, Weeks 7-8; n=52, 74 | 1.9 percentage of participants |
| Overall Population | Percentage of Participants Requiring Additional FLS Management Regimen to Relieve BIIB017-related FLS | No additional regimen, Weeks 7-8; n=52, 74 | 98.1 percentage of participants |
| BIIB017 Plus Naproxen | Percentage of Participants Requiring Additional FLS Management Regimen to Relieve BIIB017-related FLS | No additional regimen, Weeks 5-6; n=63, 76 | 97.4 percentage of participants |
| BIIB017 Plus Naproxen | Percentage of Participants Requiring Additional FLS Management Regimen to Relieve BIIB017-related FLS | Used additional regimen, first 8 weeks; n=78, 85 | 15.3 percentage of participants |
| BIIB017 Plus Naproxen | Percentage of Participants Requiring Additional FLS Management Regimen to Relieve BIIB017-related FLS | No additional regimen, Weeks 3-4; n=61, 77 | 94.8 percentage of participants |
| BIIB017 Plus Naproxen | Percentage of Participants Requiring Additional FLS Management Regimen to Relieve BIIB017-related FLS | No additional regimen, first 8 weeks; n=78, 85 | 84.7 percentage of participants |
| BIIB017 Plus Naproxen | Percentage of Participants Requiring Additional FLS Management Regimen to Relieve BIIB017-related FLS | No additional regimen, Weeks 7-8; n=52, 74 | 95.9 percentage of participants |
| BIIB017 Plus Naproxen | Percentage of Participants Requiring Additional FLS Management Regimen to Relieve BIIB017-related FLS | Used additional regimen, Weeks 0-2; n=57, 73 | 11 percentage of participants |
| BIIB017 Plus Naproxen | Percentage of Participants Requiring Additional FLS Management Regimen to Relieve BIIB017-related FLS | Used additional regimen, Weeks 5-6; n=63, 76 | 2.6 percentage of participants |
| BIIB017 Plus Naproxen | Percentage of Participants Requiring Additional FLS Management Regimen to Relieve BIIB017-related FLS | No additional regimen, Weeks 0-2; n=57, 73 | 89 percentage of participants |
| BIIB017 Plus Naproxen | Percentage of Participants Requiring Additional FLS Management Regimen to Relieve BIIB017-related FLS | Used additional regimen, Weeks 7-8; n=52, 74 | 4.1 percentage of participants |
| BIIB017 Plus Naproxen | Percentage of Participants Requiring Additional FLS Management Regimen to Relieve BIIB017-related FLS | Used additional regimen, Weeks 3-4; n=61, 77 | 5.2 percentage of participants |
Comparison: first 8 weeksp-value: 0.0834Fisher Exact
Comparison: Weeks 0-2p-value: 0.0767Fisher Exact
Comparison: Weeks 3-4p-value: 0.732Fisher Exact
Comparison: Weeks 5-6p-value: 0.5008Fisher Exact
Comparison: Weeks 7-8p-value: 0.6422Fisher Exact
Secondary
Percentage of Participants With Any FLS in the 4-Week Run-In Period, During the First 8 Weeks of Treatment, and During 48 Weeks of Treatment
Any FLS is defined as an FLS-S total score \> 0. The total FLS-S is the sum of all 4 symptom scores (muscle aches, chills, fatigue and fever), each rated from 0 (absent) to 3 (severe), with a range of 0-12 with 0 indicating no FLS and 12 indicating severe FLS. 4WRI=4-week run-in; F8W=first 8 weeks; 48W=48 weeks.
Time frame: 4-week run-in period, first 8 weeks of treatment, 48 weeks of treatment
Population: Efficacy population: randomized participants who received at least 1 dose of study treatment and had efficacy data in both the 4-week run-in period and the post-baseline treatment period.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Overall Population | Percentage of Participants With Any FLS in the 4-Week Run-In Period, During the First 8 Weeks of Treatment, and During 48 Weeks of Treatment | 48W | 95 percentage of participants |
| Overall Population | Percentage of Participants With Any FLS in the 4-Week Run-In Period, During the First 8 Weeks of Treatment, and During 48 Weeks of Treatment | 4WRI | 88 percentage of participants |
| Overall Population | Percentage of Participants With Any FLS in the 4-Week Run-In Period, During the First 8 Weeks of Treatment, and During 48 Weeks of Treatment | F8W | 91 percentage of participants |
| BIIB017 Plus Naproxen | Percentage of Participants With Any FLS in the 4-Week Run-In Period, During the First 8 Weeks of Treatment, and During 48 Weeks of Treatment | 48W | 94.7 percentage of participants |
| BIIB017 Plus Naproxen | Percentage of Participants With Any FLS in the 4-Week Run-In Period, During the First 8 Weeks of Treatment, and During 48 Weeks of Treatment | 4WRI | 91.5 percentage of participants |
| BIIB017 Plus Naproxen | Percentage of Participants With Any FLS in the 4-Week Run-In Period, During the First 8 Weeks of Treatment, and During 48 Weeks of Treatment | F8W | 88.3 percentage of participants |
| Overall Population | Percentage of Participants With Any FLS in the 4-Week Run-In Period, During the First 8 Weeks of Treatment, and During 48 Weeks of Treatment | 48W | 94.8 percentage of participants |
| Overall Population | Percentage of Participants With Any FLS in the 4-Week Run-In Period, During the First 8 Weeks of Treatment, and During 48 Weeks of Treatment | 4WRI | 89.7 percentage of participants |
| Overall Population | Percentage of Participants With Any FLS in the 4-Week Run-In Period, During the First 8 Weeks of Treatment, and During 48 Weeks of Treatment | F8W | 89.7 percentage of participants |
Secondary
Shift in Percentage of Participants With Any FLS From 4-Week Run-In Period to 48 Weeks
Any FLS is defined as an FLS-S total score \> 0. The total FLS-S is the sum of all 4 symptom scores (muscle aches, chills, fatigue and fever), each rated from 0 (absent) to 3 (severe), with a range of 0-12 with 0 indicating no FLS and 12 indicating severe FLS. Pre-dose data not were used. Data up to 48-hours after dosing were used. Total score was imputed as the highest score after dose. 4WRI=4-week run-in period; 48W=48 weeks.
Time frame: 4-week run-in period, 48 weeks of treatment
Population: Efficacy population: randomized participants who received at least 1 dose of study treatment and had efficacy data in both the 4-week run-in period and the post-baseline treatment period.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Overall Population | Shift in Percentage of Participants With Any FLS From 4-Week Run-In Period to 48 Weeks | With FLS in 4WRI / With FLS during 48W | 86.00 percentage of participants |
| Overall Population | Shift in Percentage of Participants With Any FLS From 4-Week Run-In Period to 48 Weeks | With FLS in 4WRI / Without FLS during 48W | 2.00 percentage of participants |
| Overall Population | Shift in Percentage of Participants With Any FLS From 4-Week Run-In Period to 48 Weeks | Without FLS in 4WRI / With FLS during 48W | 9.00 percentage of participants |
| Overall Population | Shift in Percentage of Participants With Any FLS From 4-Week Run-In Period to 48 Weeks | Without FLS in 4WRI / Without FLS during 48W | 3.00 percentage of participants |
| BIIB017 Plus Naproxen | Shift in Percentage of Participants With Any FLS From 4-Week Run-In Period to 48 Weeks | Without FLS in 4WRI / Without FLS during 48W | 1.06 percentage of participants |
| BIIB017 Plus Naproxen | Shift in Percentage of Participants With Any FLS From 4-Week Run-In Period to 48 Weeks | With FLS in 4WRI / With FLS during 48W | 87.23 percentage of participants |
| BIIB017 Plus Naproxen | Shift in Percentage of Participants With Any FLS From 4-Week Run-In Period to 48 Weeks | Without FLS in 4WRI / With FLS during 48W | 7.45 percentage of participants |
| BIIB017 Plus Naproxen | Shift in Percentage of Participants With Any FLS From 4-Week Run-In Period to 48 Weeks | With FLS in 4WRI / Without FLS during 48W | 4.26 percentage of participants |
| Overall Population | Shift in Percentage of Participants With Any FLS From 4-Week Run-In Period to 48 Weeks | Without FLS in 4WRI / Without FLS during 48W | 2.06 percentage of participants |
| Overall Population | Shift in Percentage of Participants With Any FLS From 4-Week Run-In Period to 48 Weeks | With FLS in 4WRI / Without FLS during 48W | 3.09 percentage of participants |
| Overall Population | Shift in Percentage of Participants With Any FLS From 4-Week Run-In Period to 48 Weeks | Without FLS in 4WRI / With FLS during 48W | 8.25 percentage of participants |
| Overall Population | Shift in Percentage of Participants With Any FLS From 4-Week Run-In Period to 48 Weeks | With FLS in 4WRI / With FLS during 48W | 86.60 percentage of participants |
p-value: 0.0525McNemar
p-value: 0.0654McNemar
p-value: 0.5488McNemar
Secondary
Shift in Percentage of Participants With Any FLS From 4-Week Run-In Period to the First 8 Weeks
Any FLS is defined as an FLS-S total score \> 0. The total FLS-S is the sum of all 4 symptom scores (muscle aches, chills, fatigue and fever), each rated from 0 (absent) to 3 (severe), with a range of 0-12 with 0 indicating no FLS and 12 indicating severe FLS. Pre-dose data not were used. Data up to 48-hours after dosing were used. Total score was imputed as the highest score after dose. 4WRI=4-week run-in period; F8W=first 8 weeks.
Time frame: 4-week run-in period, first 8 weeks of treatment
Population: Efficacy population: randomized participants who received at least 1 dose of study treatment and had efficacy data in both the 4-week run-in period and the post-baseline treatment period.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Overall Population | Shift in Percentage of Participants With Any FLS From 4-Week Run-In Period to the First 8 Weeks | With FLS in 4WRI / With FLS during F8W | 85.00 percentage of participants |
| Overall Population | Shift in Percentage of Participants With Any FLS From 4-Week Run-In Period to the First 8 Weeks | With FLS in 4WRI / Without FLS during F8W | 3.00 percentage of participants |
| Overall Population | Shift in Percentage of Participants With Any FLS From 4-Week Run-In Period to the First 8 Weeks | Without FLS in 4WRI / With FLS during F8W | 6.00 percentage of participants |
| Overall Population | Shift in Percentage of Participants With Any FLS From 4-Week Run-In Period to the First 8 Weeks | Without FLS in 4WRI / Without FLS during F8W | 6.00 percentage of participants |
| BIIB017 Plus Naproxen | Shift in Percentage of Participants With Any FLS From 4-Week Run-In Period to the First 8 Weeks | Without FLS in 4WRI / Without FLS during F8W | 3.19 percentage of participants |
| BIIB017 Plus Naproxen | Shift in Percentage of Participants With Any FLS From 4-Week Run-In Period to the First 8 Weeks | With FLS in 4WRI / With FLS during F8W | 82.98 percentage of participants |
| BIIB017 Plus Naproxen | Shift in Percentage of Participants With Any FLS From 4-Week Run-In Period to the First 8 Weeks | Without FLS in 4WRI / With FLS during F8W | 5.32 percentage of participants |
| BIIB017 Plus Naproxen | Shift in Percentage of Participants With Any FLS From 4-Week Run-In Period to the First 8 Weeks | With FLS in 4WRI / Without FLS during F8W | 8.51 percentage of participants |
| Overall Population | Shift in Percentage of Participants With Any FLS From 4-Week Run-In Period to the First 8 Weeks | Without FLS in 4WRI / Without FLS during F8W | 4.64 percentage of participants |
| Overall Population | Shift in Percentage of Participants With Any FLS From 4-Week Run-In Period to the First 8 Weeks | With FLS in 4WRI / Without FLS during F8W | 5.67 percentage of participants |
| Overall Population | Shift in Percentage of Participants With Any FLS From 4-Week Run-In Period to the First 8 Weeks | Without FLS in 4WRI / With FLS during F8W | 5.67 percentage of participants |
| Overall Population | Shift in Percentage of Participants With Any FLS From 4-Week Run-In Period to the First 8 Weeks | With FLS in 4WRI / With FLS during F8W | 84.02 percentage of participants |
p-value: 1McNemar
p-value: 0.5078McNemar
p-value: 0.5811McNemar
Secondary
Summary of Adverse Events (AEs), Serious AEs (SAEs), and Discontinuations Due to AEs
An AE was any untoward medical occurrence that did not necessarily have a causal relationship with this treatment. An SAE was any untoward medical occurrence that at any dose: resulted in death; in the view of the Investigator, placed the subject at immediate risk of death (a life-threatening event); required inpatient hospitalization or prolongation of existing hospitalization; resulted in persistent or significant disability/incapacity; resulted in a congenital anomaly/birth defect; any other medically important event that, in the opinion of the Investigator, could jeopardize the subject or could require intervention to prevent one of the other outcomes listed in the definition above. ISR=injection site reactions.
Time frame: Day 1 to Week 52
Population: Safety population: all participants who received at least 1 injection of study treatment.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Overall Population | Summary of Adverse Events (AEs), Serious AEs (SAEs), and Discontinuations Due to AEs | Moderate or severe event | 54 participants |
| Overall Population | Summary of Adverse Events (AEs), Serious AEs (SAEs), and Discontinuations Due to AEs | Discontinuations due to AEs | 14 participants |
| Overall Population | Summary of Adverse Events (AEs), Serious AEs (SAEs), and Discontinuations Due to AEs | Related event | 80 participants |
| Overall Population | Summary of Adverse Events (AEs), Serious AEs (SAEs), and Discontinuations Due to AEs | Treatment discontinuation due to FLS event | 3 participants |
| Overall Population | Summary of Adverse Events (AEs), Serious AEs (SAEs), and Discontinuations Due to AEs | Severe event | 7 participants |
| Overall Population | Summary of Adverse Events (AEs), Serious AEs (SAEs), and Discontinuations Due to AEs | Treatment discontinuation due to ISR events | 5 participants |
| Overall Population | Summary of Adverse Events (AEs), Serious AEs (SAEs), and Discontinuations Due to AEs | Serious event | 4 participants |
| Overall Population | Summary of Adverse Events (AEs), Serious AEs (SAEs), and Discontinuations Due to AEs | Study discontinuation due to an event | 13 participants |
| Overall Population | Summary of Adverse Events (AEs), Serious AEs (SAEs), and Discontinuations Due to AEs | Any event | 93 participants |
| BIIB017 Plus Naproxen | Summary of Adverse Events (AEs), Serious AEs (SAEs), and Discontinuations Due to AEs | Study discontinuation due to an event | 13 participants |
| BIIB017 Plus Naproxen | Summary of Adverse Events (AEs), Serious AEs (SAEs), and Discontinuations Due to AEs | Any event | 90 participants |
| BIIB017 Plus Naproxen | Summary of Adverse Events (AEs), Serious AEs (SAEs), and Discontinuations Due to AEs | Moderate or severe event | 60 participants |
| BIIB017 Plus Naproxen | Summary of Adverse Events (AEs), Serious AEs (SAEs), and Discontinuations Due to AEs | Severe event | 12 participants |
| BIIB017 Plus Naproxen | Summary of Adverse Events (AEs), Serious AEs (SAEs), and Discontinuations Due to AEs | Related event | 71 participants |
| BIIB017 Plus Naproxen | Summary of Adverse Events (AEs), Serious AEs (SAEs), and Discontinuations Due to AEs | Serious event | 6 participants |
| BIIB017 Plus Naproxen | Summary of Adverse Events (AEs), Serious AEs (SAEs), and Discontinuations Due to AEs | Discontinuations due to AEs | 13 participants |
| BIIB017 Plus Naproxen | Summary of Adverse Events (AEs), Serious AEs (SAEs), and Discontinuations Due to AEs | Treatment discontinuation due to FLS event | 2 participants |
| BIIB017 Plus Naproxen | Summary of Adverse Events (AEs), Serious AEs (SAEs), and Discontinuations Due to AEs | Treatment discontinuation due to ISR events | 3 participants |
Secondary
Summary of Average Duration of FLS in the 48 Weeks of Treatment
Duration of FLS for a treatment was defined as the sum of hours from the time of treatment to 48 hours with a FLS-S score \> 0. The total FLS-S is the sum of all 4 symptom scores (muscle aches, chills, fatigue and fever), each rated from 0 (absent) to 3 (severe), with a range of 0-12 with 0 indicating no FLS and 12 indicating severe FLS. If a FLS is \> 0 at an evaluation time, 6 hours were counted as the duration assuming the event started from previous evaluation time. Average duration of FLS for the first 8 weeks was defined as the mean duration from Weeks 0, 2, 4, 6, and 8. 4WRI=4-week run-in period; 48W=48 weeks.
Time frame: 4-week run-in period, 48 weeks of treatment
Population: Efficacy population: randomized participants who received at least 1 dose of study treatment and had efficacy data in both the 4-week run-in period and the post-baseline treatment period; n=number of subjects assessed at the given timepoint.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Overall Population | Summary of Average Duration of FLS in the 48 Weeks of Treatment | Average duration in 48W; n=95, 89, 184 | 16.75 hours |
| Overall Population | Summary of Average Duration of FLS in the 48 Weeks of Treatment | Average duration in 4WRI; n=88, 86, 174 | 16 hours |
| Overall Population | Summary of Average Duration of FLS in the 48 Weeks of Treatment | Change from 4WRI to 48W; n=86, 82, 168 | 2.82 hours |
| BIIB017 Plus Naproxen | Summary of Average Duration of FLS in the 48 Weeks of Treatment | Average duration in 48W; n=95, 89, 184 | 16.96 hours |
| BIIB017 Plus Naproxen | Summary of Average Duration of FLS in the 48 Weeks of Treatment | Average duration in 4WRI; n=88, 86, 174 | 12.8 hours |
| BIIB017 Plus Naproxen | Summary of Average Duration of FLS in the 48 Weeks of Treatment | Change from 4WRI to 48W; n=86, 82, 168 | 2 hours |
| Overall Population | Summary of Average Duration of FLS in the 48 Weeks of Treatment | Average duration in 4WRI; n=88, 86, 174 | 13.75 hours |
| Overall Population | Summary of Average Duration of FLS in the 48 Weeks of Treatment | Change from 4WRI to 48W; n=86, 82, 168 | 2.16 hours |
| Overall Population | Summary of Average Duration of FLS in the 48 Weeks of Treatment | Average duration in 48W; n=95, 89, 184 | 16.96 hours |
p-value: 0.0019paired t-test within 1 arm
p-value: 0.0009paired t-test within 1 arm
p-value: <0.0001paired t-test within 1 arm
Secondary
Summary of Average Duration of FLS in the First 8 Weeks of Treatment
Duration of FLS for a treatment was defined as the sum of hours from the time of treatment to 48 hours with an FLS-S score \> 0. The total FLS-S is the sum of all 4 symptom scores (muscle aches, chills, fatigue and fever), each rated from 0 (absent) to 3 (severe), with a range of 0-12 with 0 indicating no FLS and 12 indicating severe FLS. If an FLS is \> 0 at an evaluation time, 6 hours were counted as the duration assuming the event started from previous evaluation time. Average duration of FLS for the first 8 weeks was defined as the mean duration from Weeks 0, 2, 4, 6, and 8. 4WRI=4-week run-in period; F8W=first 8 weeks.
Time frame: 4-week run-in period, first 8 weeks of treatment
Population: Efficacy population: randomized participants who received at least 1 dose of study treatment and had efficacy data in both the 4-week run-in period and the post-baseline treatment period; n=number of subjects assessed at the given timepoint.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Overall Population | Summary of Average Duration of FLS in the First 8 Weeks of Treatment | Average duration in F8W; n=91, 83, 174 | 18 hours |
| Overall Population | Summary of Average Duration of FLS in the First 8 Weeks of Treatment | Average duration in 4WRI; n=88, 86, 174 | 16 hours |
| Overall Population | Summary of Average Duration of FLS in the First 8 Weeks of Treatment | Change from 4WRI to F8W; n=85, 78, 163 | 2.1 hours |
| BIIB017 Plus Naproxen | Summary of Average Duration of FLS in the First 8 Weeks of Treatment | Average duration in F8W; n=91, 83, 174 | 18 hours |
| BIIB017 Plus Naproxen | Summary of Average Duration of FLS in the First 8 Weeks of Treatment | Average duration in 4WRI; n=88, 86, 174 | 12.8 hours |
| BIIB017 Plus Naproxen | Summary of Average Duration of FLS in the First 8 Weeks of Treatment | Change from 4WRI to F8W; n=85, 78, 163 | 3.8 hours |
| Overall Population | Summary of Average Duration of FLS in the First 8 Weeks of Treatment | Average duration in 4WRI; n=88, 86, 174 | 13.75 hours |
| Overall Population | Summary of Average Duration of FLS in the First 8 Weeks of Treatment | Change from 4WRI to F8W; n=85, 78, 163 | 3 hours |
| Overall Population | Summary of Average Duration of FLS in the First 8 Weeks of Treatment | Average duration in F8W; n=91, 83, 174 | 18 hours |
p-value: 0.0009paired t-test within 1 arm
p-value: <0.0001paired t-test within 1 arm
p-value: <0.0001paired t-test within 1 arm
p-value: 0.37922-sample t-test between 2 arms
Secondary
Summary of Average Duration of FLS Within the Last 4 Weeks of the BIIB017 Treatment Period Compared With the Duration of FLS in the 4-Week Run-In Period
Average duration of FLS for the last 4 weeks (L4W) is defined as the mean duration of last 4 weeks. Duration of FLS for a treatment is defined as the sum of hours from the treatment to 48 hours with a FLS-S score \> 0. The total FLS-S is the sum of all 4 symptom scores (muscle aches, chills, fatigue and fever), each rated from 0 (absent) to 3 (severe), with a range of 0-12 with 0 indicating no FLS and 12 indicating severe FLS. If a FLS is \> 0 at an evaluation time, 6 hours were counted as the duration assuming the event started from previous evaluation time. 4WRI=4-week run-in.
Time frame: Weeks -4 to -1 (Screening), Weeks 45-48 (last 4 weeks of study)
Population: Efficacy population: randomized participants who received at least 1 dose of study treatment, had efficacy data in both the 4-week run-in period and the post-baseline treatment period, and had FLS; n=number of participants assessed at the given timepoint.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Overall Population | Summary of Average Duration of FLS Within the Last 4 Weeks of the BIIB017 Treatment Period Compared With the Duration of FLS in the 4-Week Run-In Period | Average duration in L4W; n=87, 83, 170 | 18.057 hours | Standard Deviation 9.06 |
| Overall Population | Summary of Average Duration of FLS Within the Last 4 Weeks of the BIIB017 Treatment Period Compared With the Duration of FLS in the 4-Week Run-In Period | Average duration in 4WRI; n=88, 86, 174 | 16.067 hours | Standard Deviation 8.277 |
| Overall Population | Summary of Average Duration of FLS Within the Last 4 Weeks of the BIIB017 Treatment Period Compared With the Duration of FLS in the 4-Week Run-In Period | Change from 4WRI to L4W; n=80, 77, 157 | 2.612 hours | Standard Deviation 8.067 |
| BIIB017 Plus Naproxen | Summary of Average Duration of FLS Within the Last 4 Weeks of the BIIB017 Treatment Period Compared With the Duration of FLS in the 4-Week Run-In Period | Average duration in L4W; n=87, 83, 170 | 15.892 hours | Standard Deviation 8.073 |
| BIIB017 Plus Naproxen | Summary of Average Duration of FLS Within the Last 4 Weeks of the BIIB017 Treatment Period Compared With the Duration of FLS in the 4-Week Run-In Period | Average duration in 4WRI; n=88, 86, 174 | 14.915 hours | Standard Deviation 7.637 |
| BIIB017 Plus Naproxen | Summary of Average Duration of FLS Within the Last 4 Weeks of the BIIB017 Treatment Period Compared With the Duration of FLS in the 4-Week Run-In Period | Change from 4WRI to L4W; n=80, 77, 157 | 0.943 hours | Standard Deviation 6.738 |
| Overall Population | Summary of Average Duration of FLS Within the Last 4 Weeks of the BIIB017 Treatment Period Compared With the Duration of FLS in the 4-Week Run-In Period | Average duration in 4WRI; n=88, 86, 174 | 15.497 hours | Standard Deviation 7.965 |
| Overall Population | Summary of Average Duration of FLS Within the Last 4 Weeks of the BIIB017 Treatment Period Compared With the Duration of FLS in the 4-Week Run-In Period | Change from 4WRI to L4W; n=80, 77, 157 | 1.793 hours | Standard Deviation 7.468 |
| Overall Population | Summary of Average Duration of FLS Within the Last 4 Weeks of the BIIB017 Treatment Period Compared With the Duration of FLS in the 4-Week Run-In Period | Average duration in L4W; n=87, 83, 170 | 17 hours | Standard Deviation 8.635 |
Comparison: Change from 4WRI to L4Wp-value: 0.0049paired t-test within 1 arm
Comparison: Change from 4WRI to L4Wp-value: 0.223paired t-test within 1 arm
Comparison: Change from 4WRI to L4Wp-value: 0.0031paired t-test within 1 arm
Comparison: Change from 4WRI to L4Wp-value: 0.16242-sample t-test between 2 arms
Secondary
Summary of FLS-VAS During the 48 Weeks of Treatment Compared to 4-Week Run-In Period: Effectiveness of FLS Treatment
Participants reported the effectiveness of their FLS management regimen on a 100-mm VAS between not effective (0) and very effective (100). 4WRI=4-week run-in period; 48W=48 weeks.
Time frame: 4-week run-in period, 48 weeks of treatment
Population: Efficacy population: randomized participants who received at least 1 dose of study treatment and had efficacy data in both the 4-week run-in period and the post-baseline treatment period; n=number of participants assessed at the given timepoint.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Overall Population | Summary of FLS-VAS During the 48 Weeks of Treatment Compared to 4-Week Run-In Period: Effectiveness of FLS Treatment | Effectiveness in 48W; n=99, 94, 193 | 70.547 units on a scale | Standard Deviation 21.657 |
| Overall Population | Summary of FLS-VAS During the 48 Weeks of Treatment Compared to 4-Week Run-In Period: Effectiveness of FLS Treatment | Effectiveness in 4WRI; n=91, 86, 177 | 64.5 units on a scale | Standard Deviation 27.952 |
| Overall Population | Summary of FLS-VAS During the 48 Weeks of Treatment Compared to 4-Week Run-In Period: Effectiveness of FLS Treatment | Change from 4WRI to 48W; n=90, 86, 176 | 6.803 units on a scale | Standard Deviation 24.182 |
| BIIB017 Plus Naproxen | Summary of FLS-VAS During the 48 Weeks of Treatment Compared to 4-Week Run-In Period: Effectiveness of FLS Treatment | Effectiveness in 48W; n=99, 94, 193 | 75.416 units on a scale | Standard Deviation 21.28 |
| BIIB017 Plus Naproxen | Summary of FLS-VAS During the 48 Weeks of Treatment Compared to 4-Week Run-In Period: Effectiveness of FLS Treatment | Effectiveness in 4WRI; n=91, 86, 177 | 66.398 units on a scale | Standard Deviation 28.855 |
| BIIB017 Plus Naproxen | Summary of FLS-VAS During the 48 Weeks of Treatment Compared to 4-Week Run-In Period: Effectiveness of FLS Treatment | Change from 4WRI to 48W; n=90, 86, 176 | 8.042 units on a scale | Standard Deviation 27.206 |
| Overall Population | Summary of FLS-VAS During the 48 Weeks of Treatment Compared to 4-Week Run-In Period: Effectiveness of FLS Treatment | Effectiveness in 4WRI; n=91, 86, 177 | 65.422 units on a scale | Standard Deviation 28.329 |
| Overall Population | Summary of FLS-VAS During the 48 Weeks of Treatment Compared to 4-Week Run-In Period: Effectiveness of FLS Treatment | Change from 4WRI to 48W; n=90, 86, 176 | 7.408 units on a scale | Standard Deviation 25.638 |
| Overall Population | Summary of FLS-VAS During the 48 Weeks of Treatment Compared to 4-Week Run-In Period: Effectiveness of FLS Treatment | Effectiveness in 48W; n=99, 94, 193 | 72.918 units on a scale | Standard Deviation 21.557 |
p-value: 0.0002paired t-test within 1 arm
p-value: 0.009paired t-test within 1 arm
p-value: 0.0075paired t-test within 1 arm
p-value: 0.74972-sample t-test between 2 arms
Secondary
Summary of FLS-VAS During the 48 Weeks of Treatment Compared to 4-Week Run-In Period: Satisfaction With FLS Treatment
Participants reported their satisfaction with the effectiveness of their FLS management regimen on a 100-mm VAS between not satisfied (0) and very satisfied (100). 4WRI=4-week run-in period; 48W=48 weeks.
Time frame: 4-week run-in period, 48 weeks of treatment
Population: Efficacy population: randomized participants who received at least 1 dose of study treatment and had efficacy data in both the 4-week run-in period and the post-baseline treatment period; n=number of participants assessed at the given timepoint.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Overall Population | Summary of FLS-VAS During the 48 Weeks of Treatment Compared to 4-Week Run-In Period: Satisfaction With FLS Treatment | Satisfaction in 48W; n=99, 94, 193 | 72.192 units on a scale | Standard Deviation 21.053 |
| Overall Population | Summary of FLS-VAS During the 48 Weeks of Treatment Compared to 4-Week Run-In Period: Satisfaction With FLS Treatment | Satisfaction in 4WRI; n=91, 86, 177 | 68.654 units on a scale | Standard Deviation 26.574 |
| Overall Population | Summary of FLS-VAS During the 48 Weeks of Treatment Compared to 4-Week Run-In Period: Satisfaction With FLS Treatment | Change from 4WRI to 48W; n=90, 86, 176 | 4.607 units on a scale | Standard Deviation 22.43 |
| BIIB017 Plus Naproxen | Summary of FLS-VAS During the 48 Weeks of Treatment Compared to 4-Week Run-In Period: Satisfaction With FLS Treatment | Satisfaction in 48W; n=99, 94, 193 | 76.061 units on a scale | Standard Deviation 21.075 |
| BIIB017 Plus Naproxen | Summary of FLS-VAS During the 48 Weeks of Treatment Compared to 4-Week Run-In Period: Satisfaction With FLS Treatment | Satisfaction in 4WRI; n=91, 86, 177 | 72.778 units on a scale | Standard Deviation 23.817 |
| BIIB017 Plus Naproxen | Summary of FLS-VAS During the 48 Weeks of Treatment Compared to 4-Week Run-In Period: Satisfaction With FLS Treatment | Change from 4WRI to 48W; n=90, 86, 176 | 2.274 units on a scale | Standard Deviation 21.874 |
| Overall Population | Summary of FLS-VAS During the 48 Weeks of Treatment Compared to 4-Week Run-In Period: Satisfaction With FLS Treatment | Satisfaction in 4WRI; n=91, 86, 177 | 70.658 units on a scale | Standard Deviation 25.285 |
| Overall Population | Summary of FLS-VAS During the 48 Weeks of Treatment Compared to 4-Week Run-In Period: Satisfaction With FLS Treatment | Change from 4WRI to 48W; n=90, 86, 176 | 3.467 units on a scale | Standard Deviation 22.128 |
| Overall Population | Summary of FLS-VAS During the 48 Weeks of Treatment Compared to 4-Week Run-In Period: Satisfaction With FLS Treatment | Satisfaction in 48W; n=99, 94, 193 | 74.076 units on a scale | Standard Deviation 21.098 |
p-value: 0.0545paired t-test within 1 arm
p-value: 0.3377paired t-test within 1 arm
p-value: 0.0391paired t-test within 1 arm
p-value: 0.48612-sample t-test between 2 arms
Secondary
Summary of FLS-VAS During the First 8 Weeks of Treatment Compared to 4-Week Run-In Period: Satisfaction With FLS Treatment
Participants reported their satisfaction with the effectiveness of their FLS management regimen on a 100-mm VAS between not satisfied (0) and very satisfied (100). 4WRI=4-week run-in period; F8W=first 8 weeks.
Time frame: 4-week run-in period, first 8 weeks of treatment
Population: Efficacy population: randomized participants who received at least 1 dose of study treatment and had efficacy data in both the 4-week run-in period and the post-baseline treatment period; n=number of participants assessed at the given timepoint.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Overall Population | Summary of FLS-VAS During the First 8 Weeks of Treatment Compared to 4-Week Run-In Period: Satisfaction With FLS Treatment | Satisfaction in F8W; n=96, 91, 187 | 71.153 units on a scale | Standard Deviation 21.884 |
| Overall Population | Summary of FLS-VAS During the First 8 Weeks of Treatment Compared to 4-Week Run-In Period: Satisfaction With FLS Treatment | Satisfaction in 4WRI; n=91, 86, 177 | 68.654 units on a scale | Standard Deviation 26.574 |
| Overall Population | Summary of FLS-VAS During the First 8 Weeks of Treatment Compared to 4-Week Run-In Period: Satisfaction With FLS Treatment | Change from 4WRI to F8W; n=87, 83, 170 | 3.715 units on a scale | Standard Deviation 23.307 |
| BIIB017 Plus Naproxen | Summary of FLS-VAS During the First 8 Weeks of Treatment Compared to 4-Week Run-In Period: Satisfaction With FLS Treatment | Satisfaction in F8W; n=96, 91, 187 | 74.684 units on a scale | Standard Deviation 23.671 |
| BIIB017 Plus Naproxen | Summary of FLS-VAS During the First 8 Weeks of Treatment Compared to 4-Week Run-In Period: Satisfaction With FLS Treatment | Satisfaction in 4WRI; n=91, 86, 177 | 72.778 units on a scale | Standard Deviation 23.817 |
| BIIB017 Plus Naproxen | Summary of FLS-VAS During the First 8 Weeks of Treatment Compared to 4-Week Run-In Period: Satisfaction With FLS Treatment | Change from 4WRI to F8W; n=87, 83, 170 | 0.759 units on a scale | Standard Deviation 24.729 |
| Overall Population | Summary of FLS-VAS During the First 8 Weeks of Treatment Compared to 4-Week Run-In Period: Satisfaction With FLS Treatment | Satisfaction in 4WRI; n=91, 86, 177 | 70.658 units on a scale | Standard Deviation 25.285 |
| Overall Population | Summary of FLS-VAS During the First 8 Weeks of Treatment Compared to 4-Week Run-In Period: Satisfaction With FLS Treatment | Change from 4WRI to F8W; n=87, 83, 170 | 2.272 units on a scale | Standard Deviation 23.986 |
| Overall Population | Summary of FLS-VAS During the First 8 Weeks of Treatment Compared to 4-Week Run-In Period: Satisfaction With FLS Treatment | Satisfaction in F8W; n=96, 91, 187 | 72.871 units on a scale | Standard Deviation 22.778 |
p-value: 0.1407paired t-test within 1 arm
p-value: 0.7805paired t-test within 1 arm
p-value: 0.2186paired t-test within 1 arm
p-value: 0.42342-sample t-test between 2 arms
Secondary
Summary of FLS-Visual Analogue Scale (VAS) During the First 8 Weeks of Treatment Compared to 4-Week Run-In Period: Effectiveness of FLS Treatment
Participants reported the effectiveness of their FLS management regimen on a 100-mm VAS between not effective (0) and very effective (100). 4WRI=4-week run-in period; F8W=first 8 weeks.
Time frame: 4-week run-in period, first 8 weeks of treatment
Population: Efficacy population: randomized participants who received at least 1 dose of study treatment and had efficacy data in both the 4-week run-in period and the post-baseline treatment period; n=number of participants assessed at the given timepoint.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Overall Population | Summary of FLS-Visual Analogue Scale (VAS) During the First 8 Weeks of Treatment Compared to 4-Week Run-In Period: Effectiveness of FLS Treatment | Effectiveness in F8W; n=96, 91, 187 | 69.695 units on a scale | Standard Deviation 22.423 |
| Overall Population | Summary of FLS-Visual Analogue Scale (VAS) During the First 8 Weeks of Treatment Compared to 4-Week Run-In Period: Effectiveness of FLS Treatment | Effectiveness in 4WRI; n=91, 86, 177 | 64.5 units on a scale | Standard Deviation 27.952 |
| Overall Population | Summary of FLS-Visual Analogue Scale (VAS) During the First 8 Weeks of Treatment Compared to 4-Week Run-In Period: Effectiveness of FLS Treatment | Change from 4WRI to F8W; n=87, 83, 170 | 6.525 units on a scale | Standard Deviation 23.271 |
| BIIB017 Plus Naproxen | Summary of FLS-Visual Analogue Scale (VAS) During the First 8 Weeks of Treatment Compared to 4-Week Run-In Period: Effectiveness of FLS Treatment | Effectiveness in F8W; n=96, 91, 187 | 74.253 units on a scale | Standard Deviation 23.85 |
| BIIB017 Plus Naproxen | Summary of FLS-Visual Analogue Scale (VAS) During the First 8 Weeks of Treatment Compared to 4-Week Run-In Period: Effectiveness of FLS Treatment | Effectiveness in 4WRI; n=91, 86, 177 | 66.398 units on a scale | Standard Deviation 28.855 |
| BIIB017 Plus Naproxen | Summary of FLS-Visual Analogue Scale (VAS) During the First 8 Weeks of Treatment Compared to 4-Week Run-In Period: Effectiveness of FLS Treatment | Change from 4WRI to F8W; n=87, 83, 170 | 5.694 units on a scale | Standard Deviation 29.151 |
| Overall Population | Summary of FLS-Visual Analogue Scale (VAS) During the First 8 Weeks of Treatment Compared to 4-Week Run-In Period: Effectiveness of FLS Treatment | Effectiveness in 4WRI; n=91, 86, 177 | 65.422 units on a scale | Standard Deviation 28.329 |
| Overall Population | Summary of FLS-Visual Analogue Scale (VAS) During the First 8 Weeks of Treatment Compared to 4-Week Run-In Period: Effectiveness of FLS Treatment | Change from 4WRI to F8W; n=87, 83, 170 | 6.119 units on a scale | Standard Deviation 26.231 |
| Overall Population | Summary of FLS-Visual Analogue Scale (VAS) During the First 8 Weeks of Treatment Compared to 4-Week Run-In Period: Effectiveness of FLS Treatment | Effectiveness in F8W; n=96, 91, 187 | 71.913 units on a scale | Standard Deviation 23.179 |
p-value: 0.0105paired t-test within 1 arm
p-value: 0.0789paired t-test within 1 arm
p-value: 0.0027paired t-test within 1 arm
p-value: 0.8382-sample t-test between 2 arms
Secondary
Summary of Severity of FLS (Per FLS-S) in the 48 Weeks of Treatment Compared to 4-Week Run-In Period Between Arms
The total FLS-S is the sum of all 4 symptom scores (muscle aches, chills, fatigue and fever), each rated from 0 (absent) to 3 (severe), with a range of 0-12 with 0 indicating no FLS and 12 indicating severe FLS. 4WRI=4-week run-in period; 48W=48 weeks.
Time frame: 4-week run-in period, 48 weeks of treatment
Population: Efficacy population: randomized participants who received at least 1 dose of study treatment and had efficacy data in both the 4-week run-in period and the post-baseline treatment period.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Overall Population | Summary of Severity of FLS (Per FLS-S) in the 48 Weeks of Treatment Compared to 4-Week Run-In Period Between Arms | Severity of FLS in 48W | 1.28 units on a scale | Standard Deviation 1.19 |
| Overall Population | Summary of Severity of FLS (Per FLS-S) in the 48 Weeks of Treatment Compared to 4-Week Run-In Period Between Arms | Severity of FLS in 4WRI | 1.2 units on a scale | Standard Deviation 1.22 |
| Overall Population | Summary of Severity of FLS (Per FLS-S) in the 48 Weeks of Treatment Compared to 4-Week Run-In Period Between Arms | Mean Change from 4WRI to 48W | 0.08 units on a scale | Standard Deviation 0.83 |
| BIIB017 Plus Naproxen | Summary of Severity of FLS (Per FLS-S) in the 48 Weeks of Treatment Compared to 4-Week Run-In Period Between Arms | Severity of FLS in 48W | 0.98 units on a scale | Standard Deviation 1 |
| BIIB017 Plus Naproxen | Summary of Severity of FLS (Per FLS-S) in the 48 Weeks of Treatment Compared to 4-Week Run-In Period Between Arms | Severity of FLS in 4WRI | 1.05 units on a scale | Standard Deviation 1.02 |
| BIIB017 Plus Naproxen | Summary of Severity of FLS (Per FLS-S) in the 48 Weeks of Treatment Compared to 4-Week Run-In Period Between Arms | Mean Change from 4WRI to 48W | -0.07 units on a scale | Standard Deviation 0.7 |
| Overall Population | Summary of Severity of FLS (Per FLS-S) in the 48 Weeks of Treatment Compared to 4-Week Run-In Period Between Arms | Severity of FLS in 4WRI | 1.13 units on a scale | Standard Deviation 1.13 |
| Overall Population | Summary of Severity of FLS (Per FLS-S) in the 48 Weeks of Treatment Compared to 4-Week Run-In Period Between Arms | Mean Change from 4WRI to 48W | 0.01 units on a scale | Standard Deviation 0.77 |
| Overall Population | Summary of Severity of FLS (Per FLS-S) in the 48 Weeks of Treatment Compared to 4-Week Run-In Period Between Arms | Severity of FLS in 48W | 1.14 units on a scale | Standard Deviation 1.11 |
p-value: 0.3189paired t-test within 1 arm
p-value: 0.3582paired t-test within 1 arm
p-value: 0.8484paired t-test within 1 arm
p-value: 0.17712-sample t-test between 2 arms
Secondary
Summary of Severity of FLS (Per FLS-S) in the First 8 Weeks Compared to 4-Week Run-In Period Between Arms
The total FLS-S is the sum of all 4 symptom scores (muscle aches, chills, fatigue and fever), each rated from 0 (absent) to 3 (severe), with a range of 0-12 with 0 indicating no FLS and 12 indicating severe FLS. 4WRI=4-week run-in period; F8W=first 8 weeks.
Time frame: 4-week run-in period, first 8 weeks of treatment
Population: Efficacy population: randomized participants who received at least 1 dose of study treatment and had efficacy data in both the 4-week run-in period and the post-baseline treatment period.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Overall Population | Summary of Severity of FLS (Per FLS-S) in the First 8 Weeks Compared to 4-Week Run-In Period Between Arms | Severity of FLS in F8W | 1.311 units on a scale | Standard Deviation 1.185 |
| Overall Population | Summary of Severity of FLS (Per FLS-S) in the First 8 Weeks Compared to 4-Week Run-In Period Between Arms | Severity of FLS in 4WRI | 1.198 units on a scale | Standard Deviation 1.224 |
| Overall Population | Summary of Severity of FLS (Per FLS-S) in the First 8 Weeks Compared to 4-Week Run-In Period Between Arms | Mean Change from 4WRI to F8W | 0.113 units on a scale | Standard Deviation 0.67 |
| BIIB017 Plus Naproxen | Summary of Severity of FLS (Per FLS-S) in the First 8 Weeks Compared to 4-Week Run-In Period Between Arms | Severity of FLS in F8W | 1.036 units on a scale | Standard Deviation 0.951 |
| BIIB017 Plus Naproxen | Summary of Severity of FLS (Per FLS-S) in the First 8 Weeks Compared to 4-Week Run-In Period Between Arms | Severity of FLS in 4WRI | 1.05 units on a scale | Standard Deviation 1.02 |
| BIIB017 Plus Naproxen | Summary of Severity of FLS (Per FLS-S) in the First 8 Weeks Compared to 4-Week Run-In Period Between Arms | Mean Change from 4WRI to F8W | -0.013 units on a scale | Standard Deviation 0.581 |
| Overall Population | Summary of Severity of FLS (Per FLS-S) in the First 8 Weeks Compared to 4-Week Run-In Period Between Arms | Severity of FLS in 4WRI | 1.126 units on a scale | Standard Deviation 1.129 |
| Overall Population | Summary of Severity of FLS (Per FLS-S) in the First 8 Weeks Compared to 4-Week Run-In Period Between Arms | Mean Change from 4WRI to F8W | 0.052 units on a scale | Standard Deviation 0.63 |
| Overall Population | Summary of Severity of FLS (Per FLS-S) in the First 8 Weeks Compared to 4-Week Run-In Period Between Arms | Severity of FLS in F8W | 1.178 units on a scale | Standard Deviation 1.084 |
p-value: 0.0945paired t-test within 1 arm
p-value: 0.8246paired t-test within 1 arm
p-value: 0.2533paired t-test within 1 arm
p-value: 0.16312-sample t-test between 2 arms