In patients who discontinued Copaxone® (glatiramer acetate) after suboptimal response,* TECFIDERA Improved Clinical Measures of Relapse and the Majority of Patient-Reported Outcomes1

RESPOND Study Design and Methodology:

  • Phase 4, prospective, open-label, single-arm, 12-month observational trial conducted at 63 sites in the United States

Study Population:

  • Inclusion: ≥18 years of age, received treatment with Copaxone, experienced suboptimal response* to Copaxone or discontinued treatment with Copaxone for RMS after after a suboptimal response within 30 days of enrollment
  • Exclusion: Presented with major comorbid conditions as determined by the prescribing physician, history of malignancy, current serious infection, enrolled in other studies, or received previous treatment with TECFIDERA

Outcome Measurements:

  • Primary: ARR at 12 months
  • Secondary: PPR at 12 months and change in PRO scores from baseline to 12 months. Safety as assessed by adverse events (AEs) and serious adverse events (SAEs) leading to treatment discontinuation was an additional endpoint 

Limitations:

  • Results should be interpreted with caution due to the observational nature of the study and lack of a control group, lack of a randomized or serial-selection protocol since patients were self selected, and potential bias due to regression to the mean 

*Suboptimal response=perceived suboptimal efficacy, intolerance,
or poor adherence to Copaxone, as determined by the
prescribing physician.

More patients were relapse-free after 12 months of TECFIDERA
vs the prior
12 months on Copaxone

Primary Endpoint

Unadjusted ARR 12 months before
and after TECFIDERA initiation

Rate ratio (95% CI): 0.22 (0.14-0.34)

ARR at 12 months
ARR at 12 months

Adapted with permission from Elsevier Inc.

Secondary Endpoint

Proportion of Patients With Relapses

PPR at 12 months
PPR at 12 months

Estimated PPR is based on Kaplan-Meier curve (8% of TECFIDERA patients relapsed in the 12 months after TECFIDERA initiation compared with 41% who relapsed in the 12 months before TECFIDERA initiation). 
Observed PPR. Over 12 months of treatment with TECFIDERA, 7% (22/318) of patients relapsed.

Mean changes in PRO scores from baseline to month 12
Measure Description Component Mean (SD) Change in Score Results
SF-36 8 multi-item domains
(36-item questionnaire)
assess physical and mental
components of MS
Physical summary
(n=217)
1.63 (10.46) Improved
Mental summary
(n=215)
1.71 (9.03) Improved
MFIS-5 5 items assess how fatigue
impacts patients’ lives
(n=226) –0.88 (3.51) Improved
TSQM-14 14 items assess patient
treatment satisfaction
Effectiveness
(n=225)
14.69 (24.30) Improved
Side effects
(n=222)
8.39 (27.99) Improved
Convenience
(n=222)
30.19 (21.81) Improved
Global
(n=219)
19.30 (26.03) Improved
WPAI-MS 6 items assess the number of
work hours missed, impact
on productivity, and daily
activities during past 7 days
Work impairment
(n=108)
–4.31 (23.61) Improved
Activity impairment
(n=218)
–2.11 (20.86) Stable
BDI-7 7 items assess depression
during the past 2 weeks
(n=226) –0.54 (2.99) Improved
PR-EDSS Assesses disease progression
as reported by the patients
(n=222) –0.01 (1.30) Stable

Mean changes in PRO scores from baseline to month 12

Improved Score
Stable Score
Measure

Component

SF-36

8 multi-item domains (36-item questionnaire) assess physical and mental components of MS

Physical Summary

(n=217) Mean (SD) Change in Score:
1.63 (10.46)
Mental Summary (n=215) Mean (SD) Change in Score:
1.71 (9.03)

MFIS-5

5 items assess how fatigue impacts patient's lives
(n=226) Mean (SD) Change in Score:
-0.88 (3.51)

TSQM-14

14 items assess patient treatment satisfaction

Effectiveness

(n=225)

Mean (SD) Change in Score:

14.69 (24.30)


Side Effects

(n=222) Mean (SD) Change in Score:

8.39 (27.99)


Convenience

(n=222) Mean (SD) Change in Score:

30.19 (21.81)


Global

(n=219) Mean (SD) Change in Score:

19.30 (26.03)


WPAI-MS
6 items assess the number of work hours missed, impact on productivity, and daily activities during past 7 days

Work Impairment

(n=108) Mean (SD) Change in Score:
-4.31 (23.61)

Activity Impairment

(n=218) Mean (SD) Change in Score:
-2.11 (20.86)

BDI-7

7 items assess depression during the past 2 weeks
(n=226) Mean (SD) Change in Score:
-0.54 (2.99)

PR-EDSS

Assesses disease progression as reported by the patients
(n=222) Mean (SD) Change in Score:
-0.01 (1.30)

*Suboptimal response=perceived suboptimal efficacy, intolerance, or poor adherence to Copaxone, as determined by the prescribing physician. Assessment was performed only for those patients working. A PRO score was considered stable if it had little or no change in either direction. SF-36=36-item Short Form Health Survey. Higher score indicates improved functioning (range 0–100); MFIS-5=5-item Modified Fatigue Impact Scale. Lower score indicates improved functioning (range 0–20); TSQM-14=14-item Treatment Satisfaction Questionnaire for Medication. Higher score indicates satisfaction (range 0–100); WPAI-MS=Work Productivity and Activity Impairment Questionnaire: Multiple Sclerosis. Higher score indicates higher impairment and lower productivity; BDI-7=7-item Beck Depression Inventory. Lower score indicates less severe depressive symptoms (range 0–21); PR-EDSS=Patient-Reported Expanded Disability Status Scale. Mean change in PROs from baseline to 12 months was assessed using a Wilcoxon signed-rank test.

SAEs and AEs leading to discontinuation

  • Of the 328 patients included in the safety
    population, 18% (60/328) experienced ≥1
    AE leading to treatment
    discontinuation,
    and 2% (5/328) experienced ≥1 SAE
    leading to treatment discontinuation
  • Most common SAEs were cardiac
    disorders (4/328) and vascular disorders
    (3/328)
  • The AEs most commonly leading to
    treatment discontinuation were gastrointestinal (GI) disorders (10%), skin

    and subcutaneous tissue disorders (3%),
    and vascular disorders (2%)
  • The incidence of AEs leading to treatment discontinuation due to GI disorders (10%)
    was higher than those
    reported in DEFINE
    (5%) and CONFIRM (3%) trials