Table 2.
MSTSQ, ISR, and SF-MPQ endpoints during the full-dose period of the comparative phase (intent-to-treat population)
IFNβ-1a (N = 65) | IFNβ-1b (N = 64) | p-value | |
---|---|---|---|
MSTSQ assessments | |||
MSTSQ overall satisfaction score,a mean (SD) |
1.51 (0.56) |
1.53 (0.63) |
0.616 |
MSTSQ injection system score,a mean (SD) |
1.68 (0.41) |
1.80 (0.45) |
0.156 |
MSTSQ score for background information,a mean (SD) |
2.28 (0.91) |
2.28 (0.86) |
0.734 |
Blinded assessment of ISRs | |||
Diameter of injection-site redness, mm, mean (SD) |
11.32 (14.88) |
11.75 (15.53) |
0.986 |
Patients, n (%), with: |
|
|
|
Injection-site swelling |
19 (29.2) |
16 (25.0) |
0.848 |
Injection-site bruising |
21 (32.3) |
7 (10.9) |
0.019 |
Injection-site itching |
7 (10.8) |
6 (9.4) |
0.366 |
SF-MPQ assessments | |||
SF-MPQ VAS pain score,b mm, mean (SD) |
2.54 (7.98) |
3.24 (8.78) |
0.612 |
Patients pain-free on SF-MPQ VAS,b,cn (%) | 17 (26.2) | 17 (26.6) | 0.852 |
aOn the MSTSQ, a lower score indicates a more favorable response to treatment. bThe SF-MPQ VAS recorded the maximum amount of pain experienced during the 60 min after injection, from 0 mm (no pain) to 100 mm (worst possible pain). cPain-free was defined as an SF-MPQ VAS score of 0 mm.
IFN, interferon; ISR, injection-site reaction; MSTSQ, Multiple Sclerosis Treatment Satisfaction Questionnaire; SD, standard deviation; SF-MPQ, Short-Form McGill Pain Questionnaire; VAS, visual analog scale.