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Table 2 MSTSQ, ISR, and SF-MPQ endpoints during the full-dose period of the comparative phase (intent-to-treat population)

From: Comparative injection-site pain and tolerability of subcutaneous serum-free formulation of interferonβ-1a versus subcutaneous interferonβ-1b: results of the randomized, multicenter, Phase IIIb REFORMS study

 

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,c n (%)

17 (26.2)

17 (26.6)

0.852

  1. 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.
  2. 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.