Table 1.
Comparison of patient characteristics in PEG-IFN-β-1a versus sc. IFN-β-1a treatment groups.
| Parameter | IFN-β-cohort | PEG-IFN-β-1a | sc. IFN-β-1a | p Value |
|---|---|---|---|---|
| N | 128 | 65 (50.78) | 63 (49.22) | |
| Female (sex) | 106 (82.8) | 55 (84.61) | 51 (80.95) | 0.583 |
| BMI | 25.08 (±4.90) | 26.08 (±5.72) | 24.28 (±4.03) | 0.186 |
| Age at treatment start | 33.71 (±11.16) | 33.55 (±10.80) | 33.87 (±11.59) | 0.849 |
| Age at first diagnosis | 31.25 (±10.41) | 31.33 (±10) | 31.17 (±10.89) | 0.862 |
| Diagnosis by treatment start | ||||
| CIS | 27 (21.1) | 14 (21.54) | 13 (20.63) | 0.900 |
| RRMS | 101 (78.9) | 51 (78.46) | 50 (79.36) | 0.760 |
| IFN treatment duration (months) | 23.12 (±18.74) | 18.88 (±13.41) | 26.30 (±21.68) | 0.080 |
| Pretreatment | ||||
| sc. IFN-β-1a | 11 (8.6) | 11 (16.92) | 0 | 0.001 |
| im. IFN-β-1a | 1 (0.8) | 1 (1.53) | 0 | 0.323 |
| sc. IFN-β-1b | 2 (1.6) | 1 (1.53) | 1 (1.59) | 0.982 |
| Fingolimod | 2 (1.6) | 1 (1.53) | 1 (1.59) | 0.982 |
| Dimethyl fumarate | 3 (2.3) | 3 (4.61) | 0 | 0.084 |
| Glatiramer acetate | 8 (6.3) | 8 (12.31) | 0 | 0.004 |
| Mitoxantrone | 2 (1.6) | 2 (3.1) | 0 | 0.161 |
| EDSS at treatment start | 1.082 (±1.2) | 1.15 (±1.25) | 1.02 (±1.14) | 0.574 |
| EDSS changea | 0.077 (±0.87) | 0.15 (±1.09) | 0.342 | |
| Disease activity | ||||
| Relapse | 49 (38.3) | 22 (33.85) | 27 (42.86) | 0.294 |
| Relapse rate | 0.59 (±1.58) | 0.70 (±1.93) | 0.477 (±1.12) | 0.578 |
| MRI availability b | 107 (83.6) | 51 (78.5) | 56 (88.9) | |
| MRI activity | 57 (53.27) | 26 (50.98) | 31 (55.36) | 0.650 |
| Subclinical activity c | 44 (41.12) | 23 (45.1) | 21 (37.5) | 0.375 |
| New T2-lesion | 57 (53.27) | 26 (50.98) | 31 (55.36) | 0.650 |
| Gd-enhancement | 23 (21.49) | 9 (17.65) | 14 (25) | 0.356 |
| Laboratory results | ||||
| Leukocytes baseline (cells/nl) | 7.14 (±1.94) | 7.06 (±1.69) | 7.24 (±2.20) | 0.709 |
| Leukocytes under treatment (cells/nl) | 5.27 (±1.59) | 5.10 (±1.76) | 5.73 (±1.7) | 0.046 |
| White blood cell differential at baseline d | 61 (47.65) | 38 (58.46) | 23 (36.50) | |
| Lymphocytes baseline (cells/µl) | 1997.26 (±1885.72) | 1830.12 (±500.75) | 2273.40 (±3024.62) | 0.388 |
| Neutrophils baseline (%) | 61.46 (±12.32) | 60.69 (±12.38) | 62.73 (±12.38) | 0.935 |
| Neutrophils baseline (cells/µl) | 4213.28 (±1597.13) | 4295.28 (±1573.40) | 4077.79 (±1662.08) | 0.305 |
| Lymphocytes under treatment (cells/µl) | 1505.90 (±478.85) | 1577.29 (±474.49) | 1421 (±475.04) | 0.054 |
| Neutrophils under treatment (cells/µl) | 3115.27 (±1285.04) | 2879.16 (±1245.82) | 3373.65 (±1289.06) | 0.095 |
| Neutrophils under treatment (%) | 57.26 (±9.52) | 54.79 (±8.49) | 60.12 (±9.88) | 0.003 |
| Leukopenia | 27 (21.1) | 20 (30.77) | 7 (11.1) | 0.006 |
| Neutropenia based on % | 19 (14.8) | 14 (21.53) | 5 (7.93) | 0.030 |
| Neutropenia based on cells count | 24 (18.75) | 16 (24.61) | 8 (12.7) | 0.084 |
| Adverse events e | ||||
| N | 87 (67.9) | 44 (67.69) | 43 (68.25) | 0.950 |
| Mycosis genitalis | 3 (3.4) | 2 (4.54) | 1 (2.32) | 0.570 |
| Herpes simplex labialis | 4 (4.6) | 4 (9.09) | 0 | 0.043 |
| Infection of respiratory tract | 10 (11.5) | 5 (11.36) | 5 (11.63) | 0.969 |
| Hair loss | 17 (19.5) | 6 (13.63) | 5 (11.63) | 0.778 |
| Skin rash f | 11 (12.6) | 6 (13.63) | 5 (11.63) | 0.778 |
| Injection-site reaction | 58 (66.7) | 36 (81.81) | 22 (51.16) | 0.002 |
| Diarrhea | 4 (4.6) | 2 (4.54) | 2(4.65) | 0.981 |
| Flu-like symptoms | 60 (69) | 38 (86.36) | 22 (51.16) | <0.001 |
| Joint/muscle pain | 45 (51.7) | 31 (70.45) | 14 (32.56) | <0.001 |
EDSS change is defined as the difference between EDSS at study end and EDSS at therapy start.
MRI data available in 107 of 128 patients.
Subclinical disease activity is characterized by MRI activity (new T2 lesions or Gd+ enhancing lesions) without clinical activity.
White blood cell differential at baseline refers to the number and percentage of patients who had a white blood cell differential test performed at the baseline.
Adverse events were reported via follow-up telephone questionnaire completed by 87 of 128 patients.
Skin rash was defined as a change of the skin especially regarding color after injection. Data shown as number (percentage) or mean (±standard error of the mean) as appropriate, unless stated otherwise. Significant p values are highlighted in bold.
BMI, body mass index; CIS, clinically isolated syndrome; EDSS, Expanded Disability Status Scale; Gd, gadolinium; IFN-β, interferon-beta; RRMS, relapsing-remitting multiple sclerosis; sc., subcutaneous.