Table 2. Secondary clinical outcomes.
| Outcome | 1st Year | 2nd Year | Overall (2 years of follow-up) | ||||||
| AZA (N = 63) | IFN (N = 68) | p-value1 | AZA (N = 62) | IFN (N = 65) | p-value1 | AZA (N = 62) | IFN (N = 65) | p-value1 | |
| Relapses | |||||||||
| Annualised relapse rate (95% CI) | 0.37 (0.25–0.56) | 0.47 (0.34–0.67) | p = 0.37 | 0.18 (0.10–0.32) | 0.29 (0.18–0.45) | p = 0.19 | 0.26 (0.19–0.37) | 0.39 (0.30–0.51) | p = 0.07 |
| Adjusted annualised relapse rate (95% CI)2 | - | - | - | - | - | - | 0.27 (0.19–0.38) | 0.41 (0.31–0.54) | p = 0.06 |
| No. of patients with relapse - No. (%) | |||||||||
| 0 | 45 (71.4%) | 44 (64.7%) | p = 0.63 | 52 (83.9%) | 49 (75.4%) | p = 0.42 | 39 (62.9%) | 31 (47.7%) | p = 0.22 |
| 1 | 14 (22.2%) | 17 (25.0%) | 9 (14.5%) | 13 (20.0%) | 15 (24.2%) | 23 (35.4%) | |||
| ≥2 | 4 (6.4%) | 7 (10.3%) | 1 (1.6%) | 3 (4.6%) | 8 (12.9%) | 11 (16.9%) | |||
| No. of patients with relapses treated with corticosteroids – No. (%) | |||||||||
| 0 | - | - | - | - | - | - | 40 (64.5%) | 34 (52.3%) | p = 0.22 |
| 1 | - | - | - | - | - | - | 16 (25.8%) | 22 (33.9%) | |
| ≥2 | - | - | - | - | - | - | 6 (9.7%) | 9 (13.9%) | |
| Disability 3 | |||||||||
| Patients with no confirmed disability progression - % (95% CI)4 | - | - | - | - | - | - | 98.2 (91.5–99.9) | 92.0 (81.8–97.4) | p = 0.19 |
| Change from baseline in EDSS score – Mean (95% CI)5 | - | - | - | - | - | - | −0.08 (−0.31; 0.16) | 0.22 (−0.03; 0.47) | p = 0.08 |
Abbreviations: AZA, azathioprine; IFN, interferon.
P-values for AZA vs. IFN comparison were obtained through χ2 test with one degree of freedom for rate comparison, χ2 test with two degrees of freedom for number of patients with relapses, Fisher's exact test for patients with no confirmed disability progression, and t-test for change in EDSS score.
The analyses were adjusted for number of relapses during the previous two years, baseline EDSS score, and duration of disease from symptom onset.
The analyses were based on 56 AZA and 50 IFN patients respectively, because of some missing values.
A confirmed disability progression was defined as an increase of no less than one point of the EDSS score confirmed at least after six months; 95% CI were estimated through the exact method. All the patients, with the exception of two (who did not report a disability progression), had a baseline EDSS score between 1 and 5.
Adjusted for baseline EDSS score.