Figure 1.
Flow-chart: patient allocation and follow-up.
Abbreviations: AZA, azathioprine; IFN, interferon; ITT, intention to treat; PP, per-protocol. 1One missing CRF at month 12.
Table 1.
Baseline characteristics of the patients.
Figure 2.
Primary clinical outcome over 2 years: non-inferiority of effect of AZA vs. IFN, represented as annualized relapse rate ratio (RRAZA/IFN) compared with the pre-established non-inferiority margin M ( = 1.23) and with a margin M1 = 1.0.
One-sided 99% CI of the 0.67 ratio (upper-limit, UL = 1.12), represents an effect of AZA vs. IFNs equivalent to at least 75% of the effect of IFNs vs. Placebo. One-sided 95% CI of the same ratio (UL = 0.96), represents an effect of AZA vs. IFNs equivalent to at least 100% of the effect of IFNs vs. Placebo. Abbreviations: AZA, azathioprine; IFN, interferon; PY, person-years; RR, rate ratio.
Figure 3.
Beneath the plot patients at risk and number of events (in brackets) by treatment were reported for each interval of 6 months. Abbreviations: AZA, azathioprine; IFN, interferon.
Table 2.
Secondary clinical outcomes.
Figure 4.
Non-inferiority of the effect AZA vs. IFN on new T2 lesions over 2 years.
One-sided 99% CI (upper-limit, UL = 1.63), and one-sided 95% CI (UL = 1.45), of the effect of AZA vs. IFNs as for annualized new T2 lesion rate ratio (RRAZA/IFN), compared with the pre-established non-inferiority margin (M = 1.84), representing an effect of AZA vs. IFNs equivalent to the 73% of the effect of IFNs vs placebo. Abbreviations: AZA, azathioprine; IFN, interferon; PY, person-years; RR, rate ratio.
Table 3.
MRI outcomes. New brain lesions.
Table 4.
Adverse Events.