Table 5.
Reasons for discontinuation of first-line treatment (cases where the drug was discontinued are shown; multi-answer question)
| Total, n (%) |
Interferon β-1b | Interferon β-1a | Glatiramer acetate | Dimethyl fumarate | Peginterferon β-1a | |
|---|---|---|---|---|---|---|
| Treatment failure* (total or partial) | 10 (62.5) | 3 | 2 | 2 | 2 | 1 |
| SPMS conversion | 3 (18.8) | 2 | 0 | 0 | 1 | 0 |
| Pregnancy/planned pregnancy/breastfeeding | 1 (6.3) | 0 | 0 | 0 | 1 | 0 |
| Clinically significant skin lesions | 1 (6.3) | 1 | 0 | 0 | 0 | 0 |
| Other reasons (different from SmPC) | 2 (12.5) | 0 | 0 | 1 | 1 | 0 |
| All terminated therapies | 16 (100)** | 5 | 2 | 3 | 5 | 1 |
SmPC – Summary of Product Characteristics, SPMS – secondary progressive multiple sclerosis
Total failure was defined as lack of response to a full 12-month course of first-line treatment: 1) at least two moderate relapses (increase of 1-2 EDSS points) or one severe relapse after 6 months of treatment (increase of > 2 EDSS points) and 2) new lesions on MRI performed after month 12 (> 1 Gd+ lesion or > 2 T2 lesions); the two conditions must be met simultaneously. Partial failure was defined as the occurrence of only one of the above criteria.
The total numbers/percentages of terminated therapies do not add up because in one case termination of therapy was due to two reasons.