Table 1.

Defining highly active disease.

Consensus recommendation	Strength of recommendation‡	Level of consensus¶
Q1a. What patient baseline characteristics and activity metrics indicate highly active disease: • If patients are treatment naïve? (Level of evidence: moderate)
Clinicians should consider the following activity metrics that may indicate highly active disease in a treatment naïve patient: • 1 prior clinical relapse in the last year AND evidence of subclinical MRI activity (Gd+ or new or enlarging T2 lesions) in a patient with poor prognostic factors (clinical, MRI or biomarker) OR • 2 or more clinical relapses in the last year, with or without MRI activity	8 (7.8)	88.2% (30/34)
Q1b. What patient activity metrics indicate highly active disease and suitability for high-efficacy treatment or escalation therapy: • If patients have had an appropriate course of a DMD? (Level of evidence: moderate)
Clinicians should consider the following activity metrics that may indicate highly active disease, and suitability for high-efficacy treatment or escalation therapy, in a patient who has had an appropriate course of another DMD:* • 1 prior clinical relapse in the last year with subclinical MRI activity (Gd+ or new or enlarging T2 lesions) OR • 2 prior clinical relapses in the last year without MRI activity OR • ⩾1 Gd+ lesions or ⩾ 2 new or enlarging T2 lesions in the last 12 months	8 (7.8)	88.2% (30/34)
*A new baseline MRI scan should be taken into consideration. The timing of the re-baseline scan may vary depending on the treatment.18,19

^‡Median score on a 1–9 scale (mean score in brackets).

^¶Percentage of votes with 7–9 on a 9-point scale.

DMD, disease modifying drug; Gd+, presence of gadolinium; MRI, magnetic resonance imaging.