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Table 5 Change criteria of DMD by the number of relapses and lesions by case scenarios

From: Insights on diagnosis and therapeutic decision-making patterns for multiple sclerosis treatment: cross-sectional opinion survey results from Japanese neurologists

Case scenario, questions and answers

Overall

(n = 205)

Sub-group by number of MS patients under care

P value

Group 1:

1–3 patients (n = 69)

Group 2:

4–9 patients (n = 58)

Group 3:

≥10 patients (n = 78)

Group comparison*

Trend test

Question 1: Assuming a patient is currently receiving treatment, what is the minimum number of clinical relapses over 6 months or 12 months that would prompt you to suggest a change in DMD?

 Number of relapses over 6 months, n (%)

  1 clinical relapse

120 (58.5)

38 (55.1)

34 (58.6)

48 (61.5)

0.799a

0.288b

0.684c

0.238

  2 clinical relapses

78 (38.0)

27 (39.1)

22 (37.9)

29 (37.2)

  3 clinical relapses

7 (3.4)

4 (5.8)

2 (3.4)

1 (1.3)

   ≥ 4 clinical relapses

0 (0.0)

0 (0.0)

0 (0.0)

0 (0.0)

 Number of relapses over 12 months, n (%)

  1 clinical relapse

56 (27.3)

13 (18.8)

21 (36.2)

22 (28.2)

0.175a

0.454b

0.731c

0.308

  2 clinical relapses

102 (49.8)

39 (56.5)

25 (43.1)

38 (48.7)

  3 clinical relapses

36 (17.6)

12 (17.4)

9 (15.5)

15 (19.2)

   ≥ 4 clinical relapses

11 (5.4)

5 (7.2)

3 (5.2)

3 (3.8)

Case 1: Assuming a patient with clinically stable RRMS has been receiving the same treatment for 2 years, and no changes in MRI were seen on scans after 1 year of therapy, but activity was seen on a routine MRI performed after 2 years of treatment.

Question 2: What is the lowest number of new T2 or Gd + lesions that would prompt you to suggest a change in DMD?

 Number of T2 lesions, n (%)

  1 T2 lesion

30 (14.6)

7 (11.9)

14 (28.0)

9 (13.2)

0.006a

0.985b

0.010c

0.987

  2 T2 lesions

67 (32.7)

27 (45.8)

10 (20.0)

30 (44.1)

  3–4 T2 lesions

68 (33.2)

23 (39.0)

19 (38.0)

26 (38.2)

   ≥ 5 T2 lesions

12 (5.9)

2 (3.4)

7 (14.0)

3 (4.4)

 Number of Gd + lesion, n (%)

  1 Gd + lesion

97 (47.3)

29 (45.3)

30 (58.8)

38 (52.8)

0.318a

0.471b

0.376c

0.267

  2 Gd + lesions

71 (34.6)

27 (42.2)

15 (29.4)

29 (40.3)

   ≥ 3 Gd + lesions

19 (9.3)

8 (12.5)

6 (11.8)

5 (6.9)

Case 2: Assuming a patient with clinically stable RRMS has been receiving the same treatment for 2 years, and no changes in MRI were seen on scans at 1 and 2 years.

Question 3: What is the lowest number of new T2 or Gd + lesions on a subsequent routine MRI that would prompt you to suggest a change in DMD?

 Number of T2 lesions, n (%)

  1 T2 lesion

23 (11.2)

5 (8.6)

11 (22.4)

7 (10.0)

0.118a

0.841b

0.205c

0.888

  2 T2 lesions

69 (33.7)

25 (43.1)

14 (28.6)

30 (42.9)

  3–4 T2 lesions

64 (31.2)

23 (39.7)

17 (34.7)

24 (34.3)

   ≥ 5 T2 lesions

21 (10.2)

5 (8.6)

7 (14.3)

9 (12.9)

 Number of Gd + lesion, n (%)

  1 Gd + lesion

95 (46.3)

27 (42.9)

29 (56.9)

39 (54.2)

0.224a

0.180b

0.927c

0.082

  2 Gd + lesions

63 (30.7)

22 (34.9)

16 (31.4)

25 (34.7)

   ≥ 3 Gd + lesions

28 (13.7)

14 (22.2)

6 (11.8)

8 (11.1)

  1. DMD disease-modifying drug, DMT disease-modifying therapy, MS multiple sclerosis, RRMS relapsing-remitting multiple sclerosis, MRI magnetic resonance imaging, Gd + gadolinium enhancement
  2. *Percentages were compared between two groups using the chi-square test, and the corresponding P values are indicated for the following comparisons: a: Group 1 vs. Group 2, b: Group 1 vs. Group 3, c: Group 2 vs. Group 3
  3. A trend across three groups was tested using the Cochrane-Mantel-Haenszel test
  4. In the actual question, the term DMT was used instead of DMD added supplementary explanation which means DMD