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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