Table 1.
Baseline characteristics of the study population are shown for the intention-to-treat population, for rituximab-naïve patients and for patients with or without clinical response.
| Characteristic | All patients (n = 40) | Rituximab-naïvea (n = 25) | Respondersb (n = 22) | Non-respondersc (n = 18) |
|---|---|---|---|---|
| Female, n (%) | 31 (77.5) | 18 (72.0) | 18 (81.8) | 13 (72.2) |
| Male, n (%) | 9 (22.5) | 7 (28.0) | 4 (18.2) | 5 (27.8) |
| Age, female pts, mean (min–max) | 43.0 (25.0–61.1) | 41.5 (26.6–54.6) | 41.8 (25.0–60.3) | 44.6 (26.6–61.1) |
| Age, male pts, mean (min–max) | 37.6 (21.5–53.3) | 35.1 (21.5–50.8) | 39.5 (21.5–53.3) | 36.0 (23.4–50.8) |
| BMI female ptsd, mean (min–max) | 24.5 (17.1–33.1) | 24.6 (17.1–33.1) | 24.1 (17.1–32.7) | 24.9 (19.0–33.1) |
| BMI male ptsd, mean (min–max) | 24.5 (17.4–30.6) | 23.4 (17.4–29.2) | 25.9 (17.4–30.6) | 23.4 (21.1–26.9) |
| Rituximab-naïvea, n (%) | 25 (62.5) | 25 (100.0) | 14 (63.6) | 12 (66.7) |
| Previous rituximab treatmente, n (%) | 15 (37.5) | 0 | 9 (40.9) | 6 (33.3) |
| ME/CFS disease duration | ||||
| 2–5 years, n (%) | 7 (17.5) | 7 (28.0) | 5 (22.7) | 2 (11.1) |
| 5–10 years, n (%) | 13 (32.5) | 7 (28.0) | 5 (22.7) | 8 (44.4) |
| 10–15 years, n (%) | 9 (22.5) | 4 (16.0) | 6 (27.3) | 3 (16.7) |
| >15 years | 11 (27.5) | 7 (28.0) | 6 (27.3) | 5 (27.8) |
| ME/CFS disease severity | ||||
| Mild/Moderate, n (%) | 14 (35.0) | 10 (40.0) | 9 (40.9) | 5 (27.8) |
| Moderate, n (%) | 13 (32.5) | 7 (28.0) | 9 (40.9) | 4 (22.2) |
| Moderate/severe, n (%) | 7 (17.5) | 5 (20.0) | 4 (18.2) | 3 (16.7) |
| Severef, n (%) | 6 (15.0) | 3 (12.0) | 0 | 6 (33.3) |
| Infection prior to ME/CFSg, n (%) | 26 (65.0) | 17 (68.0) | 15 (68.2) | 11 (61.1) |
| SF36 Physical Functionh, mean (min–max) | 33.0 (0–65) | 34.0 (0–65) | 35.0 (10–65) | 30.6 (0–65) |
| SF36 Physical component summary scorexi, mean (min–max) | 23.3 (13.5–41.6) | 24.5 (14.6–41.6) | 23.1 (13.5–41.6) | 23.5 (14.6–31.0) |
| Steps, mean per 24 h, mean (min–max) | 3,199 (568–9,637) | 3,282 (568–9,637) | 3,622 (1,083–8,178) | 2,681 (568–9,637) |
| Total function levelj, mean (min–max) | 16.9 (5–40) | 17.0 (5–30) | 19.3 (10–40) | 14.1 (5–25) |
| HLA-DQB1*03:03 pos, n (%)k | 10 (25.0) | 6 (24.0) | 9 (40.9) | 1 (5.6) |
| HLA-C *07:04 pos, n (%) | 4 (10.0) | 2 (8.0) | 3 (13.6) | 1 (5.6) |
| HLA-DQB1*03:03 and/or HLA-C*07:04 pos, n (%) | 12 (30.0) | 6 (24.0) | 10 (45.5) | 2 (11.1) |
Patients with no previous rituximab intervention.
Clinically significant responders, including 18 patients with long response duration (≥30 weeks), three with moderate response duration (14–28 weeks) and one with marginal response duration (6–12 weeks).
Patients with no clinically significant response.
Body Mass Index (kg/m2).
Patients treated with rituximab in previous trial (KTS-2-2010) n = 14, or outside a clinical trial (n = 1).
Two of six patients with severe ME/CFS withdrew from the study after four infusions.
Self-reported infection prior to onset of ME/CFS disease.
Short Form 36 (SF-36) physical function subscale (scale 0–100).
SF-36 Physical Health Summary Score, norm-based with population mean 50.
Baseline self-reported function level (scale 0–100%).
HLA-types determined as part of a larger study (30).