Fig 1.
Flow diagram of invited and included patients in the six-year follow-up study of the RituxME and CycloME trials.
Table 1.
Baseline data and data from six-year follow-up.
Table 2.
Baseline characteristics and outcome measures at 18 months, comparing participants and non-participants in the six-year follow-up study of the CycloME and RituxME trials.
Fig 2.
SF-36 Physical Function and Function level by trial and treatment.
(A) and (B) show SF-36 Physical Function (mean, 95% CI) from baseline, 18 months and six years in (A) the RituxME and CycloME trials and (B) both trials, with the RituxME trial divided into treatment categories; placebo and rituximab groups. (C) and (D) show self-reported Function level (%) (mean, 95% CI) from baseline, 18 months and six years in (C) the RituxME and CycloME trials and (D) both trials, with the RituxME trial divided into treatment categories; placebo and rituximab groups. All four analyses–(A), (B), (C) and (D)–were performed by General Linear Model repeated measures, adjusted for age, sex, study centre and baseline ME/CFS severity, with p-values for the interaction time-by-treatment group. The p-values for each timepoint 18 months or 6 years, as compared to baseline, are from the simple contrasts in the time domain, for the interaction term. The colours indicate treatment groups, described in the Figure. In panel (A) and (B) RituxME n = 111, due to one missing severity grade registration in the rituximab group. In panel (C) and (D) n = 108, due to missing data of severity in one patient in the rituximab group, and missing data for function level in three different patients at one timepoint.
Fig 3.
Percentages of patients with different SF-36 physical function scores at six years.
Percentages of patients with different levels of SF-36 Physical Function values at six years. The three columns represent the CycloME trial participants and the rituximab and placebo groups from the RituxME trial. The colours indicate treatment groups, described in the Figure.
Fig 4.
SF-36 Physical Function improvement and worsening, difference from baseline to 6 years.
Percentages of patients who have experienced various degrees of change in SF-36 Physical Function from baseline to 6 years. The three columns represent the CycloME trial participants and the rituximab and placebo groups from the RituxME trial. (A) shows improvement and (B) shows worsening. The colours indicate treatment groups, described in the Figure.
Fig 5.
SF-36 Physical Function by treatment group and different values of SF-36 at six years.
Fig 5 describes the individual courses of SF-36 Physical function, from baseline to 18 months and six years, by intervention group (1) CycloME, (2) RituxME rituximab group and (3) RituxME placebo group, and divided according to SF-36 PF score at six years; (A) more than 70, (B) between 40 and 70, (C) between 20 and 40, and (D) less than 20 points.
Table 3.
DePaul symptom questionnaire–short form.
Symptom scores in patients who did or did not comply with Canadian Criteria after six years.