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Table 1 Clinical efficacy measures over 2 years in intention-to-treat (ITT) analysis and per-protocol (PP) analysis

From: Comparison of the impact of Tripterygium wilfordii Hook F and Methotrexate treatment on radiological progression in active rheumatoid arthritis: 2-year follow up of a randomized, non-blinded, controlled study

Variables Year 2
ITT PP
MTX (n = 69) TwFH (n = 69) TwFH vs MTX TwFH + MTX (n = 69) TwFH + MTX vs MTX MTX (n = 14) TwFH (n = 11) TwFH vs MTX TwFH + MTX (n = 22) TwFH + MTX vs MTX
ACR20 response, n (%) 38 (55.0%) 51 (73.9%) p < 0.001 50 (72.5%) p = 0.034 8 (57.1%) 10 (90.9%) p < 0.001 14 (63.6%) p = 0.163
ACR50 response, n (%) 32 (46.4%) 40 (58.0%) p = 0.005 35 (50.7%) p = 0.609 7 (50.0%) 8 (72.7%) p < 0.001 11 (50.0%) p = 0.312
ACR70 response, n (%) 15 (21.7%) 24 (34.8%) p = 0.001 20 (29.0%) p = 0.328 4 (28.6%) 4 (36.4%) p = 0.013 7 (31.8%) p = 0.346
cDAI response, n (%) 39 (56.5%) 50 (72.5%) p = 0.001 37 (53.6%) p = 0.732 8 (57.1%) 9 (81.8%) p < 0.001 15 (68.2%) p = 0.110
EULAR good response, n (%) 16 (23.2%) 33 (47.8%) p < 0.001 28 (40.6%) p = 0.028 5 (35.7%) 7 (63.6%) p < 0.001 9 (40.9%) p = 0.259
EULAR good to moderate response, n (%) 50 (72.5%) 57 (82.6%) p = 0.002 59 (85.5%) p = 0.060 12 (85.7%) 10 (90.9%) p = 0.003 21 (95.5%) p = 0.072
DAS28 remission, n (%) 12 (17.4%) 30 (43.5%) p < 0.001 24 (34.8%) p = 0.020 4 (28.6%) 7 (63.6%) p < 0.001 7 (31.8%) p = 0.346
DAS28 remission and LDA, n (%) 18 (26.1%) 33 (47.8%) p < 0.001 28 (40.6%) p = 0.071 5 (35.7%) 7 (63.6%) p < 0.001 8 (36.4%) p = 0.784
  1. MTX methotrexate, TwHF Tripterygium wilfordii Hook F, ACR American College of Rheumatology, cDAI clinical Disease Activity Index, EULAR European League Against Rheumatism, DAS28 28-joint count Disease Activity Score, LDA low disease activity
  2. The number within each bracket represents the patients who reached the response criteria in each group. The percentage of response was calculated with the denominator of total enrolled patients (69 for each group) in the ITT analysis or patients who finished the originally allocated treatment in the PP analysis (14, 11 and 22 for the MTX, the TwHF and the combination groups, respectively). In the ITT analysis, those patients who withdrew from the trial prematurely or switched to the combination group were classed as missing data, which were calculated using the last observation carried forward imputation method when performing the ITT analysis
  3. The p values for comparison between the MTX group and the TwHF group were calculated using the non-inferiority test. Comparison of the combination treatment and MTX monotherapy was calculated using the χ2 test