Table 2.
Treatment groups | |||||||||
---|---|---|---|---|---|---|---|---|---|
Steroids (L)+AZA | Steroids (L)+MMF | Steroids (L)+TAC | Steroids (L) | Steroids (H) | AZA | MMF | TAC | RTX | |
Clinical relapses | |||||||||
Patients with relapses, No. (%) | 60 (22.4) | 17 (27.0) | 14 (12.7) | 63 (44.4) | 39 (17.2) | 39 (37.5) | 13 (35.1) | 8 (12.5) | 3 (6.1) |
Person‐years | 693.78 | 160.72 | 343.86 | 273.53 | 546.85 | 223.31 | 101.78 | 136.88 | 149.65 |
HR, crude (95% CI) | ‐ | 1.22 (0.71‐2.09) | 0.47 (0.26‐0.85) | 2.69 (1.89‐3.84) | 0.83 (0.56‐1.24) | 2.05 (1.37‐3.08) | 1.49 (0.82‐2.72) | 0.68 (0.33‐1.43) | 0.23 (0.07‐0.74) |
P value | .4741 | .0114 | <.0001 | .3662 | .0005 | .1910 | .3113 | .0137 | |
HR, adjusted (95% CI) | ‐ | 1.19 (0.69‐2.05) | 0.45 (0.25‐0.81) | 2.78 (1.94‐3.99) | 0.85 (0.57‐1.28) | 2.14 (1.42‐3.23) | 1.75 (0.95‐3.23) | 0.69 (0.33‐1.45) | 0.27 (0.08‐0.86) |
P value | .5297 | .0077* | <.0001* | .4390 | .0003* | .0745 | .3265 | .0268* | |
Thymoma (A, AB, B1 type) and no thymoma | |||||||||
Patients with relapses, No. (%) | 30 (18.2) | 12 (25.5) | 10 (11.5) | 44 (45.8) | 32 (17.5) | 32 (39.0) | 8 (28.6) | 6 (12.5) | 1 (3.3) |
HR, crude (95% CI) | ‐ | 1.29 (0.66‐2.52) | 0.51 (0.25‐1.04) | 3.47 (2.18‐5.53) | 1.00 (0.61‐1.65) | 2.46 (1.49‐4.05) | 1.31 (0.60‐2.85) | 0.84 (0.35‐2.01) | 0.16 (0.02‐1.15) |
P value | .4576 | .0631 | <.0001 | .9989 | .0004 | .5033 | .6887 | .0689 | |
HR, adjusted (95% CI) | ‐ | 1.25 (0.63‐2.46) | 0.50 (0.24‐1.02) | 3.55 (2.22‐5.67) | 0.99 (0.60‐1.64) | 2.48 (1.49‐4.10) | 1.44 (0.65‐3.17) | 0.80 (0.33‐1.95) | 0.17 (0.02‐1.24) |
P value | .5205 | .0573 | <.0001* | .9771 | .0004* | .3705 | .6269 | .0806 | |
Thymoma (B2, B3, C type) | |||||||||
Patients with relapses, No. (%) | 30 (29.1) | 5 (31.2) | 4 (17.4) | 19 (41.3) | 7 (15.9) | 7 (31.8) | 5 (55.6) | 2 (12.5) | 2 (10.5) |
HR Crude (95% CI) | ‐ | 1.46 (0.56‐3.79) | 0.52 (0.18‐1.49) | 1.85 (1.04‐3.30) | 0.65 (0.28‐1.47) | 1.68 (0.73‐3.87) | 3.04 (1.17‐7.90) | 0.52 (0.13‐2.20) | 0.31 (0.07‐1.29) |
P value | .4344 | .2245 | .0361 | .2975 | .2209 | .0224 | .3772 | .1073 | |
HR adjusted (95% CI) | ‐ | 1.60 (0.60‐4.22) | 0.44 (0.15‐1.27) | 1.93 (1.05‐3.54) | 0.71 (0.30‐1.64) | 1.99 (0.85‐4.66) | 4.32 (1.58‐11.80) | 0.67 (0.16‐2.87) | 0.42 (0.10‐1.84) |
P value | .3472 | .1272 | .0347* | .4162 | .1137 | .0044* | .5929 | .2499 | |
Drug discontinuation | |||||||||
Patients who discontinued therapy, No. (%) | 89 (33.2) | 31 (49.2) | 26 (23.6) | 79 (55.6) | 108 (47.6) | 56 (54.8) | 22 (59.5) | 24 (37.5) | 10 (20.4) |
Median drug survival time, yr | 5.41 | 3.50 | 3.13 | 2.27 | 3.87 | 2.55 | 3.55 | 3.82 | 5.19 |
HR, crude (95% CI) | ‐ | 1.51 (1.01‐2.28) | 0.58 (0.37‐0.89) | 2.27 (1.67‐3.08) | 1.42 (1.07‐1.90) | 2.20 (1.57‐3.06) | 1.73 (1.08‐2.75) | 1.45 (0.92‐2.27) | 0.53 (0.28‐1.02) |
P value | .0467 | .0134 | <.0001 | .0164 | <.0001 | .0221 | .1094 | .0579 | |
HR, adjusted (95% CI) | ‐ | 1.53 (1.01‐2.31) | 0.56 (0.36‐0.87) | 2.27 (1.69‐3.13) | 1.44 (1.08‐1.93) | 2.25 (1.60‐3.14) | 1.91 (1.19‐3.08) | 1.48 (0.94‐2.33) | 0.58 (0.30‐1.13) |
P value | .0446* | .0101* | <.0001* | .0145* | <.0001* | .0079* | .0950 | .1105 |
Abbreviations: AZA, azathioprine; HR, Hazard Ratio; MMF, mycophenolate mofetil; RTX, rituximab; TAC, tacrolimus.
Indicates significance (P < .05) compared to patients on lower‐dose steroids in combination with azathioprine.