Table 4 Patient-reported severity of adverse events associated with biologic therapies, subcutaneous methotrexate, and oral methotrexate
Severity of hair loss | ||||||||
Therapy, n (%) | N | No | Trivial | Mild | Moderate | Marked | Severe | So severe I had to stop |
Biologic therapies | 218 | 197 (90) | 2 (1) | 4 (2) | 12 (6) | 0 (0) | 3 (1) | 0 (0) |
SQ MTX | 49 | 32 (65) | 1 (2) | 9 (18) | 2 (4) | 5 (10) | 0 (0) | 0 (0) |
Oral MTX | 115 | 80 (70) | 2 (2) | 10 (9) | 8 (7) | 13 (11) | 2 (2) | 0 (0) |
P value for row mean score < 0.0001 | ||||||||
P value for row mean score differs (excluding “No” responses) = 0.37 | ||||||||
Severity of diarrhea | ||||||||
Therapy, n (%) | N | No | Trivial | Mild | Moderate | Marked | Severe | So severe I had to stop |
Biologic therapies | 218 | 210 (96) | 1 (.5) | 1 (.5) | 3 (1.5) | 1 (.5) | 2 (1) | 0 (0) |
SQ MTX | 49 | 43 (88) | 0 | 3 (6) | 0 (0) | 2 (4) | 1 (2) | 0 (0) |
Oral MTX | 115 | 89 (77) | 2 (2) | 9 (8) | 11 (10) | 1 (1) | 3 (2) | 0 (0) |
P value for row mean score < 0.0001 | ||||||||
P value for row mean score differs (excluding “No” responses) = 0.50 | ||||||||
Severity of vomiting | ||||||||
Therapy, n (%) | N | No | Trivial | Mild | Moderate | Marked | Severe | So severe I had to stop |
Biologic therapies | 218 | 210 (96) | 0 | 5 (2) | 1 (.5) | 1 (.5) | 1 (.5) | 0 (0) |
SQ MTX | 49 | 45 (91) | 2 (4) | 1 (2) | 0 | 1 (2) | 0 (0) | 0 (0) |
Oral MTX | 115 | 107 (93) | 1 (1) | 2 (1) | 4 (4) | 1 (1) | 0 (0) | 0 (0) |
P value for row mean score = 0.63 | ||||||||
P value for row mean score differs (excluding “No” responses) = 0.15 | ||||||||
Severity of nausea | ||||||||
Therapy, n (%) | N | No | Trivial | Mild | Moderate | Marked | Severe | So severe I had to stop |
Biologic therapies | 218 | 190 (87) | 0 (0) | 7 (3) | 11 (5) | 6 (3) | 2 (1) | 2 (1) |
SQ MTX | 49 | 22 (45) | 0 (0) | 7 (14) | 11 (22) | 4 (8) | 3 (6) | 2 (4) |
Oral MTX | 115 | 76 (66) | 12 (10) | 17 (15) | 10 (9) | 0 (0) | 0 (0) | 0 (0) |
P value for row mean score < 0.0001 | ||||||||
P value for row mean score differs (excluding “No” responses) = 0.21 | ||||||||
Severity of other stomach problems | ||||||||
Therapy, n (%) | N | No | Trivial | Mild | Moderate | Marked | Severe | So severe I had to stop |
Biologic therapies | 218 | 204 (94) | 0 (0) | 3 (1) | 4 (2) | 5 (2) | 2 (1) | 0 (0) |
SQ MTX | 49 | 46 (94) | 0 (0) | 1 (2) | 0 | 0 | 2 (4) | 0 (0) |
Oral MTX | 115 | 108 (94) | 0 (0) | 1 (1) | 5 (4) | 0 | 1 (1) | 0 (0) |
P value for row mean score = 0.87 | ||||||||
P value for row mean score differs (excluding “No” responses) = 0.50 | ||||||||
Severity of fatigue | ||||||||
Therapy, n (%) | N | No | Trivial | Mild | Moderate | Marked | Severe | So severe I had to stop |
Biologic therapies | 218 | 170 (78) | 1 (.5) | 5 (2) | 17 (8) | 10 (4.5) | 13 (6) | 2 (1) |
SQ MTX | 49 | 13 (27) | 0 | 4 (8) | 16 (33) | 5 (10) | 10 (20) | 1 (2) |
Oral MTX | 115 | 51 (44) | 0 | 5 (4) | 25 (22) | 23 (20) | 10 (9) | 1 (1) |
P value for row mean score = <0.0001 | ||||||||
P value for row mean score differs (excluding “No” responses) = 0.90 | ||||||||
Severity of malaise | ||||||||
Therapy, n (%) | N | No | Trivial | Mild | Moderate | Marked | Severe | So severe I had to stop |
Biologic therapies | 218 | 187 (86) | 2 (1) | 3 (1) | 13 (6) | 9 (4) | 3 (1) | 1 (1) |
SQ MTX | 49 | 26 (53) | 1 (2) | 4 (8) | 12 (24) | 5 (10) | 1 (2) | 0 (0) |
Oral MTX | 115 | 77 (67) | 0 | 12 (10) | 20 (17) | 5 (4) | 1 (1) | 0 (0) |
P value for row mean score = <0.0001 | ||||||||
P value for row mean score differs (excluding “No” responses) = 0.09 | ||||||||
Severity of mental fog | ||||||||
Therapy, n (%) | N | No | Trivial | Mild | Moderate | Marked | Severe | So severe I had to stop |
Biologic therapies | 218 | 185 (85) | 0 | 7 (3) | 15 (7) | 7 (3) | 2 (1) | 2 (1) |
SQ MTX | 49 | 31 (63) | 0 | 4 (8) | 11 (22) | 3 (6) | 0 | 0 (0) |
Oral MTX | 115 | 82 (71) | 2 (2) | 15 (13) | 9 (8) | 6 (5) | 1 (1) | 0 (0) |
P value for row mean score = 0.01 | ||||||||
P value for row mean score differs (excluding “No” responses) = 0.03 | ||||||||
Severity of infection | ||||||||
Therapy, n (%) | N | No | Trivial | Mild | Moderate | Marked | Severe | So severe I had to stop |
Biologic therapies | 218 | 195 (95) | 0 (0) | 3 (1) | 8 (1) | 3 (1) | 5 (2) | 4 (2) |
SQ MTX | 49 | 45 (92) | 0 (0) | 1 (2) | 2 (4) | 1 (2) | 0 (0) | 0 (0) |
Oral MTX | 115 | 110 (96) | 0 (0) | 1 (1) | 3 (2) | 1 (1) | 0 (0) | 0 (0) |
P value for row mean score = 0.06 | ||||||||
P value for row mean score differs (excluding “No” responses) = 0.16 | ||||||||