Table 3. Six-Month Adverse Events From a Randomized Clinical Trial Comparing Methotrexate and Mycophenolate Mofetil for Noninfectious Uveitis.
| Event Typea | No. (%) of Patients Reporting ≥1 Adverse Event | |
|---|---|---|
| Methotrexate (n = 107) |
Mycophenolate Mofetil (n = 109)b |
|
| Nonserious ocular | ||
| Ocular hypertension >24 mm Hg | 10 (9.3) | 13 (12.0) |
| Peripheral and/or central vitreous hemorrhage | 3 (2.8) | 3 (2.8) |
| Suspect or confirmed glaucoma diagnosis | 2 (1.9) | 2 (1.9) |
| Intraocular pressure <5 mm Hg without structural damage | 0 | 1 (0.9) |
| Visually significant cataract, surgery indicated | 5 (4.7) | 2 (1.9) |
| Decrease in vision or defective vision (self-reported) | 9 (8.4) | 19 (17.6) |
| Eye pain (self-reported) | 9 (8.4) | 4 (3.7) |
| Serious ocular | ||
| Glaucoma | 0 | 1 (0.9) |
| Retinal detachment | 1 (0.9) | 0 |
| Nonserious laboratory | ||
| Elevated ALT or AST (2 to 5 times upper limit of normal <28 d) | 14 (13.0) | 8 (7.4) |
| Low hemoglobin (>6.5 to <9 g/dL lasting <28 d) | 2 (1.9) | 3 (2.8) |
| Low leukocyte count (>1000 and <2500/μL lasting <28 d) | 3 (2.8) | 1 (0.9) |
| Elevated creatinine (>1.5 to <2 mg/dL lasting <28 d) | 1 (0.9) | 0 |
| Serious laboratory | ||
| Extremely elevated ALT or AST (>5 times the upper limit of normal or 2 to 5 times the upper limit of normal ≥28 d)c | 3 (2.8) | 2 (1.9) |
| Nonserious systemic | ||
| Fatigue | 62 (57.9) | 59 (54.6) |
| Headache | 55 (51.4) | 45 (41.7) |
| Mood changes (self-reported, not requiring therapy) | 33 (30.8) | 26 (24.1) |
| Hair loss | 6 (5.6) | 2 (1.9) |
| Nausea | 42 (39.3) | 30 (27.8) |
| Muscle weakness, no decrease in function | 32 (29.9) | 26 (24.1) |
| Numbness or tingling | 25 (23.4) | 18 (16.7) |
| Diarrhea | 25 (23.4) | 24 (22.2) |
| Dyspnea | 21 (19.6) | 22 (20.4) |
| Vomiting | 26 (24.3) | 24 (22.2) |
| Allergic reaction | 14 (13.1) | 11 (10.2) |
| Fever <39°C for 12 h | 11 (10.3) | 18 (16.7) |
| Mild congestive heart failure or arrhythmia not requiring therapy | 4 (3.7) | 2 (1.9) |
| Systemic infection | 25 (23.4) | 27 (25.0) |
| Other systemic (no treatment required) | 65 (60.7) | 63 (58.3) |
| Serious systemic | ||
| Death | 1 (0.9) | 0 |
| Diarrhea | 0 | 1 (0.9) |
| Disability or permanent damage | 1 (0.9) | 0 |
| Hospitalization | 2 (1.9) | 2 (1.9) |
| Serious systemic infection | 0 | 1 (0.9) |
| Vomiting | 1 (0.9) | 0 |
| Other serious eventd | 3 (2.8) | 1 (0.9) |
Abbreviations: ALT, alanine aminotransferase; AST, aspartate aminotransferase.
SI conversion: for creatinine to μmol/L, multiply by 88.4.
a
Criteria for defining serious and nonserious adverse events are included in eTable 1 in Supplement 1.
b
One patient in the mycophenolate mofetil group never received mycophenolate mofetil due to medical contraindication discovered postrandomization.
c
All drug-related serious adverse events were due to extremely elevated ALT, AST, or both in some patients.
d
Indicates stroke, injury to finger, and lower limb pain within the methotrexate group and extreme flank pain within the mycophenolate mofetil group.