Table 6.
Summary of category 2 methotrexate studies included in the SLR
| Study | Study type | Baseline severity | Sample size (completers) | Treatments | Duration of disease | Response assessment(s)† | Response assessment period | Main efficacy findings | Tolerability/safety |
|---|---|---|---|---|---|---|---|---|---|
| Category 2: non-randomized trials, observational studies, RCT without PBO | |||||||||
| Alsufyani et al. [41] | Retrospective | AA: multifocal, AT, AU, diffuse |
N = 28 Multifocal: n = 14 AT: n = 2 AU: n = 9 Diffuse: n = 3 |
MTX (10–25 mg per Wk) N = 9 MTX (10–25 mg per Wk) + systemic CS: 20–30 mg/d N = 19 |
Median 5 Yr (range 0.4–42) |
Hair regrowth: 0–25% regrowth 26–50% regrowth 51–75% regrowth 76–99% regrowth 100% regrowth |
NR FU: to 3–51 Mth |
MTX alone > 50% regrowth: 4/9 (44%) 100%: 1/9 (11%) MTX + CS > 50% regrowth: 15/19 (79%) 100%: 5/19 (26%) Relapse: 7/19 (37%) with > 50% regrowth |
AEs: nausea, epigastric pain, diarrhea, leucopenia, transaminase activity elevations |
| Asilian et al. [42] | RCT without PBO control |
Severe AA: Baseline SALT 100% |
N = 36 |
MTX (15 mg QW) N = 12 BM (3 mg/d, QW) N = 12 MTX + BM N = 12 |
4.5–6.4 (units NR) | Improvement in SALT score |
EOT: 6 Mth FU + 3 Mth |
Mean SALT score (BL/9 Mth) MTX: 100%/78% BM: 100%/74% MTX + BM: 100%/57% |
AEs: gastrointestinal symptoms |
| English and Heinisch [43] | Retrospective | AA: > 50% scalp hair loss, AT, AU | N = 31 |
MTX (15 or 20 mg QW) ± Prednisone: 1 mg/kg/d, 21 d |
NR | % Hair regrowth | Average 12 Mth |
Cosmetically acceptable hair regrowth: 8/31 (26%) Relapse mean 2.3 Mth after EOT: 7/8 (88%) |
NR |
| Firooz and Fouladi [44] | Non-randomized | Severe AA‡, AU, ophiasis |
N = 10 AU: n = 9 Ophiasis: n = 1 |
MTX (5 or 10 mg QW) + Prednisolone 0.5 mg/kg/d |
Mean 8.1 Yr (range 0.5–15) |
Grade 1: regrowth of vellus hair Grade 2: regrowth of sparse pigmented terminal hair Grade 3: regrowth of terminal hair with patches of alopecia Grade 4: regrowth of terminal hair on scalp (success) |
NR FU: to mean 14.4 Mth (4–32) |
Grade 3: 2/10 (20%) Grade 4 (success): 8/10 (80%) Relapse: 4/8 (50%) |
AEs: acne, herpes, anemia, hypertension, weight gain, amenorrhea, muscle cramp |
| Joly et al. [45] | Retrospective | AT, AU | N = 22 |
MTX (15, 20, or 25 mg QW) for 9–18 Mth (N = 6) MTX (15, 20, or 25 mg QW) + PN (10 or 20 mg/d) for 9–18 Mth (N = 16) |
Mean 11.1 Yr (range 1–33) | Complete hair regrowth (total regrowth of terminal hair during treatment) |
NR FU: median EOT + 15 Mth (range 6–72) |
Complete hair regrowth MTX: 3/6 (50%) MTX + CS: 11/16 (69%) Relapse: 8/14 (57%) |
AEs: transient transaminase activity elevations, persistent nausea No severe AEs |
All drugs administered orally unless otherwise mentioned
AA, alopecia areata, AE, adverse event, AT, alopecia totalis, AU, alopecia universalis, BL, baseline, BM, betamethasone, CS, corticosteroid, d, day(s), EOT, end of therapy, FU, follow-up period, Mth, month(s), MTX, methotrexate, N, total number of patients, n = number of patients in the category, NR, not reported, PBO, placebo, QW, once a week, RCT, randomized controlled trial, SALT, severity of alopecia tool, SLR, systematic literature review; Wk, week(s), Yr, year(s)
†Including primary hair regrowth endpoint (where specified); other hair regrowth endpoints focus on SALT50 and eyebrow and eyelash regrowth and relapse, where reported
‡Definition of severity class not available