Table 3.
Summary of category 1 and 2 systemic corticosteroid 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 1: PBO-controlled RCT | |||||||||
| Kar et al. [18] | PBO-controlled RCT | Severe AA: ≥ 40% scalp hair loss or > 10 patches scattered over scalp and body |
N = 43 (N = 36) |
PN (200 mg QW) (PT) N = 23 PBO N = 20 |
PN: mean 3.1 Yr PBO: mean 2.8 Yr |
> 30% hair regrowth > 60% hair regrowth Relapse (hair loss > 20%) |
3 Mth FU: EOT + 3 Mth |
Hair regrowth > 30% PN: 8/20 (40%) PBO: 0/16 (0%) P < 0.03 Hair regrowth > 60% PN: 2/20 (10%) PBO: 0/16 (0%) Relapse PN: 2/8 (25%) |
AE rates: PN: 11/20 (55%) PBO: 2/16 (13%) P < 0.05 AEs: weakness, acne, weight gain, gastrointestinal symptoms, facial mooning, oligomenorrhea |
| Category 2: non-randomized trials, observational studies, RCT without PBO control | |||||||||
| Dehghan et al. [19] | Non-randomized | Severe AA: ≥ 30% of scalp hair loss or > 10 patches on scalp and body |
N = 40 (N = 35) |
PN (200 mg QW for 3 Mth) (PT) N = 20 MP (500 mg IV 3 × per Mth for 6 Mth) (PT) N = 20 |
PN; mean 3.3 Yr MP: mean 2.9 Yr |
31–60% hair regrowth > 60–90% hair regrowth 91–100% hair regrowth |
≤ 12 Mth |
6 Mth Hair regrowth 60–90% PN: 4 (22%) MP: 10 (59%) Hair regrowth 91–100% PN: 5 (28%) MP: 7 (41%) 12 Mth Hair regrowth 60–90% PN: 3 (17%) MP: 6 (35%) Hair regrowth 91–100% PN: 4 (22%) MP: 7 (41%) |
AEs: acne, heartburn, striae |
| Kurosawa et al. [20] | Retrospective | “Extensive” AA: single or multiple patches or AT/AU |
N = 91 AA: n = 51 AT/AU: n = 38 |
PN (80 mg/d for 3 days Q3M) (PT) N = 29 IM TA (40 mg 1 Q1M, then Q1.5 M for 1 Yr) N = 43 DM (0.5 mg/d for 6 Mth) N = 19 |
NR |
> 40% regrowth of terminal hair (response) Relapse (appearance of new patches or abnormal increase in hair loss) |
EOT FU: EOT: + ≥ 3 Mth |
Response rates in AA (patches) PN: 9/12 (75%) TA: 24/31 (77%) DM: 4/10 (40%) Response rates in AT/AU PN: 10/17 (59%) TA: 8/12 (67%) DM: 3/9 (33%) Relapse rates in AA (patches) PN: 3/12 (25%) TA: 10/31 (33%) DM: 5/10 (50%) Relapse rates in AT/AU PN: 8/17 (47%) TA: 9/12 (75%) DM: 9/9 (100%) |
AE rates: PN: 3/29 (10%) TA: 23/56 (41%) DM: 6/20 (30%) AEs: dysmenorrhea, abdominal discomfort, acne, weight gain, weakness, mooning |
| Vano-Galvan et al. [21] | Non-randomized | AT, AU |
N = 31 AT: n = 9 AU: n = 22 |
DM (0.1 mg/kg/d 2 × per Wk) (PT) N = 31 | NR |
Complete response: regrowth on ≥ 75% of scalp Partial response: regrowth on < 75% of scalp Persistent response: > 75% regrowth for ≥ 3 Mth after EOT |
4 Mth FU: EOT + 3 Mth |
Complete response: 22/31 (71%) Partial response: 3/31 (10%) Persistent response: 10/31 (32%) |
AE rate: 10/31 (32%) AEs: weight gain, Cushing syndrome, striae, irritability AE-related discontinuations: n = 1 |
| Yoshimasu et al. [22] | Non-randomized |
S1 (< 25% hair loss) S2 (25–49% hair loss); S3 (50–74% hair loss) S4 (75–99% hair loss); S5 (100% hair loss) |
N = 55 S1 & S2 for ≤ 6 Mth: n = 18 S1 & S2 for > 6 Mth: n = 2 S3 & S4 for ≤ 6 Mth: n = 18 S3 & S4 for > 6 Mth: n = 11 S5 for ≤ 6 Mth): n = 2 S5 for > 6 Mth:n = 4 |
MP (500 mg/d IV for 3 days Q1M for up to 3 courses) (PT) | Severity groups divided according to duration ≤ 6 vs. > 6 Mth |
Short-term FU response: any regrowth of vellus hair Long-term FU response: > 75% regrowth |
Short-term FU: EOT Long-term FU: EOT + 6 Mth |
Response rates S1 & S2 for ≤ 6/ > 6 Mth: 100%/100% (short-term FU) 100%/100% (long-term FU) S3 & S4 ≤ 6/ > 6 Mth: 83%/82% (short-term FU) 67%/73% (long-term FU) S5 (≤ 6/ > 6 Mth): 100%/0% (short-term FU) 50%/0% (long-term FU) |
AE rate: 20/55 (36%) AEs: myalgia/numbness, edema, stomach discomfort, infection, arthralgia, burning sensation |
All drugs administered orally unless otherwise mentioned
AA alopecia areata, AE adverse event, AT alopecia totalis, AU alopecia universalis, d day(s), DM dexamethasone, EOT end of therapy, FU follow-up period, IM intramuscularly, IV intravenously, MP methylprednisolone, Mth month(s), N total number of patients, n number of patients in the category, NR not reported, PBO placebo, PN prednisolone, PT pulse therapy, QxM every x months, QW once a week, RCT randomized controlled trial, SLR systematic literature review, TA triamcinolone acetate, 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