. 2023 Oct 13;13(12):2951–2991. doi: 10.1007/s13555-023-01044-5

Table 7.

Summary of category 2 azathioprine 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
Vañó-Galván et al. [46]	Non-randomized	AU	N = 14	Azathioprine 2.5 mg/kg/d for 1–36 Mth	Mean 24.5 Mth (range 8–72)	Complete response: regrowth on ≥ 75% of scalp Partial response: regrowth on < 75% of scalp Persistent response: > 75% of regrowth > 6 Mth after EOT	NR FU: Mean 18 Mth (range 6–30)	Regrowth on ≥ 75% of scalp: 6/14 (43%) Regrowth on < 75% of scalp: 0/14 Persistent response: 4/14 (29%)	AEs: elevated liver enzymes, pancreatitis (serious), bone marrow suppression (serious), diarrhea Treatment discontinuations: n = 4

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

Vañó-Galván et al. [46]

Non-randomized

N = 14

Azathioprine 2.5 mg/kg/d for 1–36 Mth

Mean 24.5 Mth (range 8–72)

Complete response: regrowth on ≥ 75% of scalp

Partial response: regrowth on < 75% of scalp

Persistent response: > 75% of regrowth > 6 Mth after EOT

FU: Mean 18 Mth (range 6–30)

Regrowth on ≥ 75% of scalp: 6/14 (43%)

Regrowth on < 75% of scalp: 0/14

Persistent response: 4/14 (29%)

AEs: elevated liver enzymes, pancreatitis (serious), bone marrow suppression (serious), diarrhea

Treatment discontinuations: n = 4

^†Including primary hair regrowth endpoint (where specified); other hair regrowth endpoints focus on SALT₅₀ and eyebrow and eyelash regrowth and relapse, where reported

AE adverse event, AU alopecia universalis, d day, Mth month, FU follow-up period, N total number of patients, n = number of patients in the category, PBO placebo, RCT randomized controlled trial, SLR systematic literature review, Yr year(s)