Table 4.
Systemic Treatments for AA With select studies, regimens and outcomes of interest.
| Medication | Highest level of evidence | Select dosing/ Frequency | Efficacy | Side effects |
|---|---|---|---|---|
| Minoxidil | LoE 2 retrospective study (n = 12 adults with tofacitinib) |
2.5 mg PO daily (F) 2.5 mg PO BID (Male) |
>75% SALT: 67% (combo with tofacitinib) |
Hypertrichosis 50% |
| Antihistamines |
LoE 2 1 RCT (fexofenadine) 3 clinical trials 3 retrospective reviews 2 case series 3 case reports |
Fexofenadine 60-120mg/day Ebastine 20 mg/da y Oxatamide 60 mg/day |
Hair regrowth Decreased erythema and pruritus |
Headache with fexofenadine (n = 2) Mild sedation with ebastine |
| Systemic Coticosteroids |
LoE 1 PULSE DOSING Any age: 41 studies (n = 1078) including 1 randomized placebo-controlled trial Children: 8 studies (n = 216) |
Dexamethasone 2.5-5mg x2days/wkMethylprednisolone 500 mg-1g x1-3 days/month Dexamethasone 1.5 mg/kg/day x1-3days/month Methylprednisolone 8-30mg/kg/day x1-3 days/month |
CR: 43% (466/1078) >50 regrowth:56% |
Total SEs: 21% (225/1078) Acne: 0.01% (3/216) GI discomfort (7/216) Headache: 8/216 Cushings: 0.01% (2/216) Allergic reaction |
| Methotrexate | LoE 1 Adults: 11 studies (n = 361) Children: At least 6 studies (n = 68) |
Adults: 15-25mg/week Children: 7.5-25mg/week (0.2, 0.4mg/kg/week) |
Complete response: 45.7% (165/361)Good/complete response: 70.3% (154/219) Good/complete response:50% (34/68) |
Total AEs: 24.2% (64/319) (Gastrointestinal symptoms, liver and hematologic abnormalities, all < 5%) Total AEs: 14.5% (6/44) |
| Cyclosporine | 14 studies (n = 340) | Cyclosporine monotherapy: 5-6mg/kg/day Cyclosporine with systemic steroid: 2-4mg/kg/day |
Response rate at end of treatment: CsA alone: 69.41%; (0 to 80%) CsA with steroid: 57.02% (6.67 to 100%) |
Overall AEs: 36.8% (125/340) Gastrointestinal: n≥28 Hypertrichosis: n≥20 Hypertension: n≥9 Dyslipidemia: n≥8 Headache: n≥7 |
| Azathioprine | LoE 1 Open-label pilot study (n = 20) Open-label, randomized comparative study (n = 50) |
Azathioprine 2 mg/kg/day Azathioprine (Aza) 300 mg weekly vs Betamethasone (BM) 5 mg/dy x 2 days/wk |
6 months: SALT < 25%: 50% 4 months: Change in SALT: Aza: 9.5 (0-13.5) BM: 14 (4-19) |
Transaminitis: 5% (n = 1) Leukopenia: 15% (n = 3) Nausea/Vomiting: 5% (n-1) Aza: nausea: 35% BM: facial puffiness: 76.2% wt gain 33%, GERD 24%, Acne 24%, striae 9.5% |
| Dupilumab (IL4/13 inhibitor) |
LoE 1 Randomized double blind placebo-controlled trial (n = 40) |
300 mg subcutaneous once weekly | Week 24 SALT £30: Dupilumab: 17.5% Placebo: 10% |
Week 24: Injection site reaction: 5% Conjunctivitis: 7.5% URTI: 5% |
| Tofacitinib (JAK1/3 inhibitor) |
LoE 2 Open label comparative study, Case series |
5 mg PO BID | Month 6 SALT50: 78.4% |
URTI 8.1% Folliculitis 10.8% Headache: 5.4% wt gain: 5.4% Triglyceride increase 5.4% |
| Baricitinib (JAK1/2 inhibitor) |
LoE 1 2 randomized placebo-controlled phase 3 trials (n = 654 + 546) |
2 or 4 mg PO daily | Week 36 SALT ≤20: 4 mg: 38.8% 2 mg: 22.8% Placebo: 6.2% |
Acne: 4.7%,5.8% Zoster: 0.9%, 1.9% HSV: 0%, 3.9% CK increase: 0%, 5.7% LDL increase: 20.5%, 30.3% |
| Beprocitinib (TYK2, JAK1/2 inhibitor) |
LoE 1 Phase 2 a RCT (n = 47) |
60 mg PO daily x 4 wks then 30 mg daily x 20 weeks | Week 24 SALT 50: 53.2% |
URTI/Nasopharyngitis 32% Acne 11% Headache 9% *Rhabdomyolysis in 2/47 |
| Ruxolitinib (JAK1/2 inhibitor) |
LoE 2 Open label comparative study |
2 ng PO BID | Month 6 SALT50: 84.2% |
Urinary tract infection 13.2% Headache 5.3% Folliculitis 2.6% wt gain 2.6% AST/ALT increase 7.9% |
| Deuroxolitinib (deuterated ruxolitinib) |
LoE 2 Phase 2 clinical trial in adults (n = 140) |
4 mg PO BID or 8mg PO BID or 12mg PO BID |
Week 24 SALT ≤50% 12 mg: 58% 8 mg: 47% 4 mg: 21% Placebo: 9% |
Acne: 13.48-16.7% Headache: 17.2- 19.4% CK increase: 10.3%, 5.3%, 2.8% LDL increase: 0, 10.5%, 0 |
| Ritlecitinib (JAK3 inhibitor) |
LoE 1 Phase 2 a RCT(n = 48) |
200 mg PO daily x 4 wks then 50 mg daily x 20 weeks | Week 24 SALT 50: 39.6% |
URTI/Nasopharyngitis 21% Acne 10% Headache 13% Folliculitis 6% |
Abbreviations: CR, complete regrowth; PR, good/moderate regrowth.
Levels of Evidence (LoE):
Level 1 (systematic review of randomized controlled trials [RCTs] or high-quality randomized controlled trial)
Level 2 (lesser quality RCT or prospective cohort study)
level 3 (case-control study, non-randomized controlled cohort or follow-up study)
Level 4 (case series), or level 5 (expert opinion, mechanism-based reasoning).