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. 2021 Jun 25;14:691–714. doi: 10.2147/CCID.S309215

Table 3.

Clinical Research Studies of Ruxolitinib & Baricitinib in Alopecia Areata Treatment

Study Authors & Year Study Design Patient Info. (No./Sex/Age) Indication JAKi Used Outcome & F/U Data Adverse Effects
(Xing et al, 2014)12 Case series 3 patients; 2males and 1 female; ages not reported -AA Oral ruxolitinib (20mg BD x 3–6 months)

  • Near-complete regrowth occurred for all patients by 3–5 months, with earliest regrowth observed at 12 weeks.

  • None reported
(Higgins et al, 2015)59 Case report 1 patient; female; 28 years -AA & CMC Oral ruxolitinib (20mg BD x 6 months)

  • Full regrowth by 12 weeks, with earliest regrowth observed at 2 weeks; sustained 6 months after cessation of therapy.

  • Resolution of CMC symptoms

  • None reported
(Pieri et al, 2015)60 Case report 1 patient; female; 24 years -AU & ET Oral ruxolitinib (15mg BD x 10 months)

  • Full regrowth at 10 months; sustained >50 months after therapy

  • None reported
(Craiglow et al, 2016)61 Case report 1 patient; female; late teens -AU Topical 0.6% ruxolitinib (BD) x 3 months

  • 10% regrowth of scalp hair with near-complete regrowth of eyebrows at 12 weeks

  • None reported
(Harris et al, 2016)62 Case report 1 patient; male; 35 years -AA with vitiligo Oral ruxolitinib (20mg BD x 6 months)

  • 85% regrowth at 12 weeks, with initial regrowth observed at 4 weeks; near-complete regrowth at 20 weeks

  • Regrowth maintained 3 months after cessation of therapy

  • 51% repigmentation at 20 weeks; relapsed after drug cessation

  • None reported
(Mackay-Wiggan et al, 2016)63 Open-label, single-arm trial 12 patients; patient characteristics not reported -AA Oral ruxolitinib (20mg BD x 3–6 months)

  • 9 (75%) out of 12 patients responded with ≥50% regrowth at 12 weeks; 7 of 9 patients had >95% regrowth at 6 months

  • 3 patients did not respond

  • All responders had a 92% reduction in SALT

  • Patients followed 3 months after drug cessation: all patients relapsed (3 had major hair loss by week 12 and 6 had increased shedding without major hair loss)

  • Limited to grade I & II infections: URTI (7), UTI (1), minor bacterial skin infections (1), mild pneumonia (1)

  • Conjunctival hemorrhage (1)

  • Mild G.I symptoms (1)

  • Anemia (1)
(Bayart et al, 2017)39 Case series 6 patients; 2 males and 4 females; 3–17 years -AA
-AU
-AT		 −2 patients: Topical 1–2% ruxolitinib (BD)
-4 patients: Topical 2% tofacitinib (BD)
x 3–12 months

  • Data for ruxolitinib treated patients only:


Of the 2 patients treated, 1 patient had >75% regrowth of upper eyelash hair with no regrowth of eyebrows

  • 1 patient failed to respond to therapy

  • None reported


(Both patients treated with ruxolitinib).
(Deeb & Beach, 2017)64 Case report 1 patient; male; 66 years -AA Topical 0.6% ruxolitinib (BD) x 3–6 months

  • Patient did not respond to treatment

  • None reported
(Vandiver et al, 2017)65 Case series 2 patients; females; 45 and 59 years -AA
-AU
-AT		 Oral ruxolitinib (10mg-30mg daily x 13–14 months)

  • Both patients responded to therapy

  • 1 patient had complete regrowth at 8 months with initial regrowth observed at 2 months (regrowth sustained at 14 months)

  • 1 patient had near-complete regrowth at 6 months with initial regrowth observed at 2 months (regrowth sustained at 13 months)

  • Weight gain (1)

  • Bloating and bruising (1)
(Ramot & Zlotogorski, 2018)66 Case report 1 patient; male; 33 years -AU Oral ruxolitinib (20mg BD x 12 months)

  • 50% regrowth of scalp hair and complete regrowth of beard by 4 months; sustained regrowth after 12 months treatment

  • None reported
(Liu & King, 2019)67 Case series 8 patients; 4 males and 4 females; 14–57 years -AA
-AU
-AT		 Oral ruxolitinib (10mg- 25mg BD x 5–31 months)

  • 5 out of 8 patients responded to therapy; all 5 patients had complete or near-complete regrowth (98% reduction in SALT)

  • 3 patients were nonresponders

  • URTI

  • Weight gain

  • Acne

  • Bruising

  • Fatigue


(all reported as mild)
(Olsen et al, 2019)68 2-Part double-blind, randomized, vehicle-controlled phase 2 study:
Part A- open label
Part B- double-blind, vehicle-controlled		 Part A:
12 patients; 25–67 years
Part B:
78 patients (39 assigned to ruxolitinib and 39 to vehicle); 18–69 years		 -AA Part A & B: Topical 1.5% ruxolitinib (BD) x 24 weeks (both part A & B had a 24- week extension period)

  • Part A: >50% SALT was achieved in 3 patients at week 12, 4 at week 18 and 6 at week 24; 9 patients (5 with <50% and 4 with >50% SALT) continued to the extension period (3 maintained >50% SALT, 1 achieved 90% SALT & 5 did not achieve 50% SALT).

  • Part B: out of 39 patients that received ruxolitinib therapy 2 achieved >50% SALT at week 8, 3 at 12 weeks and 5 at 18–24 weeks. 63 patients continued to the extension period, but many dropped out of the study. No statistical significance between the ruxolitinib and vehicle therapy was noted.

  • Local skin reactions: pruritus, folliculitis, dry skin


(2 patients in Part A and 5 in Part B)
(Fetter et al, 2020)69 Case report 1 patient; female; 40s -AU & recalcitrant DM Oral ruxolitinib (20–30 mg daily x 4 months)

  • Complete regrowth by 4 months; sustained regrowth with therapy

  • Resolution of DM symptoms

  • None reported
(Peterson & Vesely, 2020)70 Case report 1 patient; male; 9 years -AT Oral ruxolitinib (10mg-20mg BD x 12 months)

  • Near-complete regrowth by 4 months, with complete regrowth by 12 months

  • Sustained regrowth after 12 months therapy (ruxolitinib tapered to 10mg daily)

  • None reported
Baricitinib Studies
(Jabbari et al, 2015)71 Case report 1 patient; male; 17 years -AA with CANDLE syndrome Oral baricitinib (7mg am and 4mg pm x 9 months)

  • Complete regrowth by 9 months with initial regrowth observed at 3 months

  • Sustained regrowth after therapy (patient continued treatment)

  • Resolution of CANDLE syndrome symptoms

  • None reported
(Olamiju et al, 2019)72 Case report 1 patient; female; 60s -AA Oral baricitinib (4mg daily x 8 months)

  • Near-complete regrowth (97%) by 8 months

  • Sustained regrowth 13 months after therapy (patient continued treatment)

  • None reported

Abbreviations: JAKi, janus kinase inhibitor; F/U, follow up; BD, twice daily; AA, alopecia areata; AU, alopecia universalis; AT, alopecia totalis; CMC, chronic mucocutaneous candidiasis; ET, essential thrombocytopenia; SALT, severity of alopecia tool; URTI, upper respiratory tract infection; UTI, urinary tract infection; G.I, gastrointestinal; DM, dermatomyositis; CANDLE, chronic atypical neutrophilic dermatosis with lipodystrophy and elevated temperature