A Comprehensive Literature Review of JAK Inhibitors in Treatment of Alopecia Areata

Figures & data

Table 1 Therapeutic Options Used in Managing Alopecia Areata

Therapeutic Agent	Class	Modality	Studies	Efficacy	Adverse Effects
Steroids	Immuno-suppressant	-Topical -Intralesional -Systemic	Paediatric RCT; no RCT on intralesional steroids.^Citation24 Some studies included a Phase II clinical trial.^Citation9	Collectively, there is no significant RCT evidence that suggests that steroids (topical/intralesional/systemic) are beneficial in AA.^Citation24 However, appears to be the most effective treatment among children with new hair growth by 6–8 wks.^Citation9	Topical: atrophy of the skin, depigmentation (mostly in darker individuals), telangiectasias. Systemic: acne, weight gain, hyperglycemia, adrenal suppression, etc.
Ciclosporine	Immuno-suppressant/ Immuno-modulator	-Topical -Intralesional -Systemic	No RCTs on systemic and intralesional ciclosporine use; few trials on topical ciclosporine use.^Citation24	No significant/ acceptable hair growth observed within a 6 to12 month period.^Citation24	Topical: Hyperkeratosis and folliculitis
Methotrexate	Immuno-suppressant/ Immuno-modulator	Systemic	No RCTs; Retrospective study.^Citation25	More than 50% regrowth within a 3-month period.^Citation25	Myelosuppression /pancytopenia, rash, acne, mucositis, nausea, diarrhea, hepatotoxicity, etc.
Azathioprine	Immuno-suppressant/ Immuno-modulator	Systemic	No RCTs; Prospective study.^Citation26	Limited benefit; no significant hair growth within a 6-month period.^Citation26	Myelosuppression /pancytopenia, rash, nausea, diarrhea, hepatotoxicity, etc.
Retinoids	Vitamin A derivative	Topical	No RCTs.^Citation9	Limited benefit but use is common in children.^Citation9	Skin irritation and dermatitis (bexarotene).
Minoxidil	Hair growth stimulant	Topical: gel or foam	Few RCTs.^Citation24	Limited benefit; no significant hair growth within a 6 to12 month period. No benefit after treatment is discontinued.^Citation24	Dermatitis, pruritis (gel more than foam); hair growth at distant, non- affected sites.
Contact immunotherapy: DPCP and SADBE	Immuno-therapy	Topical	Retrospective study in children;^Citation9 one RCT.^Citation24	Up to 70% response rate within a 3-month period.^Citation9	Blistering, erythema, urticaria, dermatitis, pruritus, depigmentation and lymphadenopathy/edema.
Anthralin	Immuno-therapy	Topical	No RCTs.^Citation24	Modest benefit within a 3-month period; use common in children.^Citation9	Staining of skin, hair, and clothing in brown colour.
PUVA	Phototherapy/ Immuno-suppressant	Topical: Psoralens by mouth and UVA exposure	Few RCTs.^Citation24	No improvement seen that was cosmetically acceptable.^Citation24	Blistering, erythema, dryness, dermatitis, pruritus, nausea, headache, etc.

Abbreviations: PUVA, psoralen and ultraviolet A; RCTs, randomized controlled trials; SADBE, squaric acid dibutyl ester; DPCP, diphenylcyclopropenone.

Figure 1 The Janus kinase signal transducer and activator of transcription (JAK-STAT) signaling pathway.

Notes: (1) Cytokine binding induces receptor dimerization. (2) Phosphorylation of tyrosine residues by JAK. (3) STATs recruited to phosphorylated cytokine receptor followed by JAK-mediated phosphorylation. (4) Dimerization of STATs. (5) Translocation to nucleus with activation of targeted gene transcription. Created with BioRender.com.

Abbreviations: JAK, janus kinase; STAT, signal transducer and activator of transcription.

Figure 2 Role of JAKis in the JAK-STAT pathway.

Notes: JAKis inhibit the JAK-STAT pathway by blocking JAK phosphorylation and hence STAT activation, leading to a downregulation or termination of inflammatory mediators (eg IFN γ, cytokines, chemokines etc). Created with BioRender.com.

Abbreviations: JAKis, JAK inhibitors; JAK, janus kinase; STAT, signal transducer and activator of transcription.

Table 2 Clinical Research Studies of Tofacitinib in Alopecia Areata Treatment

Study Authors & Year	Study Design	Patient Info. (No./Sex/Age)	Indication	JAKi Used	Outcome & F/U Data	Adverse Effects
(Craiglow & King, 2014)^Citation32	Case report	1 patient; male; 25 years	-AU with plaque psoriasis	Oral tofacitinib (15mg daily: 10mg am and 5mg pm x 8 months)	Full regrowth within 8 months.	None reported
(Anzengruber et al, 2016)^Citation33	Case report	1 patient; male; 51 years	-AU	Oral tofacitinib (5mg BD with MTX 15mg/week x 6 months)	Some regrowth after 3 months; complete relapse after 1 month of treatment.	None reported
(Dhayalan & King, 2016)^Citation34	Case series	3 patients; 2 males and 1 female; 20–50 years	-AU & AA associated nail dystrophy	Oral tofacitinib (5mg BD x 5–6 months)	2 patients achieved regrowth; 1 patient had no regrowth All patients had resolution of nail changes with 5–6 months.	None reported
(Ferreira et al, 2016)^Citation35	Case report	1 patient; male; 38 years	-AU & AA associated nail dystrophy	Oral tofacitinib (5mg BD x 10 months)	Full regrowth and resolution of nail changes by 10 months. Initial regrowth observed within 2 months. No cessation of drug; patient maintained on current dose.	None reported
(Gupta et al, 2016)^Citation36	Case series	2 patients; young males	-AU	Oral tofacitinib (5mg BD x 8 months)	Full regrowth in both patients by 8 months with initial regrowth observed within 1 and 3 months.	Fatigue and viral infection (1)
(Jabbari et al, 2016)^Citation37	Open-label pilot study	1 patient; female; 40 years	-AA	Oral tofacitinib (5mg BD x 4 months)	Up to 94% regrowth after 2–3 months with near complete regrowth at 4 months. Patient followed for 16 weeks after drug cessation; patchy hair loss noted at 8 weeks and near-complete hair loss at 18 weeks.	None reported
(Kennedy Crispin et al, 2016)^Citation38	Open-label, single-arm trial	66 patients; 31 males and 35 females; 19–65 years	-AA -AU -AT	Oral tofacitinib (5mg BD x 3 months)	64% responded to treatment 32% of patients experienced at least ≥ 50% regrowth Patients followed for 3 months after drug cessation; all patients available for F/U experienced disease relapse within 8.5 weeks.	Limited to grade I & II infections: 25% of patients developed infections- URTI (11), UTI (2), paronychia (1), zoster (1), conjunctivitis (1), bronchitis (1), mononucleosis (1). Acne (5), headache (5), abdominal pain (5), fatigue (4), diarrhea (4), pruritus (2), folliculitis (2), numbness (2), nausea (1), cough (1), liver enzyme abnormality (1), weight gain (1)
(Bayart et al, 2017)^Citation39	Case series	6 patients; 2 males and 4 females; 3–17 years	-AA -AU -AT	− 4 patients: Topical 2% tofacitinib (BD) - 2 patients: Topical 1–2% ruxolitinib (BD) x 3–12 months	Data for tofacitinib treated patients only: Of the 4 patients treated, 2 patients had >80% regrowth (1 patient achieved near-complete regrowth at >95%), 1 patient achieved 20% regrowth of eyebrows 1 patient failed to respond to therapy.	Liver enzyme abnormality (1) Transient leukopenia (1) (Both patients treated with tofacitinib).
(Castelo-Soccio, 2017)^Citation40	Case series	8 patients; 12–19 years	-AU	Oral tofacitinib (5mg BD x 5–18 months)	All patients experienced >50% regrowth by 5 months with initial regrowth observed within 3 months No patient achieved full regrowth by 18 months. No cessation of drug; patients continued with therapy.	None reported
(Craiglow et al, 2017)^Citation41	Retrospective study	13 patients; 10 males and 3 females; 12–17 years	-AA -AU -AT	Oral tofacitinib (5mg BD x 2–16 months)	9 patients achieved significant regrowth (> 70%); 1 patient experienced full regrowth by 5 months.	URTI (4) Headache (3) Liver enzyme abnormality (4)
(Erduran et al, 2017)^Citation42	Case report	1 patient; female; 23 years	-AU	Oral tofacitinib (5mg BD x 2 months, then 15 mg daily:10mg am and 5mg pm x 4 months)	Hair growth observed after 2 months of treatment with complete regrowth by 6 months. No cessation of treatment; patient continued on 15mg maintenance therapy for > 19 months (experienced hair loss after dose reduced to 10mg daily at 12 month).	Acneiform eruptions
(Ibrahim et al, 2017)^Citation43	Retrospective study	13 patients; 1 male and 12 females; 20–70 years	-AA -AU -AT	Oral tofacitinib (5mg BD x 4–12 months)	50–90% regrowth observed within 1 to 9 months with initial regrowth within 3months 2 patients stopped therapy after 3 months and relapsed within 2 weeks; 11 patients continued treatment until full regrowth (12 months)	Liver enzyme abnormalities (2) Morbilliform eruption and peripheral edema (1)
(Kim & Kim, 2017)^Citation44	Case report	1 patient; female; 28 years	-AU	Oral tofacitinib (5mg BD x 32 weeks)	Hair growth occurred after 2 weeks with complete regrowth by 32 weeks. No AU recurrence observed after drug cessation	None reported
(Liu et al, 2017)^Citation45	Retrospective study	90 patients; 40 males and 50 females; 18–70 years	-AA -AU -AT	Oral tofacitinib ± prednisone (5mg BD + prednisone, 10 mg BD ± prednisone x 4–18 months)	77% of patients achieved >50% regrowth; 56.9% of patients had intermediate to moderate regrowth, with 20% of patients achieving full regrowth (median 12 months) 23.1% of patients did not respond to therapy (median 7 months) Patients followed for 3 months after drug cessation; most patients available for F/U experienced disease relapse within 2–3 months.	Limited to grade I & II infections: 38.9% of patients developed infections- URTI (26), UTI (3), tonsillitis (2), conjunctivitis (1), zoster (1), bronchitis (1) Liver enzyme abnormalities (1) Transient leukopenia (1)
(Mrowietz et al, 2017)^Citation46	Case report	1 patient; young female	-AU with plaque psoriasis and psoriatic arthritis	Oral tofacitinib (15mg the 10 mg daily x 9 months)	Full regrowth by 6 months with significant regrowth within 4 weeks Resolution of psoriatic arthritis Plaque psoriasis refractory to treatment.	Herpes zoster
(Park et al, 2017)^Citation47	Retrospective study	32 patients; 16 males and 6 females; 18–54 years	-AA -AU -AT	Oral tofacitinib (5mg, 10mg BD, 20mg daily x 12 months)	24 patients achieved 50-≥90% regrowth within 7–10 months. 8 patients failed to respond to therapy. All patients relapsed after drug cessation.	None reported
(Salman et al, 2017)^Citation48	Case report	1 patient; male; 25 years	-AU & plaque psoriasis	Oral tofacitinib (5mg BD x 3 months)	No regrowth observed despite total clearance of plaque psoriasis at 3 months.	None reported
(Scheinberg et al, 2017)^Citation49	Case series	4 patients; 2 males and 2 females; 20–60 years	-AU	Oral tofacitinib (5mg BD)	All patients achieved regrowth with initial regrowth observed within 6 weeks to 7 months. 1 patient achieved full regrowth at 6 months Hair growth persisted in 1 patient after dose reduced to 5mg daily.	None reported
(Strazzulla et al, 2017)^Citation50	Case report	1 patient; young male	-AU	Oral tofacitinib (unspecified dose) with triamcinolone injections (2.5 mg/mL)	Near-complete regrowth within 10 months	None reported
(Jabbari et al, 2018)^Citation51	Open-label, single-arm trial	12 patients; 4 males and 8 females; 18–52 years	-AA -AU -AT	Oral tofacitinib (5mg BD then TID, 10mg BD, x 6–12 months)	≥90% regrowth in 11 patients, with 25% of patients showing 50% regrowth within 4 weeks 1 patient had no regrowth Patients followed for 6 months after drug cessation; 8 patients available for F/U (7 patients experienced disease relapse within 8 weeks which continued for the duration of F/U); 1 patient did not relapse.	Limited to grade I & II infections All patients developed infections- URTI (11), asymptomatic bacteriuria (2), conjunctivitis (1), acne (3)
(Liu et al, 2018)^Citation52	Open-label, single-center pilot study	10 patients; 6 males and 4 females; 19–58 years	-AA	Topical 2% tofacitinib (BD x 6 months)	Regrowth occurred in 3 patients- 1 patient achieved 61% regrowth and remaining 2 achieved <35% regrowth. 7 patients had no regrowth	Scalp irritation (4) Folliculitis (1) Minimal total cholesterol increase (4)
(Patel et al, 2018)^Citation53	Case series	2 patients; males; 17 and 40 years	-AU	Oral tofacitinib (5mg BD, 10mg BD)	Up to 90% regrowth; both patients experienced significant regrowth within 5 months of treatment. No cessation of treatment; drug maintained at current dose	None reported
(Shivanna et al, 2018)^Citation54	Case series	6 patients; 3 males and 3 females; 22–35 years	-AU -AT	Oral tofacitinib (5–10mg BD x 3 to 6 months)	Significant hair growth observed in all patients by the end of 3 months. Treatment continued until complete regrowth. Patients followed for 6 months after drug cessation; 1 patient had no hair loss within 4 months; 2 patients had a relapse within 2 and 4 months.	Acneiform eruptions (2)
(Akdogan et al, 2019)^Citation55	Retrospective study	9 patients; 4 males and 5 females; 13–33 years	-AA -AU	Oral tofacitinib (5mg BD x 6 months)	Of the 9 patients, 5 patients responded to therapy: 3 patients were moderate responders (6–50% reduction in SALT), 1 patient was intermediate (51–90% reduction in SALT) and 1 patient was a complete responder (>90% reduction in SALT). 4 patients did not respond.	Limited to grade I & II infections.
(Ferreira et al, 2019)^Citation56	Case report	1 patient; female; 13 years	-AA	Oral tofacitinib (5mg BD x 4–12 months)	Significant hair growth observed at 4 months with full regrowth after 12 months. No cessation of treatment; patient continued on 5mg maintenance therapy for >19 months.	None reported
(Jerjen et al, 2021)^Citation57	Retrospective study	14 patients; 7 males and 7 females; 7–11 years	-AA -AU -AT	Oral tofacitinib (between 2.5 and 7.5mg daily (mean 4.1mg)); increased every 1–3 months (mean max daily dose of 7.8mg) x 7–38 months	Of the 14 patients 11 completed >6 months treatment and were included in the analysis. 9 out of 11 patients were responders (>26–50% improvement in SALT) and 2 were nonresponders; 7 achieved >50% improvement in SALT and 3 patients had complete regrowth (SALT score of 0). 7 patients continued with therapy.	Mild and transient: Liver enzyme abnormalities (5), URTI (3) transient leukopenia (5), elevated urea (3), hyperkalemia (3), elevated triglycerides (1) hypercholesterolemia (3), low protein (1) asymptomatic hyperbilirubinemia (1).
(Dincer Rota et al, 2021)^Citation58	Retrospective study	13 patients; 5 males and 8 females; 17–49 years	-AA -AU	Oral Tofacitinib (10 mg daily x 3–15 months (average 12 months))	Of the 13 patients 8 had improvement in SALT with 7 out of 8 achieving >76% improvement; 1 patient had <10% improvement; 5 patients did not respond to therapy. Patients were available for F/U for 13–21 months; 5 patients relapsed within 2 and 12 months.	Acneiform lesions (9) Liver enzyme abnormalities (2)

Abbreviations: JAKi, janus kinase inhibitor; F/U, follow up; AA, alopecia areata; AU, alopecia universalis; AT, alopecia totalis; BD, twice daily; TID, three times daily; URTI, upper respiratory tract infection; UTI, urinary tract infection; SALT, severity of alopecia tool.

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)^Citation12	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)^Citation59	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)^Citation60	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)^Citation61	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)^Citation62	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)^Citation63	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)^Citation39	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)^Citation64	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)^Citation65	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)^Citation66	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)^Citation67	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)^Citation68	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)^Citation69	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)^Citation70	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)^Citation71	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)^Citation72	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

Table 4 Current Clinical Trials Listed for AA Treatment- First Generation & Newer JAKis, According to http://clinicaltrials.gov

Trial Number	Indication	JAKi	Target & Administration	Study Design & Phase	Recruitment Status	Start Date
NCT03800979	-AA (extensive and recalcitrant)	Tofacitinib	-JAK1/3 -Oral	-Cohort study -Phase IV	Completed	Jan 11, 2019
NCT04246372	-AA & other immune skin conditions in Down Syndrome	Tofacitinib	-JAK1/3 -Oral	-Open label -Phase II	Recruiting	Jan 29, 2020
NCT03732807	-AA	PF-06651600	-JAK3 -Oral	-Randomized, double-blind, placebo-controlled -Phase IIB/III	Active, not recruiting	Nov 7, 2018
NCT04006457	-AA	PF-06651600	-JAK3 -Oral	-Open label -Phase III	Recruiting	Jul 5, 2019
NCT03898479	-AA (moderate to severe)	CTP-543	-JAK1/2 -Oral	-Open label -Phase II	Active, not recruiting	Apr 2, 2019
NCT03941548	-AA (moderate to severe)	CTP-543	-JAK1/2 -Oral	-Randomized Parallel-group -Phase II	Completed	May 8, 2019

Abbreviations: AA, alopecia areata; JAKi/s, janus kinase inhibitor/s.

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