Introduction
Methods
Protocol and Registration
Literature Search and Eligibility Criteria
Data Chart
Report of Results
Compliance with Ethics Guidelines
Protocol versus Overview
Results
Mapping Studies on Use of JAK Inhibitors
Atopic Dermatitis
Vitiligo
Alopecia Areata
Evidence of Efficacy and Safety of Treatment with JAK Inhibitors
Atopic Dermatitis
Study [references] | Type | Drug | Dosage | Administration route | Period (weeks) | Number of patients | Outcomes | Efficacy | Safety |
---|---|---|---|---|---|---|---|---|---|
1 [22] | RCT phase IIb | Upadacitinib | 7.5/15/30 mg PO | Systemic | 16 | 167 | At week 16 EASI score Pruritus NRS score EASI-75 | EASI: 39.4%/61.7%/74.4% for UPA vs 23.0% placebo NRS: 39.6%/ 48.0%/68.9% UPA vs 9.7% placebo EASI-75: 28.6%/52.4%/69.0% UPA vs 9.8% placebo | Mild: Upper respiratory tract infection, AD exacerbation Severe: appendicitis, pericoronitis, skin infection (all of them n = 1) |
2 [23] | Case report | Tofacitinib | 5 mg BID PO | Systemic | 40 | 1 | NRS score | NRS score changed from 8/10 to 3/10 | None |
3 [24] | RCT phase II | Upadacitinib | 7.5/15/30 mg QD PO | Systemic | 16 | 163 | At week 16 SCORAD POEM ≥ 4 improvement in NRS | SCORAD: 33%/47%/60% UPA vs 12% placebo POEM: 5.5/8.6/12.3 UPA vs 1.6 placebo NRS: 24%/59%/53% UPA vs 6% placebo | Upper respiratory tract infection, AD exacerbation |
4 [25] | RCT phase I | Tofacitinib | 0.03%; 0.1%; 0.3%; 1%; 3% | Topical | 1 | 66 | EASI score Pruritus NRS score | Clear and rapid improvement | White blood cell count decreased (n = 1 with 3% tofacitinib) Erysipela (n = 1 with 1% tofacitinib) AD exacerbation (n = 1 with 1% and n = 1 with 3%) |
5 [26] | Case series | Ruxolitinib | NA | NA | NA | 4 | Clinical endpoints | Remarkable improvement | – |
6 [27] | RCT phase II | Cerdulatinib | 0.25%, 0.5%, 1%, or 3% | Topical | 4 | 327 | EASI score Pruritus NRS score IGA score BSA | All doses had greater efficacy than vehicle in all studied efficacy parameters. Rapid significant pruritus NRS score reduction | Mild |
7 [28] | Case report | Tofacitinib | 5 mg BID PO | Systemic | 24 | 1 | EASI score | EASI = 0 (complete remission) within 3 months | Upper respiratory tract infection Diarrhea |
8 [29] | RCT phase IIa | Tofacitinib | 2% | Topical | 4 | 69 | EASI score Pruritus NRS score IGA score BSA | Significant improvements vs vehicle across all efficacy endpoints | Mild and infrequent |
9 [30] | Case series | Tofacitinib | 5 mg/day or BID PO | Systemic | 29 | 6 | SCORAD index | Decrease in SCORAD for all patients, maintained during follow-up period | None |
10 [31] | RCT phase IIb | Ruxolitinib | 1.5% QD; 1.5% BID | Topical | 8 | 65 | Serum proteomic changes from baseline | NA | Suspected herpes zoster-associated encephalitis during oral treatment with tofacitinib in alopecia universalis |
11 [32] | RCT phase II | Upadacitinib | 7.5 mg/15 mg/30 mg QD PO vs placebo | Systemic | 16 | 167 | EASI score Pruritus NRS score Histological changes | Mean % improvements in EASI (39.4%, 61.7%, 74.4% vs 23% placebo) and pruritus NRS (39.6%, 48%, 68.9% vs 9.7% placebo) Lesional and non-lesional biopsies from 50 patients: reduction of epidermal hyperplasia and number of dendritic cells, associated with clinical improvements, in upadacitinib 15 mg and 30 mg | NA |
12 [33] | RCT phase II | Baricitinib | 2/4 mg QD vs placebo PO | Systemic | 16 | 124 | EASI-75 Pruritus NRS score SCORAD IGA DLQI POEM | Achievement of EASI-50 (61% 4 mg, 37% placebo) was significant as early as week 4, although it was not significant for 2 mg vs placebo EASI reduction at week 16: 65% for 2 mg and 4 mg vs 46% for placebo Significant improvement in pruritus and sleep loss, as well as HRQoL measures | Adverse events were reported in 24 (49%) placebo, 17 (46%) baricitinib 2 mg, and 27 (71%) baricitinib 4 mg cases Placebo: Lymphopenia (n = 3) and eczema Baricitinib 2 mg: neutropenia (n = 1) Baricitinib 4 mg: neutropenia (n = 5), white cell count decreases (n = 2), abnormal lymphocyte count, headache, eczema, benign polyp of the large intestine (n = 1) |
13 [34] | RCT phase Ib | Gusacitinib | 20/40/80 mg PO vs placebo | Systemic | 4 | 36 | EASI-50 EASI-75 BSA Pruritus NRS score IGA POEM | EASI-50 (20%, 100%, 83% vs 22% placebo) EASI-75 (0%, 71%, 33% vs 22% placebo) Change in pruritus NRS score (− 1.3 ± 2.1, − 3.1 ± 2.7, − 4.7 ± 2.1 vs − 1.6 ± 1.8 placebo) | Adverse events were mild and similar across all groups, including headache, nausea, diarrhea, nasopharyngitis, back pain, mild hypertension, and low lymphocyte levels |
14 [35] | RCT phase II | Upadacitinib | 7.5/15/30 mg QD PO | Systemic | 16 | 36 | EASI score Pruritus NRS score AEC Serum IgE | Mean percentage EASI reduction at week 16: 39.4%, 61.7%, 74.4% vs 23% placebo, all of them significant Mean percentage pruritus NRS reduction at week 16: 39.6%, 48%, 68.9% vs 9.7% placebo, all significant Week 16 AEC significantly lowered with 15 mg and 30 mg vs placebo, as early as week 2 (these changes strongly correlated with EASI) Changes in IgE levels were not significant | NA |
15 [36] | RCT phase II | Ruxolitinib | 0.15% QD; 0.5% QD; 1.5% QD; 1.5% BID | Topical | 8 | 111 | EASI score TARC/CCL17 levels AEC Serum IgE | Significant reduction of TARC/CCL17 levels with ruxolitinib 1.5% BID Total serum IgE levels reduction with ruxolitinib 1.5% QD or BID These changes did not predict ruxolitinib treatment response (percentage reductions in EASI) | NA |
16 [37] | RCT phase IIb | Upadacitinib | 7.5/15/30 mg QD PO | Systemic | 16 | 166 | SCORAD Pruritus NRS score POEM | Mean improvement in SCORAD itch VAS: 3.3, 3.4, 4.7 vs 1.2 placebo | NA |
17 [38] | RCT phase IIa | Tofacitinib | 2% | Topical | 4 | 67 | Pharmacokinetics | NA | For adult and pediatric patients with > 70% BSA, concentrations could exceed 12.4 ng/mL for ointment application rates > 2 mg/cm2 Additional safety monitoring requirements may have to be considered |
18 [39] | RCT phase Ib | Cerdulatinib | 0.4% BID | Topical | 2 | 8 | EASI Histological, immune, and gene expression analyses | Significant clinical improvements (EASI improvement 65%), reversal of epidermal hyperplasia, reduced immune cell infiltration and AD‐related inflammatory gene expression | All treatment-related adverse events were grade 1 (34/35 events) or grade 2 (1/35 events), with no safety-related withdrawals |
19 [40] | RCT phase IIb | Abrocitinib | 10/30/100/200 mg QD PO | Systemic | 12 | 267 | EASI-50/75/90 Pruritus NRS score SCORAD | Significative changes in SCORAD (40.7% for 100 mg), in EASI (47.4% for 100 mg), and in pruritus NRS (25.4% for 200 mg; 20.7% for 100 mg) EASI-50 achievement: 78.5% for 200 mg, 55.3% for 100 mg, and 27.4% for placebo EASI-75 achievement: 63.7% for 200 mg, 41.6% for 100 mg, and 15.6% for placebo EASI-90 achievement: 51.6% for 200 mg, 26.8% for 100 mg, and 10.3% for placebo | Adverse events and laboratory anomalies were found in 184 patients (68.9%). Serious AE were observed in 9 patients (3.4%). No deaths were registered |
20 [41] | RCT phase IIb | Abrocitinib | 10/30/100/200 mg QD PO | Systemic | 12 | 267 | Pruritus NRS score PtGA POEM DLQI | 200 mg significantly improved ALL outcomes. 100 mg only pruritus NRS, DLQI, and POEM | NA |
Vitiligo
Article | Type, subtype of study | Drug | Dosage | Administration route | Period (weeks) | Number of patients | Outcomes | Efficacy | Safety |
---|---|---|---|---|---|---|---|---|---|
1 [42] | Open label | Ruxolitinib | 1.5% BID | Topical | 52 | 8 | VASI score PGA score DLQI score BSA | 5/8 patients responded (facial VASI—mean improvement 92% ± 7.1 [n = 4], VASI—mean improvement: non-acral upper extremities 12.6% ± 19.5 [n = 3], trunk 16.7% ± 16.7 [n = 2]) Not statistically significant: PGA, DLQI, and BSA | Minor (erythema [n = 3], transient acne [n = 2]) |
2 [43] | Open label | Tofacitinib | 2.5 mg BID PO | Systemic | NA | 25 | Repigmentation | NA | NA |
3 [44] | Case series | Tofacitinib | 5 mg BID PO | Systemic | 12–18 | 2 | Repigmentation | Facial repigmentation: nearly complete in case #1; 75% case #2 Body repigmentation: > 75% in case #1, 0% case #2 | None |
4 [45] | Case series | Tofacitinib | Topical 1.5%; 5 mg BID PO | Topical | 12 | 2 | Repigmentation | Facial and body repigmentation, preferential in sun-exposed areas | NA |
5 [46] | Case series | Tofacitinib | 5–10 mg BID PO | Systemic | 40 | 10 | Repigmentation | 5/10 patients responded (BSA 5.4% decrease, 3 of them only in sun-exposed areas) | Upper respiratory tract infection [n = 2], weight gain [n = 1], arthralgia [n = 1], mild lipid elevation [n = 4] |
6 [47] | Case report | Tofacitinib | Topical | Topical | NA | 1 | NA | NA | NA |
7 [48] | Open label | Ruxolitinib | 1.5% BID | Topical | 20 | 11 | VASI score Repigmentation | 8/11 patients responded (VASI 23% mean improvement, facial repigmentation [n = 8], periocular repigmentation [n = 2], non-acral upper extremities repigmentation [n = 3]) | Erythema [72%], transient acne [n = 2] |
8 [49] | Case report | Tofacitinib | 5 mg BID PO | Systemic | 24 | 1 | VASI score | Only marginal improvement (VASI from 4.68 at baseline to 3.95 at 5 months) | Upper respiratory tract infection and diarrhea |
9 [50] | Case report | Ruxolitinib | 20 mg BID PO | Systemic | 20 | 1 | Repigmentation | 51% facial repigmentation, repigmentation on other areas | NA |
10 [51] | Case report | Tofacitinib | 5 mg PO every other day; later, daily | Systemic | 20 | 1 | Repigmentation | Partial facial and upper extremities repigmentation, nearly complete in forehead and hands | None |
Alopecia Areata
Study [references] | Type, subtype of study | Drug | Dosage | Administration route | Follow-up (weeks) | Number of patients | Outcomes | Efficacy | Safety |
---|---|---|---|---|---|---|---|---|---|
1 [52] | Case report | Tofacitinib | 5 mg BID PO; later, 15 mg/day | Systemic | 40 | 1 | Hair regrowth | Near complete by 6 months, loss of regrown hair at 8 months | Herpes zoster |
2 [53] | RCT phase II | Tofacitinib | 5 mg to 10 mg BID PO | Systemic | 72 | 12 | ≥ 50% regrowth SALT score | ≥ 50% regrowth (n = 8), overall SALT improvement (n = 11) | Hypertension (n = 1) |
3 [23] | Case report | Tofacitinib | 5 mg BID PO | Systemic | 40 | 1 | Hair regrowth | Hair regrowth on all affected body parts | None |
4 [54] | Case series | Tofacitinib | 2% | Topical | – | 11 | SALT score | Average SALT reduction of 32.3% | Application-site irritation (n = 1) |
5 [55] | Open label | Tofacitinib | 2.5 mg QD PO, modified according to response | Systemic | 24/72 | 200 | % change in SALT score | Eleven out of 12 patients attained a global overall improvement in SALT score at the end of treatment with results ranging from 12.1% to 100% regrowth, with an average 56.8% regrowth | None |
6 [56] | Case series | Tofacitinib | 10 mg PO | Systemic | ≥ 16 | 33 | Nail improvement | Improvement in nail changes in 11/15 patients (73.3%) | NA |
7 [57] | Case report | Ruxolitinib | 20 mg BID PO | Systemic | 48 | 1 | Hair regrowth | Complete regrowth (beard) and partial (50%) regrowth (scalp), maintained after 1 year | NA |
8 [58] | RCT phase II | Tofacitinib | 5 mg BID PO | Systemic | 12 | 30 | HRQoL scale Skindex-16 scale | Significant improvement for all subjects | NA |
9 [59] | Open label | Tofacitinib | 2% BID | Topical | 24 | 10 | Hair regrowth SALT score | Hair regrowth in 3 patients (61%, 18%, 25% improvement in SALT score) | Skin irritation, folliculitis |
10 [60] | Case series | Tofacitinib | 5 mg QD or BID PO | Systemic | 20 | 2 | SALT score | Patient 1: SALT 100 to 15 (85% change). Patient 2: SALT 100 to 10 (90% change) | Increased appetite, weight gain |
11 [61] | RCT phase I | Tofacitinib, Ruxolitinib | Tofacitinib 2% Ruxolitinib 1% Tofacitinib 5 mg PO | Topical/systemic | 28 | 16 | Hair regrowth Global photography IGA score PtGA | Partial regrowth (n = 6 with 2% T, n = 5 with 1% R, n = 10 with clobetasol propionate 0.05%, n = 0 with placebo) | None |
12 [23] | Case report | Tofacitinib | 5 mg BID PO | Systemic | 24 | 1 | Hair regrowth | Hair regrowth on scalp, beard, extremities, eyebrows, and eyelashes | Upper respiratory tract infections, diarrhea |
13 [62] | Open label | Tofacitinib | 5 mg BID PO 10 mg QD PO 20 mg QD PO | Systemic | 30 | 32 | SALT50 | 18/32 patients achieved SALT50 | None |
14 [63] | Case series | Ruxolitinib | 5 mg BID to 30 mg QD | Systemic | 56 | 2 | Hair regrowth | Complete or nearly complete regrowth | None |
15 [64] | Case series | Tofacitinib Ruxolitinib | Tofacitinib 1% Ruxolitinib 2% | Topical | NA | 6 | Hair regrowth | Partial regrowth in 4 patients (20%, 75%, 95%, 80%, respectively) | None |
16 [65] | Case report | Ruxolitinib | 0.6% nightly to BID | Topical | 14 | 1 | SALT score | Lack of improvement | None |
17 [66] | Case report | Tofacitinib | 5 mg PO | Systemic | 20 | 1 | Hair regrowth | Regrowth on scalp, eyebrows, and extremities | Increased appetite, weight gain |
18 [67] | Case series | Tofacitinib | 5 mg BID PO, increased by 5 mg per month | Systemic | 36 | 13 | Regrowth rate, response time | Rate 2–90%, mean (sd) 44.3% (31.9), median 50.5%. Response time 1–9 months, mean (sd) 4.2 (2.6) months | Morbilliform eruption, peripheral edema, lipid and liver abnormalities |
19 [68] | Case report | Tofacitinib | NA | NA | 40 | 1 | Hair regrowth Nail improvement | Near complete regrowth, mild nail improvement | None |
20 [69] | Case series | Tofacitinib | NA | NA | 16–52 | 13 | Hair regrowth | Regrowth range 2–90%, mean 44.3%, median 50.5% | NA |
21 [70] | Case report | Tofacitinib | 5 mg BID PO | Systemic | 32 | 1 | Hair regrowth | Complete regrowth in scalp | None |
22 [71] | Case series | Tofacitinib | 5 mg BID PO | Systemic | 48 | 8 | Hair regrowth SALT score | > 50% regrowth in scalp, eyebrows, eyelashes, and body hair (n = 8) | None |
23 [72] | Case report | Tofacitinib | 15 mg QD PO to 10 mg QD PO | Systemic | 36 | 1 | Hair regrowth | Significant regrowth in scalp and body. No regrowth in eyebrows and eyelashes | Herpes zoster |
24 [73] | Case series | Tofacitinib | 5 mg BID to 10 mg BID PO | Systemic | 16–52 | 90 | Hair regrowth SALT score | 69/90 patients with response, 52/90 patients achieved > 50% change in SALT score | Upper respiratory (28.9%) and urinary tract (3.3%) infections, tonsillitis (2.2%), headache (14.4%), acne (7.8%), fatigue (6.7%). Leukopenia (n = 1). LDL-c increase (n = 15) |
25 [74] | Case report | Tofacitinib | 5 mg BID PO | Systemic | 12 | 1 | Hair regrowth | No hair regrowth | NA |
26 [75] | Case report | Tofacitinib | 5 mg BID to 10 mg am + 5 mg nightly | Systemic | 24 | 1 | Hair regrowth | Complete hair regrowth throughout the entire body | None |
27 [76] | Case report | Tofacitinib | 5 mg BID PO | Systemic | 36 | 2 | Hair regrowth | Partial regrowth on scalp, eyebrows, and axillae | NA |
28 [77] | Case series | Tofacitinib | NA | 26 | 13 | Hair regrowth SALT score | Clinically significant regrowth (n = 9), mean SALT change 93% | Headache, upper respiratory infections, mild and transient increase in transaminases | |
29 [78] | RCT phase II | Tofacitinib | 5 mg BID PO | Systemic | 12 | 66 | SALT score | 36% were non-responders (< 5% SALT change), 32% intermediate responders (5–50% change), 32% strong responders (> 50% SALT change) | Grade I and grade II leukopenia |
30 [79] | RCT phase II | Ruxolitinib | 20 mg BID PO | Systemic | 12–24 | 12 | ≥ 50% regrowth Changes in mean SALT score | 9/12 ≥ 50% regrowth 7/9 responders achieved > 95% regrowth. Mean SALT from 65.8% ± 28.0% (baseline) to 7.3% ± 13.5% (end of treatment) | Minor bacterial skin infections, upper respiratory or urinary infections, allergy, pneumonia, conjunctival hemorrhage, mild gastrointestinal symptoms. Lowered Hb (n = 1) |
31 [80] | Case report | Tofacitinib | 5 mg BID PO | Systemic | 40 | 1 | Hair regrowth Nail improvement | At 10 months, complete hair regrowth, nail growth, and nail plate normalization | None |
32 [81] | Case report | Tofacitinib | 5 mg BID PO | Systemic | 16 | 1 | Hair regrowth | Nearly complete scalp hair regrowth. Significant regrowth in eyebrows and eyelashes. Near-complete hair loss at treatment cessation | None |
33 [82] | Case report | Tofacitinib | 5 mg BID PO | Systemic | 128 | 1 | Hair regrowth | Beard, body, scalp, eyebrow, and eyelash hair regrowth | None |
34 [83] | Case report | Ruxolitinib | 5 mg BID to 20 mg/day PO | Systemic | 24 | 1 | Hair regrowth | Progressive regrowth until complete recovery. Relapse after 6 months of durable remission after treatment end | Mild anemia |
35 [84] | Case report | Ruxolitinib | 0.6% BID | Topical | 12 | 1 | Hair regrowth | Nearly complete eyebrow regrowth, 10% scalp hair regrowth | None |
36 [85] | Case report | Ruxolitinib | 5 mg BID to 15 mg/day PO | Systemic | 24 | 3 | Hair regrowth Nail improvement | Remission of nail changes (n = 3), hair regrowth (n = 2) | None |
37 [49] | Case report | Ruxolitinib | 20 mg BID PO | Systemic | 20 | 1 | Hair regrowth | 85% scalp hair regrowth, maintained after 12 weeks from end of treatment | NA |
38 [86] | Case report | Tofacitinib | 5 mg BID PO | Systemic | 16 | 1 | Hair regrowth | Growth of short terminal pigmented hair after 3 months, which then completely disappeared within a month | NA |
39 [87] | Case series | Tofacitinib | 5 mg BID PO | Systemic | 32 | 2 | Hair regrowth | Beard, body, scalp, eyelash, and eyebrow hair regrowth in both patients | Viral infections, fatigue |
40 [88] | Case report | Baricitinib | 7 mg/day, later 7 mg am + 4 mg pm PO | Systemic | 60 | 1 | Hair regrowth | Complete scalp hair regrowth | NA |
41 [89] | Case report | Ruxolitinib | 15 mg BID PO | Systemic | 40 | 1 | Hair regrowth | Nearly complete regrowth durable at > 50 months | NA |
42 [90] | Case series | Ruxolitinib | 20 mg BID PO | Systemic | 12–18 | 3 | Hair regrowth | Nearly complete hair regrowth in all patients | NA |
43 [91] | Case report | Tofacitinib | 5 mg BID to 10 mg am + 5 mg nightly PO | Systemic | 32 | 1 | Hair regrowth | Complete hair regrowth at all body sites except extremities | None |
44 [92] | Case series | Tofacitinib | 5 to 10 mg BID PO | Systemic | 12–18 | 6 | Hair regrowth Photography SALT score Physical examination | Nearly complete regrowth. Mean SALT score went from 77.9% to 25.5% | Acneiform eruptions (n = 2) |
45 [93] | RCT phase II | PF-06651600, PF-06700841 | PF-06651600: 200 mg QD during induction and 50 mg QD during maintenance PF-06700841: 60 mg QD during induction and 30 mg QD during maintenance | Systemic | 24 | 46 | To evaluate changes in lesional scalp biomarkers | Gene-level changes (PF-06651600 and PF-06700841, respectively): 62% and 115% at week 12, 162% and 104% at week 24, vs 18% and 6% placebo. Downregulation of Th1, Th2 and IL-12/23 immune responses and upregulation of hair keratins. These changes correlated with clinical (SALT score) improvement | NA |
46 [94] | Case report | Tofacitinib | 5 mg BID PO | Systemic | 36 | 1 | Efficacy | Hair regrowth: complete hair regrowth at 5 months, maintained after 4 months of follow-up. Regrowth started in the area of contact dermatitis | NA |
47 [95] | Case series | Tofacitinib | 2.5 mg QD, then 2.5 mg QD for 4 days and 5 mg QD for 3 days each week | Systemic | 48 | 3 | Efficacy and safety | With 2.5 mg: unsatisfactory hair regrowth (< 20%) When 2.5/5 mg: patient #1 > 90% regrowth; patient #2 > 50% by month 6; patient #3 > 50% by 21 months (complete regrowth of eyebrows and eyelashes and partial scalp hair) | Mild diarrhea. Upper respiratory tract infection |
48 [96] | Case series | Tofacitinib | Patient #1: 5 mg BID. Then cycles of 5 mg BID PO 8 weeks/5 mg once daily 4 weeks/no treatment 10–12 weeks. Then 5 mg once daily 5 months/off drug 8 weeks/5 mg BID 8 weeks. Patient #2: 5 mg BID PO | Systemic | 3 years | 2 | Efficacy and safety | Patient #1: almost complete regrowth at 3 months, relapsing after 8–10 weeks of stopping drug. With the 3rd cycling pattern, almost complete regrowth and no relapses Patient #2: complete regrowth after 2 months | No adverse effects |
49 [97] | Case series | Tofacitinib, ruxolitinib | Tofacitinib 5 mg BID PO Ruxolitinib 1.5% BID topical | Systemic/topical | 52/16 | 2 | Rebound effect after JAK inhibitor treatment discontinuation | Patient #1 on tofacitinib: SALT improvement from 60% to 25%. After discontinuation, relapse and SALT 90% Patient #2 on ruxolitinib: SALT score improvement from 80% to 7%. After discontinuation, relapse and SALT > 99% | |
50 [98] | Case series | Ruloxitinib | 10 to 25 mg BID PO | Systemic | 20/124 | 8 | Efficacy and safety | 5/8 patients achieved complete or nearly complete regrowth. Mean SALT improvement of 98% (SD 4%). 3/8 patients: no regrowth | Mild adverse effects: upper respiratory infections, weight gain, acne, easy bruising, fatigue. One patient had decreased white blood cell count |
51 [99] | Open label | Tofacitinib, ruxolitinib | Tofacitinib 5 mg BID PO Ruxolitinib 20 mg BID PO | Systemic | 36 | 75 | Efficacy and safety | % change in SALT score: 93.8 ± 3.25 for ruxolitinib/95.2 ± 2.69 for tofacitinib. aRUXO group (38 patients): 3 low, 3 medium, 6 good, 18 excellent, 8 complete. Relapse: 28 (73.3%) aTOFA group (n = 35): 4 low, 4 medium, 5 good, 16 excellent, 8 complete. Relapse: 26 (74.2%) | Adverse effects were infrequent and minor: leukopenia (n = 4), AST/ALT mild elevation (n = 5), serum triglycerides elevation (n = 2), cholesterol elevation (n = 1), acute infections (n = 25), mild gastrointestinal symptoms, headache, weight gain, fatigue No differences between both drugs |
52 [100] | Case series | Tofacitinib | 5 mg BID PO | Systemic | 24/60 | 4 | Efficacy | Hair regrowth: complete (n = 2) after 3–6 months, 62% (n = 1), scarce (n = 1) | NA |
53 [101] | Case series | Tofacitinib | 5 mg BID PO, then decreased to 7.5 mg daily | Systemic | NA | 63 | Efficacy and safety | 25/63 patients had > 90% SALT score change. Of these, 15/24 achieved 100% change in SALT score | Mild adverse effects: hyperseborrhea, upper respiratory infections, acneiform eruptions |
54 [102] | Case report | Tofacitinib | 5 mg BID PO | Systemic | 24 | 1 | Hair regrowth | 40% regrowth | NA |
55 [103] | Case report | Ruloxitinib | 5 mg BID then 10 mg BID PO | Systemic | 40 | 1 | Hair regrowth | Nearly complete hair regrowth | NA |
56 [104] | Case report | Tofacitinib | 2% BID | Topical | 32 | 1 | Eyelashes regrowth | Nearly complete eyelashes regrowth | NA |
57 [105] | Case report | Tofacitinib | 5 mg BID PO | Systemic | 24 | 1 | Efficacy and safety | Complete regrowth of eyebrows and scalp hair (SALT of 0) | Mild headaches |
58 [106] | Case series | Tofacitinib | 5 mg QD PO 5 mg BID PO | Systemic | 16/108 | 11 | Efficacy and safety | The mean SALT score improvement from baseline was calculated to be 61.18% (n = 10, range, 0–100%) | One patient developed hyperlipidemia and weight gain while on 11 mg extended release twice daily, which improved with exercise and diet changes while remaining on treatment. Other side effects included gastrointestinal symptoms and mild acne. One patient stopped treatment because of new-onset multiple sclerosis |
59 [107] | Case series | Tofacitinib | Tofacitinib 5 mg BID PO, increased to 5 mg 3 times daily for 4 unresponsive patients, and then to 10 mg BID for one of these Comparators: oral conventional treatment (steroids + cyclosporine) and diphenylcyclopropenone (DPCP) | Systemic/topical | 24 | 74 | Efficacy and safety | Median SALT change: 3rd month: tofacitinib 34.6 (range 0–80), conventional 34.7 (0–89.2), and DPCP 0 (0–53.0) 6th month: tofacitinib 36.5 (0–91.5), conventional 39.9 (0–91.6), and DPCP 0 (0–80) SALT50 3rd month: Tofacitinib: 9 patients (50%), conventional: 7 patients (26.9%), DPCP: 1 patient (3.6%) SALT50 6th month: Tofacitinib: 8 (44.4%), conventional: 9 (37.5%), DPCP: 3 (11.1%) | In the tofacitinib group, 6 patients (33.3%) suffered abdominal discomfort and acneiform eruption, most of them mild and transient |
60 [108] | Case series | Tofacitinib | 5 mg BID PO | Systemic | 64 | 9 | Efficacy and safety | 3/9 patients responded (showing 25–75% regrowth at 6 months) | No significant clinical or laboratory adverse events |
61 [109] | Open label | Tofacitinib | 5 mg BID PO, increased to 10 mg BID PO in non-responders | Systemic | 24 | 12 | Efficacy | 8/12 patients ≥ 50% hair regrowth, 3/12 partial < 50% regrowth, and 1 patient no regrowth | NA |
62 [110] | Case series | Tofacitinib | 5 mg BID PO | Systemic | 28/36 | 4 | Efficacy | Patient #1: progressive hair growth after 9 months Patient #2: partial growth of scalp, eyebrow, and axillary hair Patient #3: hair growth on scalp, eyebrows, and skin after 7 months Patient #4: complete regrowth | NA |
63 [111] | Case report | Tofacitinib | 5 mg BID PO | Systemic | 32 | 1 | Efficacy and safety | Almost complete full body hair regrowth | No adverse effects or laboratory abnormalities |
64 [112] | Open label | Tofacitinib | 5 mg BID PO, then escalated to 10 mg BID PO | Systemic | 24 | 12 | Efficacy | 7/12 patients achieved ≥ 50% regrowth (60% response rate) | NA |
65 [113] | Open label | Tofacitinib | 5 mg BID PO, then escalated to 10 mg BID PO | Systemic | 24 | 12 | Efficacy | 8/12 patients ≥ 50% improvement (hair regrowth). Skin gene expression profiles and ALADIN scores correlated with clinical response | NA |
66 [114] | Case report | Tofacitinib | 5 mg BID PO | Systemic | 20 + 8 | 1 | Efficacy and safety | Complete hair regrowth. At 5 months treatment discontinuation because of herpes zoster infection. When resolved, tofacitinib was restarted but without clinical response at 2 months, then it was discontinued | Herpes zoster-associated encephalitis |