The efficacy and safety of tacrolimus as mono‐ and adjunctive therapy for vitiligo: A systematic review of randomised clinical trials

Arora, Charan Jeet; Rafiq, Muhammad; Shumack, Stephen; Gupta, Monisha

doi:10.1111/ajd.13096

Cited by 19 publications

(26 citation statements)

References 32 publications

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“…While in children, the marked response was achieved only in 31.7% of patients in five studies. 7 Another recent Systematic review of RCTs, evaluated total 19 studies including 814 patients to investigate the efficacy and safety of topical tacrolimus monotherapy in treatment of vitiligo. The trials were searched to October 2018 (2005-2018, published RCTs were included) also hints that combining tacrolimus to other treatment options like steroids, phototherapy and laser may be superior to using tacrolimus alone.…”

Section: No Single Treatment Modality Has Been Shown To Have Excellent Results In Vitiligo Repigmentation By Virtue Of the Interplay Of Mmentioning

confidence: 99%

Basic Fibroblast Growth Factor (bFGF) related decapeptide 0.1% Solution, with Tacrolimus 0.1% ointment combination therapy compared with Tacrolimus 0.1% ointment monotherapy in the treatment of stable vitiligo: A Phase IV, randomized 12 months Study

Teli¹,

Parsad²,

Godse³

et al. 2020

IJCED

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Basic Fibroblast growth factor (bFGF) increases proliferation of melanocytes in the pigmentation of vitiligous area. Tacrolimus is well established topical immunomodulator with action at multiple immune as well as inflammatory pathways. The combination of treatment modalities acting via different mechanisms have proven beneficial in management of vitiligo A phase IV, randomized, open label, non-comparative, prospective, multicenter study conducted among patients with stable vitiligo to evaluate efficacy and safety of topical combination of bFGFrP and tacrolimus in comparison with tacrolimus monotherapy. The efficacy assessment parameters after 12 months of treatment were, improvement in extent of repigmentation (EOR), grade of repigmentation (GOR), patient global assessment (PGA). Out of 120 randomized patients, at the end of the study, after 12 months of treatment, the combination group (bFGFrP + T) showed significant improvement in EOR with 66.7% patients (n=54) achieving greater than 50% of repigmentation as compared to only 39.2% in tacrolimus group (n=51). Significantly higher mean response rate (66.75%) was observed in combination group than tacrolimus monotherapy group (46.47%). After 12 months of treatment, combination of bFGFrP and Tacrolimus leads to significantly better results with rapid repigmentation and response rates in stable vitiligo patients, with a favorable safety profile.

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Section: No Single Treatment Modality Has Been Shown To Have Excellent Results In Vitiligo Repigmentation By Virtue Of the Interplay Of Mmentioning

confidence: 99%

Basic Fibroblast Growth Factor (bFGF) related decapeptide 0.1% Solution, with Tacrolimus 0.1% ointment combination therapy compared with Tacrolimus 0.1% ointment monotherapy in the treatment of stable vitiligo: A Phase IV, randomized 12 months Study

Teli¹,

Parsad²,

Godse³

et al. 2020

IJCED

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“…Response rates were seen in one-fourth of patients with better response to vitiliginous lesions on the head and neck [11]. Further, three recent systemic reviews showed topical tacrolimus and NB-UVB combination to be superior to NB-UVB alone [12][13][14]. Another meta-analysis demonstrated no significant difference between NB-UVB monotherapy versus combination NB-UVB with calcineurin inhibitors [15].…”

Section: Narrowband Ultraviolet B Combination Therapy For Vitiligomentioning

confidence: 99%

An Update on Narrowband Ultraviolet B Therapy for the Treatment of Skin Diseases

Myers¹,

Kheradmand²,

Miller³

2021

Cureus

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The objective of this review is to provide an update on narrowband ultraviolet B (NB-UVB) as a treatment for various skin conditions. NB-UVB works by suppressing the cutaneous cell-mediated immune response and has been shown to be an efficacious and clinically tolerable treatment for a range of inflammatory dermatoses. A literature search was conducted by advanced searches of PubMed for NB-UVB treatment of dermatologic skin diseases with a focus on reports from 2010 to 2021, including both office-based and home-based phototherapy (HBPT). Data were prioritized based on studies with a high level of evidence using the Oxford Evidence-Based Medicine guidance. We found that NB-UVB continues to serve as an effective form of therapy for several cutaneous conditions, including vitiligo, psoriasis, atopic dermatitis, mycosis fungoides, and other inflammatory dermatoses. The recent introduction of Janus kinase inhibitors in combination with NB-UVB suggests future promise in the treatment of vitiligo. Despite its rise in popularity, a decline was seen in office-based NB-UVB treatment during the coronavirus disease 2019 pandemic. Options are available to deliver NB-UVB at home with comparable efficacy to office-based treatments. In conclusion, for a select group of patients and conditions, NB-UVB continues to serve as an effective treatment modality with minimal side effects, with HBPT serving as an option to improve patient compliance.

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“…tacrolimus) was discouraged in the past, because of concerns over a possible increased risk of skin cancer, a number of studies assessing this combination of treatment have been published over the last few years. A systematic review by Arora et al 85 identified three studies comparing a combination of NB-UVB and tacrolimus with NB-UVB monotherapy. Meta-analysis of two of these studies showed combination treatment to be more effective than NB-UVB monotherapy in achieving > 75% repigmentation, although only just (risk ratio 1.34, 95% CI 1.05 to 1.71).…”

Section: Relevance To the Wider Literaturementioning

confidence: 99%

Home-based narrowband UVB, topical corticosteroid or combination for children and adults with vitiligo: HI-Light Vitiligo three-arm RCT

Batchelor

Kim

Akram

et al. 2020

Health Technol Assess

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Background Systematic reviews suggest that narrowband ultraviolet B light combined with treatments such as topical corticosteroids may be more effective than monotherapy for vitiligo. Objective To explore the clinical effectiveness and cost-effectiveness of topical corticosteroid monotherapy compared with (1) hand-held narrowband ultraviolet B light monotherapy and (2) hand-held narrowband ultraviolet B light/topical corticosteroid combination treatment for localised vitiligo. Design Pragmatic, three-arm, randomised controlled trial with 9 months of treatment and a 12-month follow-up. Setting Sixteen UK hospitals – participants were recruited from primary and secondary care and the community. Participants Adults and children (aged ≥ 5 years) with active non-segmental vitiligo affecting ≤ 10% of their body area. Interventions Topical corticosteroids [mometasone furoate 0.1% (Elocon®, Merck Sharp & Dohme Corp., Merck & Co., Inc., Whitehouse Station, NJ, USA) plus dummy narrowband ultraviolet B light]; narrowband ultraviolet B light (narrowband ultraviolet B light plus placebo topical corticosteroids); or combination (topical corticosteroids plus narrowband ultraviolet B light). Topical corticosteroids were applied once daily on alternate weeks and narrowband ultraviolet B light was administered every other day in escalating doses, with a dose adjustment for erythema. All treatments were home based. Main outcome measures The primary outcome was self-assessed treatment success for a chosen target patch after 9 months of treatment (‘a lot less noticeable’ or ‘no longer noticeable’ on the Vitiligo Noticeability Scale). Secondary outcomes included blinded assessment of primary outcome and percentage repigmentation, onset and maintenance of treatment response, quality of life, side effects, treatment burden and cost-effectiveness (cost per additional successful treatment). Results In total, 517 participants were randomised (adults, n = 398; and children, n = 119; 52% male; 57% paler skin types I–III, 43% darker skin types IV–VI). At the end of 9 months of treatment, 370 (72%) participants provided primary outcome data. The median percentage of narrowband ultraviolet B light treatment-days (actual/allocated) was 81% for topical corticosteroids, 77% for narrowband ultraviolet B light and 74% for combination groups; and for ointment was 79% for topical corticosteroids, 83% for narrowband ultraviolet B light and 77% for combination. Target patch location was head and neck (31%), hands and feet (32%), and rest of the body (37%). Target patch treatment ‘success’ was 20 out of 119 (17%) for topical corticosteroids, 27 out of 123 (22%) for narrowband ultraviolet B light and 34 out of 128 (27%) for combination. Combination treatment was superior to topical corticosteroids (adjusted risk difference 10.9%, 95% confidence interval 1.0% to 20.9%; p = 0.032; number needed to treat = 10). Narrowband ultraviolet B light was not superior to topical corticosteroids (adjusted risk difference 5.2%, 95% confidence interval –4.4% to 14.9%; p = 0.290; number needed to treat = 19). The secondary outcomes supported the primary analysis. Quality of life did not differ between the groups. Participants who adhered to the interventions for > 75% of the expected treatment protocol were more likely to achieve treatment success. Over 40% of participants had lost treatment response after 1 year with no treatment. Grade 3 or 4 erythema was experienced by 62 participants (12%) (three of whom were using the dummy) and transient skin thinning by 13 participants (2.5%) (two of whom were using the placebo). We observed no serious adverse treatment effects. For combination treatment compared with topical corticosteroids, the unadjusted incremental cost-effectiveness ratio was £2328.56 (adjusted £1932) per additional successful treatment (from an NHS perspective). Limitations Relatively high loss to follow-up limits the interpretation of the trial findings, especially during the post-intervention follow-up phase. Conclusion Hand-held narrowband ultraviolet B light plus topical corticosteroid combination treatment is superior to topical corticosteroids alone for treatment of localised vitiligo. Combination treatment was relatively safe and well tolerated, but was effective in around one-quarter of participants only. Whether or not combination treatment is cost-effective depends on how much decision-makers are willing to pay for the benefits observed. Future work Development and testing of new vitiligo treatments with a greater treatment response and longer-lasting effects are needed. Trial registration Current Controlled Trials ISRCTN17160087. Funding This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 24, No. 64. See the NIHR Journals Library website for further project information.

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The efficacy and safety of tacrolimus as mono‐ and adjunctive therapy for vitiligo: A systematic review of randomised clinical trials

Cited by 19 publications

References 32 publications

Basic Fibroblast Growth Factor (bFGF) related decapeptide 0.1% Solution, with Tacrolimus 0.1% ointment combination therapy compared with Tacrolimus 0.1% ointment monotherapy in the treatment of stable vitiligo: A Phase IV, randomized 12 months Study

Basic Fibroblast Growth Factor (bFGF) related decapeptide 0.1% Solution, with Tacrolimus 0.1% ointment combination therapy compared with Tacrolimus 0.1% ointment monotherapy in the treatment of stable vitiligo: A Phase IV, randomized 12 months Study

An Update on Narrowband Ultraviolet B Therapy for the Treatment of Skin Diseases

Home-based narrowband UVB, topical corticosteroid or combination for children and adults with vitiligo: HI-Light Vitiligo three-arm RCT

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