Innovative Use of Topical Calcineurin Inhibitors




Topical tacrolimus and pimecrolimus are indicated for treatment of atopic dermatitis, but they have been studied in many off-label uses. Double-blind and open studies have shown favorable results with topical tacrolimus and pimecrolimus in oral lichen planus. In 1 study of oral lichen planus, blood tacrolimus was detected in 54% of patients, but there were no signs of systemic toxicity. Double-blind and open studies of vitiligo have shown favorable results with tacrolimus in combination with excimer laser, especially for lesions over bony prominences and on extremities. Similarly, double-blind studies of vitiligo have shown favorable results when pimecrolimus is combined with narrow-band UVB, especially for facial lesions. Double-blind and open studies of psoriasis have shown favorable results for tacrolimus and pimecrolimus, especially for inverse psoriasis. Topical calcineurin inhibitors have been effective in many other cutaneous disorders, and further studies would help clarify their roles.


Topical tacrolimus and pimecrolimus are calcineurin inhibitors (TCI) that are indicated and approved for the treatment of atopic dermatitis in patients 2 years of age or older. This article reviews the many studies that have assessed their efficacy in disorders other than atopic dermatitis (ie, off-label uses), focusing on disorders for which efficacy was assessed in double-blind studies. These include oral lichen planus, psoriasis, and vitiligo, in which double-blind studies have shown efficacy for tacrolimus and pimecrolimus. The efficacy of TCI in contact dermatitis, seborrheic dermatitis, rosacea, cutaneous lupus erythamatosus, perioral dermatitis, cutaneous Crohn disease, and other dermatoses is also examined.


Oral lichen planus


Oral lichen planus is 1 of the best studied off-label uses for topical calcineurin inhibitors. Investigators have shown that tacrolimus and pimecrolimus are effective in double-blind studies.


Tacrolimus


In one head to head study involving 32 patients, tacrolimus 0.1% ointment and clobetasol propionate 0.05% ointment showed significant improvement from baseline, and, notably, tacrolimus was significantly better than clobetasol ( P <.001). Medication was applied four times a day for 4 weeks, and patients were not allowed to eat or drink for 30 minutes after application. In another study of 30 patients with oral erosive/ulcerative lichen planus, tacrolimus 0.1% ointment was as effective as topical clobetasol propionate 0.05% ointment, both showing significant improvement from baseline. In 1 open study of 50 patients with oral erosive/ulcerative lichen planus, tacrolimus 0.1% ointment resulted in complete resolution in 14% of patients, partial resolution in 80%, and no benefit in 6%. Whole blood tacrolimus was detected in 27 patients, with mean maximum of 2.7 μg/L (range up to 11 μg/L). This level compares with the lower therapeutic level for renal transplant patients of 5 to 10 μg/L. No adverse clinical events related to systemic tacrolimus absorption were observed. Favorable results were also seen in 4 other open studies. Another open study showed initial results that were better than triamcinolone acetonide ( P = .007). Favorable results were also seen in 2 retrospective reviews, and 1 questionnaire survey of 37 patients.


Pimecrolimus


In 2 double-blind studies, pimecrolimus 1% cream was superior to placebo in oral erosive lichen planus. In another double-blind study, pimecrolimus 1% cream and triamcinolone acetonide 0.1% paste showed significant improvement from baseline, but there was no significant difference between the 2 treatments ( P = .70, .38, .86).


Summary


Tacrolimus and pimecrolimus have a definite place in the treatment of oral lichen planus. Open studies have shown that tacrolimus 0.1% ointment can be effective in oral erosive lichen planus, but double-blind studies have shown that it may be more effective, or as effective, as clobetasol 0.05%. In 1 study, blood tacrolimus was detected in up to 54% of patients, but there were no signs of systemic toxicity. Double-blind studies showed that pimecrolimus 1% cream is superior to vehicle, and is equal in efficacy to triamcinolone acetonide paste, especially in oral erosive lichen planus.




Vitiligo


Double-blind studies have shown that tacrolimus and pimecrolimus are effective in vitiligo.


Tacrolimus


In 1 double-blind study, tacrolimus 0.1% ointment plus excimer laser resulted in greater than 75% repigmentation in areas in which vitiligo is generally considered to be UV resistant (bony prominences, extremities) in 60% of patients; this end point was not achieved in any of the patients treated with excimer laser monotherapy ( P <.002). In another double-blind study, this same end point was achieved in 50% of patients treated with tacrolimus 0.1% ointment plus excimer laser, compared with 19% of patients treated with placebo plus excimer laser. Less encouraging results were reported in 2 other double-blind studies. In 1 study, tacrolimus plus narrow-band UVB was equal to placebo plus narrow-band UVB ; another study showed tacrolimus 0.1% ointment was superior to clobetasol 0.05%, as measured by computerized morphometric analysis of lesions, but no significant difference when measured by clinical evaluation. One observer-blinded study comparing once or twice daily topical tacrolimus showed favorable results for facial lesions.


One open study of 110 patients showed that greater than 75% repigmentation occurred in the face of 40% of patients, 23% in the limbs, 21.5% in the trunk, but only 1% of the hands/feet, and none in the genitals. In another open study of 9 patients, partial repigmentation occurred in all lesions treated with tacrolimus and excimer laser, and none of the sites treated only with tacrolimus. Five other open studies showed favorable results when tacrolimus was used alone, especially in facial lesions. Two retrospective reviews also showed favorable results when tacrolimus was used alone.


Pimecrolimus


A double-blind study showed that pimecrolimus plus narrow-band UVB was superior to placebo plus narrow-band UVB in repigmentation of facial lesions ( P <.05). Several others have shown mixed results. One study showed pimecrolimus was superior to placebo in vitiligo, but another showed no difference. One study showed pimecrolimus was less effective than clobetasol propionate 0.05% ointment.


Three open studies have shown favorable results with pimecrolimus 1% cream in vitiligo. Another open study showed that it was as effective as clobetasol propionate 0.05% cream. A retrospective study of 8 patients with facial vitiligo showed pimecrolimus resulted in mean improvement of surface area of 72.5%. Case reports of 3 patients with facial vitiligo showed favorable results.


In 1 open study comparing narrow-band UVB, tacrolimus, and pimecrolimus, no statistically significant differences in repigmentation for any anatomic site were recorded with the 3 treatments.


One study showed that pimecrolimus 1% cream combined with microdermabrasion was superior to pimecrolimus alone and placebo in nonsegmental childhood vitiligo. A single-blinded study showed that pimecrolimus 1% cream plus excimer laser was superior to excimer laser alone in childhood vitiligo.


Summary


Double-blind studies have shown that tacrolimus 0.1% ointment is superior to placebo when combined with excimer laser, especially for UV-resistant areas, and that when used alone, it is almost as effective as clobetasol 0.05%. Open studies have shown it can be effective, especially for facial lesions. Double-blind studies have shown that pimecrolimus 1% cream is superior to placebo when combined with narrow-band UVB, especially for facial lesions. However, double-blind and open studies have shown conflicting results when pimecrolimus is compared with clobetasol propionate. Similarly, double-blind studies showed conflicting results when it is compared with placebo. Additional studies would be helpful in clarifying the role of pimecrolimus in vitiligo.




Vitiligo


Double-blind studies have shown that tacrolimus and pimecrolimus are effective in vitiligo.


Tacrolimus


In 1 double-blind study, tacrolimus 0.1% ointment plus excimer laser resulted in greater than 75% repigmentation in areas in which vitiligo is generally considered to be UV resistant (bony prominences, extremities) in 60% of patients; this end point was not achieved in any of the patients treated with excimer laser monotherapy ( P <.002). In another double-blind study, this same end point was achieved in 50% of patients treated with tacrolimus 0.1% ointment plus excimer laser, compared with 19% of patients treated with placebo plus excimer laser. Less encouraging results were reported in 2 other double-blind studies. In 1 study, tacrolimus plus narrow-band UVB was equal to placebo plus narrow-band UVB ; another study showed tacrolimus 0.1% ointment was superior to clobetasol 0.05%, as measured by computerized morphometric analysis of lesions, but no significant difference when measured by clinical evaluation. One observer-blinded study comparing once or twice daily topical tacrolimus showed favorable results for facial lesions.


One open study of 110 patients showed that greater than 75% repigmentation occurred in the face of 40% of patients, 23% in the limbs, 21.5% in the trunk, but only 1% of the hands/feet, and none in the genitals. In another open study of 9 patients, partial repigmentation occurred in all lesions treated with tacrolimus and excimer laser, and none of the sites treated only with tacrolimus. Five other open studies showed favorable results when tacrolimus was used alone, especially in facial lesions. Two retrospective reviews also showed favorable results when tacrolimus was used alone.


Pimecrolimus


A double-blind study showed that pimecrolimus plus narrow-band UVB was superior to placebo plus narrow-band UVB in repigmentation of facial lesions ( P <.05). Several others have shown mixed results. One study showed pimecrolimus was superior to placebo in vitiligo, but another showed no difference. One study showed pimecrolimus was less effective than clobetasol propionate 0.05% ointment.


Three open studies have shown favorable results with pimecrolimus 1% cream in vitiligo. Another open study showed that it was as effective as clobetasol propionate 0.05% cream. A retrospective study of 8 patients with facial vitiligo showed pimecrolimus resulted in mean improvement of surface area of 72.5%. Case reports of 3 patients with facial vitiligo showed favorable results.


In 1 open study comparing narrow-band UVB, tacrolimus, and pimecrolimus, no statistically significant differences in repigmentation for any anatomic site were recorded with the 3 treatments.


One study showed that pimecrolimus 1% cream combined with microdermabrasion was superior to pimecrolimus alone and placebo in nonsegmental childhood vitiligo. A single-blinded study showed that pimecrolimus 1% cream plus excimer laser was superior to excimer laser alone in childhood vitiligo.


Summary


Double-blind studies have shown that tacrolimus 0.1% ointment is superior to placebo when combined with excimer laser, especially for UV-resistant areas, and that when used alone, it is almost as effective as clobetasol 0.05%. Open studies have shown it can be effective, especially for facial lesions. Double-blind studies have shown that pimecrolimus 1% cream is superior to placebo when combined with narrow-band UVB, especially for facial lesions. However, double-blind and open studies have shown conflicting results when pimecrolimus is compared with clobetasol propionate. Similarly, double-blind studies showed conflicting results when it is compared with placebo. Additional studies would be helpful in clarifying the role of pimecrolimus in vitiligo.




Psoriasis


Tacrolimus


One double-blind study of 167 patients showed that tacrolimus 0.1% ointment, when applied twice a day to facial or intertriginous psoriasis, was superior to placebo ( P = .004), with improvement as early as day 8. Two other double-blind studies also showed tacrolimus is superior to vehicle, and 1 other double-blind study of facial/genital-femoral psoriasis showed tacrolimus 0.03% ointment was superior to calcitriol, which is a natural, bioactive 1,25-dihydroxyvitamin D 3 , available as an ointment in Europe. Seven open studies showed favorable results with tacrolimus, especially for facial/inverse/genital psoriasis.


Pimecrolimus


Investigators have assessed pimecrolimus in several double-blind studies of inverse psoriasis. One double-blind study showed pimecrolimus is superior to vehicle for inverse psoriasis. Another showed that pimecrolimus is superior to vehicle for inverse psoriasis, but inferior to calcipotriol and clobetasol. Another showed that pimecrolimus is superior to calcipotriol, but inferior to betamethasone valerate 0.1%. One open study showed pimecrolimus 1% cream resulted in significant improvement in all clinical parameters in facial psoriasis lesions.


Summary


Based on double-blind and open studies, tacrolimus 0.1% ointment is effective in psoriasis, especially for facial, inverse, and genital psoriasis. Similarly, 1 double-blind study showed that pimecrolimus 1% cream is superior to vehicle, especially for inverse psoriasis. Further studies are required to determine if pimecrolimus is more or less effective compared with potent corticosteroids and calcipotriol. Considering the high risk for the development of cutaneous atrophy when potent corticosteroids are applied to intertriginous skin, it seems reasonable to initiate therapy with TCI first.




Contact dermatitis


For nickel-induced allergic contact dermatitis, double-blind studies showed that tacrolimus is superior to placebo ; pimecrolimus 0.6% cream has been shown to be effective in 1 open study. In 1 double-blind study of contact dermatitis, there was no difference among tacrolimus 0.1% cream, pimecrolimus 1% cream, clobetasol propionate 0.05% ointment, triamcinolone acetonide 0.1% ointment, and placebo, but there was a clear trend in favor of active drug treatment.


Additional studies and case reports have shown positive results for tacrolimus and pimecrolimus for the management of allergic contact dermatitis. Pimecrolimus has also been effective in irritant contact dermatitis of the skin and lips, and in the cutaneous reaction to jelly fish sting.




Seborrheic dermatitis


Two open studies showed favorable results with tacrolimus 0.1%. In 1 double-blind study, pimecrolimus 1% cream was superior to vehicle ; in another study, it was equal to 1% hydrocortisone acetate cream. In 1 open study, it was equal to ketoconazole 2% cream ; another open study showed that pimecrolimus was more effective than topical metronidazole and topical methylprednisolone. Thus, multiple approaches to seborrhea exist, including the use of TCI and antifungal agents instead of topical corticosteroids.




Rosacea


Two open studies showed that tacrolimus 0.1% ointment can be effective for rosacea. One double-blind and 1 open study showed that pimecrolimus 1% cream is not more effective than vehicle. One open study showed that pimecrolimus is not more efficacious than metronidazole cream. Two open studies showed that pimecrolimus 1% cream can be effective in steroid-induced rosacea. Because there is a paucity of evidence in this regard, TCI should be reserved for otherwise recalcitrant rosacea.




Cutaneous lupus erythematosus


In 1 double-blind study, tacrolimus 0.1% ointment was equal to clobetasol propionate 0.05% ointment in facial lupus erythematosus (LE), especially malar rash, and lesions of discoid LE and subacute cutaneous LE. In open studies and case reports, treatment with tacrolimus also led to favorable results. A double-blind study showed that pimecrolimus 1% cream was comparable with betamethasone valerate 0.1% cream in discoid lupus. Pimecrolimus 1% cream was effective in cutaneous LE in open studies and case reports. More investigation, especially placebo- or vehicle-controlled studies, is required before TCI can be unequivocally recommended for cutaneous LE.




Perioral dermatitis


Two double-blind studies showed pimecrolimus 1% cream was superior to vehicle. Additional work is needed in this area.




Cutaneous Crohn disease


One double-blind study showed that tacrolimus 0.1% ointment is superior to placebo in perianal or anal ulcerative Crohn disease, but is unlikely to be effective if there are fistulae. In 1 open study, tacrolimus 0.5% ointment was effective in oral and perineal Crohn disease. In 1 patient treated with tacrolimus 0.05% in Orabase for orofacial Crohn disease, systemic absorption with a blood level of 9 μg/mL was documented.




Lichen sclerosus


Tacrolimus


In 1 open study of 84 patients (49 women, 32 men, 3 girls) with lichen sclerosus (79 with anogenital lichen sclerosus, 5 with extragenital lichen sclerosus) treated with tacrolimus 0.1% twice a day for 16 weeks, clearance of active lichen sclerosus was reached in 43% of patients at 24 weeks. Favorable results were also seen in smaller open studies in patients with vulvar lichen sclerosus and lichen sclerosus of the penis. Several case reports have also shown favorable results in vulvar lichen sclerosus, anogenital lichen sclerosus, and extragenital lichen sclerosus including lichen sclerosus of the lip.


Pimecrolimus


Several open studies and 1 case report showed favorable results of topical pimecrolimus in vulvar lichen sclerosus. One male patient with extragenital lichen sclerosus did not respond to pimecrolimus cream.


Summary


Potent topical corticosteroids remain the treatment of choice for lichen sclerosus. Nonetheless, response is unpredictable, and TCI offer a viable alternative therapeutic intervention. Lichen sclerosus may be associated with the development of squamous cell carcinoma and, therefore, before TCI therapy is started, the clinician should perform a careful examination to exclude the presence of neoplasia in this situation.




Morphea/scleroderma


A double-blind study showed that tacrolimus 0.1% ointment was more effective than petrolatum in morphea. An open study showed favorable results in localized scleroderma. Additional research is necessary.




Netherton syndrome


In 1 study, 3 patients with Netherton syndrome treated with 0.1% tacrolimus had very high blood tacrolimus levels, up to 37.2 μg/L, but none showed signs or symptoms of toxic effects of tacrolimus. Tacrolimus should be used with extreme caution, if at all, in patients with Netherton syndrome.




Tacrolimus: lack of efficacy


One open study and 3 case reports showed that tacrolimus 0.1% ointment is not effective in alopecia areata. One double-blind study of 22 patients with hemodialysis-related pruritus showed that tacrolimus was not more effective than vehicle. Additional studies and case reports showed that tacrolimus was not effective in frontal fibrosing alopecia, factitial panniculitis, and UV-induced erythema.




Pimecrolimus: lack of efficacy


Studies have shown lack of efficacy of pimecrolimus in alopecia areata and acne vulgaris. One prospective study of cetuximab-induced papulopustular eruption showed pimecrolimus did not result in clinically meaningful benefit, but 1 case report did show efficacy.




Other disorders


Investigators have shown that tacrolimus and pimecrolimus can be effective in many other disorders, sometimes as adjunctive therapy.


Tacrolimus


One review cited reports of favorable results with tacrolimus for the following: balanitis xerotica obliterans, lichen striatus, pyostomatitis vegetans, acrodermatitis continua suppurativa, Sjogren syndrome, Zoon balanitis, ichthyosis linearis circumflexa, lichen nitidus, intertrigo, itch of primary biliary cirrhosis, uremic pruritus, pemphigus folicacious, chronic actinic dermatitis, cutaneous sarcoid, granuloma annulare, lichen amyloidosis, idiopathic annular erythema, epidermolysis bullosa pruriginosa, exfoliative cheilitis, eosinophilic pustular folliculitis, reticular erythematosus, erosive pustular dermatosis of the leg and scalp, necrobiosis lipoidica, pityriasis lichenoides, paraneoplastic pemphigus, skin lesions of dermatomyositis, Hailey-Hailey disease (1 other report documented complete failure of topical tacrolimus), scleroderma, morphea, and vasculitic leg ulcer of rheumatoid arthritis.


In addition, a small number of studies and case reports have shown that tacrolimus can be effective in the following: granuloma faciale, chronic paronychia, lichen planus pigmentosus, pityriasis alba, annular lichenoid dermatitis of youth, genital pruritus, chronic otitis externa, incontinentia pigmenti, plasma cell cheilitis, granulomatous cheilitis, inflammatory linear verrucous epidermal nevus, jogger’s nipples, juvenile plantar dermatosis, lower extremity ulcer, localized lichen myxedematosus of discrete type, lichen simplex chronicus, lichenoid tattoo reaction, linear IgA bullous disease, mycosis fungoides, necrolytic acral erythema, plasma cell vulvitis, stasis dermatitis, and cheilitis glandularis.


Pimecrolimus


One review cited reports that pimecrolimus can be effective in Behcet disease, acne keloidalis nuchae, vulvar lichen simplex chronicus, vulvar pruritus,, graft versus host disease, lichen striatus, annular elastolytic giant cell granuloma, balanitis circinata, lichen aureus, granuloma annulare, lichen myxedematosus, nodular scabies, Fox-Fordyce disease, cutaneous plasmacytosis, granuloma faciale, chronic actinic dermatitis, telangiectasia macularis eruptiva perstans, erythema annulare centrifugum, lymphocytic infiltration of Jessner, and eosinophilic pustular folliculitis.


Additional reports indicate pimecrolimus can also be effective in vulvar lichen simplex chronicus, frontal fibrosing alopecia, dyshydrosis eczema, eruptive pseudo-angiomatosis, follicular mucinosis, pityriasis rubra pilari, pyoderma gangrenosum, reticular erythematous mucinosus, Zoon balanitis, and pityriasis alba.


Summary


Topical tacrolimus and pimecrolimus have been assessed in the treatment of many disorders other than atopic dermatitis. Double-blind and open studies have shown favorable results with topical tacrolimus and pimecrolimus in oral lichen planus. In 1 study of oral lichen planus, blood tacrolimus was detected in 54% of patients, but there were no signs of systemic toxicity. Double-blind and open studies of vitiligo have shown favorable results with tacrolimus in combination with excimer laser, especially for lesions over bony prominences and on extremities. Similarly, double-blind studies of vitiligo have shown favorable results when pimecrolimus is combined with narrow-band UVB, especially for facial lesions. Double-blind and open studies of psoriasis have shown favorable results for tacrolimus and pimecrolimus, especially for inverse psoriasis. Topical calcineurin inhibitors have been effective in many other cutaneous disorders, and further studies would help clarify their roles.


Dr Lin has been a paid speaker for Astellas Pharma Canada, Inc.



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Feb 12, 2018 | Posted by in Dermatology | Comments Off on Innovative Use of Topical Calcineurin Inhibitors

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