Pimecrolimus 1% cream for cutaneous lupus erythematosus

doi:10.1016/j.jaad.2004.01.044

Journal of the American Academy of Dermatology

Volume 51, Issue 3, September 2004, Pages 407-410

https://doi.org/10.1016/j.jaad.2004.01.044 Get rights and content

Abstract

Topical treatment of cutaneous lupus erythematosus usually includes potent glucocorticosteroids. However, prolonged use causes adverse side effects including skin atrophy as the foremost concern. In contrast to glucocorticosteroids, the anti-inflammatory and immunosuppressive macrolactam pimecrolimus has no atrophogenic potential. Affected areas of 11 patients with different forms of lupus erythematosus were treated with pimecrolimus 1% cream under semiocclusive conditions twice daily for 3 weeks. Skin involvement before and after therapy was assessed by means of a clinical score. In all patients, significant regression of skin lesions was observed after therapy (P < .001). This was an open and uncontrolled study on a limited number of cases. We suggest that pimecrolimus 1% cream could be an efficacious and safe treatment option for cutaneous lupus erythematosus.

Section snippets

Patients

A total of 11 patients (9 female and 2 male) with cutaneous manifestations of LE were included in this case series (Table I). The patients ranged in age from 11 to 76 years with a mean age of 47.2 years. The duration of LE ranged from 1 month to 23 years. Detailed history and physical examination, complete blood cell count, antinuclear antibody test, routine blood chemistry testing, urine analysis, chest radiography, phototesting, and ultrasound of the abdomen were performed in each patient

Results

Treatment with pimecrolimus 1% cream was well accepted and completed by all patients. Table I summarizes the clinical features and clinical response after application of pimecrolimus 1% cream twice daily. Clinically, the results obtained were satisfactory for both the patients and the physicians. In all patients, palpation and inspection showed a remarkable improvement of former affected skin lesions resulting in a highly significant decrease (P < .001) of the clinical score from 6.45 ± (0.80)

Discussion

Pimecrolimus (SDZ ASM 981) belongs to the ascomycin class of macrolactam immunosuppressives, acting by the inhibition of T-cell activation by the calcineurin pathway and inhibition of the release of numerous inflammatory cytokines, thereby preventing the cascade of immune and inflammatory signals.9., 10., 11. Like its “big brother” tacrolimus, it is primarily used for the treatment of atopic dermatitis.11., 12. In the dermatologic field, tacrolimus ointment has also shown to be effective in

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Guideline for the diagnosis, treatment and long-term management of cutaneous lupus erythematosus
2021, Journal of Autoimmunity
Citation Excerpt :
The results showed that the DLE disease activity decreased by 84% and 73%, respectively, in the two treatment groups, with the difference not statistically significant [50]. Other observational studies have documented the efficacy of 1% pimercrolimus cream in treatment of CLE patients [59,60]. Retinoids, including tazarotin gel, 0.05% retinoid cream and 0.025% retinoic acid gel, have not been tested by RCT studies for their efficacy in treating CLE.
Cutaneous lupus erythematosus (CLE) is an inflammatory, autoimmune disease encompassing a broad spectrum of subtypes including acute, subacute, chronic and intermittent CLE. Among these, chronic CLE can be further classified into several subclasses of lupus erythematosus (LE) such as discoid LE, verrucous LE, LE profundus, chilblain LE and Blaschko linear LE. To provide all dermatologists and rheumatologists with a practical guideline for the diagnosis, treatment and long-term management of CLE, this evidence- and consensus-based guideline was developed following the checklist established by the international Reporting Items for Practice Guidelines in Healthcare (RIGHT) Working Group and was registered at the International Practice Guideline Registry Platform. With the joint efforts of the Asian Dermatological Association (ADA), the Asian Academy of Dermatology and Venereology (AADV) and the Lupus Erythematosus Research Center of Chinese Society of Dermatology (CSD), a total of 25 dermatologists, 7 rheumatologists, one research scientist on lupus and 2 methodologists, from 16 countries/regions in Asia, America and Europe, participated in the development of this guideline. All recommendations were agreed on by at least 80% of the 32 voting physicians. As a consensus, diagnosis of CLE is mainly based on the evaluation of clinical and histopathological manifestations, with an exclusion of SLE by assessment of systemic involvement. For localized CLE lesions, topical corticosteroids and topical calcineurin inhibitors are first-line treatment. For widespread or severe CLE lesions and (or) cases resistant to topical treatment, systemic treatment including antimalarials and (or) short-term corticosteroids can be added. Notably, antimalarials are the first-line systemic treatment for all types of CLE, and can also be used in pregnant patients and pediatric patients. Second-line choices include thalidomide, retinoids, dapsone and MTX, whereas MMF is third-line treatment. Finally, pulsed-dye laser or surgery can be added as fourth-line treatment for localized, refractory lesions of CCLE in cosmetically unacceptable areas, whereas belimumab may be used as fourth-line treatment for widespread CLE lesions in patients with active SLE, or recurrence of ACLE during tapering of corticosteroids. As for management of the disease, patient education and a long-term follow-up are necessary. Disease activity, damage of skin and other organs, quality of life, comorbidities and possible adverse events are suggested to be assessed in every follow-up visit, when appropriate.
Management of cutaneous manifestations of lupus erythematosus: A systematic review
2020, Seminars in Arthritis and Rheumatism
Citation Excerpt :
Topical therapy with CNIs however, has been formally studied and these may be a good first-line topical steroid-sparing therapy for CLE. This search has identified moderate consistent evidence to support topical CNI therapy to reduce dependence on topical steroids (Table 1) [5–17]. Furthermore, in sensitive areas such as facial skin, these agents carry a lower risk of complications including telangiectasia and striae compared with topical corticosteroids [9].
Cutaneous lupus erythematosus (CLE), occurring with or without systemic lupus erythematosus (SLE), is a group of inflammatory skin diseases that can be very debilitating, causing significant psychological distress, and sometimes scarring.
We sought to comprehensively present the evidence for different treatment modalities in patients with cutaneous manifestations of lupus erythematosus (LE).
Medline, Embase, Scopus and Cochrane CENTRAL were searched electronically from 1990 to March 2019, using keywords related to cutaneous lupus and synonyms and treatment. Articles retrieved were screened for relevance, including reference lists of retrieved reviews. We included clinical trials, observational studies or case series with ≥5 patients focussing on treatment of CLE, with or without SLE.
The search identified 6637 studies, of which 107 were included. Each study commonly included a heterogeneous mixture of CLE subtypes, with or without SLE. The 107 included studies investigated 11 different categories of treatment in 7343 patients. Treatments included topical calcineurin inhibitors (13 studies), sun protection (5 studies), R-salbutamol cream (2 studies), antimalarials (22 studies), synthetic DMARDs (10 studies), retinoids (2 studies), thalidomide/lenalidomide (22 studies), biologic therapies (15 studies), intravenous immune globulin (3 studies), laser (6 studies) and other therapies (7 studies). General measures to be considered include smoking cessation, sun protection measures and optimisation of vitamin D levels. Moderate evidence exists for benefit with topical CNIs, particularly as a steroid sparing agent in areas at high risk of steroid complications (e.g. facial skin). There is moderate evidence for hydroxychloroquine, which is first-line in SLE patients, limited evidence to support other synthetic DMARDs, and moderate evidence supporting thalidomide but with significant risk of toxicity. Of biologic therapies, there are moderate data to support belimumab. Limited evidence exists for other therapies.
Many management options are available for CLE, including topical, systemic and biologic therapies, with a variable balance of efficacy and toxicity. There is a paucity of high-quality clinical trial data. Further trials are required to better understand optimal management of CLE, particularly in specific subgroups.
Topical Calcineurin Inhibitors
2020, Comprehensive Dermatologic Drug Therapy, Fourth Edition
With the ever-evolving landscape of pharmacotherapy and the greater understanding of various dermatological conditions, topical inhibitors play a vital role as treatment alternatives and treatment approaches of different conditions patients may experience. These nonsteroidal anti-inflammatory agents are a commonly used class for the treatment of atopic dermatitis. Unlike topical corticosteroids, these immunomodulating agents work to reduce inflammation through targeting cytokine production without affecting the collagen production of the skin and therefore avoiding atrophy of the skin. This overall benefit may serve as a valuable alternative for the treatment of inflammatory conditions in the pediatric population, in whom topical corticosteroids are not an option because of their clinical circumstances or lack of favor by caregivers. There are two types of topical calcineurin inhibitors—tacrolimus ointment (Protopic 0.03% and 0.1%) and cream (Elidel 1%), the lipophilic nature of which allows for their use as topical agents. The evidence concerning their safety is still questioned amongst health and safety regulatory boards throughout the world, with some showing concern regarding their use and others not. However, we can be confident about their efficacy and that they offer a reasonable and efficacious approach after assessing an individual's needs.
Systemic lupus erythematosus in childhood and adolescence
2018, Dubois' Lupus Erythematosus and Related Syndromes
Although it presents more commonly in adulthood, systemic lupus erythematosus (SLE) may affect children and adolescents. Pediatric patients with SLE have many of the same manifestations as adults, although unique issues with compliance and family dynamics often make this population difficult to treat. Delays in diagnosis may occur because of a lack of physician familiarity with the disease, and they may contribute to poor prognosis. With proper medical and psychosocial management, children with lupus can thrive.
SLE in Childhood and Adolescence
2013, Dubois' Lupus Erythematosus and Related Syndromes: Eighth Edition
Topical calcineurin inhibitors
2012, Comprehensive Dermatologic Drug Therapy: Expert Consult - Online and Print

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TherapyPimecrolimus 1% cream for cutaneous lupus erythematosus☆

Abstract

Section snippets

Patients

Results

Discussion

J Am Acad Dermatol

J Am Acad Dermatol

J Am Acad Dermatol

Systemic lupus erythematosus

Cutaneous lupus erythematosus: diagnosis and management

Am J Clin Dermatol

A short-term trial of tacrolimus ointment for atopic dermatitis: European tacrolimus multicenter atopic dermatitis study group

N Engl J Med

Topical FK506 (tacrolimus) therapy for facial erythematous lesions of cutaneous lupus erythematosus and dermatomyositis

Eur J Dermatol

Topical tacrolimus therapy for lesions of cutaneous lupus erythematosus–reply to the comments of Drs Walker, Kirby and Chalmers

Eur J Dermatol

The effect of topical tacrolimus on severe recalcitrant chronic discoid lupus erythematosus

Eur J Dermatol

Lupus erythematosus tumidus–a neglected subset of cutaneous lupus erythematosus: report of 40 cases

Arch Dermatol

Therapy
Pimecrolimus 1% cream for cutaneous lupus erythematosus☆