Atopic dermatitis efficacy

The evidence of the safety and efficacy of pimecrolimus was derived from studies primarily in patients with mild-to-moderate atopic dermatitis tacrolimus data was derived from moderate-to-severe patients. 

Atopic dermatitis has been proposed to be the cutaneous manifestation of IgE-mediated hypersensitive reaction to allergenic substances [29]. Conceptually, antagonizing IgE emerges as a logical therapeutic option. Systemic treatment with omalizumab, however, appears to be less efficacious in the skin than in the airway mucosa [23]. It is possible that small molecule Syk inhibitors may offer a more suitable mode to reach and prevent activation of sensitized dermal mast cells and dendritic cells. 

Allen BR, Lakhanpaul M, Morris A, Lateo S, Davies T, Scott G Cardno M, Ebelin ME, Burtin P, Stephenson TJ. (2003) Systemic exposure, tolerability, and efficacy of pimecrolimus cream 1% in atopic dermatitis patients. 

Ashcroft DM, Dimmock P, Garside R, Stein K, Williams HC. Efficacy and tolerability of topical pimecrolimns and tacrolimus in the treatment of atopic dermatitis meta-analysis of randomised controlled trials. BMJ 2005 330 516-21. 

Numerous glucocorticosteroids for topical application are available. Essentially they all suppress the symptoms of inflammatory and hypersensitivity reactions and their mechanism of action is similar. Their indications include seborrhoeic and atopic dermatitis, phototoxic reactions, psoriasis, chronic discoid lupus, hypertrophic lichen planus and alopecia areata. However it has to be kept in mind that the use of corticosteroids for these conditions in most cases only gives symptomatic relieve and that the problem tends to recur on cessation of therapy. Traditionally topical corticosteroid formulations are grouped according to approximate relative efficacy. This efficacy is determined by both the potency of the agent and the concentration in which the corticosteroid is used. 

Atopic dermatitis effect. Rice bran broth, administered to 17 patients with atopic dermatitis as bath therapy, was safe and clinically useful. The rice bran broth was dissolved in the bathtub as a medicinal bath. One of the patients discontinued therapy after developing redness and itching of the skin just after bathing. The other 16 patients continued the bath for 2-5 months and recorded skin conditions once a month. The efficacy of the therapy in alleviating skin symptoms was excellent in four patients, good in seven, slightly effective in four, and effective in one. Recurrence of initial symptoms was not detected in any patients during the rice bran broth bath-ing 4 . 

Baranov A, Geppe N, Karpushkina A (1997) Efficacy of Enterosgel in therapy of bronchial asthma and atopic dermatitis in children. In Biosorption methods and preparations in prophylactic and therapeutic practice. First Conference, Kyiv (In Ukrainian), pp. 50-52... 

Pacor ML, Biasi D, Maleknia T The efficacy of long-term specific immunotherapy for Dermatophagoides pteronyssinus in patients with atopic dermatitis. Recenti Prog Med 1994 85 273-277. 

RCTs it is therefore possible to gain information about the efficacy of moisturizers as monotherapy. The effect of the cream base varies. In a stable, dry, and scaly dermatosis such as psoriasis, active treatment with calcipotriol reduces disease severity as assessed by PASI scores by 56%, whereas the use of the cream base reduces it 35%.1 Dry skin is also a key diagnostic element in atopic dermatitis and moisturizers are therefore extensively used in this disease. Looking at the placebo-arm in RCTs of topical treatment of atopic dermatitis the placebo effect appears to be in the range of 20%.2 6 The disease is however also more dynamic, and it waxes and wanes more frequently than psoriasis, which may explain the difference seen between the two disseases. 

Meurer, M., Fartasch, M., Albercht, G. et al. Long-term efficacy and safety of pimecrolimus cream 1% in adults with moderate atopic dermatitis. Dermatology 2004 208 365-72. 

Berardesca, E., Barbareschhi, M., Veraldi, S., and Pimpinelh, N. Evaluation of the efficacy of a skin lipid mixture in patients with irritant contact dermatitis, allergic contact dermatitis or atopic dermatitis a multicenter study. Contact Dermatitis 2001 45 280-5. 

The level of evidence for the clinical efficacy of 4 to 10% urea in the treatment of dry skin in patients with atopic dermatitis support evidence-level lb. A formal meta-analysis may give further support for level la. 

Hagstromer, L., Nyren, M., and Emtestam, L., Do urea and sodium chloride together increase the efficacy of moisturizers for atopic dermatitis skin. A comparative, double-blind and randomised study, Skin Pharmacol. Appl. Skin Physiol., 14, 27, 2001. 

Stucker, M. et al., Topical vitamin B12 — a new therapeutic approach in atopic dermatitis-evaluation of efficacy and tolerability in a randomized placebo-controlled multicentre clinical trial, Br. J. Dermatol., 150, 977, 2004. 

Letawe, C., Pierard-Franchimont, C., and Pierard, G.E. Squamometry in rating the efficacy of topical corticosteroids in atopic dermatitis. Eur. J. Clin. Pharmacol. 51, 253-258 (1996). 

Some trials have suggested that ketotifen has similar efficacy to cromoglicate in asthma (2) and also a small steroid-sparing effect (3). It is more effective than placebo in the treatment of atopic dermatitis (4). The normal therapeutic dose is 1-2 mg/day. 

Pimecrolimus is a non-steroidal ascomycin derivative with topical anti-inflammatory activity. In a 1% cream it is effective and safe in atopic dermatitis in infants, children, and adults (1-3), although its efficacy has been questioned (4). 

Eichenfield LF, Lucky AW, Boguniewicz M, Langley RG, Cherill R, Marshall K, Bush C, Graeber M. Safety and efficacy of pimecrolimus (ASM 981) cream 1% in the treatment of mild and moderate atopic dermatitis in children and adolescents. J Am Acad Dermatol 2002 46(4) 495-504. 

Jablonska S, Rustin M. Safety and efficacy of 1 year of tacrolimus ointment monotherapy in adults with atopic dermatitis. The European Tacrolimus Ointment Study Group. Arch Dermatol 2000 136(8) 999-1006. 

Kang S, Lucky AW, Pariser D, Lawrence I, Hanifin JM. Long-term safety and efficacy of tacrolimus ointment for the treatment of atopic dermatitis in children. J Am Acad Dermatol 2001 44(Suppl l) S58-64. 

Pimecrolimus and tacrolimus are calcineurin inhibitors capable of exerting a local immunomodulating effect that may serve to normalize hyperproliferation of epidermis. As topical agents, tacrolimus and pimecrolimus are approved for the treatment of atopic dermatitis however, regulatory approval regarding the efficacy of these agents in psoriasis is yet to be completed. 

Klein PA, Clark RAF. An evidence-based review of the efficacy of antihistamines in relieving pruritus in atopic dermatitis. Arch Dermatol 1999 135 1522-1525. 

Wahn U, Bos JD, Goodfield M, et al. Efficacy and safety of pimecroUmus cream in the long-term management of atopic dermatitis in children. Pediatrics 2002 110(1 Pt. I) e2. 

The role of both T and B lymphocytes in a variety of disease states beyond transplantation has become increasingly important in the past decade. This is especially true of those diseases frequently referred to as autoimmune in their etiology, such as rheumatoid arthritis, nephrotic syndrome, systemic lupus erythematosus, inflammatory bowel disease, and so on. In addition, several other major diseases are also known to have a component of T- or B-cell-mediated pathogenesis, for example, atopic dermatitis, psoriasis, and asthma. Until very recently, the mainstay of therapy for these diseases was the corticosteroids, which were often less than satisfactory in efficacy and often associated with undesirable side effects, especially in growing children and the elderly. Thus, the search for new agents with different mechanisms of action and which did not have the same adverse event profile as conventional corticosteroids led to the subsequent evaluation of drugs such as tacrolimus and sirolimus to treat several of these diseases. 

---