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• W2149787024 abstract "To the Editor: Efalizumab is a humanized monoclonal immunoglobulin G1 antibody against the CD11a subunit of the lymphocyte function–associated antigen 1 that has been approved by the US Food and Drug Administration (FDA) as a treatment for moderate-to-severe plaque psoriasis. Several randomized, placebo-controlled, double-blind trials reported few side effects.1Scheinfeld N. Efalizumab: a review of events reported during clinical trials and side effects.Expert Opin Drug Saf. 2006; 5: 197-209Crossref PubMed Scopus (86) Google Scholar Autoimmune thrombocythemia was observed in 0.3% of cases. To add to the potential list of possibly induced autoimmune diseases, we report a case of bullous pemphigoid (BP) occurring after injections of efalizumab.A 51-year-old white male with a 10-year history of moderate psoriasis treated topically without previous hospitalization was seen in our department in August 2005 for a flare of psoriatic erythroderma and bullae after two injections of efalizumab. In May 2005, he had been treated by corticosteroids and psoralen plus ultraviolet A light (PUVA) phototherapy for an unusually extended psoriasis flare with incomplete clearance.Efalizumab was prescribed in July 2005, with a first injection of 1 mg/kg and a second injection of 1 mg/kg 10 days later. An increased number of plaques was seen 3 days before the second injection, and blisters then developed on the psoriatic plaques, which led to the discontinuation of efalizumab. The patient received two injections of methicillin 2 g (4 g total) and was referred to our department 15 days after the onset of blisters.On admission, the skin examination revealed the following: psoriasis involving >90% of the body surface area, a Psoriasis Area and Severity Index score of 39 (out of 72), and diffuse, large purpuric plaques and thick scales on his body and a scaly helmet on the scalp. There were a few erosions on the neck, and about 10 tense bulla were observed on the psoriatic plaques, along with two erythematous postbullous lesions on the upper lip and scrotum, respectively. No lesions were seen on the mucous membranes, and the remainder of the clinical examination was unremarkable.Laboratory examination revealed a white blood cell count of 18,800/mm3. Eosinophils, hemoglobin, platelet count, asparate aminotransferase, and alanine aminotransferase values were within normal limits, and antinuclear antibodies were negative. Histologic examination of a blister specimen revealed a subepidermal bulla occurring on the psoriatic skin. Direct immunofluorescence of the perilesional skin showed IgG and C3 linear deposits on the dermoepidermal junction. By indirect immunofluorescence, circulating anti–basement membrane zone antibodies were detected on human normal skin cryostat sections (titer, 1:80) but not on rat esophagus substrate. With the use of 1 mol NaCl on split normal human skin, the serum reacted with the epidermal site of the substrate (titer, 1:80). Enzyme-linked immunosorbent assay and immunoblotting of epidermal extracts identified antibodies to BPAG2 (180 kD). The diagnosis was made of BP occurring on psoriatic skin after two injections of efalizumab.Treatment with 20 g of topical corticosteroids over the course of 1 month stopped the formation of new blisters, and acitretin 15 mg per day successfully controlled his psoriasis. One month later, the anti–basement membrane zone antibodies titer decreased to 1:20. No relapse of BP was observed in the follow-up period of 40 months after efalizumab withdrawal and efficient psoriasis treatment.BP associated with psoriasis has been reported in the literature.2Wilczek A. Sticherling M. Concomitant psoriasis and bullous pemphigoid: coincidence or pathogenic relationship?.Int J Dermatol. 2006; 45: 1353-1357Crossref PubMed Scopus (58) Google Scholar Both diseases have high rates of incidence, but the younger mean age of patients presenting with both psoriasis and BP compared to BP alone suggests some common pathogenic factors. Chronic disruption of the basement membrane layer in psoriasis may result in altered antigenicity and the subsequent generation of antibodies against BP 180.2Wilczek A. Sticherling M. Concomitant psoriasis and bullous pemphigoid: coincidence or pathogenic relationship?.Int J Dermatol. 2006; 45: 1353-1357Crossref PubMed Scopus (58) Google Scholar The development of BP after PUVA therapy in some cases suggests that ultraviolet light damage plays a role in epidermal structural changes, and the Koebner phenomenon may explain a psoriasis flare after BP. In our patient, BP caused by PUVA therapy was eliminated because of the long interval between the onset of blisters and the PUVA.The results of a recent 3-year continuous study of efalizumab did not reveal an increased risk of serious infections or adverse events.3Leonardi C. Menter A. Hamilton T. Caro I. Xing B. Gottlieb A.B. Efalizumab: results of a 3-year continuous dosing study for the long-term control of psoriasis.Br J Dermatol. 2008; 158: 1107-1116Crossref PubMed Scopus (81) Google Scholar Most adverse events occurred after treatment discontinuation or withdrawal. Reports of early or delayed autoimmune cytopenias also pointed out efalizumab's role in the dysregulation of autoantibody production.4Kwan J.M. Reese A.M. Trafeli J.P. Delayed autoimmune hemolytic anemia in efalizumab-treated psoriasis.J Am Acad Dermatol. 2008; 58: 1053-1055Abstract Full Text Full Text PDF PubMed Scopus (16) Google Scholar In October 2008, the FDA published an alert concerning cases of progressive multifocal leukoencephalopathy associated with efalizumab therapy.5Adis InternationalEfalizumab: progressive multifocal leukoencephalopathy (first case) in an elderly patient: case report.Reactions. 2008; 1223: 10Google Scholar No cases of BP associated with efalizumab therapy have been reported in the literature or to the French Pharmacovigilance Network.Our patient presented with BP 3 weeks after the first drug challenge, which rapidly improved after efalizumab discontinuation. The development of BP by efalizumab therapy suggests its possible induction of skin autoimmunity. To the Editor: Efalizumab is a humanized monoclonal immunoglobulin G1 antibody against the CD11a subunit of the lymphocyte function–associated antigen 1 that has been approved by the US Food and Drug Administration (FDA) as a treatment for moderate-to-severe plaque psoriasis. Several randomized, placebo-controlled, double-blind trials reported few side effects.1Scheinfeld N. Efalizumab: a review of events reported during clinical trials and side effects.Expert Opin Drug Saf. 2006; 5: 197-209Crossref PubMed Scopus (86) Google Scholar Autoimmune thrombocythemia was observed in 0.3% of cases. To add to the potential list of possibly induced autoimmune diseases, we report a case of bullous pemphigoid (BP) occurring after injections of efalizumab. A 51-year-old white male with a 10-year history of moderate psoriasis treated topically without previous hospitalization was seen in our department in August 2005 for a flare of psoriatic erythroderma and bullae after two injections of efalizumab. In May 2005, he had been treated by corticosteroids and psoralen plus ultraviolet A light (PUVA) phototherapy for an unusually extended psoriasis flare with incomplete clearance. Efalizumab was prescribed in July 2005, with a first injection of 1 mg/kg and a second injection of 1 mg/kg 10 days later. An increased number of plaques was seen 3 days before the second injection, and blisters then developed on the psoriatic plaques, which led to the discontinuation of efalizumab. The patient received two injections of methicillin 2 g (4 g total) and was referred to our department 15 days after the onset of blisters. On admission, the skin examination revealed the following: psoriasis involving >90% of the body surface area, a Psoriasis Area and Severity Index score of 39 (out of 72), and diffuse, large purpuric plaques and thick scales on his body and a scaly helmet on the scalp. There were a few erosions on the neck, and about 10 tense bulla were observed on the psoriatic plaques, along with two erythematous postbullous lesions on the upper lip and scrotum, respectively. No lesions were seen on the mucous membranes, and the remainder of the clinical examination was unremarkable. Laboratory examination revealed a white blood cell count of 18,800/mm3. Eosinophils, hemoglobin, platelet count, asparate aminotransferase, and alanine aminotransferase values were within normal limits, and antinuclear antibodies were negative. Histologic examination of a blister specimen revealed a subepidermal bulla occurring on the psoriatic skin. Direct immunofluorescence of the perilesional skin showed IgG and C3 linear deposits on the dermoepidermal junction. By indirect immunofluorescence, circulating anti–basement membrane zone antibodies were detected on human normal skin cryostat sections (titer, 1:80) but not on rat esophagus substrate. With the use of 1 mol NaCl on split normal human skin, the serum reacted with the epidermal site of the substrate (titer, 1:80). Enzyme-linked immunosorbent assay and immunoblotting of epidermal extracts identified antibodies to BPAG2 (180 kD). The diagnosis was made of BP occurring on psoriatic skin after two injections of efalizumab. Treatment with 20 g of topical corticosteroids over the course of 1 month stopped the formation of new blisters, and acitretin 15 mg per day successfully controlled his psoriasis. One month later, the anti–basement membrane zone antibodies titer decreased to 1:20. No relapse of BP was observed in the follow-up period of 40 months after efalizumab withdrawal and efficient psoriasis treatment. BP associated with psoriasis has been reported in the literature.2Wilczek A. Sticherling M. Concomitant psoriasis and bullous pemphigoid: coincidence or pathogenic relationship?.Int J Dermatol. 2006; 45: 1353-1357Crossref PubMed Scopus (58) Google Scholar Both diseases have high rates of incidence, but the younger mean age of patients presenting with both psoriasis and BP compared to BP alone suggests some common pathogenic factors. Chronic disruption of the basement membrane layer in psoriasis may result in altered antigenicity and the subsequent generation of antibodies against BP 180.2Wilczek A. Sticherling M. Concomitant psoriasis and bullous pemphigoid: coincidence or pathogenic relationship?.Int J Dermatol. 2006; 45: 1353-1357Crossref PubMed Scopus (58) Google Scholar The development of BP after PUVA therapy in some cases suggests that ultraviolet light damage plays a role in epidermal structural changes, and the Koebner phenomenon may explain a psoriasis flare after BP. In our patient, BP caused by PUVA therapy was eliminated because of the long interval between the onset of blisters and the PUVA. The results of a recent 3-year continuous study of efalizumab did not reveal an increased risk of serious infections or adverse events.3Leonardi C. Menter A. Hamilton T. Caro I. Xing B. Gottlieb A.B. Efalizumab: results of a 3-year continuous dosing study for the long-term control of psoriasis.Br J Dermatol. 2008; 158: 1107-1116Crossref PubMed Scopus (81) Google Scholar Most adverse events occurred after treatment discontinuation or withdrawal. Reports of early or delayed autoimmune cytopenias also pointed out efalizumab's role in the dysregulation of autoantibody production.4Kwan J.M. Reese A.M. Trafeli J.P. Delayed autoimmune hemolytic anemia in efalizumab-treated psoriasis.J Am Acad Dermatol. 2008; 58: 1053-1055Abstract Full Text Full Text PDF PubMed Scopus (16) Google Scholar In October 2008, the FDA published an alert concerning cases of progressive multifocal leukoencephalopathy associated with efalizumab therapy.5Adis InternationalEfalizumab: progressive multifocal leukoencephalopathy (first case) in an elderly patient: case report.Reactions. 2008; 1223: 10Google Scholar No cases of BP associated with efalizumab therapy have been reported in the literature or to the French Pharmacovigilance Network. Our patient presented with BP 3 weeks after the first drug challenge, which rapidly improved after efalizumab discontinuation. The development of BP by efalizumab therapy suggests its possible induction of skin autoimmunity." @default.
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