Immunogenicity and skin clearance recapture in clinical studies of brodalumab.

Abstract:

BACKGROUND:Antidrug antibodies (ADAs) may change pharmacokinetic or pharmacodynamic profiles of biologic therapies, potentially decreasing efficacy. OBJECTIVE:To evaluate the potential effects of brodalumab immunogenicity on safety, efficacy, and retreatment. METHODS:Data from 1 phase 2 and 3 phase 3 studies of brodalumab in psoriasis were analyzed. RESULTS:Overall, 2.7% of patients had positive test results for binding ADAs after receiving brodalumab; ADAs were transient in 1.4% of patients, and there were no neutralizing ADAs. Among ADA-positive patients, 60.0% (3/5) achieved a static physician's global assessment score of 0 or 1 at week 12 in the group receiving the brodalumab 210 mg every 2 weeks, compared with 79.1% (1131/1429) of ADA-negative patients. All patients (100%) who experienced return of disease and were retreated with brodalumab 210 mg every 2 weeks (none were ADA positive) achieved at least a 75% improvement in Psoriasis Area And Severity Index, ≥90% of whom regained response by week 8 of retreatment. Hypersensitivity reactions were less frequent with brodalumab than with placebo. Injection site reactions occurred in 1.8% of patients treated with brodalumab versus 2% of patients treated with ustekinumab. LIMITATIONS:Retreatment could be assessed in only 1 phase 3 brodalumab study. CONCLUSION:Brodalumab compares favorably with other biologics in terms of immunogenicity and high rates of efficacy recapture upon retreatment.

journal_name

J Am Acad Dermatol

authors

Bagel J,Lebwohl M,Israel RJ,Jacobson A

doi

10.1016/j.jaad.2019.05.094

subject

Has Abstract

pub_date

2020-02-01 00:00:00

pages

344-351

issue

2

eissn

0190-9622

issn

1097-6787

pii

S0190-9622(19)30898-9

journal_volume

82

pub_type

杂志文章
  • Vascular cell adhesion molecule-1: expression in normal and diseased skin and regulation in vivo by interferon gamma.

    abstract:BACKGROUND:Vascular cell adhesion molecule-1 (VCAM-1) is an endothelial protein with adhesive properties for inflammatory cells including lymphocytes. Its role in skin disease and regulation in vivo are uncertain. OBJECTIVE:Our purpose was to determine expression of VCAM-1 in normal and inflamed skin and the effect on...

    journal_title:Journal of the American Academy of Dermatology

    pub_type: 杂志文章

    doi:10.1016/0190-9622(93)70154-l

    authors: Groves RW,Ross EL,Barker JN,MacDonald DM

    更新日期:1993-07-01 00:00:00

  • Proceedings of the International Consensus Conference on Cutaneous T-cell Lymphoma (CTCL) Treatment Recommendations. Boston, Massachusetts, Oct. 1 and 2, 1994.

    abstract::At the International Consensus Conference for Cutaneous T-Cell Lymphoma (CTCL) Treatment Recommendations (held in Boston, Massachusetts, Oct. 1 and 2, 1994), international experts were asked to assess where consensus existed and to identify areas that required clinical research. We review the epidemiology, pathology, ...

    journal_title:Journal of the American Academy of Dermatology

    pub_type: 共识发展会议,杂志文章,评审

    doi:10.1016/s0190-9622(97)80226-5

    authors: Demierre MF,Foss FM,Koh HK

    更新日期:1997-03-01 00:00:00

  • Propranolol treatment of infantile hemangioma is not associated with psychological problems at 7 years of age.

    abstract:BACKGROUND:Concern has been raised about the potential long-term effects of propranolol treatment for infantile hemangioma (IH). OBJECTIVES:We sought to assess psychologic (social, emotional, behavioral, and executive) functioning in children treated with propranolol for IH. METHODS:Twenty-seven patients with IH (6.1...

    journal_title:Journal of the American Academy of Dermatology

    pub_type: 杂志文章

    doi:10.1016/j.jaad.2017.01.025

    authors: Moyakine AV,Spillekom-van Koulil S,van der Vleuten CJM

    更新日期:2017-07-01 00:00:00

  • Role of immunohistochemistry in the diagnosis of undifferentiated tumors involving the skin.

    abstract::Twenty undifferentiated skin tumors were examined by immunostaining in an attempt to achieve more precise identification. Light microscopy yielded only a differential diagnosis, whereas immunostaining of formalin-fixed, paraffin-embedded tissue sections with a panel of antibodies to intermediate filaments and other ce...

    journal_title:Journal of the American Academy of Dermatology

    pub_type: 杂志文章

    doi:10.1016/s0190-9622(86)70133-3

    authors: Kahn H,Baumal R,From L

    更新日期:1986-06-01 00:00:00

  • Metastatic cutaneous carcinoid.

    abstract::A case of malignant bronchial carcinoid with multiple cutaneous metastases is reported. Despite the extremely aggressive behavior of the disease and the presence of multiple hepatic metastases, the patient did not exhibit the usual clinical features of the carcinoid syndrome. The relevance of the finding of elevated 2...

    journal_title:Journal of the American Academy of Dermatology

    pub_type: 杂志文章

    doi:10.1016/s0190-9622(85)70175-2

    authors: Archer CB,Wells RS,MacDonald DM

    更新日期:1985-08-01 00:00:00

  • The specificity and sensitivity of Nikolskiy sign in the diagnosis of pemphigus.

    abstract:BACKGROUND:The Nikolskiy sign is a well-known mechanical symptom that can be helpful in the diagnosis of pemphigus. The reports about associations with other than pemphigus cause confusion concerning the diagnostic importance of the Nikolskiy sign in pemphigus. OBJECTIVE:Our purpose was to examine the significance and...

    journal_title:Journal of the American Academy of Dermatology

    pub_type: 杂志文章

    doi:10.1016/j.jaad.2005.10.019

    authors: Uzun S,Durdu M

    更新日期:2006-03-01 00:00:00

  • Hypomelanosis of Ito. Report of a case and review of the literature.

    abstract::A 5-month-old boy with hypomelanosis of Ito was studied. Lesions presented as bizarre, hypopigmented whorls and streaks. Histologic studies showed that the hypopigmented areas contained normal melanocytes with decreased content of intracellular melanin. A review of the literature revealed the disease to be a discrete ...

    journal_title:Journal of the American Academy of Dermatology

    pub_type: 杂志文章

    doi:10.1016/s0190-9622(81)70023-9

    authors: Buzas JW,Sina B,Burnett JW

    更新日期:1981-02-01 00:00:00

  • Widespread cutaneous vascular papules associated with peripheral blood eosinophilia and prominent inguinal lymphadenopathy.

    abstract::A new section entitled "Dermatology Grand Rounds at the NIH" appears this month. The idea behind it is to provide a unique look at instructive dermatologic cases being presented at the weekly Dermatology Branch Grand Rounds at the National Cancer Institute, National Institutes of Health (NIH), Bethesda, Maryland. Pati...

    journal_title:Journal of the American Academy of Dermatology

    pub_type: 杂志文章

    doi:10.1067/mjd.2000.108372

    authors: Blauvelt A,Cobb MW,Turner ML

    更新日期:2000-10-01 00:00:00

  • Intratumoral DNA stem-line heterogeneity in superficial spreading melanoma.

    abstract:BACKGROUND:In primary melanomas, data on the degree of intratumoral heterogeneity to date have been lacking. OBJECTIVE:Our purpose was to investigate intratumoral DNA stem-line heterogeneity in superficial spreading melanoma (SSM). METHODS:Multiple measuring fields of 54 SSMs (tumor thickness median 1.60 mm) were stu...

    journal_title:Journal of the American Academy of Dermatology

    pub_type: 杂志文章

    doi:10.1016/j.jaad.2004.12.049

    authors: Helmbold P,Altrichter D,Klapperstück T,Marsch WCh

    更新日期:2005-05-01 00:00:00

  • Neonate with a fibrosarcoma and consumptive coagulopathy.

    abstract::We report a case of a neonate with a congenital tumor on the left palm. The patient had a grapefruit-sized tumor and coagulopathy at birth and was presumed to have a hemangioendothelioma with associated Kasabach-Merritt phenomenon. When the tumor failed to respond to systemic steroids, a biopsy specimen was taken, rev...

    journal_title:Journal of the American Academy of Dermatology

    pub_type: 杂志文章

    doi:10.1016/s0190-9622(03)01486-5

    authors: Asgari M,Rubin BP,Hornung RL

    更新日期:2004-02-01 00:00:00

  • Analysis of patients with suspected photosensitivity referred for investigation to an Australian photodermatology clinic.

    abstract:BACKGROUND:Australia's first dedicated photodermatology clinic was established at St Vincent's Hospital Melbourne in 1993. OBJECTIVE:We sought to review clinical diagnoses and results of investigations performed on patients seen at this institution. METHODS:A database was created to enable a retrospective and prospec...

    journal_title:Journal of the American Academy of Dermatology

    pub_type: 杂志文章

    doi:10.1067/mjd.2003.219

    authors: Crouch RB,Foley PA,Baker CS

    更新日期:2003-05-01 00:00:00

  • Photoprotection: part II. Sunscreen: development, efficacy, and controversies.

    abstract::In addition to the naturally occurring, physical, and systemic photoprotective agents reviewed in part I, topical ultraviolet radiation filters are an important cornerstone of photoprotection. Sunscreen development, efficacy, testing, and controversies are reviewed in part II of this continuing medical education artic...

    journal_title:Journal of the American Academy of Dermatology

    pub_type: 杂志文章

    doi:10.1016/j.jaad.2013.08.022

    authors: Jansen R,Osterwalder U,Wang SQ,Burnett M,Lim HW

    更新日期:2013-12-01 00:00:00

  • High-dose curcuminoids are efficacious in the reduction in symptoms and signs of oral lichen planus.

    abstract:BACKGROUND:Curcuminoids are components of turmeric (Curcuma longa) that possess anti-inflammatory properties. OBJECTIVE:We sought to study the efficacy of curcuminoids in controlling the signs and symptoms of oral lichen planus, at doses of 6000 mg/d (3 divided doses), and their safety at this dose. METHODS:Twenty co...

    journal_title:Journal of the American Academy of Dermatology

    pub_type: 杂志文章,随机对照试验

    doi:10.1016/j.jaad.2011.04.022

    authors: Chainani-Wu N,Madden E,Lozada-Nur F,Silverman S Jr

    更新日期:2012-05-01 00:00:00

  • A systematic review of adult-onset clinically amyopathic dermatomyositis (dermatomyositis siné myositis): a missing link within the spectrum of the idiopathic inflammatory myopathies.

    abstract:OBJECTIVE:Classical dermatomyositis (CDM) patients display the hallmark cutaneous manifestations of dermatomyositis (DM), proximal muscle weakness, and laboratory evidence of myositis. The epidemiology and management of both adult-onset and juvenile-onset CDM has been well characterized. However, the clinical significa...

    journal_title:Journal of the American Academy of Dermatology

    pub_type: 杂志文章,评审

    doi:10.1016/j.jaad.2005.10.041

    authors: Gerami P,Schope JM,McDonald L,Walling HW,Sontheimer RD

    更新日期:2006-04-01 00:00:00

  • Disfiguring cutaneous manifestation of sarcoidosis treated with thalidomide: a case report.

    abstract::A patient with sarcoidosis was treated with thalidomide for disfiguring and painful steroid unresponsive sarcoidal granulomas of the skin. The duration of the therapy was 14 months, during which time, the skin lesions resolved almost completely. The initial dosage was 200 mg a day, which was increased to 400 mg a day ...

    journal_title:Journal of the American Academy of Dermatology

    pub_type: 杂志文章

    doi:10.1016/s0190-9622(98)70360-3

    authors: Lee JB,Koblenzer PS

    更新日期:1998-11-01 00:00:00

  • Surgical margins required for basal cell carcinomas treated with Mohs micrographic surgery according to tumor features.

    abstract:BACKGROUND:Basal cell carcinomas (BCCs) with high-risk features are preferably treated by Mohs micrographic surgery. Studies have shown clinicopathologic characteristics that may predict more stages required for clearance. However, few studies have correlated such factors with the number of millimeters removed per stag...

    journal_title:Journal of the American Academy of Dermatology

    pub_type: 杂志文章

    doi:10.1016/j.jaad.2020.04.008

    authors: Cerci FB,Kubo EM,Werner B,Tolkachjov SN

    更新日期:2020-08-01 00:00:00

  • Long-term use of psoralens and ultraviolet A for psoriasis: evidence for efficacy and cost savings.

    abstract::A 7.3-year prospective study of 1,380 patients with psoriasis who were treated with oral methoxsalen (8-methoxypsoralen) and ultraviolet A photochemotherapy (PUVA) revealed that patients who continued on PUVA therapy used inpatient hospital treatment less than one fourth as often as those who had discontinued treatmen...

    journal_title:Journal of the American Academy of Dermatology

    pub_type: 杂志文章

    doi:10.1016/s0190-9622(86)70066-2

    authors: Stern RS

    更新日期:1986-03-01 00:00:00

  • Histologically specific skin lesions in disseminated cytomegalovirus infection.

    abstract::A diabetic renal transplant recipient developed fever, generalized rash, and genital ulcers which showed typical histologic changes of cytomegalovirus (CMV) infection in the dermal vascular endothelium. This infection was confirmed by rising serologic titer of specific antibody, positive viral cultures, and typical nu...

    journal_title:Journal of the American Academy of Dermatology

    pub_type: 杂志文章

    doi:10.1016/s0190-9622(83)70212-4

    authors: Pariser RJ

    更新日期:1983-12-01 00:00:00

  • Indoor and outdoor efficacy testing of a broad-spectrum sunscreen against ultraviolet A radiation in psoralen-sensitized subjects.

    abstract::The efficacy of a sunscreen containing an investigational drug, butyl methoxydibenzoylmethane in combination with padimate O against the erythemogenic effect of ultraviolet A (UVA) radiation was evaluated in two double-blind studies involving subjects sensitized with topical 8-methoxypsoralen. UVA radiation was suppli...

    journal_title:Journal of the American Academy of Dermatology

    pub_type: 临床试验,杂志文章

    doi:10.1016/s0190-9622(87)70195-9

    authors: Lowe NJ,Dromgoole SH,Sefton J,Bourget T,Weingarten D

    更新日期:1987-08-01 00:00:00

  • Lymphomatoid papulosis.

    abstract::Lymphomatoid papulosis is a chronic disease of cutaneous lymphoid infiltration characterized clinically by involuting and recurring papules, plaques, and nodules. The intriguing combination of a usually benign clinical course, a cytologically malignant lymphoid infiltrate on histologic examination, and a clear, but sp...

    journal_title:Journal of the American Academy of Dermatology

    pub_type: 杂志文章,评审

    doi:10.1016/s0190-9622(94)70045-1

    authors: Karp DL,Horn TD

    更新日期:1994-03-01 00:00:00

  • Effect of pH on the production of irritation in a chamber irritation test.

    abstract::This study was designed to investigate the relationship between alteration of skin surface pH and the development of skin irritation. Application of a phosphate/borate/acetate buffer adjusted to pH 4.0-10.5 in a standard chamber irritation test did not result in significant clinical irritation. This was true in spite ...

    journal_title:Journal of the American Academy of Dermatology

    pub_type: 杂志文章

    doi:10.1016/s0190-9622(88)70010-9

    authors: Murahata RI,Toton-Quinn R,Finkey MB

    更新日期:1988-01-01 00:00:00

  • Treatment of pyoderma gangrenosum.

    abstract::Critical to the proper management of pyoderma gangrenosum are correct diagnosis, identification and treatment of any underlying disorder, and the proper choice of topical and systemic therapy. Many agents are available for the treatment of pyoderma gangrenosum. We review the current therapeutic options, their efficacy...

    journal_title:Journal of the American Academy of Dermatology

    pub_type: 杂志文章,评审

    doi:10.1016/s0190-9622(96)90285-6

    authors: Chow RK,Ho VC

    更新日期:1996-06-01 00:00:00

  • Methotrexate for alopecia areata: A systematic review and meta-analysis.

    abstract:BACKGROUND:Methotrexate has been used both as monotherapy and as an adjunct to corticosteroids in the treatment of alopecia areata (AA), though there exists a paucity of definitive evidence and guidelines in this setting. OBJECTIVES:To 1) determine the efficacy and risks associated with methotrexate therapy for AA, 2)...

    journal_title:Journal of the American Academy of Dermatology

    pub_type: 杂志文章,meta分析

    doi:10.1016/j.jaad.2018.06.064

    authors: Phan K,Ramachandran V,Sebaratnam DF

    更新日期:2019-01-01 00:00:00

  • A kindred with congenital vellus hair cysts.

    abstract::Vellus hair cysts were present from birth in two of four siblings and their mother. There has been no tendency for remission. This is the first report of vellus hair cysts appearing at birth, and the second report of a kindred in which there was apparent autosomal dominant inheritance. This disorder appears to represe...

    journal_title:Journal of the American Academy of Dermatology

    pub_type: 杂志文章

    doi:10.1016/s0190-9622(81)70127-0

    authors: Piepkorn MW,Clark L,Lombardi DL

    更新日期:1981-12-01 00:00:00

  • Treatment of extensive chronic cutaneous graft-versus-host disease in an infant with topical pimecrolimus.

    abstract::We report a case of generalized cutaneous chronic graft-versus-host disease in a 17-month-old infant. Topical treatment with the novel ascomycin substance pimecrolimus once daily for 4 weeks led to a near complete clearance of skin lesions. Importantly, this excellent clinical response was obtained without additional ...

    journal_title:Journal of the American Academy of Dermatology

    pub_type: 杂志文章

    doi:10.1016/j.jaad.2004.02.010

    authors: Ziemer M,Gruhn B,Thiele JJ,Elsner P

    更新日期:2004-06-01 00:00:00

  • Bullous systemic lupus erythematosus: detection of antibodies against noncollagenous domain of type VII collagen.

    abstract::A 9-year-old girl with systemic lupus erythematosus developed bullous eruption. Histopathologic examination showed subepidermal blistering and immunoglobulins (IgG, IgM, IgA) and complement components (C1q, C3) deposited linearly at the basement membrane zone. IgG in this patient's serum bound to the dermal side of 1 ...

    journal_title:Journal of the American Academy of Dermatology

    pub_type: 杂志文章

    doi:10.1016/s0190-9622(98)70472-4

    authors: Shirahama S,Furukawa F,Yagi H,Tanaka T,Hashimoto T,Takigawa M

    更新日期:1998-05-01 00:00:00

  • Regression of Kaposi's sarcoma during therapy with HIV-1 protease inhibitors: a prospective pilot study.

    abstract:BACKGROUND:Early studies using HIV protease inhibitors (PI) showed regression of Kaposi's sarcoma (KS) lesions in some patients. OBJECTIVE:Our purpose was to determine prospectively the influence of PI on HIV-related KS. METHODS:KS lesions of nine patients with progressive cutaneous disease were prospectively evaluat...

    journal_title:Journal of the American Academy of Dermatology

    pub_type: 杂志文章

    doi:10.1016/s0190-9622(98)70124-0

    authors: Krischer J,Rutschmann O,Hirschel B,Vollenweider-Roten S,Saurat JH,Pechère M

    更新日期:1998-04-01 00:00:00

  • Sulfur revisited.

    abstract::Sulfur is a time-honored therapeutic agent useful in a variety of dermatologic disorders. Its keratolytic action is due to formation of hydrogen sulfide through a reaction that depends upon direct interaction between sulfur particles and keratinocytes. The smaller the particle size, the greater the degree of such inte...

    journal_title:Journal of the American Academy of Dermatology

    pub_type: 杂志文章

    doi:10.1016/s0190-9622(88)70079-1

    authors: Lin AN,Reimer RJ,Carter DM

    更新日期:1988-03-01 00:00:00

  • Zosteriform zygomycosis.

    abstract::We describe a patient with zygomycosis that resembled herpes zoster infection. The diagnosis was readily made with a potassium hydroxide preparation that revealed sparsely to non-septate hyphae. The patient responded to combination antifungal therapy with amphotericin B and fluconazole. The clinical response correlate...

    journal_title:Journal of the American Academy of Dermatology

    pub_type: 杂志文章

    doi:10.1016/0190-9622(95)90403-4

    authors: Woods SG,Elewski BE

    更新日期:1995-02-01 00:00:00

  • Heart disease in psoriasis.

    abstract::Psoriasis has been traditionally viewed as an inflammatory skin disorder of unknown origin. Recent advances in the immunopathogenesis and genetics of psoriasis have broadened our understanding of psoriasis. Psoriasis is now considered a systemic inflammatory condition analogous to other inflammatory immune disorders. ...

    journal_title:Journal of the American Academy of Dermatology

    pub_type: 杂志文章,评审

    doi:10.1016/j.jaad.2007.02.007

    authors: Kremers HM,McEvoy MT,Dann FJ,Gabriel SE

    更新日期:2007-08-01 00:00:00