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Insa Joost, Johannes Steinfurt, Philipp T Meyer, Winfried V Kern, Siegbert Rieg
BACKGROUND: Ustekinumab (Stelara®), a human monoclonal antibody targeting the p40-subunit of interleukin (IL)-12 and IL-23, is indicated for moderate to severe plaque psoriasis and psoriatic arthritis. In large multicenter, prospective trials assessing efficacy and safety of ustekinumab increased rates of severe infections have not been observed so far. CASE PRESENTATION: Here, we report the case of a 64-year old woman presenting with chills, pain and swelling of her right foot with dark maculae at the sole, and elevated inflammatory markers...
October 20, 2016: BMC Infectious Diseases
Tao Gu, Neel Shah, Gaurav Deshpande, Derek H Tang, Debra F Eisenberg
BACKGROUND: The relative cost of biologics in the treatment of autoimmune disorders, including rheumatoid arthritis, psoriatic arthritis, psoriasis, and ankylosing spondylitis, is a key consideration for managed care payers. OBJECTIVES: Our objective was to estimate biologic costs and treatment patterns in US managed care patients with rheumatoid arthritis, psoriatic arthritis, psoriasis, and/or ankylosing spondylitis. METHODS: This retrospective study used administrative claims data from the HealthCore Integrated Research Database (HIRD(SM)) for adults with rheumatoid arthritis, psoriatic arthritis, psoriasis, and/or ankylosing spondylitis who received abatacept, adalimumab, certolizumab, etanercept, golimumab, infliximab, rituximab, tocilizumab, or ustekinumab between 1 July 2009 and 31 January 2013...
October 18, 2016: Drugs—Real World Outcomes
Maddalena Napolitano, Nicola Balato, Francesco Caso, Luisa Costa, Matteo Megna, Teresa Cirillo, Anna Balato, Raffaele Scarpa
OBJECTIVES: To evaluate the incidence of new cases of psoriatic arthritis (PsA) in patients with plaque psoriasis receiving biologic drugs. METHODS: A retrospective study was performed on 434 psoriatic patients under biologic treatment, attending the Psoriasis Care Centre of Dermatology at the University Federico II of Naples from January 2011 to November 2015. As part of the routine clinical practice, assessment of disease activity was made at baseline, and every 3 months...
September 8, 2016: Clinical and Experimental Rheumatology
Doris Weiss, Michaela Schaschinger, Robin Ristl, Robert Gruber, Tamara Kopp, Georg Stingl, Christine Bangert
BACKGROUND: It has recently been suggested that patients with moderate to severe atopic dermatitis (AD) may profit from anti-interleukin (IL)-12/-23 p40 therapy. OBJECTIVE: We sought to assess the immunologic effects of ustekinumab treatment on AD skin and to correlate them with the clinical efficacy of this drug. METHODS: We investigated the course of 3 patients with severe AD who were administered 45 mg of subcutaneous ustekinumab over a period of 16 weeks...
October 13, 2016: Journal of the American Academy of Dermatology
Ai Matsumoto, Mayumi Komine, Masaru Karakawa, Megumi Kishimoto, Mamitaro Ohtsuki
We report a case of a 70-year-old woman with generalized pustular psoriasis (GPP) who responded well to infliximab therapy and adalimumab therapy after secondary failure of infliximab therapy, but did not respond to ustekinumab therapy. We speculate that the pathogenic factor in this case favored anti-tumor necrosis factor (TNF)-α therapy to anti-interleukin-12/23 therapy. Herein, we also briefly present three additional cases of treatment with adalimumab after secondary failure of infliximab. GPP is often difficult to treat, and no placebo-controlled trials have been conducted to guide the use of biologics against it because of a paucity of cases...
October 15, 2016: Journal of Dermatology
A Paganelli, S Ciardo, G Odorici, G Pellacani, A Conti
Pityriasis rubra pilaris (PRP) is a rare, chronic inflammatory skin disorder characterized by the presence of small follicular hyperkeratotic papules that coalesce into yellow-pink (salmon-colored) patches, usually beginning at the head and neck and often resulting in generalized erythroderma(1) . Other main clinical features are "islands" of sparing within the affected skin, palmoplantar keratoderma, nail dystrophy, oral involvement and eventually ectropion. The age of onset has a peak between 50 and 70 years but a juvenile presentation is not uncommon...
October 14, 2016: Journal of the European Academy of Dermatology and Venereology: JEADV
J Loget, J Plee, F Antonicelli, P Bernard
Predisposing factors for bullous pemphigoid (BP), the most common autoimmune blistering disease, include neurological disorders, chronic use of certain drugs (spironolactone, loop diuretics, psycholeptics).(1) The coexistence of psoriasis with classical BP is occasionally observed, whereas half of the patient population with anti-laminin γ1 pemphigoid of Japanese origin have coexisting psoriasis.(2-3) We report for the first time a case of relapsing BP associated with psoriasis, in which both dermatoses completely disappeared after treatment with ustekinumab, a monoclonal antibody that targets the p40 subunit of IL-12/23...
October 12, 2016: Journal of the European Academy of Dermatology and Venereology: JEADV
Michael A Mancano
The purpose of this feature is to heighten awareness of specific adverse drug reactions (ADRs), discuss methods of prevention, and promote reporting of ADRs to the US Food and Drug Administration's (FDA's) MedWatch program (800-FDA-1088). If you have reported an interesting, preventable ADR to MedWatch, please consider sharing the account with our readers. Write to Dr. Mancano at ISMP, 200 Lakeside Drive, Suite 200, Horsham, PA 19044 (phone: 215-707-4936; e-mail: Your report will be published anonymously unless otherwise requested...
November 2015: Hospital Pharmacy
Reem Al-Raddadi, Camille Frances, Philippe Moguelet, Claude Bachmeyer, Sarah Guégan
is missing (Short communication).
October 10, 2016: Acta Dermato-venereologica
R Andersen, G B E Jemec
Hidradenitis suppurativa (HS) is difficult to treat. Official guidelines have only recently been developed, and suggest that patients should be provided with both adjuvant, medical and surgical therapy. The guidelines are the result of resurgent interest in this disease, in which etiology and pathogenesis are only partially understood at present. Recent research has, however, identified possible targets for specific intervention using biologicals. In addition, classical clinically driven developments of new treatments continue to evolve, leading to several interesting new therapies for HS patients...
August 2016: Drugs of Today
Paweł Moćko, Paweł Kawalec, Andrzej Pilc
BACKGROUND: Crohn disease (CD) is an inflammatory bowel disease which occurs especially in developed countries of Western Europe and North America. The aim of the study was to compare the safety profile of biologic drugs in patients with CD. METHODOLOGY: A systematic literature search was performed using PubMed, Embase, and CENTRAL databases, until April 27, 2016. We included randomized controlled trials (RCTs) that compared the safety of biologic drugs (infliximab, adalimumab, vedolizumab, certolizumab pegol, and ustekinumab) with one another or with placebo in patients with CD...
August 1, 2016: Pharmacological Reports: PR
Paula Dávila-Seijo, Esteban Dauden, M A Descalzo, Gregorio Carretero, José-Manuel Carrascosa, Francisco Vanaclocha, Francisco-José Gómez-García, Pablo De la Cueva-Dobao, Enrique Herrera-Ceballos, Isabel Belinchón, José-Luis López-Estebaranz, Merce Alsina, José-Luis Sánchez-Carazo, Marta Ferrán, Rosa Torrado, Carlos Ferrandiz, Raquel Rivera, Mar Llamas, Rafael Jiménez-Puya, Ignacio García-Doval
Information regarding the safety of biological drugs prescribed to psoriasis patients on daily and long-term bases is insufficient. We used data from the BIOBADADERM registry (Spanish Registry of Adverse Events for Biological Therapy in Dermatological Diseases) to generate crude rates of infection during therapy with systemic drugs, including biological drugs (infliximab, etanercept, adalimumab, and ustekinumab) and non-biological drugs (acitretin, cyclosporine, and methotrexate). We also calculated unadjusted and adjusted risk ratios (RR) (with propensity score adjustment) of infection, serious infections, and recurrent infections of systemic therapies compared with methotrexate, using Poisson regression...
September 24, 2016: Journal of Investigative Dermatology
Joel Correa da Rosa, Jaehwan Kim, Suyan Tian, Lewis E Tomalin, James G Krueger, Mayte Suárez-Fariñas
There is an 'assessment gap' between the moment patient treatment-response is biologically determined and when response can actually be determined clinically. Patients' biochemical profiles are a major determinant of clinical outcome for a given treatment. It is therefore feasible that molecular-level patient information could be used to decrease the assessment gap. Due to clinically accessible biopsies, high-quality molecular data for psoriasis patients is widely available. Psoriasis is therefore an excellent disease for testing the prospect of predicting treatment outcome from molecular data...
September 22, 2016: Journal of Investigative Dermatology
Andrew Blauvelt, Kristian Reich, Tsen-Fang Tsai, Stephen Tyring, Francisco Vanaclocha, Külli Kingo, Michael Ziv, Andreas Pinter, Ronald Vender, Sophie Hugot, Ruquan You, Marina Milutinovic, Diamant Thaçi
BACKGROUND: Secukinumab demonstrated superior efficacy to ustekinumab at week 4 and week 16 of the CLEAR study, with comparable safety, in subjects with moderate-to-severe plaque psoriasis. OBJECTIVE: To compare the efficacy and safety of secukinumab and ustekinumab use over 52 weeks. METHODS: Analysis of 52-week data from CLEAR, a randomized, double-blind, phase 3b study. RESULTS: Among 676 randomized subjects, secukinumab demonstrated superiority to ustekinumab at week 52 in the proportion of subjects with ≥90% improvement in Psoriasis Area and Severity Index (PASI 90) (76% vs 61% [P < ...
September 20, 2016: Journal of the American Academy of Dermatology
F Bardazzi, M Lambertini, M A Chessa, M Magnano, A Patrizi, B M Piraccini
BACKGROUND: Psoriasis (Pso) has a strong impact on quality of life and a positive association has been reported between nail psoriasis (NP) and more severe disease, together with a longer duration of skin lesions. The treatment of NP represents a challenge and biological therapy can be recommended for severe disease. OBJECTIVE: The first end point of this retrospective study was to evaluate the time to achieve Psoriasis Area Severity Index (PASI) 75 in patients with and without NP treated with biological therapy...
September 23, 2016: Journal of the European Academy of Dermatology and Venereology: JEADV
Catherine Copley-Merriman, Susan Zelt, Marci Clark, Ari Gnanasakthy
Although some symptoms of dermatologic diseases, such as pruritus and pain, can be subjectively assessed only by patients, the most commonly used endpoints in dermatology drug research traditionally have been clinician-reported outcomes. Research has found that patient-reported outcomes (PROs) were included in only one-quarter of 125 trials conducted between 1994 and 2001. Our objective was to characterize the impact of PROs in dermatology drug development from the patient, prescriber, regulator, payer, and manufacturer perspectives using a case study approach...
September 15, 2016: Patient
B Hellmich
Imaging methods, such as joint and color duplex sonography, magnetic resonance imaging (MRI) and positron emission tomography (PET) nowadays facilitate the diagnosis of polymyalgia rheumatica and large vessel vasculitides and have now been included in the new classification criteria. In patients with typical symptoms, color duplex sonography of the temporal artery can replace a biopsy of the temporal artery for the diagnosis of giant cell arteritis (GCA); however, the role of these methods for patient follow-up and assessment of prognosis is unclear...
September 8, 2016: Der Internist
Ryan L Kelly, Yao Yu, Tingwan Sun, Isabelle Caffry, Heather Lynaugh, Michael Brown, Tushar Jain, Yingda Xu, K Dane Wittrup
The importance of the neonatal Fc receptor (FcRn) in extending the serum half-life of monoclonal antibodies (mAbs) is well demonstrated, and has led to the development of multiple engineering approaches designed to alter Fc interactions with FcRn. Recent reports have additionally highlighted the effect of nonspecific interactions on antibody pharmacokinetics (PK), suggesting an FcRn-independent mechanism for mAb clearance. In this report we examine a case study of two anti-interleukin-12/23 antibodies, ustekinumab and briakinumab, which share the same target and Fc, but differ in variable region sequences...
September 9, 2016: MAbs
F M Perrotta, E Lubrano
Psoriatic arthritis (PsA) is a chronic inflammatory disease that possibly leads to structural damage and to a reduction of joint function and poor quality of life. Treatment of PsA has changed since its introduction of anti- TNF drugs, which have shown to reduce the symptoms and signs of the disease and slow the radiographic progression. However, recently, the discovery of new pathogenic mechanisms have made possible the development of new molecules that target pro-inflammatory cytokines involved in skin, joint and entheseal inflammation...
2016: Reumatismo
Claudio Bonifati, Viviana Lora, Dario Graceffa, Lorenzo Nosotti
The systemic therapies available for the management of Psoriasis (PsO) patients who cannot be treated with more conservative options, such as topical agents and/or phototherapy, with the exception of acitretin, can worsen or reactivate a chronic infection. Therefore, before administering immunosuppressive therapies with either conventional disease-modifying drugs (cDMARDs) or biological ones (bDMARDs) it is mandatory to screen patients for some infections, including hepatitis B virus (HBV) and hepatitis C virus (HCV)...
July 28, 2016: World Journal of Gastroenterology: WJG
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