Candidates For Biologic Therapy Research Articles

Exploring the role of systemic immune-inflammation index and neutrophil-lymphocyte ratio in cardiovascular risk stratification for patients with hidradenitis suppurativa: A cross-sectional study.

Hidradenitis suppurativa (HS) is a chronic inflammatory disease of the hair follicle that has previously been associated with a higher cardiovascular risk (CVR). Although different methods have been described for CVR stratification in HS, there is little evidence about the role of hemogram indexes in CVR in HS. Given its potential convenience, the aim of this study was to assess the role of the hemogram indexes systemic immune-inflammation index (SII) and neutrophil-lymphocyte ratio (NLR) in CVR stratification for patients with HS. A cross-sectional study was performed to assess the role of SII and NLR in CVR stratification in patients with moderate to severe HS who were candidates for biologic therapy. SII, NLR, carotid intima-media thickness, and other clinical and biochemical CVR factors were assessed before the start of the treatment. Fifty patients were included. The male:female ratio was 3:2, and the mean International Hidradenitis Suppurativa Severity Score System score was 21.6. After multivariate analysis, SII correlated with higher values of systolic blood pressure, metabolic syndrome, and higher risk of insulin resistance (p < 0.05). NLR was associated with insulin resistance (p < 0.05). These associations were independent of age, sex, body mass index, severity of the disease, and tobacco consumption. The implementation of SII and NLR in daily practice may be of benefit for identifying patients with HS at higher risk of high blood pressure, insulin resistance, or metabolic syndrome. Since these indexes are simple to calculate, they could be used as a screening tool in HS-specific units.

Cumulative Inflammation and HbA1c Levels Correlate with Increased Intima-Media Thickness in Patients with Severe Hidradenitis Suppurativa.

Hidradenitis suppurativa (HS) is a chronic inflammatory skin disease that has been associated with a greater risk of metabolic and cardiovascular comorbidities. The aim of this study is to assess cardiovascular risk by means of intima-media thickness (IMT), metabolic syndrome, and other potential biomarkers in patients with severe hidradenitis suppurativa who are candidates for biologic therapy and to explore potentially associated factors. A cross-sectional study was performed. Body mass index (BMI), carotid intima-media thickness (IMT), and blood tests, including glycemic and lipid profile, insulin, vitamin D, and inflammation markers were performed. Fifty patients were included in the study; the male/female ratio was 3:2. The mean age was 38 years, and the mean disease duration was 21.8 years. The mean carotid IMT was 651.39 μm. A positive association of IMT with disease duration, tobacco consumption, and HbA1c levels was observed. HbA1c correlated with the age of onset, hypertension, metabolic syndrome, and glucose levels. Vitamin D levels inversely correlated with the number of areas affected. In conclusion, patients with severe HS present a higher cardiovascular risk, but it is not distributed equally within the patients: Tobacco consumption, inadequate glycemic control, and disease duration could be useful clinical and biochemical markers to identify patients at higher risk.

Safety and efficacy of intravenous Colchicine in children with Familial Mediterranean Fever.

Familial Mediterranean Fever (FMF), the most common monogenic inflammatory disease, is mainly treated by oral Colchicine. However, 5% of patients are considered non-responders and, therefore, candidates for biologic therapy. Intravenous (IV) Colchicine treatment has been shown to be effective and safe in adult patients. The objective of this study was to evaluate the safety of IV Colchicine for pediatric FMF patients in our hospital, refractory to oral Colchicine, by reviewing their medical records. Inclusion criteria were all patients with FMF who commenced treatment with IV Colchicine before the age of 18years, and received at least 6months of IV therapy. The patients completed questionnaires to assess the efficacy of the treatment. Between 2004 and 2017, 7 pediatric FMF patients receiving maximal oral Colchicine doses and deemed non-responders were treated with weekly IV Colchicine, including 38 cumulative patient years of follow-up data (a full blood count, renal and liver function tests). All patients were homozygous for the M694V genotype. Long-term follow-up showed normal laboratory results with no Colchicine-related hospital admissions or toxicity. Global health assessment and the number of disease-free days have significantly improved (P < 0.05). Prolonged IV Colchicine use is described in pediatric FMF patients for the first time, with an excellent safety profile in our population, and decrease in intensity and frequency of attacks. In the biological era, IV Colchicine, although not leading to complete remission, may be considered a second-line option in countries where anti-interleukin 1 blockers are not available, or as a third-line option in case of failure to respond to biologics.

Prevention and treatment of tuberculosis infection in candidates for biologic therapy: A multidisciplinary consensus statement adapted to the dermatology patient

Patients with chronic inflammatory diseases being treated with immunosuppressive drugs, and with tumor necrosis factor inhibitors in particular, have an increased risk of infection by Mycobacterium tuberculosis. Screening for latent tuberculosis infection and preventive therapy to reduce the risk of progression to active tuberculosis are mandatory in this group of patients. This updated multidisciplinary consensus document presents the latest expert opinions on the treatment and prevention of tuberculosis in candidates for biologic therapy and establishes recommendations based on current knowledge relating to the use of biologic agents.

Consenso multidisciplinar sobre prevención y tratamiento de la tuberculosis en pacientes candidatos a tratamiento biológico. Adaptación al paciente dermatológico

Patients with chronic inflammatory diseases being treated with immunosuppressive drugs, and with tumor necrosis factor inhibitors in particular, have an increased risk of infection by Mycobacterium tuberculosis. Screening for latent tuberculosis infection and preventive therapy to reduce the risk of progression to active tuberculosis are mandatory in this group of patients. This updated multidisciplinary consensus document presents the latest expert opinions on the treatment and prevention of tuberculosis in candidates for biologic therapy and establishes recommendations based on current knowledge relating to the use of biologic agents.

PHS28 - Costs Related to Infusion Therapy Room and Staff for Rheumatoid Arthritis in a Specialized Center

Rheumatoid arthritis (RA) is a systemic, autoimmune disease with a prevalence of nearly 1% worldwide. Patients become candidates for biological therapy when the disease activity continues in moderate or severe disease activity. Some of the biological medications recommended for the treatment for RA are administrated in a hospital or infusion setting center. The aim of this study was to estimate the costs related to the infusion therapy for patients with rheumatoid arthritis. We retrospectively conducted a cost-descriptive analysis using a bottom-up approach. During a 12-month period, we estimated the costs of biological therapy for patients that required monitoring in an infusion room (Infliximab, Golimumab, Tocilizumab, Abatacept and Rituximab). We costed the following items: biological therapy, time spent providing care (nurse), time spent in the infusion preparation (pharmaceutical chemistry), and the materials and supplies needed for each patient in the infusion therapy. We reported the costs in US dollars using the official rate of exchange for December 2017. During 2017 we included 185 patients that required the administration of biological therapy in an infusion room therapy. The cost for each patient treated per year was USD$13.004 for Golimumab, USD$8736 for Tocilizumab, USD$8.227 for Abatacept, USD$5.518 for Infliximab, and USD for $4059 Rituximab. The total cost for treating all patients was $1.531.010 million US dollars. Biological therapy represents a high cost associated to RA care. Additionally, personnel and supplies add 7% overhead costs to the therapy. Compared to other studies, our cost estimations are ten time less than studies carried out in hospitals from the United States. This micro-costing analysis is an important input for stakeholders and decision makers about the financial impact of the usage of biological therapy in patients with RA.

HLA-C*18:01: A Rare Allele in the European Caucasian Population Coinciding with Difficult-to-Treat Plaque Psoriasis

Advances in knowledge about the metabolic pathways involved in the pathogenesis of psoriasis and related diseases have led to a search for new therapeutic targets and the development of new biological drugs. Several studies have focused on HLA-C*06 and investigated correlations between the genetic risk factors of psoriasis and clinical parameters such as the severity of the disease and the response to treatment. Our objective is to share experience from our institution in the observation of two patients with severe chronic plaque psoriasis who were unresponsive to any anti-TNF-α treatment and only partially responsive to ustekinumab. The patients are carriers of a rare allele of HLA-C that occurs in Caucasians. The patients with moderate-to-severe chronic plaque psoriasis, and candidates for biological therapy were typed for the HLA-C locus at high resolution via polymerase chain reaction sequence-specific oligonucleotide probes (PCR-SSOP) using a commercial kit (LAB(®)Type, One Lambda Inc., Canoga Park, CA, USA). The socio-demographic variables and clinical data were collected. In our cohort of 134 patients, only two showed the presence of the allele HLA-C*18:01. To our knowledge, a coincidence between HLA-C*18 and severe psoriasis in Caucasian patients has not previously been described. The fact that both of these patients showed the same clinical history (unresponsive to any anti-TNF-α treatment and partially responsive to ustekinumab) cannot be attributed to a random observation because HLA-C*18 is extremely rare in Europe. As a consequence, at this latitude, it probably indicates a severe disease for which the proper therapy has still not been identified.

Providing Guidance for Patients With Moderate-to-Severe Psoriasis Who Are Candidates for Biologic Therapy

Providing Guidance for Patients With Moderate-to-Severe Psoriasis Who Are Candidates for Biologic Therapy

Screening for Latent Tuberculosis in the Patient With Moderate to Severe Psoriasis Who Is a Candidate for Systemic and/or Biologic Therapy

Screening to detect latent tuberculosis infection (LTBI) is essential before patients with moderate to severe psoriasis start treatment with biologics and vigilance will continue to be needed during and after such treatment. The most recently analyzed statistics from the BIOBADADERM registry show a 20.5% prevalence of LTBI in psoriasis patients treated with biologics in Spain. Various screening protocols are in effect in different countries according to their levels of endemic TB and bacillus Calmette-Guérin (BCG) vaccination, and there is no consensus on a gold-standard approach to the diagnosis of LTBI. Tuberculin skin testing (TST) continues to be the diagnostic method of choice in spite of its limited sensitivity, mainly in immunocompromised patients. Additional problems include the TST's well-established lack of specificity, errors in application, subjectivity in the interpretation of results (which must be read during a second visit), and lack of privacy; the main advantages of this test are its low cost and ease of application. Most cost-benefit studies are therefore inclined to favor using interferon-γ release assays to detect LTBI because they minimize false positives (especially in BCG-vaccinated individuals), thereby eliminating the extra costs and side effects of unnecessary chemoprophylaxis. We review the methods used for LTBI screening in psoriasis patients who are candidates for biologic therapy. Additionally, given the fact that most guidelines do not currently consider it necessary to screen patients about to start conventional systemic therapy, we discuss the reasons underlying the need for such screening.

Providing Guidance for Patients With Moderate-to-Severe Psoriasis Who Are Candidates for Biologic Therapy: Role of the Nurse Practitioner and Physician Assistant.

ABSTRACTPsoriasis is a chronic, immune-mediated disease characterized by itchy, scaly, and often painful plaques in the skin. Psoriasis can have significant psychosocial burdens and increased risks for numerous comorbidities, including diabetes, hypertension, and cardiovascular disease, particularly in patients with moderate-to-severe disease. Dermatology nurse practitioners and physician assistants are an important part of the healthcare team, contributing to all aspects of psoriasis management. This review reinforces the unique aspects of care that nurse practitioners and physician assistants provide to patients with psoriasis, such as facilitating conversations about managing disease, setting appropriate expectations, and considering treatment options, including when treatment response or tolerability is suboptimal. The importance of relationship building is stressed. Patient management topics discussed include helpful tips about assessing treatment options, initiating biologic therapy, optimizing patient adherence, and managing comorbidities. Also reviewed are how to deal with common barriers including lack of knowledge about psoriasis or making healthy lifestyle changes, fear of injections or side effect risks, lack of health insurance, and concerns about treatment costs. Overall, by forming meaningful relationships and engaging patients in their psoriasis care, nurse practitioners and physician assistants can help to optimize clinical efficacy outcomes and consistently manage moderate-to-severe psoriasis and its comorbidities over the patient’s life course.

Providing Guidance for Patients With Moderate-to-Severe Psoriasis Who Are Candidates for Biologic Therapy

Providing Guidance for Patients With Moderate-to-Severe Psoriasis Who Are Candidates for Biologic Therapy

Despistaje de tuberculosis latente en el paciente con psoriasis moderada grave candidato a terapia sistémica y/o biológica

Screening to detect latent tuberculosis infection (LTBI) is essential before patients with moderate to severe psoriasis start treatment with biologics and vigilance will continue to be needed during and after such treatment. The most recently analyzed statistics from the BIOBADADERM registry show a 20.5% prevalence of LTBI in psoriasis patients treated with biologics in Spain. Various screening protocols are in effect in different countries according to their levels of endemic TB and bacillus Calmette-Guérin (BCG) vaccination, and there is no consensus on a gold-standard approach to the diagnosis of LTBI. Tuberculin skin testing (TST) continues to be the diagnostic method of choice in spite of its limited sensitivity, mainly in immunocompromised patients. Additional problems include the TST's well-established lack of specificity, errors in application, subjectivity in the interpretation of results (which must be read during a second visit), and lack of privacy; the main advantages of this test are its low cost and ease of application. Most cost-benefit studies are therefore inclined to favor using interferon-γ release assays to detect LTBI because they minimize false positives (especially in BCG-vaccinated individuals), thereby eliminating the extra costs and side effects of unnecessary chemoprophylaxis. We review the methods used for LTBI screening in psoriasis patients who are candidates for biologic therapy. Additionally, given the fact that most guidelines do not currently consider it necessary to screen patients about to start conventional systemic therapy, we discuss the reasons underlying the need for such screening.

Latent tuberculosis infection in patients with chronic plaque psoriasis who are candidates for biological therapy.

Screening for latent tuberculosis infection (LTBI) is mandatory in patients with psoriasis prior to biological therapy. To investigate the prevalence of LTBI in patients with psoriasis who are candidates for biological therapy. LTBI was investigated in patients with moderate-to-severe psoriasis (n = 243), Crohn disease (n = 64) or rheumatoid arthritis (RA) (n = 56) and in healthcare workers (n = 1683). LTBI diagnosis was based on positive QuantiFERON-B Gold In-Tube (QFT-GIT) in vitro assay without any clinical, radiological or microbiological evidence of active tuberculosis. LTBI was diagnosed in 8.2% of patients with psoriasis, 7% with Crohn disease and 9% with RA, and in 8.8% of healthcare workers (P = 0.9). Patients with psoriasis who also had LTBI (n = 20) received a 9-month prophylaxis with isoniazid (5 mg kg(-1) daily). None of these patients developed active tuberculosis infection after receiving biological therapy (etanercept, adalimumab, infliximab or ustekinumab) for 37 ± 32 weeks (mean ± SD). All patients with psoriasis were retested for LTBI after 31 ± 1.7 months. Five of the 20 patients with LTBI presented QFT-GIT reversion and two patients out of 243 (0.8%) had QFT-GIT conversion and received antibiotic prophylaxis. The prevalence of LTBI in patients with psoriasis is similar to that in patients with Crohn disease or RA and in healthcare workers. Prophylaxis with isoniazid is effective in preventing tuberculosis reactivation in patients with LTBI receiving biological therapy.

Latent tuberculosis infection and active tuberculosis in patients with psoriasis: a study on the incidence of tuberculosis and the prevalence of latent tuberculosis disease in patients with moderate–severe psoriasis in Spain. BIOBADADERM registry

The incidence of tuberculosis (TB) or the prevalence of latent tuberculosis infection (LTBI) in psoriasis patients has not been described in the Spanish population. We carried out a study with the objectives: (i) To describe the incidence of TB in patients with psoriasis on systemic treatment in the Spanish population; (ii) To determine the prevalence of LTBI in patients who are candidates for biological treatment; and (iii) To investigate the level of compliance with current recommendations for LTBI and TB screening. Data were obtained from BIOBADADERM (Spanish registry for systemic biological and non-biological treatments in psoriasis). An analysis was performed of the exposed cohort to determine the prevalence of LTBI and to describe compliance with the screening guidelines. A total of 1425 patients were registered in BIOBADADERM. They included 793 (56%) patients exposed to biological treatment and 632 (44%) treated with conventional systemic drug. Overall follow-up was 3720 person-years. Of the 793, 20.5% (163) were diagnosed with LTBI before starting biological treatment. The rate of active TB for the exposed cohort was 145 cases × 100,000 patient-years (95% CI 54-389). No case of TB was found in the control group. Screening for LTBI was performed in 83% of the exposed sample. Patients with psoriasis who are exposed to biological treatment appear to be at greater risk for tuberculosis. In Spain, up to 20% of patients with psoriasis who are candidates for biological therapy have LTBI. There continues to be a significant percentage of errors in compliance with clinical guidelines.

Position paper on tuberculosis screening in patients with immune mediated inflammatory diseases who are candidates for biological therapy

Chronic immunosuppression is a known risk factor for tuberculosis. Our aim was to reach a consensus on screening and prevention of tuberculosis in patients with immune mediated inflammatory diseases who are candidates to biologic therapy. MethodsCritical appraisal of the literature and expert opinion on immunosuppressive therapies and risk of tuberculosis. Results and conclusionThe currently recommended method for screening is the tuberculin skin test and the interferon gamma assay, after exclusion of active tuberculosis. Positively screened patients should be treated for latent tuberculosis infection. Patients may start biological therapy after 1–2 months, as long as they are strictly adhering to and tolerating their preventive regimen.

Nursing management considerations with trastuzumab (herceptin).

To review nursing management consideration for patients with advanced breast cancer who are candidates for trastuzumab. Research articles and the trastuzumab product insert. Identification of appropriate candidates for trastuzumab therapy should include a review of HER2 status, previous treatments, presence of comorbid diseases, and determination of cardiac function. Nurses will manage the administration of trastuzumab. Therefore, they must understand how antibodies work at the cellular level, how to treat infusion-related events, and how to choose the best candidates for biological therapy.