Current concepts in cancer therapy: biologic therapy and chemotherapy.
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Animals↗
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Management of the patient receiving parenteral biologic therapy.
Biologic therapies are becoming the preferred treatment option for many complex medical conditions, especially in the areas of oncology and immunology. Cytokines, monoclonal antibodies, and immunomodulators all have their own specific roles, clinical applications, mechanisms of action, and side effects. As newer biologic agents are approved and used for treatment, the nurse involved in the care of the patient receiving parenteral biologic therapy or in the administration of parenteral biologic therapies must know and understand the technology and mechanisms of action associated with these agents as well as guidelines for their safe administration to ensure positive patient outcomes. This article discusses biologic therapies, focusing on monoclonal antibodies used in oncology and immunology. The indications, use, and administration of parenteral biologic therapies, as well as the nursing management of the patients receiving the therapies, are presented.
Antibodies, Monoclonal↗
Combination biologic therapy.
Biologic therapies refer to genetically engineered treatments such as monoclonal antibodies and receptor-immunoglobulin fusion proteins. Following many disappointments, the introduction of anti-tumor necrosis factor (anti-TNF alpha) therapies into the clinic has clearly demonstrated the exciting potential of biologic agents. Many of these have been designed to modulate a specific aspect of the underlying autoimmune process, thus avoiding generalized immunosuppression. They include products which interfere with the trimolecular complex of major histocompatibility complex II-Antigen-T cell receptor interaction; others designed to block the secondary signals for T cell activation and T cell interaction with antigen-presenting cells; and cytokine agonists as well as antagonists. Whilst reducing the degree of global immunosuppression associated with therapy, this targeted specificity may reduce the likelihood that a single therapeutic agent will provide long-term disease control. On the other hand, animal models have demonstrated synergy of combination biologic therapy, particularly for the re-induction of self-tolerance. As our knowledge of immune physiology and, particularly, immune regulation improves, it can be expected that many combination biologic therapies will be tested in the clinic. Pilot studies of combined anti-CD4 and TNF alpha blockade are underway; combination use of TNF alpha and interleukin-1 beta inhibitors are expected. This article reviews the potential for combination biologic therapy, including likely adverse effects, for the treatment of rheumatoid arthritis and other autoimmune diseases.
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Biologic therapy.
Biologic therapy has evolved as a fourth treatment option for patients with melanoma and other malignancies. Interrelated advances in molecular diagnostics and gene therapy techniques will further accelerate therapeutic advances in this new arena. A variety of biologic therapeutic options available to the patient with high risk melanoma are reviewed.
Antibodies, Monoclonal↗
[On the problem of the differentiation of work therapy and biological therapy in psychiatric wards for acute conditions].
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Biological Therapy↗
Gene therapy and biologic therapy with interleukin-4.
For more than two decades, there has been a concerted effort to define the biology of, and develop the clinical applications for, cytokines that influence the immune system. However, intrinsic potency and toxicity have complicated application of cytokines as therapeutic agents when applied systemically. Indeed, one of the major characteristics of most cytokines is that they regulate immunity at a local or regional level, and systemic levels provided by most conventional schema fail to mimic the induction of an effective immune response. IL-4 has pleiotropic effects on immune cells of multiple lineages, endothelial cells and tumor cells. Accumulating data in pre-clinical studies demonstrate that sustained expression of IL-4 at the targeted organs or tissues may provide an effective means for therapy of variety of diseases including cancers and immunologic disorders. This review discusses biological properties and therapeutic applications of IL-4, particularly when it is delivered as a transgene in the settings of gene therapy.
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Cellular and biological therapies of gastrointestinal tumors: overview of clinical trials.
Because of the high relapse rate of resected gastrointestinal malignancies and the modest responses of metastatic disease to currently available therapies, biologic agents that harness host-tumor immunologic interactions have received increased attention. Based on promising preclinical data, current clinical trials in cellular and biologic therapies are evaluating the safety and efficacy of passive immunotherapy with tumor-reactive lymphocytes activated ex vivo and active immunotherapy with peptide, viral vector, and cellular vaccines. This review will describe the background, rationale, and experimental approach of these clinical trials. Although equally promising, antibodies, gene therapies, and antiangiogenic strategies will not be discussed.
Adoptive Transfer↗
Role of novel biological therapies in psoriatic arthritis: effects on joints and skin.
Psoriatic arthritis (PsA) is a partly debilitating disease that may affect small and large joints and the spine. Patients with PsA are divided into different subgroups according to joint involvement and their disease may be classified as part of the spectrum of spondyloarthritides or seronegative rheumatoid arthritis. Traditional treatment comprises nonsteroidal anti-inflammatory drugs, systemic and intra-articular corticosteroids and disease-modifying antirheumatic drugs such as sulfasalazine, methotrexate and cyclosporin. On the basis of the very recent studies performed in the US and Germany, patients with severe disease can be treated with anti-tumour necrosis factor (TNF) therapy. Biologicals such as etanercept and infliximab have been used successfully to treat PsA. While etanercept is a 75kD TNF receptor fusion protein that binds to TNFalpha and TNFbeta, infliximab is a chimeric monoclonal antibody that binds to TNFalpha both in its soluble form in the serum and on the cell membrane. Adalimumab is a fully humanised antibody recognising TNFalpha that has not been tested in PsA to date. Another biological agent, alefacept, is directed against the adhesion molecule lymphocyte function-associated antigen (LFA)-2, which is known to interfere with T-cell activation. Alefacept has been shown to be efficacious in a limited number of patients with PsA. Taken together, there has been definite recent progress in the treatment of PsA. Severely affected patients may especially have substantial benefit from therapy with biologicals directed against TNFalpha and other targets.
Alefacept↗
Wegener's granulomatosis: is biologic therapy useful?
Wegener's granulomatosis (WG) is a complex autoimmune disorder that has been transformed from a uniformly lethal process to a chronic disease with a relapsing-remitting course. In the setting of frequent relapses, the need to manage cumulative disease damage and drug toxicities has spurred the identification and development of new potent and directed therapies. Biologic agents, which offer the potential for remission-induction and drug-sparing approaches to treat WG, have been studied in several small, open-label clinical series and one large, randomized, placebo-controlled clinical trial. This article discusses the results of these trials and the potential of these biologic agents to treat WG.
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Report from the society for biological therapy and vascular biology faculty of the NCI workshop on angiogenesis monitoring.
The field of tumor angiogenesis has seen explosive growth over the last 5 years. Preclinical as well as early clinical evaluation of novel compounds is progressing at a rapid pace. To gain a perspective on the field and to take stock of advances in the understanding of molecular mechanisms underlying the process of tumor angiogenesis as well as ways of monitoring the activity of agents, the Society for Biologic Therapy and the National Cancer Institute's Vascular Biology Faculty convened a Workshop on Angiogenesis Monitoring in November 2002. The Workshop was composed of invited speakers and participants from academia, industry, and government. It was divided into 3 sessions, each chaired by leaders in the field. The first focused on advances in the understanding of the cellular and molecular mechanisms of angiogenesis in tumors. The second examined preclinical assay systems that are useful in vascular biology. The third addressed the translation to the clinic and monitoring of antiangiogenic activity of agents in patients and novel trial designs. What follows is a summary of the discussions and findings of each session.
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Biologic therapies for dyslipidemia.
Biologic therapies involve the utilization of proteins, DNA, antibodies, or other substances derived or synthesized from living tissue for therapeutic effects. There are several biologic therapies in clinical development for the prevention and treatment of atherosclerosis. The most advanced in human trials are apolipoprotein mimetics, which include apolipoprotein A-1 Milano and phospholipid complexes. Infusions of these apolipoprotein mimetics have been demonstrated to reduce atherosclerotic development in both animal models and humans. Autoimmunization to create neutralizing antibodies to cholesteryl ester transfer protein is also in human trials. Gene therapies to reduce low-density lipoproteins and increase high-density lipoproteins are on the horizon, but the ability to safely prolong gene expression in humans will require the development of novel vectors.
Apolipoprotein A-I↗
[Drug therapy and other biological therapies in mood disorders].
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Antidepressive Agents↗
Differentiating the new rheumatoid arthritis biologic therapies.
Current understanding of the mechanisms behind the pathogenesis of rheumatoid arthritis (RA) has led to the development of therapies involving biologic agents that target specific mediators of the disease process. Although the biologic agents used to treat RA share the ability to alter the cytokine cascade, they differ in ways that are clinically important. For example, they vary with regard to how they block cytokine activity (ie, as receptors, as receptor blockers, or as anticytokine antibodies) and the particular cytokine they target (eg, tumor necrosis factor [TNF] versus interleukin-1). Biologic therapies for RA also differ in mode of administration. Several are administered subcutaneously, whereas others are given intravenously. They also have molecular dissimilarities that result in differences in pharmacokinetics (ie, long versus medium half-life) and that may influence their safety profiles.Some biologic agents, such as the TNF inhibitors etanercept and infliximab, have been rigorously examined for long-term safety and efficacy, whereas other agents, like the TNF inhibitor adalimumab, have not. Differences between the various biologic agents may relate to the usefulness of each individual drug as a long-term treatment in RA. For example, the need for physician visits may impact the practicality of drugs that are administered intravenously. Also, physicians should be aware that use of cytokine inhibitors increases the risk of infection. The prevalence of tuberculosis during therapy with infliximab exceeds the background rate in patients with RA. Accordingly, physicians should be familiar with the updated warnings in the package inserts that accompany these drugs.
Journal Article↗
Biologic therapies for chronic inflammatory bowel disease.
Crohn's disease (CD) and ulcerative colitis (UC) make up the so-called chronic inflammatory bowel disease (IBD). Advances in the understanding of IBD pathophysiologic mechanisms in the last few years have allowed the development of novel therapies such as biologic therapies, which at least theoretically represent a more specific management of this disease with fewer side effects. Currently, the only effective and widely accepted biologic therapy for the treatment of intraluminal, fistulizing CD, both for remission induction and maintenance, is infliximab. The role of other monoclonal antibodies such as adalimumab is not clearly established. It could be deemed an alternative for patients with allergic reactions to infliximab, and for those with lost response because of anti-infliximab antibody development. However, relevant issues such as dosage and administration regimen remain to be established. Anti-integrin a4 therapies, despite encouraging results in phase-3 studies, are still unavailable, as their marketing authorization was held back in view of a number of reports regarding progressive multifocal leukoencephalopathy cases. Immunostimulating therapy may be highly relevant in the near future, as it represents a novel strategy against disease with the inclusion of granulocyte-monocyte colony-stimulating factors.Regarding ulcerative colitis, results from the ACT-1 and ACT-2 studies showed that infliximab is also useful for the management of serious UC flare-ups not responding to standard treatment, which will lead to a revision of therapeutic algorithms, where this drug should be given preference before intravenous cyclosporine. In the next few years, the role of anti-CD3 drugs (vilisilizumab), T-cell inhibiting therapies, and epithelial repair and healing stimulating factors will be established.
Antibodies, Monoclonal↗
Therapy of ankylosing spondylitis. Part II: biological therapies in the spondyloarthritides.
Therapeutic options for patients with active and severe spondylarthritis (SpA) have been fairly limited in the past decades. There is now accumulating evidence that biological therapy with agents directed against tumour necrosis factor-alpha (TNF-alpha) is highly efficacious in the spondyloarthritides, especially in ankylosing spondylitis (AS) and psoriatic arthritis (PsA). The TNF blocking agents currently available, infliximab (Remicade), etanercept (Enbrel), and adalimumab (Humira), are approved for the treatment of rheumatoid arthritis (RA) in Europe and the USA. In contrast to rheumatoid arthritis (RA) disease-modifying anti-rheumatic drugs (DMARDs) have limited efficacy in SpA. No DMARDs are available for AS patients with active spinal disease. Thus, for AS patients whose condition is not sufficiently controlled with non-steroidal anti-inflammatory drugs (NSAIDs), therapy with TNF blockers may be considered as a first-line treatment. For infliximab, a dose of 3-5 mg/kg seems to be required, and intervals between 6 and 12 weeks are necessary to suppress disease activity continually. The standard dosage of etanercept is 2 x 25 mg subcutaneously (s.c.) per week. There are very few studies with adalimumab (standard dose in RA 20-40 mg s.c. every 1-2 weeks) in SpA. Infliximab and etanercept are now both approved for AS in Europe. There is some evidence that both agents also work in other SpA, especially in PsA. Withdrawal of long-term therapy in AS patients led to relapses of disease after several months. Less radiographic progression after 2 years of continuous treatment with infliximab compared to conventional therapy has been suggested in a small study. Serious adverse events on anti-TNF therapy have remained rare. However, severe infections, including tuberculosis, have been reported. These can be largely prevented by appropriate screening. The benefits of anti-TNF therapy in AS seem to outweigh these shortcomings.
Antirheumatic Agents↗
Patient satisfaction with psoriasis therapies: an update and introduction to biologic therapy.
BACKGROUND: Psoriasis is a chronic, immune-mediated skin condition that often requires lifelong treatment. Many patients report dissatisfaction with traditional nonbiologic therapies because they are ineffective for their psoriasis, are associated with side effects, or impact negatively on quality of life. OBJECTIVES: The aim of this article is to review the effect on patient quality of life of traditional nonbiologic psoriasis therapies and to discuss the impact of biologic psoriasis therapies on patient satisfaction. METHODS: A review of the literature is presented. RESULTS: Traditional nonbiologic psoriasis therapies can negatively impact quality of life due to a variety of factors including inconvenience and toxicity. Biologic agents have been developed that target the immunopathogenesis of psoriasis. Based on favorable efficacy and safety results in clinical trials, some of these agents are now approved for clinical use. Evidence suggests that patients receiving biologic therapies experience significant improvements in health-related quality of life. CONCLUSION: Biologic agents offer new hope for patients with psoriasis that their chronic condition can be controlled in a manner that improves their quality of life and may lead to high levels of satisfaction with their treatment.
Alefacept↗
Biological therapies for ulcerative colitis.
Biological therapies are being increasingly investigated for the treatment of inflammatory bowel disease. However, a great deal more study has been devoted to studies of Crohn's disease rather than ulcerative colitis. Ulcerative colitis, like Crohn's disease, represents an area of high clinical need, particularly for those patients who have disease inadequately responsive to corticosteroids and 5-aminosalicylates. The distinct anatomic distribution of inflammation in ulcerative colitis represents an important model for study, with the entire involved mucosa entirely accessible to endoscopy. In addition, there is an opportunity for local delivery of biologic agents in left-sided disease. Distinct pathogenetic factors in ulcerative colitis raise the possibility of therapies quite different from those used in Crohn's disease. This work describes the current state of knowledge regarding biological therapy in ulcerative colitis. The role of probiotic therapy, and studies of cytokine-directed therapies, therapies targeting adhesion and recruitment, and restitution and repair are described.
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Biologic therapy of inflammatory bowel disease.
Advancing knowledge regarding the biology of chronic inflammation has led to the development of specific biologic therapies that mechanistically target individual inflammatory pathways. Many biologic therapies are being evaluated for the treatment of the chronic inflammatory bowel diseases, Crohn's disease and ulcerative colitis. Biologic compounds proven to be effective for Crohn's disease include monoclonal antibodies to tumor necrosis factor (infliximab and CDP571) and to the leukocyte adhesion molecule alpha4 integrin (natalizumab). Other biologic compounds for which there is insufficient evidence to judge efficacy for inflammatory bowel disease include: p55 tumor necrosis factor binding protein (onercept); interferon alpha; interferon beta-1a; anti-interferon gamma antibody; anti-interleukin 12 antibody; p65 anti-sense oligonucleotide (blocks NF-kappaB); granulocyte colony stimulating factor, and granulocyte macrophage colony stimulating factor; anti-interleukin 2 receptor antibody; epidermal growth factor; keratinocyte growth factor 2 (repifermin); human growth hormone; anti-CD4 antibody; and anti-alpha4beta7 antibody. Biologic therapies that have been proven ineffective for inflammatory bowel disease include: interleukin 10; interleukin 11; anti-sense intercellular adhesion molecule-1; and the tumor necrosis factor receptor fusion protein etanercept. Based on the early successes of infliximab, CDP571 and natalizumab, it seems certain that biologic therapy will play an important role in the future treatment of inflammatory bowel disease.
Biological Therapy↗