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PubMed2003

[Biologic therapy of inflammatory bowel disease].

Biological therapies in inflammatory bowel disease reflect the exponential advancement in understanding the human intestinal immune system and particularly the biology of intestinal inflammation during the past decade. The better understanding of the mechanisms of inflammatory bowel disease has evolved from desriptive clinical data and genetically engineered animal models. It led to great interest in the evaluation of a variety of new therapeutic agents with novel actions. This review will discuss the mechanisms of biologicals (antibodies against pro-inflammatory cytokines, T cell antibodies, anti-inflammtory cytokines, adhesion molecule blockers, growth factors, hormones, colony stimulating factors, fusion proteins, anti-sense oligonucleotides, trefoil peptides, immunostimulatory [ISS] DNA) used in the treatment of inflammatory bowel disease and summarizes the available data on established biologic therapies as well as investigational agents and briefly touch on probiotics. Based on the data discussed, it seems that biologicals will play an important role in managing inflammatory bowel disease in the near future.

Animals↗
PubMed1998

Timely delivery of biological therapy after cytoreductive nephrectomy in carefully selected patients with metastatic renal cell carcinoma.

PURPOSE: We determine whether cytoreductive surgery delays or precludes the administration of systemic biological therapy in patients with previously untreated metastatic renal cell carcinoma. MATERIALS AND METHODS: We evaluated 79 patients 22 to 73 years old with untreated renal cell carcinoma for possible cytoreductive surgery before the administration of systemic biological therapy. Based on performance status, overall disease burden and subjective clinical assessment 13 patients were referred for initial systemic biological therapy and 66 underwent cytoreductive surgery as initial treatment. We evaluated patient ability to receive postoperative biological therapy, time to therapy, surgical complications and mortality. RESULTS: Cytoreductive surgery had a minimal impact on the administration of timely systemic biological therapy in these carefully selected patients. Of the 66 patients 54 (82%) received postoperative systemic biological therapy beginning a median of 40 days after nephrectomy. Two patients (3%) died postoperatively (within 30 days) and in 1 (1.5%) postoperative deterioration in performance status precluded the administration of systemic therapy. The other 9 patients did not have measurable residual disease postoperatively, did not need or refused systemic therapy, or were followed elsewhere. CONCLUSIONS: Systemic biological therapy can be administered in a timely manner (median 40 days) to the majority of patients (82% treated) after cytoreductive surgery. Surgery alone does not preclude the administration of systemic biological therapy in carefully selected patients.

Adult↗
PubMed2004

Routes to regenerating islet cells: stem cells and other biological therapies for type 1 diabetes.

New biological therapies for type 1 diabetes are emerging from the forefront of stem cell and islet cell biology. Basic research in animal models has uncovered a variety of mechanisms by which natural regeneration of pancreatic islet cells occurs, despite the underlying autoimmune defect. Two mechanisms - in particular, beta-islet cell proliferation and stem cell differentiation - can be harnessed in innovative ways in order to regenerate islets lost to disease. This review provides a background on stem cells and describes a range of potential biological therapies for type 1 diabetes, including the use of adult stem cells from the spleen, an organ not previously considered a source of pancreatic stem cells. Stem cells of the spleen have been demonstrated to home to the pancreas, where they mature into fully functional islet cells responsible for restoring normoglycemia. If the underlying autoimmune defect can be eradicated, stem cells of the spleen, as well as related strategies, can be used in order to regrow islets destroyed by type 1 diabetes.

Cell Differentiation↗
PubMed1994

A case report of recurrent cervical cancer which responded to a combination of biological therapies.

Adoptive immunotherapy with tumor-infiltrating lymphocytes (TIL) has been challenged to human cancer patients during these years. However, as the efficacy of the therapy alone is still limited, another approach, a combination with other therapies may be required to obtain more favorable antitumor effects. Tumor necrosis factor alpha (TNF) is worth considering for combination, because at least its various potential roles in immune response suggest that it might increase the killing activity of T cells against autologous tumor cells. We attempted to treat the cancer patients with TIL combined with TNF therapy. A patient with recurrent cervical cancer was treated with multiple biological therapies including TIL and TNF therapy, and irradiation. Biological therapies consisted of endogenous and exogenous TNF (EET) therapy, TIL, administration of rTNF-SAM2 combined with hyperthermia and several biological response modifiers such as schizophyllan and lentinan. After 50 days of therapy, the recurrent tumor had remarkably decreased in size, and cystic change of the tumor was observed by CT scanning. By further continuation of these therapies, the disease condition was much improved. As these antitumor effects cannot well be explained by irradiation therapy alone, multiple biological therapies are considered to be potentially effective against the highly malignant advanced tumors.

Adult↗
PubMed2005

Update on the mechanisms and efficacy of biological therapies for psoriasis.

Biologically based agents (biologics) are novel therapeutic options in the treatment of moderate-to-severe psoriasis. Unlike traditional systemic anti-psoriatic drugs, which are chemically synthesized, these agents are unique in that they are derived from living organisms and hence called "biologics." In addition, they are the first group of "custom-designed" molecules that precisely target steps in the pathogenesis of psoriasis. The specificity of these biologics can theoretically avoid the side effects of the prebiologically developed systemic agents including the effects of hepatotoxicity, nephrotoxicity, and bone marrow suppression. However, there is also a tendency for a more precisely targeted agent to have a less overall efficacy. Due to the varying efficacies and high costs of the new biologic agents that are currently approved for psoriasis in the United States, the precise way they fit into the range of treatments for moderate-to-severe psoriasis should be defined pending future clinical experiences.

Adalimumab↗
PubMedDate not supplied

Immunologic monitoring of cancer vaccine therapy: results of a workshop sponsored by the Society for Biological Therapy.

The Society for Biological Therapy held a Workshop last fall devoted to immune monitoring for cancer immunotherapy trials. Participants included members of the academic and pharmaceutical communities as well as the National Cancer Institute and the Food and Drug Administration. Discussion focused on the relative merits and appropriate use of various immune monitoring tools. Six breakout groups dealt with assays of T-cell function, serologic and proliferation assays to assess B cell and T helper cell activity, and enzyme-linked immunospot assay, tetramer, cytokine flow cytometry, and reverse transcription polymerase chain reaction assays of T-cell immunity. General conclusions included: (1) future vaccine studies should be designed to determine whether T-cell dysfunction (tumor-specific and nonspecific) correlated with clinical outcome; (2) tetramer-based assays yield quantitative but not functional data (3) enzyme-linked immunospot assays have the lowest limit of detection (4) cytokine flow cytometry have a higher limit of detection than enzyme-linked immunospot assay, but offer the advantages of speed and the ability to identify subsets of reactive cells; (5) antibody tests are simple and accurate and should be incorporated to a greater extent in monitoring plans; (6) proliferation assays are imprecise and should not be emphasized in future studies; (7) the reverse transcription polymerase chain reaction assay is a promising research approach that is not ready for widespread application; and (8)there is a critical need to validate these assays as surrogates for vaccine potency and clinical effect. Current data and opinion support the use of a functional assay like the enzyme-linked immunospot assay or cytokine flow cytometry in combination with a quantitative assay like tetramers for immune monitoring. At present, assays appear to be most useful as measures of vaccine potency. Careful immune monitoring in association with larger scale clinical trials ultimately may enable the correlation of monitoring results with clinical benefit.

Animals↗
PubMed1996

The future use of biologic therapies in combination for the treatment of rheumatoid arthritis.

The complexity of the immune system, exemplified by the pleiotropic effects of many cytokines and the redundancy of regulatory networks controlling immune responses, suggests that single therapeutic interventions will offer transient or less than clinically meaningful benefit. Theoretically, combination therapy using 2 or more biologic agents will modulate important symptomatic and objective manifestations of rheumatoid arthritis (RA). Data from animal models suggest that use of biologic agents in combination can be synergistic and may alter the severity and course of disease. Although combinations of biologic agents have yet to be used in human disease, successful examples employing immunosuppressive agents exist: cyclosporin (CsA) with methotrexate in patients with persistent active RA, as well as azathioprine and/or mycophenolate mofitil with CsA in organ transplantation and acute graft rejection. There are many arguments against the use of combination biologic therapies including acute infusion related toxicities, infection, malignancy, autoimmune manifestations, and expense. While caution dictates that phase I-II clinical trials be performed in patients with longstanding, refractory disease, subsequent trials should be conducted in patients with earlier, more responsive disease. Successful combination biologic therapies must afford sufficient duration of benefit (at least 6, preferably 12 months), cost comparable to approved 2nd line agents, ease of treatment, and an acceptable safety profile.

Animals↗
PubMed1997

Advances in the biological therapy and gene therapy of malignant disease.

Biological and gene therapy of cancer have become important components of clinical cancer research. Advances in this area are based on evidence for the presence of tumor antigens, antitumor immune responses, evasion of host control by tumors, and the recognition of host defense failure in cancer patients. These mechanisms are being corrected or exploited in the development of biological and gene therapy. Over the last decade, 9 biological therapies have received Food and Drug Administration approval, and another 12 appear promising and will likely be approved in the next few years. Our approach to gene therapy has been to allogenize tumors by the direct intratumoral injection of HLA-B7/beta2-microglobulin genes as plasmid DNA in a cationic lipid into patients with malignant melanoma. In four Phase I studies, we found a 36% response by the local injected tumor and a 19% systemic antitumor response. In other cancers, gene transfer, expression, and an intratumoral T-cell response were seen, but no clinical response was seen. A variety of follow-up studies with HLA-B7 and other genes are planned. Evasion of host control is now a major target of gene therapy. Strategies to overcome this include up-regulation of MHC and introduction of cell adhesion molecules into tumor cells, suppression of transforming growth factor and interleukin 10 production by tumor cells, and blockade of the fas ligand-fas interaction between tumor cells and attacking lymphocytes. With these approaches, it seems likely that gene therapy may become the fifth major modality of cancer treatment in the next decade.

BCG Vaccine↗
PubMed2006

Novel biological therapies for inflammatory bowel disease.

The success of biological therapy is best advocated by infliximab (IFX), which has dramatically improved medical therapy for Crohn's disease and now has been shown to be effective in the treatment of ulcerative colitis. Other anti-tumor necrosis factor (TNF) compounds have been tested in the treatment of Crohn's disease and will soon appear in the therapeutic armament. However, neutralization of TNF does not seem to be the most important mechanism of action of these therapies. Apoptosis of activated T cells was demonstrated after IFX treatment, and this may be the key to its success. Thus, other therapies that induce apoptosis in activated T cells, such as visilizumab, have a great chance to be of benefit. Biological therapies applied in inflammatory bowel disease appear to be safe, although therapy-related adverse events clearly have been recognized.

Journal Article↗
PubMed2005

Biologic therapy for colon cancer.

Targeted biologic therapy remains a very active and evolving field since the US Food and Drug Administration approved cetuximab, a recombinant, human/mouse chimeric monoclonal antibody against the endothelial growth factor receptor, and bevacizumab, a humanized monoclonal antibody directed against vascular endothelial growth factor, for the treatment of colorectal cancer. Benefits of these reagents in diverse clinic settings combined with different chemotherapeutic agents are being defined. Current research is focused on defining which patients will benefit from these treatments and how best to use them in the clinic. Additional preclinical and clinical studies will enable better usage of these biologic agents and lead to the development of new targeted therapies for the treatment of colon cancer.

Animals↗
PubMed1996

Renal cell carcinoma metastatic to the lung: potential benefit in the combination of biological therapy and surgery.

PURPOSE: We evaluated outcomes in cases of renal cell carcinoma metastatic to the lung treated with surgery or biological therapy followed by surgery. MATERIALS AND METHODS: We retrospectively evaluated 22 patients treated with surgical resection and 29 treated with biological therapy followed by surgery. RESULTS: At the time of this study 31 patients (61%) were alive, including 15 with no residual disease and 16 with disease. Of the 22 patients treated with surgery without initial biological therapy 12 (55%) were alive at a median followup of 57 months (range 17 to 148) and 19 of the 29 (66%) treated with combination therapy were alive at a median followup of 48 months (range 19 to 78). A total of 19 patients (37%) died of progressive disease. CONCLUSIONS: Our results suggest a role for an aggressive surgical approach in select patients with metastatic renal cell carcinoma, and demonstrate that patients who do not achieve a complete response to biological therapy may benefit from surgical resection of residual disease.

Actuarial Analysis↗
PubMed2002

Biologic therapy for psoriasis: the new therapeutic frontier.

OBJECTIVES: (1) To develop a clinically useful model with which dermatologists can understand the potential uses of biologic therapy for psoriasis and understand the potential differences among these novel drugs, (2) to discuss the process by which recombinant DNA technology is used to develop rationally designed protein medications along with the potential benefits and difficulties of therapy with biologic agents, and (3) to provide a short review of the medications under development for psoriasis. DATA SOURCES: The pertinent literature was reviewed with particular emphasis on published, randomized, and placebo-controlled trials. Phase 1 and early phase 2 trials were also included in our review when more stringent studies were not available. Studies presented as peer-reviewed abstracts at major conferences were also reviewed. CONCLUSIONS: With the development of recombinant DNA techniques, it has become possible to develop new biologic therapies that can be designed to specifically alter physiological responses. These new drugs are in use in many different medical fields and will soon be available for the treatment of dermatological diseases, primarily psoriasis. Dermatologists should be familiar with the potential benefits and risks of these therapies to make rational decisions concerning their use in the treatment of their patients with psoriasis.

Adjuvants, Immunologic↗
PubMed2002

Examining the efficacy of biologic therapy: are there real differences?

Biologic therapy with anakinra, etanercept, and infliximab effectively reduced the signs and symptoms of active rheumatoid arthritis (RA) in randomized controlled trials. Clinical efficacy was determined by American College of Rheumatology (ACR) response criteria. In patients failing previous disease modifying antirheumatic drug (DMARD) therapy, both anakinra and etanercept were significantly more effective than placebo. In patients with inadequate responses to methotrexate (MTX), addition of anakinra, etanercept, or infliximab to stable MTX therapy was significantly more effective than MTX alone. Etanercept has also shown efficacy in early stage, methotrexate-naive patients. Comparisons of the efficacy of these biologics across clinical studies are problematic due to differences in study design, study conduct, and patient populations. Moreover, ACR response rates do not allow comparisons of agents that each achieve these responses relative to placebo. Until comparative clinical studies are conducted, in which 2 biologics are evaluated using the same protocol and patient population, the only conclusion that can be reached from published studies is whether an individual biologic agent is safe and effective. All 3 biologics - anakinra, etanercept, and inflixmab - are effective.

Antibodies, Monoclonal↗
PubMed2000

Where is biological therapy going?

The substantial progress in our understanding of molecular and cellular biology has allowed us to design biological therapeutics ('biologicals') with defined targets and effector functions. These biologicals have greatly contributed to our current knowledge of pathogenetic mechanisms in autoimmune diseases. However, although some of the biologicals have been extremely successful in treating the symptoms of chronic inflammation, biological therapy has not yet met the expectations of permanently silencing the chronic immune response. In this commentary we discuss current concepts and future directions of biological therapy, and the potential usefulness of biologicals as a treatment of human autoimmune diseases in appropriate critical applications with the use of suitably designed agents.

Autoimmune Diseases↗
PubMed2007

Biologic therapies in rheumatology: lessons learned, future directions.

During the past decade biologic therapies such as monoclonal antibodies and fusion proteins have revolutionized the management of rheumatic disease. By targeting key cytokines and immune cells biologics have provided more specific therapeutic interventions with less immunosuppression. Clinical use, however, has revealed that their theoretical simplicity hides a more complex reality. Efficacy, toxicity and even pharmacodynamic effects can deviate from those predicted, as poignantly illustrated by the catastrophic effects witnessed during the first-into-human administration of TGN1412. This review summarizes lessons gleaned from practical experience and discusses how these can inform future discovery and development of new biologic therapies for rheumatology.

Animals↗
PubMed2004

Biological therapy for the inner ear.

Biological therapy for the inner ear has the potential to revolutionise the treatment of sensorineural hearing loss, the most common form of deafness. Progress in the molecular understanding of hearing and hearing loss, combined with advances in the fields of both gene and cellular therapy for the inner ear, is providing a robust foundation from which clinical translation is plausible. Potential areas of interest in gene therapy and its preclinical application to deafness are reviewed, and experimental progress that has occurred in cellular therapy for the inner ear is examined.

Animals↗
PubMed2004

Biological therapies in the systemic management of psoriasis: International Consensus Conference.

Psoriasis is a chronic, immune-mediated disorder that usually requires long-term treatment for control. Approximately 25% of patients have moderate to severe disease and require phototherapy, systemic therapy or both. Despite the availability of numerous therapeutic options, the long-term management of psoriasis can be complicated by treatment-related limitations. With advances in molecular research and technology, several biological therapies are in various stages of development and approval for psoriasis. Biological therapies are designed to modulate key steps in the pathogenesis of psoriasis. Collectively, biologicals have been evaluated in thousands of patients with psoriasis and have demonstrated significant benefit with favourable safety and tolerability profiles. The limitations of current psoriasis therapies, the value of biological therapies for psoriasis, and guidance regarding the incorporation of biological therapies into clinical practice are discussed.

Age Factors↗