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Side effects of biologic agents 

Side effects of biologic agents 

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Article
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Biologic agents are targeted immune modulating agents that have been widely used in the treatment of inflammatory and neoplastic conditions with favorable results. The purpose of this review is to provide an update on the biologic agents that have been used in the treatment of diseases that affect the oral mucosa. Identification of relevant data, c...

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... In comparison to traditional immunosuppressant, these act as a pathogenesis- (19) based treatment rather than just palliative care. ...
... Serious infusion reactions, cardiac arrest, infections, and progressive multifocal encephalopathynegative consequences. Treatment recommendations for NHL (B cell variation), SLE, Pemphigus, Pemphigoid, Epidermolysis Bullosa, Ig G4 associated salivary illness, (12) (18) Sjogren's syndrome .An observational study in patients with Pemphigus vulgaris treated with rixathon, a biosimulant of rituximab exhibited excellent results with significant (19) decrease in anti-Desmoglein3 values ...
Article
Immunity plays a vital role in maintaining the health of an individual. Immunomodulators are a class of drugs that maintain the homeostasis of the immune system when it is altered by any disease.The immunity can be either improved or suppressed with immunostimulants and immunosuppressant respectively. These drugs are inevitably used in the treatment of various oral diseases.This review article focuses on the various immunomodulators used in dentistry.
... The basis of treatment with BAs is pathogenesis-based and not just organ-based palliative therapy. [1][2][3][4] The three broad classes 1 ...
... The basis of treatment with BAs is pathogenesis-based and not just organ-based palliative therapy. [1][2][3][4] The three broad classes 1 ...
... The majority of affected patients are diagnosed with SS in the absence of other autoimmune conditions (primary SS-pSS). Some patients, however, may develop secondary SS (sSS) as a sequela of rheumatological conditions including systemic lupus erythematosus and rheumatoid arthritis (Georgakopoulou, Andreadis, Arvanitidis, & Loumou, 2013). ...
Article
Objective. This systematic review evaluated the efficacy of immunobiologics for management of oral disease in Sjögren’s syndrome. Materials and Methods. MEDLINE®, Embase, Scopus and the Cochrane Library were searched for evidence on the use of immunobiologics for management of glandular disease in Sjögren’s syndrome. Primary outcomes were xerostomia and salivary gland dysfunction, assessed via visual analogue scales, disease-specific scales for Sjögren’s syndrome, measurement of salivary flow, ultrasound data, and quality of life measures. Results. Seventeen studies (11 randomized controlled trials and 6 observational studies) met inclusion criteria. Rituximab showed efficacy in improving salivary gland function but not xerostomia. Abatacept showed promise in improving both xerostomia and salivary flow. Belimumab exhibited long term improvement of salivary flow and subjective measures. The novel agent CFZ533 improved both disease activity and patient-reported indexes. Conclusions. There is strong evidence pointing to the efficacy of rituximab in the management of oral disease in Sjögren’s syndrome. Future controlled trials may elucidate the efficacy of belimumab and abatacept. The new drug CFZ533 is a promising alternative for the management of Sjögren’s syndrome and its salivary gland involvement. In considering these agents, the promise of efficacy must be balanced against the harmful effects associated with biologic agents.
... Although the safety and efficacy of anti-TNFα agents have already been established, the risk of lymphoma appears higher in patients treated with immune-modulating agents [1,2]. This case report describes a patient with highly suspected primary intraocular lymphoma (PIOL), possibly associated with use of the approved anti-TNFα agent etanercept for treatment of rheumatoid arthritis (RA) [3]. ...
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Background To describe a case of highly suspected primary intraocular lymphoma (PIOL) in a patient using etanercept for the treatment of rheumatoid arthritis. Case presentationA 50-year-old female patient presented with decreased vision in her left eye that lasted for a week. She had a 15-year history of seropositive rheumatoid arthritis (RA), and had been taking weekly etanercept for the preceding 8 months. Funduscopic examination and SD-OCT showed a swollen ellipsoid zone (EZ) and a retinal pigment epithelium (RPE) irregularity of the right eye. We also noted EZ disruption and a RPE irregularity in the left eye. As subretinal infiltration was aggravated in the right eye after the initial treatment, we completed a vitrectomy. Vitreous cytology revealed PIOL with positive CD20 immunostaining. She was treated with serial intravitreal methotrexate injections and systemic chemotherapy. After the treatment, subretinal infiltration and subRPE deposits were decreased in the right eye with no evidence of recurrence in either eye. Conclusions This case suggests a potential relationship between immunosuppression with anti-TNFα medication, and increased risk for lymphoma, especially in patients with underlying rheumatologic disorders and especially in patients with suspected chronic refractory uveitis.
... Biologics are generated by recombinant technology and comprises a large number of monoclonal antibodies and fusion proteins which act by targetting specific pro inflammatory pathways. Guidelines for the use of biologicsin licensed indications include use of biologics in off situations, eligibility for use, adverse effects, infection control andtheir relevance to oral medicine.[1]Regulatory guidelines for the development of biologics include validations of various steps in development, standard guidelines, manufacturing guidelines, analytical tests. ...
... Biologics treatments are innovative treatment aimed at TNF-α inhibitors, IL inhibitors and lymphocyte modulators. They have several potential applications in oral medicine and are increasingly used in treating patient with only refractory mediated diseases.[1][2][3]Biologics are generated by recombinant technology and umber of monoclonal antibodies and fusion proteins which act by targetting specific proinflammatory pathways. ...
... In recent years usage of the Tumor necrosis alpha blockers (Anti-TNFα) in romatologic diseases has been increased and their efficacy has been proved. Etanercept is a fusion protein resembling TNF receptors type-II, which acts by blocking circulating TNF and lymphotoxin-a [1]. It is approved for the treatment of Rheumatoid arthritis, Psoriatic arthritis, Ankylosing spondylitis, Moderate to severe plaque psoriasis and Severely active polyarticular juvenile idiopathic arthritis in children aged 2 years and older [1]. ...
... Etanercept is a fusion protein resembling TNF receptors type-II, which acts by blocking circulating TNF and lymphotoxin-a [1]. It is approved for the treatment of Rheumatoid arthritis, Psoriatic arthritis, Ankylosing spondylitis, Moderate to severe plaque psoriasis and Severely active polyarticular juvenile idiopathic arthritis in children aged 2 years and older [1]. While the importance of these drugs is folding up, some questions are appearing in the minds, like whether they lead or facilitate the malign process. ...
Article
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Potential for developing malignancies with Tumor necrosis alpha blockers (Anti-TNFα) in romatologic diseases is an important question in our minds, contrary to the proved efficacy of them. To our knowledge, yet no case report has been established about papillary thyroid carcinoma during etanercept therapy for psoriatic arthritis. Here we reported a patient who was diagnosed as papillary thyroid carcinoma while she was using etanercept for psoriatic arthritis. She had medical history for familial trait of carcinoma. Radioactive iodine therapy was administered after the surgery. We preferred to stop etanercept therapy and there was no increase in clinical and laboratory disease activity.
... Rituximab is currently an offlabel agent used in refractory cases of pemphigus vulgaris and Sjogren syndrome (see below), but clinicians should treat such cases with caution. [7][8][9]20 A newer anti-B-cell agent, belimumab, has recently been approved for the treatment of systemic lupus erythematosus. ...
... Infliximab and rituximab for example, must be given as periodic intravenous infusions, while etanercept, adalimumab and ustekinumab are given as regular subcutaneous injections (bi-weekly, weekly, every two weeks or monthly), with schedules varying with the condition being treated. 7,8,20 ...
Article
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Biological agents - biologics, biologicals or biopharmaceuticals - are any medicinal product manufactured in, or extracted from, a biological source. They are often generated by DNA recombinant biotechnology and several dozen therapeutic monoclonal antibodies (mAbs) are now marketed for a variety of indications, increasingly in the management of inflammatory immune-mediated disorders, transplantation rejection and cancer treatments. Immunomodulatory mAbs are expensive, must be given by injection or infusion and can have adverse effects but are increasingly used and can be highly effective agents. This paper reviews these agents and their increasing relevance to oral science and healthcare.
... In our case the patient had an excellent response and we could not ignore the fact that her response may be related to the cessation of etanercept, a clinical observation reported in the literature (10). In addition, the fact that etanercept was combi- (8). Etanercept is a fusion protein resembling TNF receptors type-II, which acts by blocking circulating TNF and lymphotoxin-a (8). ...
... In addition, the fact that etanercept was combi- (8). Etanercept is a fusion protein resembling TNF receptors type-II, which acts by blocking circulating TNF and lymphotoxin-a (8). It is approved for the treatment of Rheumatoid arthritis, Psoriatic arthritis, Ankylosing spondylitis, Moderate to severe plaque psoriasis and Severely active polyarticular juvenile idiopathic arthritis in children aged 2 years and older (8). ...
... Etanercept is a fusion protein resembling TNF receptors type-II, which acts by blocking circulating TNF and lymphotoxin-a (8). It is approved for the treatment of Rheumatoid arthritis, Psoriatic arthritis, Ankylosing spondylitis, Moderate to severe plaque psoriasis and Severely active polyarticular juvenile idiopathic arthritis in children aged 2 years and older (8). Cases of lymphomas have been reported in adult patients with Rheumatoid arthritis and children with Juvenile idiopathic arthritis (9), and the FDA added a black box label for this reason, but still questions remain whether etanercept risk for NHL is higher than that attributed to the underlying disease used for (9). ...
Article
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Oral non-Hodgkin’s lymphomas (O-NHLs) are a rare group of diverse lymphoid tissue malignancies and represent less than 5% of the oral cavity malignancies and 2% of all extra-nodal NHLs. Oral-NHLs affect the Waldeyer’s-ring, the salivary glands, the bone of the jaws and the oral mucosa, their clinical appearance is very heterogeneous. Among the risk factors for NHLs are immunosuppression (primary or secondary), autoimmunity and inflammation. O-NHLs share the same risk factors. This case report describes a patient with O-NHL which was possibly linked to the combination of methotrexate and etanercept for the treatment of her rheumatoid arthritis. To our knowledge this is probably among the first cases of O-NHL with possible relation to the use of a Tumor Necrosis Factor (TNF) antagonist biological agent (etanercept). This case could contribute to the sensitization of the dentists for the signs and symptoms of this rare malignancy. It also underlines the need for thorough medical history and medication recording for all the dental patients. Key words:Lymphoma (oral) methotrexate, etanercept.
Chapter
Aphthosis is an inflammatory disease characterized by painful, recurrent oral ulcerations. The cause of aphthosis is unknown, and several studies indicate a role of the immune system in the physiopathogenesis of this disease. Oral lesions mainly appear on the non-keratinized mucosa as painful, regular, round, or oval ulcers covered by a gray pseudomembrane and surrounded by an erythematous halo. The diagnosis of aphthosis is mainly established on clinical grounds. Treatment depends on the severity, recurrence rate, and response to previous therapies.KeywordsRecurrent aphthous stomatitisOral ulcersAphthosis
Article
Background Immune-mediated diseases are a diverse group of conditions characterized by alteration of cellular homeostasis and inflammation triggered by dysregulation of the normal immune response. Several immune-mediated diseases exhibit oral signs and symptoms. Traditionally, these conditions are treated with corticosteroids or immunosuppressive agents, including azathioprine, cyclophosphamide, and thalidomide. Recent research into the developmental pathways of these diseases has led to the exploration of novel approaches in treatment. This review examines newer treatment modalities for the management of immune-mediated diseases with oral presentations. Topical calcineurin inhibitors (TCIs) such as tacrolimus and pimecrolimus have been employed successfully in managing oral lichen planus and pemphigus vulgaris. Biologic agents, comprising monoclonal antibodies, fusion proteins, and recombinant cytokines, can provide targeted therapy with fewer adverse effects. Neutraceutical agents comprising aloe vera, curcumin, and honey are commonly used in traditional medicine and offer a holistic approach. They may have a place as adjuvants to current standard therapeutic protocols. Photodynamic therapy (PDT) and low-level laser therapy (LLLT) utilize a specific wavelength of light to achieve desired cellular change. While the use of PDT in immune-mediated diseases is contentious, LLLT has shown positive results. Newer therapeutic modalities involve kinase inhibitors, S1P1 receptor modulators, MSCs, and iRNA providing targeted treatment of specific diseases.