scholarly journals OPTIMIZATION OF BIOLOGICAL THERAPY IN PATIENTS WITH ULCERATIVE COLITIS (CASE REPORT)

2015 ◽  
Vol 6 (2) ◽  
pp. 15-23
Author(s):  
O V Knyazev ◽  
A V Kagramanova ◽  
N A Fadeeva ◽  
M V Kirova ◽  
N V Orlova ◽  
...  
Keyword(s):  
Adverse Events ◽  
High Efficiency ◽  
Biological Therapy ◽  
Opportunistic Infections ◽  
Response To Therapy ◽  
Biological Drugs ◽  
Secondary Loss ◽  
Loss Of Response ◽  
Tnf Α ◽  
Drug Activation

Now in Russia registered two biological drugs for the treatment of UC is infliximab and golimumab. The largest experience with the use of infliximab (IFX) shows that, despite the high efficiency, in some patients the IBD (20-30%) will develop acquired secondary loss of response to the drug. The development of secondary loss of anti-cytokine therapy is influenced by the following causes - irregular administration of the drug, monotherapy with monoclonal antibodies, initial high levels of TNF-α and low albumin, the presence of antibodies to the drug, activation of opportunistic infections, and changes in pathogenesis of the disease. The appearance at present in the arsenal of gastroenterologists of golimumab (GLM) has expanded the possibilities of treatment of patients with UC in the case of secondary loss of response to therapy with anti-TNF-α or the development of adverse events on IFX. This clinical case shows that after discontinuation IFX, there is a risk of recurrence of the disease, which according to the literature is 50 %. The example also demonstrated that GLM is well tolerated in patients who develop adverse events on IFX in the form of anaphylaxis. This is because GLM are fully human inhibitor of TNF-α. Golimumab is a new, effective inhibitor of TNF-α, which may help to optimize therapy in UC.

scholarly journals Biologics Drugs in Behçet’s Disease: A Single Centre Experience

2021 ◽  
Vol 28 (4) ◽  
Author(s):  
Luísa Serpa Pinto ◽  
Sara Xavier Pipa ◽  
Graziela Carvalheiras ◽  
Ana Campar ◽  
António Marinho ◽  
...  
Keyword(s):  
Biological Therapy ◽  
Systemic Vasculitis ◽  
Bowel Perforation ◽  
Gastroduodenal Ulcer ◽  
Retinal Vasculitis ◽  
Screening Tests ◽  
Biological Drugs ◽  
Necrosis Factor Alpha ◽  
Tnf Α

Introduction: Behçet´s disease (BD) is a systemic vasculitis of unknown cause. Several cytokines, such as tumor necrosis factor-alpha (TNF-α), appear to play a substantial role. Therefore, biologics such as anti-TNF-α agents are rising to control severe or refractory BD´s manifestations.   We aimed to describe the biological therapy´s outcomes in BD patients.   Methods: A longitudinal, prospective, unicentric cohort study with patients followed in a specialized outpatient clinic. We collected data regarding BD´s manifestations, treatments, and outcomes during follow-up.   Results: Our cohort includes 243 patients, of whom 31% were male. During follow-up, 20 patients (8%) were treated with biological drugs. Patients who received biological therapies were younger (p = 0.030), had less frequently genital aphthosis (p = 0.009), and more frequently erythema nodosum (p = 0.009), polyarthritis (p = 0.002), spondyloarthritis (p = 0.024), retinal vasculitis (p = 0.011) and gastrointestinal manifestations (p = 0.024), namely gastroduodenal ulcer (p = 0.035), digestive bleeding from ulcers (p = 0.002), and bowel perforation (p = 0.004). Anti-TNF-α agents were used in all of these patients, most frequently infliximab. Patients started biologicals after classical immunosuppressors failure, and most went into remission (93%). Three patients developed tuberculosis during treatment, regardless of regular screening tests. It was possible to stop biological therapy in five patients, so far, without recurrence, with 33 months of mean follow-up time after suspension.   Discussion: Anti-TNF-α agents are highly effective for refractory BD´s manifestations, although they are not innocuous. Little is known about the optimal duration of these therapies, regarding when and how to stop these drugs. This issue is essential not only to avoid relapses but also to reduce therapy side-effects.

scholarly journals Loss of response and frequency of adverse events in patients with ulcerative colitis and Crohn’s disease when switching from the original infliximab to its biosimilars

2021 ◽  
Vol 93 (2) ◽  
pp. 150-157
Author(s):  
O. V. Knyazev ◽  
M. Yu. Zvyaglova ◽  
A. V. Kagramanova ◽  
I. A. Li ◽  
E. A. Sabelnikova ◽  
...  
Keyword(s):  
Ulcerative Colitis ◽  
Adverse Events ◽  
Mechanism Of Action ◽  
The Other ◽  
Induction Treatment ◽  
Tnf Inhibitor ◽  
Crohns Disease ◽  
Secondary Loss ◽  
Loss Of Response ◽  
Trade Name

Aim. To define the frequency of adverse events and loss of the response in patients with ulcerative colitis (UC) and Crohns disease (CD), treated with original medicine infliximab (IFX) Remicaide and its biosimilars. Materials and methods. We included 154 patients with IBD: 78 UC patients (50.6%) и 76 CD patients (49.4%), treated with original medicine IFX Remicade and its biosimilars. In our study we did not include patients, who previously underwent induction treatment with IFX and its biosimilar. Results. Among 78 UC patients, IFX was cancelled in 25 (32.0%) patients and they were switched to the other anti-TNF inhibitor or medicine with the another mechanism of action; in patients group, treated with biosimilar 16 (20.5%) and 9 (11.5%) patients, who were interchanged biosimilar and/or original IFX. Among 76 CD patients IFX was cancelled in 20 (26.3%) patients: 11 (14.5%) patients in group, treated with similar trade name biosimilar, 8 (10.5%) patients, who were interchanged biosimilar and/or original IFX and 1 patient (1,3%), receiving original IFX. We found no difference in the secondary loss of response and adverse events in patients with CD and UC, switched from original IFX to biosimilar (p=0.6257 and p=0.6635, correspondingly). The frequency of the secondary loss of response or adverse events in patients with UC and CD, switched from original IFX to IFX biosimilar, was similar (p0.05). Conclusion. Approximately 30% of IBD patients, receiving IFX biosimilar, will be switched to the other anti-TNF therapy or medicine with the another mechanism of action because of secondary loss of response or adverse events.

P082 ANTI-TNF EFFICACY AFTER PRIMARY VEDOLIZUMAB FAILURE IN PEDIATRIC INFLAMMATORY BOWEL DISEASE

2020 ◽  
Vol 26 (Supplement_1) ◽  
pp. S71-S72
Author(s):  
Michael Dolinger ◽  
Priya Rolfes ◽  
Becky Phan ◽  
Stephanie Pan ◽  
Marla Dubinsky
Keyword(s):  
Inflammatory Bowel Disease ◽  
Adverse Events ◽  
Median Duration ◽  
Bowel Disease ◽  
Clinical Remission ◽  
Secondary Loss ◽  
Loss Of Response ◽  
Inflammatory Bowel ◽  
Pediatric Ibd

Abstract Background Vedolizumab (VDZ) is less effective in Inflammatory Bowel Disease (IBD) when used in anti-Tumor Necrosis Factor (TNF) failures as compared to anti-TNF naïve patients. However, the outcomes of sequencing anti-TNF after VDZ failure remain unknown. We report on the effectiveness and safety of anti-TNF as a second-line biologic after VDZ failure in pediatric IBD patients. Methods Data was collected as part of an ongoing pediatric IBD observational treatment registry and included demographics, disease behavior, location, disease activity (Harvey Bradshaw index (HBI) for Crohn’s disease (CD) or partial Mayo score (pMS) for ulcerative colitis (UC) and IBD-unspecified (IBD-U)), adverse events, treatment and surgical history. Primary outcome was steroid-free clinical remission at last follow up. Secondary outcomes were CRP normalization and adverse events including infusion reactions, infections, hospitalizations, and IBD related surgeries. Descriptive statistics summarized the data (median [interquartile range (IQR)]) and univariate analyses tested associations. Results A total of 21 children and young adults (6 CD:14 UC:1 IBD-U; 19/21 colonic only disease) were treated with VDZ for a median [IQR] duration of 25 [11–59] weeks. VDZ was discontinued due to primary non-response (57%), secondary loss of response (38%), or an adverse event (5%). Nineteen (90%) patients were induced with infliximab (IFX), 1 with adalimumab, and 1 with golimumab and were followed for a median of 100 [35–148] weeks after anti-TNF induction (Table 1). Fifteen (71%) patients remained on anti-TNF therapy at last follow up for a median duration of 53 [34–112] weeks. All 15 patients achieved steroid-free clinical remission, and 9 (60%) patients also had a normal CRP (Figure 1). Remission rates were numerically higher in UC/IBD-U vs. CD (80% vs. 50% P = 0.27). All 6 (28%) patients (3 CD and 3 UC) who discontinued anti-TNF therapy after a median duration of 15 [7–24] weeks initially had a primary non-response to VDZ. Three patents had a primary non-response to anti-TNF, 2 had a secondary loss of response, and 1 had an anaphylactic infusion reaction. No serious adverse events, hospitalizations or serious infections attributable to anti-TNF therapy occurred. Conclusions Our results suggest that anti-TNF therapy is efficacious and safe after primary failure with VDZ in pediatric IBD patients and this was particularly so in patients with colonic disease location, regardless of IBD classification.

scholarly journals Lethal disseminated tuberculosis in patients under biological treatment – two clinical cases and a short review

2018 ◽  
Vol 46 (7) ◽  
pp. 2961-2969 ◽  
Author(s):  
Elena Dantes ◽  
Doina Ecaterina Tofolean ◽  
Ariadna Petronela Fildan ◽  
Liviu Craciun ◽  
Elena Dumea ◽  
...  
Keyword(s):  
Biological Treatment ◽  
Biological Therapy ◽  
Opportunistic Infections ◽  
Short Review ◽  
Rapid Progression ◽  
Disseminated Tuberculosis ◽  
Increased Risk ◽  
Tnf Α ◽  
Bowel Diseases ◽  
Inflammatory Bowel

Tumour necrosis factor (TNF)-α inhibitors are highly used in Romania for the treatment of autoimmune disorders, such as rheumatoid arthritis (RA), psoriasis, inflammatory bowel diseases, and ankylosing spondylitis. Biological therapy using TNF-α inhibitors is very effective but is associated with an increased risk of opportunistic infections, including active tuberculosis. Here, two cases are presented of patients with RA and psoriasis under biological therapy who developed very aggressive forms of disseminated tuberculosis, with a rapid progression to death. The authors conclude that patients undergoing biological therapy require thorough evaluation prior to initiating treatment, followed by continuous and rigorous monitoring by a multidisciplinary team during biological treatment, particularly in countries with a high incidence of tuberculosis.

scholarly journals Safety and Efficacy of Vaccines during COVID-19 Pandemic in Patients Treated with Biological Drugs in a Dermatological Setting

Healthcare ◽  
2021 ◽  
Vol 9 (4) ◽  
pp. 401
Author(s):  
Oriana Simonetti ◽  
Giulio Rizzetto ◽  
Elisa Molinelli ◽  
Federico Diotallevi ◽  
Giulia Radi ◽  
...  
Keyword(s):  
Randomized Clinical Trials ◽  
Biological Therapy ◽  
Previous History ◽  
Biological Drugs ◽  
Level Of Evidence ◽  
Safety And Efficacy ◽  
Tnf Α ◽  
History Of ◽  
Inactivated Vaccines ◽  
Broad Overview

The BNT162b2 and mRNA-1273 vaccines, consisting of mRNA, have recently become available. The absolute novelty of these vaccines introduces questions about their safety and efficacy, especially in patients who are treated with biological drugs in dermatology. The aim of our review was to provide a broad overview of the current use of all available vaccinations in concomitance with biological therapy and to suggest indications for the new mRNA Covid-19 vaccines. We conducted a narrative review of the literature regarding the indications and safety of the various types of vaccines currently available in dermatological patients treated with biological therapy. The safety and efficacy of administering inactivated vaccines in patients undergoing biological therapy with inhibitors of TNF-α, IL-17, IL-12/23, and IL-4/13 was confirmed. Inactivated vaccines can be administered during therapy with inhibitors of IL-23 and IgE, taking into account that the level of evidence is lower due to the lack of specific studies. Live attenuated vaccines were contraindicated in concomitance with all biological therapies considered, except omalizumab. According to this evidence, we assume that there are currently no contraindications to the administration of the new Covid-19 BNT162b2 and mRNA-1273 vaccines during biological therapy with inhibitors of TNF-α, IL-17, IL-12/23, IL-23, and IL-4/13, since these vaccines are comparable to inactivated ones. For patients with chronic urticaria or allergic asthma treated with omalizumab, we currently recommend caution in using the mRNA Covid-19 vaccines (30 min observation). The only contraindications were a previous history of hypersensitivity to the Covid-19 vaccines themself or to their excipients. In conclusion, further randomized clinical trials are needed to evaluate the efficacy of the antibody response in these patients.

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