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Purpose: To report the clinical profile of Behcet's disease and its management with immunosuppressants and biologics in a cohort of 25 patients from a tertiary eye care center in South India. Methods: This was a retrospective, observational study. Records of 45 eyes of 25 patients between January 2016 and December 2021 were retrieved from the hospital database. Complete ophthalmic evaluation and systemic examination by the rheumatologist with appropriate investigations had been done. Results were analyzed using Statistical Package for the Social Sciences (SPSS) software. Results: Males (19, 76%) were found to be more affected than females (6, 24%). Mean age of presentation was 27.68 ± 11.08 years. Twenty patients had bilateral involvement (80%), and unilateral involvement was seen in five patients (20%). Seven eyes of four patients (16%) had isolated anterior uveitis, out of which one patient had unilateral and three patients had bilateral involvement. Twenty-six eyes of 16 patients (64%) had posterior uveitis, out of which six patients had unilateral and 10 had bilateral involvement. Twelve eyes of seven patients (28%) had panuveitis, out of which two patients had unilateral and five had bilateral involvement. Hypopyon was seen in five eyes (11.1%) and posterior synechiae in seven eyes (15.55%). Posterior segment findings included vitritis (24.44%), vasculitis (17.78%), retinitis (17.78%), disc hyperemia (11.11%), and disc pallor (8.89%). Steroids alone were given in five patients (20%) and intravenous methylprednisolone (IVMP) was given in four patients (16%). Immunosuppressive agents along with steroids were given in 20 patients (80%), of which azathioprine alone was given in seven patients (28%), cyclosporin alone was given in two patients (8%), mycophenolate mofetil alone was given in three patients (12%), combination of azathioprine and cyclosporin was given in six patients (24%), and combination of methotrexate and mycophenolate mofetil was given in one patient (4%). Biologics were given in 10 patients (40%) -- adalimumab in seven patients (28%) and infliximab in three patients (12%). Conclusion: Behcet's disease is an uncommon uveitis in India. Addition of immunosuppressants and biologics to conventional steroid therapy gives better visual outcomes. [ABSTRACT FROM AUTHOR]

Objectives To carry out a review of clinical characteristics, laboratory profiles, management and outcomes of patients with Kawasaki disease (KD) and macrophage activation syndrome (MAS). Methods Medical records of patients treated for KD and MAS between January 1994 and December 2019 were reviewed. Patient demographics, clinical signs, laboratory values, coronary artery abnormalities, treatments and outcomes of patients with KD and MAS were recorded. We also performed a review published studies on the subject. Results Of the 950 cases with KD, 12 (1.3%; 10 boys, 2 girls) were diagnosed with MAS. The median age at diagnosis was 4 years (range 9 months–7.5 years). The median interval between onset of fever and diagnosis of KD was 11 days (range 6–30). Thrombocytopenia was seen in 11 patients. The median pro-brain natriuretic peptide value was 2101 pg/ml (range 164–75 911). Coronary artery abnormalities were seen in 5 (41.7%) patients; 2 had dilatation of the left main coronary artery (LMCA), 1 had dilatation of both the LMCA and right coronary artery (RCA), 1 had dilatation of the RCA and 1 had bright coronary arteries. All patients received IVIG as first-line therapy for KD. MAS was treated with i.v. methylprednisolone pulses followed by tapering doses of oral prednisolone. Additional therapy included i.v. infliximab (n  = 4), second-dose IVIG (n  = 1) and oral ciclosporin (n  = 1). Conclusion MAS is an unusual and underrecognized complication of KD. In our cohort of 950 patients with KD, 1.3% had developed MAS. KD with MAS is associated with an increased propensity towards development of coronary artery abnormalities. [ABSTRACT FROM AUTHOR]

Purpose: Infliximab (IFX) therapy in inflammatory bowel disease (IBD) is associated with loss of response in half the patients, due to complex pharmacokinetic and immunological factors. Dashboard's Bayesian algorithms use information from model and individual multivariate determinants of IFX concentration and can predict dose and dosing interval. Aim: To compare measured IFX concentrations in our laboratory with values predicted by iDose dashboard system and report its efficacy in managing patients not responding to conventional dosing schedule. Method: Clinical history, demographic details, and laboratory findings such as albumin and C-reactive protein (CRP) data of IBD patients (n = 30; median age 23 years (IQR: 14.25 – 33.5)) referred for IFX drug monitoring in our laboratory from November 2017 to November 2019 were entered in iDose software. The IFX concentration predicted by iDose based on this information was compared with that measured in our laboratory. In addition, a prospective dashboard-guided dosing was prescribed in 11 of these 30 patients not responding to conventional dosing and was followed to assess their clinical outcome. Result: IFX monitoring in our 30 patients had shown therapeutic concentration in 12, supratherapeutic in 2 and subtherapeutic concentration in 16 patients. The iDose predicted concentration showed concordance in 21 of these 30 patients. Of 11 patients managed with iDose-assisted prospective dosing, 8 achieved clinical remission, 2 showed partial response, and one developed antibodies. Conclusion: Retrospective data analysis showed concordance between laboratory measured and iDose-predicted IFX level in 70% of patients. iDose-assisted management achieved clinical remission and cost reduction. [ABSTRACT FROM AUTHOR]

The article describes the case of a 13-year-old boy with fever, loose stools, vomiting, redness of eyes and a generalized maculopapular rash for a week and developed peeling of skin over palms and soles. Topics discussed include findings on his systemic examination, his diagnosis of Kawasaki disease, and the separation of his nails which suggested onchomadesis.

Moderate to severe psoriasis often needs to be addressed with standard disease modifying therapies such as methotrexate, cyclosporine, acitretin or ultraviolet radiation, which have their potential benefits and limitations. The tumor necrosis factor-alpha (TNF-α) is elevated in psoriatic plaques compared to non lesional skin as well as in the plasma of patients with moderate to severe psoriasis. Infliximab, a TNF-α blocker, has been recommended for the treatment of moderate to severe plaque psoriasis in adults who have failed to respond to these therapies or who cannot tolerate them. Its specific action on the bound and membrane forms of the pro-inflammatory cytokine TNF-α has made it the molecule of choice for obtaining quicker and longer remission in recalcitrant cases. However, the widespread use of infliximab in the Indian subcontinent is limited by its cost. This article reviews the international guidelines for use of infliximab, its dosage patterns, and efficacy in chronic plaque psoriasis, nail psoriasis, erythrodermic psoriasis, and pustular psoriasis as well as Indian experience. [ABSTRACT FROM AUTHOR]

Abstract: Reactivation of latent tuberculosis (TB) with TNF blockers is a cause of concern particularly in developing countries like India, which has a high burden of TB infection. Although etanercept and infliximab are available in India, published data on Indian experience are scant. Limited data indicate that risk of reactivation of TB is substantially increased. With the growing use of these agents in India inspired by encouraging results in various rheumatic conditions a rise in cases of TB is expected. At present, no guidelines exist in India with regard to treatment of latent TB. Indian rheumatologists must adopt a rational approach when treating rheumatic diseases with TNF blockers. [Copyright &y& Elsevier]

Aims: To review the Indian experience with anti-tumor necrosis factor (TNF)-α therapy. Methods: ‘PubMed’ and ‘IndMED’ were searched for Indian studies on anti-TNF-α therapy. Data were compiled and analysed. Results: Data on infliximab from 176 patients from five different series were collated. One hundred and forty-seven had ankylosing spondylitis (AS), nine had polyarticular juvenile idiopathic arthritis (JIA), 12 had rheumatoid arthritis (RA), six had undifferentiated spondyloarthropathy, one had inflammatory bowel disease-related spondyloarthritis and one had psoriatic arthritis. Thus, 155/176. (88%) had spondyloarthropathy (SpA). No screening for latent tuberculosis was done in any of the studies. One series comprising 108 cases of AS, used 3 mg/kg infliximab infusions (instead of 5 mg/kg) at 8-weekly intervals with omission of the 2-week and 6-week doses. All others with SpA ( n = 47) followed the standard protocol: 171/176 patients had a significant improvement. Reactivation tuberculosis developed in 5/47 (10.6%) SpA patients treated with standard doses of infliximab. This amounted to 56 times increased risk compared to baseline (0.187%). None of the 129 patients treated with 3 mg/kg infusions of infliximab developed reactivation tuberculosis (AS −108, RA −12, JIA −9). The lone study on etanercept showed good efficacy in 40 patients with RA. However, seven serious adverse events occurred. Conclusions: Infliximab showed expected efficacy in SpA, RA and JIA. Reactivation tuberculosis developed in 10.6% of the SpA group treated with standard regimen. Patients treated with lower doses of infliximab which included a large subgroup of SpA patients and those with RA or JIA did not develop tuberculosis. [ABSTRACT FROM AUTHOR]

Study design: A retrospective analysis of the use of Biological Response Modifiers (BRMs) infliximab and etanercept in patients with inflammatory spine (ankylosing spondylitis-AS) and inflammatory joint conditions (rheumatoid arthritis-RA) – experience of the author at Apollo Hospitals, Hyderabad and Indraprastha Apollo Hospitals, New Delhi over the past 5 years. Methods: The patients were evaluated with special reference to the ACR (American College of Rheumatology) 20, 50, and 70 responses, the DAS (Disease Activity Score) 28 responses, and the BASDAI (Baath Ankylosing Spondylitis Disease Activity Index). Biochemical parameters and side effect/toxicity profile of these agents was reviewed where data was available. Results: Each of the three patients (between years 2000–2003) with RA who were administered infliximab, achieved ACR 20, 50 and 70 responses respectively, depending on the duration of therapy. The three RA patients treated with infliximab (years 2004–2005) achieved significant improvement and two of these had DAS 28 scores less than 4. The three patients with RA (2004–2005) treated with etanercept had equally good responses and one patient discontinued after near complete remission. All three patients with AS (2004–2005) treated with infliximab achieved significant reductions in the disease activity index (BASDAI); one patient with AS and a second with psoritic arthritis, both of whom were treated with etanercept did moderately well. No major side effects or toxicities were reported (except mild allergic reactions in two patients). Discussion: Anti TNF α agents were found to be safe and effective in treatment of refractory RA and AS and these are significant additions to the existing armamentarium of medications for this indication. [Copyright &y& Elsevier]

Background: Evidence supports therapeutic drug monitoring (TDM) in improving efficacy and cost-effectiveness of anti-TNF therapy in inflammatory bowel disease (IBD). Data on perceptions and barriers to TDM use are limited and no data are available from India. Our objective was to assess clinicians' attitudes and barriers to TDM use in IBD., Methods: A 16-question survey was distributed to members of the Indian Society of Gastroenterology. Information on clinician characteristics, demographics, use and barriers towards TDM with anti-TNFs was collected. Logistic regression was used to predict factors influencing TDM use., Results: Two hundred and forty-two respondents participated (92.5% male); 83% were consultant gastroenterologists. Of 104 respondents meeting inclusion criteria (treating > 5 IBD patients and at least 1 with an anti-TNF per month), complete responses were available for 101 participants. TDM was utilized by 20% (n = 20) of respondents. Of them, 89.5% (n = 17) used TDM for secondary loss of response; 73.7% (n = 14) for primary non-response and 5.3% (n = 1) proactively. Barriers to TDM use were cost (71.2%), availability (67.8%), time lag in results (58.7%) and the perception that TDM is time-consuming (45.7%). Clinicians treating > 30 IBD patients were more likely to check TDM (OR = 4.9, p = 0.02). Of 81 respondents not using TDM, 97.5% (n = 79) would do so if all the barriers were removed., Conclusion: Significant barriers to TDM use were availability, cost and time lag for results. If these barriers were removed, almost all the clinicians would use TDM at least reactively and 25% would use proactively. There is an urgent need to address these barriers and optimize anti-TNF therapy for optimal outcomes.

BCD-055 is a biosimilar of innovator infliximab (IFX). Here we present the 54-week results from phase 3 clinical study in patients with rheumatoid arthritis (RA). The aim of this study was to demonstrate the equivalent efficacy and safety of BCD-055 and IFX in patients with active rheumatoid arthritis. 426 adults with active RA were enrolled. Patients were randomized into 2 study arms in 2:1 ratio to receive BCD-055 or IFX innovator in dose of 3 mg/kg at week 0, 2, 6 and then every 8 weeks up to week 54. Primary efficacy endpoint was the rate of American College of Rheumatology (ACR) 20 response at week 14. The equivalence margin was set as 15%. Immunogenicity and safety were also assessed. Rate of ACR20 at week 14 in PP (Per-Protocol) population was 71.2% in BCD-055 group and 67.9% in IFX group. Difference in ACR20 rates between groups was 3.2% with 95% CI [- 7.0%; 13.5%] (р = 0.587). Throughout 54-week study period, both groups were characterized by similar rates of ACR20/50/70 response at all timepoints without significant differences (p > 0.05). The rates of adverse events (AE) were similar in groups (74.64% in BCD-055 arm vs 66.67% in IFX arm, p = 0.111). Antibodies to infliximab were detected in 28.46% patients for BCD-055 arm and 26.56% for IFX arm (p = 0.786). BCD-055 and IFX were comparable in efficacy (including radiographic progression), safety and immunogenicity throughout the 54-week study.Trial registration ClinicalTrials.gov ID, number NCT02762838.

Introduction: The role of infliximab in the treatment of acute severe ulcerative colitis is established. However, all the data available in the literature are from western countries. This is the first report on the use of infliximab in patients with severe steroid-refractory ulcerative colitis from India., Methods: Retrospective analysis of 28 patients who had received infliximab therapy for induction of remission, with three doses of 5 mg/kg at 0, 2, and 6 weeks, was performed., Results: Twenty-four (85.6 %) patients had shown a clinical response by week 8 and, hence, avoided urgent colectomy. In 2 years of follow up, 9/16 (56 %) patients had not required colectomy., Conclusion: Infliximab averted colectomy in a proportion of patients with severe steroid-refractory ulcerative colitis.

Anti-tumour necrosis factor (TNF)-alpha treatments are immunosuppressant and represent an important risk factor for developing infections. We report a case of Salmonella paratyphi bacteraemia associated with soft tissue infection in a patient who used infliximab and had recently travelled to India. This case report provides supporting evidence, essentially based only on case reports, that patients receiving anti-TNF-alpha treatments have an increased susceptibility to Salmonella infections, which may develop at unusual and disseminated sites. We emphasize the importance of appropriate counselling of patients undergoing anti-TNF treatment and travelling to areas in which Salmonellae are endemic, as well as the importance of advice to these patients concerning food hygiene.

Objective: To test the efficacies of a strategy for preventing tuberculosis (TB) in Indian patients with inflammatory rheumatic diseases (IRD) treated with tumor necrosis factor-alpha (TNF-alpha) inhibitor., Methods: The screening strategy included tuberculosis skin test (TST), QuantiFERON-TB Gold (QTG) test, standard chest radiograph, and contrast enhanced-computerized tomography of the chest (CT)., Results: Among 53 patients screened, 17 (32%) had >or= 1 test positive, with 5 (9.4%) patients having TB infection (clinical, CT, biopsy). The remaining 12 patients showed latent TB; 1 additional patient with negative screening tests was diagnosed with latent TB retrospectively for he developed TB disease within a few weeks of receiving infliximab. The remaining 35 patients tested negative with all tests. The combination of 4 screening tests gave a sensitivity of 0.83, specificity of 0.74, positive predictive value (PPV) 0.29, and negative predictive value (NPV) 0.97. Only 22 patients could afford treatment with TNF-alpha inhibitors; 19 of them were negative in the screening tests. Three patients who were positive on TST and/or QTG received prophylactic treatment with TNF-alpha inhibitor. Since implementation of the screening strategy, only 1 of 22 (4.5%) patients given TNF-alpha inhibitor developed probable TB disease., Conclusion: With the use of these 4 TB screening tests in India, where TB is highly prevalent, TB could be excluded with a high degree of certainty (NPV 0.97). However, as even this combination of tests has only moderate sensitivity and specificity and poor PPV for detecting TB, vigilance may be advisable even if only one of the tests is positive.