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Objectives To compare the efficacy and safety of biosimilar adalimumab injection manufactured by Enzene Biosciences Ltd. with innovator adalimumab (iADA, HUMIRA®) in subjects with active ankylosing spondylitis (AS). Methods The prospective, multicenter, randomized, double-blind, phase III study involved 192 subjects with active AS recruited at 20 centers across India. The subjects who fulfilled the eligibility criteria were randomized in a ratio of 2:1 (i.e.,125 subjects in biosimilar adalimumab arm and 67 subjects in the iADA arm). The selected subjects received both the investigational products at a dose of 40 mg subcutaneously (pre-filled syringe contained 40 mg adalimumab in 0.4 ml as the active ingredient) every other week for a total of 12 weeks. Efficacy assessment was done based on ASAS response criteria. Safety assessment was based on complete physical examination, adverse event (AE) monitoring, vital signs, ECG, anti-adalimumab antibody (ADA) assessment, and laboratory tests. Results At 12 weeks, the ASAS 20/40/70 responses were achieved by 97.5%, 94.1%, and 68.9% patients who received biosimilar injection as compared to 98.4%, 96.7%, and 77% patients in iADA arm. Safety assessment showed that 19 (15.2%) subjects reported 33 AEs in the biosimilar adalimumab arm and 8 (11.9%) subjects reported 11 AEs in iADA arm. ADA for positive and negative subjects was statistically non-significant (P 0.3516) between the two arms. Conclusion The ASAS 20/40/70 response rates at week 12 were equivalent between patients treated with biosimilar adalimumab injection manufactured by Enzene Biosciences Ltd and those treated with iADA. Both the drugs had comparable safety and tolerability profiles. Trial registry name: The Clinical Trials Registry- India (CTRI), URL: http://ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=42640&EncHid=&userName=enzene Trial registration no: no. CTRI/2020/09/028070

Acute Respiratory Distress Syndrome (ARDS) is a known complication of acute febrile illness (AFI). The in-hospital mortality rate of ARDS is between 35-44%. Our study aimed to identify the different parameters that could be used to detect patients at higher risk of poor outcome in AFI complicated by ARDS.130 patients with AFI complicated by ARDS as per Berlin definition, admitted at the Medical Intensive Care Unit of Seth GS Medical College KEM Hospital Mumbai, were studied over a period of 18 months. Investigations done during the course of MICU stay were noted. From the reports, SOFA score, delta SOFA score, Lung Injury Score (LIS), Disseminated Intravascular Coagulation (DIC) score (by ISTH scoring system) were also calculated. Main outcome was recorded as transfer out from the MICU or death.Etiology of the 130 patients of AFI with ARDS was as follows-dengue 32 patients (24.6%), H1N1 -31(23.8%), undifferentiated fever -30 (23.1%), leptospirosis-22 (16.9%), malaria-15 (11.5%). Our study had a mortality rate of 25.4 %( n=33). 40.8% of the study population required invasive ventilation at admission. SOFA score at admission and 48 hours, delta SOFA score, PaO2/ FiO2 ratio at admission and 48 hours, Blood Urea Nitrogen (BUN), creatinine, bicarbonate and albumin were the significant predictors of overall outcome. Hemoglobin, platelets and leukocyte counts, pH, pO2 , pCO2 at admission and 48 hours, Lung Injury Score (LIS) and DIC score were not significant predictors of outcome.SOFA score at admission and 48 hours, delta SOFA score and PaO2 / FiO2 ratio were significant predictors of outcome in patients of acute febrile illness with ARDS. LIS and DIC score were not significant predictors of outcome.

Remdesivir and Tocilizumab are two experimental drugs used in severely ill COVID-19 patients. Various clinical trials studying these drugs are giving conflicting results. Our aim is to study these two drugs and share the experience in our setting.Our Study is a retrospective analysis of Clinico-laboratory details and outcome of three groups of patients who were given either (i) Remdesivir or (ii) Tocilizumab or (iii)both Remdesivir and Tocilizumab . We compared the outcome of these patients with other patients who did not receive either of these drugs, when it was not available or not introduced as experimental drugs earlier in treatment guidelines.Out of a total of 521 patients, in the above three groups who received either or both Remdesivir or Tocilizumab, 334 survived. Out of 214 patients who did not receive any of the two drugs only 74 survived. The outcome was better individually for all the three groups of patients receiving either or both of the drugs as compared to neither of the drugs.(p0.01)Remdesivir and Tocilizumab were useful drugs in treatment of severely ill covid -19 patients as compared with the patients who did not receive any of the above drugs.

Background: Skin manifestations are an important clue to underlying rheumatological conditions and at times the first manifestation of the disease. Their identification helps in diagnosis, classification and follow up of these diseases. Hence we conducted this study to assess the new onset cutaneous lesions in patients with rheumatic diseases and correlate skin lesions with disease activity and study the response to therapy over a period of 3 months. Materials and Methods: This prospective observational study was done in KEM Hospital, Mumbai over 18 months recruiting 78 patients, presenting to Rheumatology OPD / wards with new onset skin manifestations. Disease activity was calculated as per standard indices for each rheumatological disease. Skin lesions appearing due to adverse effects of drugs or unrelated to the disease were excluded from the study. The outcome of the skin lesions was assessed at 3 months follow up. Results: Mean age of patients was 38 years with 91% being females. SLE was the most common diagnosis. The most common skin lesions were malar rash among SLE patients; rheumatoid nodules in patients of RA; Sclerodactyly in the Scleroderma patients and Heliotrope rash amongst the dermatomyositis patients. The mean SLEDAI score in the group with LE non -specific lesions was significantly higher compared to the group with LE-specific lesions (P

To evaluate the incidence of cardiovascular abnormalities in newly identified hyperthyroid patients and their outcome with anti-thyroid therapy.A total of 96 patients who were newly diagnosed to have hyperthyroid disease were screened and out of them, 40 patients who presented with cardiovascular symptoms and sign were included in study (30 females, 10 males). Hyperthyroid patients were re-evaluated after antithyroid therapy. Findings in patients were compared at presentation, and after 3 month of treatment. All had undergone a structured cardiovascular history and examination, including measurements of blood pressure (BP) and pulse rate. All had resting 12-lead electrocardiogram and 2D ECHO.Cardiovascular symptoms and signs, as well as abnormal hemodynamic and dysrhythmias, especially supraventricular, were frequent among patients with hyperthyroidism. Palpitation and atrial fibrillation (AF) were more recurrent in overt hyperthyroid subjects than those with subclinical hyperthyroidism and remained more prevalent after 3 month of antithyroid treatment in that subject who had persistently high serum T3 and T4 level.Cardiovascular abnormalities are one of the most common presentations in patients with hyperthyroidism and they respond very well to treatment before the structural changes occur in the cardiovascular system.

Background: Acute inflammatory demyelinating polyneuropathy (AIDP) often described as Guillain-Barre syndrome (GBS) is an ascending neuropathy involving demyelination of peripheral nerves. Very few studies on GBS have been conducted in Indian scenario in recent years. Taking into account this background, we undertook this study to have better outlook to the spectrum of disease and outcome. The objective was to study the patient’s clinical profile, outcome of the disease and response to plasmapheresis (PP) versus intravenous immunoglobulin (IVIG) therapy in a case of GBS. Methods: This was a prospective observational study. In this study 34 consecutive patients who fulfilled the inclusion and exclusion criteria and who gave a written informed consent were recruited over a period of 2 years. A detailed history and physical examination was carried out in every patient. History of preceding illnesses and clinical symptoms were recorded. End points of the study were either death during hospital stay or discharge from the hospital, whichever was early. Results: Outcome in the present study was assessed using the modified Barthel index and modified Rankin’s scale. In IVIG group both MRS and MBS showed statistically favourable outcome, at the end of study (p

Hepatic encephalopathy is challenging complication of liver dysfunction. Therapeutic treatment options for hepatic encephalopathy are currently limited and have appreciable risks and benefits associated with their use. Rifaximin is a novel anti microbiological agent with wide spectrum of activity that has shown promise as an alternative option for hepatic encephalopathy.The present study was undertaken to compare the effectiveness of Rifaximin and Lactulose as a combination vs Lactulose alone, to compare the adverse effects and to study the rapidity of therapeutic effects of Rifaximin and Lactulose.It was a prospective observational study. 60 patients suffering from hepatic encephalopathy (HE) were studied. Patients were investigated and treated as per treating physician's decision. At the time of analysis, patients were divided into 2 groups, Rifaximin group who received Rifaximin+Lactulose (R+L) and Lactulose group(L), who received Lactulose only. Parameters such as mental status grade, Asterixis grade, Serum Ammonia grade, Number Connection Test grade (NCT grade), Hepatic Encephalopathy Index (HE index) were evaluated and compared in both groups. Clinical efficacy was determined using HE index improvement. Primary end points were decrease in HE index and reversal of HE grades. Secondary end points were mortality from HE or any other cause, decrease in mental status grade, asterixis grade, serum Ammonia grade, NCT grade.Out of 60 patients, 32 received Rifaximin+Lactulose combination and 28 patients received Lactulose alone. Mean Child-Turcotte-Pugh score (CTP score) was 10.6 in R+L group and 10.32 in L group. There was statistically significant improvement in mental status grade, Asterixis grade, Serum Ammonia grade, NCT grade, Hepatic encephalopathy index in both groups, p value0.05 but no statistically significant difference between improvement in mental status grade, Asterixis grade, Serum Ammonia grade, NCT grade, HE index between the two groups. Rifaximin + Lactulose combination was effective in 31 out of 32 i.e.96.87% and Lactulose alone in 24 out of 28 patients, i.e. in 85.71%, which is not statistically different, p=0.3251.Rifaximin+ Lactulose combination is not superior to Lactulose alone in treatment of refractory hepatic encephalopathy. Addition of Rifaximin may help in the treatment of refractory hepatic encephalopathy.Rifaximin + Lactulose combination is effective, but not superior to Lactulose alone in treatment of hepatic encephalopathy.

To evaluate the correlation between the levels of CD4, CD8 and CD25 cells and SLE disease in active phase and in remission.A total of 25 SLE patients, aged between 18-60 years, and fulfilling the ACR criteria with preferential Renal and CNS involvement were included in this study. Baseline CD4/CD8 and CD25 counts, lab parameters etc were conducted. Approximately at the end of 6 months with the settlement of the disease activity blood sample was drawn for the CD4, CD8 and CD25 counts and other lab parameters.ESR showed a statistical significant decrease while the SLEDAI score and proteinuria showed a decreasing trend as the patients underwent remission. The C3 showed an increasing trend, while the C4 showed more or less a stable pattern. Rise in %CD4 and %CD25 count was statistically significant. There was negative correlation between % CD4 count and SLEDAI score, while positive correlation between % CD25 count and SLEDAI score.%CD4 count is a sensitive, specific, reliable and valid marker of active disease in SLE and can be used to follow disease activity. %CD25 count can also be used as a marker to follow disease activity.

Background: Monoarthritis is a common rheumatological complaint. Inspite of investigations, many cases remain undiagnosed. Prompt investigation and treatment is important in acute arthritis especially septic arthritis else joint destruction, permanent disability or even death can result. This study was conducted to etiologically categorise patients as inflammatory, non-inflammatory and infective arthritis and to study the outcome. Methods: This observational prospective study conducted at a tertiary care hospital in Mumbai enrolled 40 patients above the age of 12 yrs presenting with first episode of mono-articular arthritis. They were treated with standard treatment guidelines and followed up every 3 monthly for one year. Outcome was assessed using ESR, CRP values and Health Assessment Questionnaire. Results: Mean age at diagnosis was 38 years with a male to female ratio of 1.4:1. Acute and chronic mono-articular arthritis cases were 16.2% and 83.7% respectively. Knee joint was most commonly involved (38%). Etiologically inflammatory, infectious and non-inflammatory cases were 59.5%, 29.7% and 10.8% respectively. In 21% cases etiology was tuberculosis. 27 % evolved into oligoarthritis over one year. The serial ESR, CRP values and Stanford Health Assessment Questionarre scores decreased significantly across all etiological groups with treatment. Conclusions: Knee is the most commonly affected joint in mono-articular arthritis. Tuberculosis is the most common etiology. Irrespective of the etiology, if patients are treated according to standard guidelines promptly mono-articular arthritis has a good response to therapy as assessed by the health assessment questionnaire (HAQ) and serial measurements of proinflammatory markers like ESR, CRP.

Hemophagocytic lymphohistiocytosis (HLH), is an uncommon, life-threatening hyperinflammatory syndrome caused by severe hypercytokinemia with excessive activation of lymphocytes and macrophages due to a highly stimulated but ineffective immune process. We report a case of Hemophagocytic Lymphohistiocytosis in a 15 year old boy presenting with fever, lymphadenopathy and pancytopenia due to infection caused by Klebsiella Pneumoniae and Acinetobacter.

Dermatomyositis is a rare autoimmune inflammatory myopathy with proximal muscle weakness and skin affection. Only 4 cases of HIV that subsequently developed dermatomyositis have been reported. This is the first case of dermatomyositis being the initial presentation of an acute seroconversion illness. We highlight the pathophysiology of dermatomyositis in HIV infection along with the complex issues of treatment in such cases. We report a case of a 50-year-old woman who presented with a 2 months' history of proximal muscle weakness with classic signs of dermatomyositis and consistent electromyographic and muscle biopsy. HIV (by enzyme-linked immunosorbent assay) was initially nonreactive, indeterminate at 4 weeks, and positive at 8 weeks. It was further confirmed by Western blot and polymerase chain reaction. She was treated with prednisolone and antiretroviral therapy. A high degree of suspicion is required to diagnose HIV seroconversion when an individual presents with dermatomyositis. A fine balance of immunosuppressants and antiretroviral therapy needs to be maintained in the treatment of such cases.

Background: Systemic lupus erythematosus (SLE) is a multisystem autoimmune disorder that is greatly subject to the combined effect of genetic, environmental, demographic and geographical factors. Hematological manifestations are very common in SLE, with many patients presenting with anemia. The cause of Anemia could be varied, with Autoimmune hemolytic anemia, anemia of chronic disease, iron deficiency being the common causes. The aim of the present study was to estimate the proportion of patients with prevalence of different causes of anemia in SLE and it‘s association between immunological and clinical parameters and to correlate the severity of anemia with SLEDAI score and SLICC/ACR score. Methods: This was an observational and prospective study conducted on 52 patients satisfying ACR criteria for SLE and WHO definition of anemia. All patients underwent baseline investigations for hematological, biochemical parameters and immunological investigations for C3 and C4. Other special investigations were done as per the treating rheumatologists’ opinion. Patients were followed up after three months to evaluate the response to therapy. Results: In this study, most of the patients were in the age group between 20-50 years (94.22%) and female:male ratio was 13:1. At presentation 55.76% patients had severe anemia, 38.46% had moderate anemia and 5.78% had mild anemia. After therapy (three months) only 3.84% patients had severe anemia. The most common cause of anemia was AIHA (38.46%). Mean SLEDAI score at presentation was >20 but after three months therapy the score was reduced to 4. There was no correlation between aneamia and SLICC/ACR damage index. Conclusions: Anaemia usually occurs at the onset of SLE and its recurrence rate will become low after three months of therapy. SLEDAI scores, SLICC/ACR damage index and serum complement levels (C3 and C4) acts as good indices for assessment and follow up of SLE.

Rickettsial fevers are known to have neurological involvement, mostly in the form of meningoencephalitis. Focal neurodeficits, including isolated cranial nerve palsies have been rarely reported. We hereby report a case of a 25 year old man who presented to us with high grade fever caused by rickettsia and left sided partial third cranial nerve palsy. He responded to doxycycline.

Melioidosis is an infection caused by Burkholderia pseudomallei. The disease is known as a remarkable imitator due to the wide and variable clinical spectrum of its manifestations. Septic arthritis is rare but well-recognized manifestation of this disease. We report a case of melioidosis in a 52 year male with uncontrolled diabetes mellitus (DM) presenting with a rare combination of septic arthritis and abscesses in the chest wall, liver and subcutaneous tissue. The patient responded to prolonged treatment of intravenous ceftazidime followed by oral co-trimoxazole.

Mycotic aneurysm (MA) is an infrequent complication of infective endocarditis (IE), reported in 3 to 15% of the patients with IE. The commonest site for such aneurysm is intracranial vessels (65%) followed by abdominal and then the peripheral vessels. We describe a case of 32 year old man with recently diagnosed rheumatic heart disease and mitral regurgitation. He had infective endocarditis (IE) and developed a large mycotic popliteal artery aneurysm (MPAA) and a small profunda femoris arterial aneurysm (PFAA) while he was on antibiotic therapy. The patient was successfully treated with prolonged antibiotic therapy and embolisation of the MPAA while PFAA was managed conservatively.