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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

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

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

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.

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.