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Chopra A.,Center for Rheumatic Disease | Chandrashekara S.,ChanRe Rheumatology and Immunology Center and Research | Iyer R.,St Johns Medical College Hospital | Rajasekhar L.,Nizam's Institute of Medical Sciences | And 9 more authors.
Clinical Rheumatology | Year: 2016

The objective of this study was to assess the safety and efficacy of itolizumab with methotrexate in active rheumatoid arthritis (RA) patients who had inadequate response to methotrexate. In this open-label, phase 2 study, 70 patients fulfilling American College of Rheumatology (ACR) criteria and negative for latent tuberculosis were randomized to four arms: 0.2, 0.4, or 0.8 mg/kg itolizumab weekly combined with oral methotrexate, and methotrexate alone (2:2:2:1). Patients were treated for 12 weeks, followed by 12 weeks of methotrexate alone during follow-up. Twelve weeks of itolizumab therapy was well tolerated. Forty-four patients reported adverse events (AEs); except for six severe AEs, all others were mild or moderate. Infusion-related reactions mainly occurred after the first infusion, and none were reported after the 11th infusion. No serum anti-itolizumab antibodies were detected. In the full analysis set, all itolizumab doses showed evidence of efficacy. At 12 weeks, 50% of the patients achieved ACR20, and 58.3% moderate or good 28-joint count Disease Activity Score (DAS-28) response; at week 24, these responses were seen in 22 and 31 patients. Significant improvements were seen in Short Form-36 Health Survey and Health Assessment Questionnaire Disability Index scores. Overall, itolizumab in combination with methotrexate was well tolerated and efficacious in RA for 12 weeks, with efficacy persisting for the entire 24-week evaluation period. (Clinical Trial Registry of India, http://ctri.nic.in/Clinicaltrials/login. php, CTRI/2008/091/000295). © International League of Associations for Rheumatology (ILAR) 2015.


Gieseke F.,Research Institute Childrens Cancer Center | Kruchen A.,Research Institute Childrens Cancer Center | Tzaribachev N.,Center for Rheumatic Disease | Bentzien F.,University of Hamburg | And 2 more authors.
European Journal of Immunology | Year: 2013

Human multipotent mesenchymal stromal cells (MSCs) are clinically applied to treat autoimmune diseases and graft-versus-host disease due to their immunomodulatory properties. Several molecules have been identified to mediate these effects, including constitutively expressed galectin-1. However, there are indications in the literature that MSCs exert enhanced immunosuppressive functions after interaction with an inflammatory environment. Therefore, we analyzed how inflammatory stimuli influence the expression of the galectin network in MSCs and functionally tested the relevance for the immunomodulatory effects of MSCs. We found that galectin-9 was strongly induced in MSCs upon interaction with activated PBMCs. Proinflammatory cytokines, such as interferon-gamma (IFN-γ) and tumor necrosis factor-alpha (TNF-α), and also ligands of the Toll-like receptors (TLRs) TLR2, TLR3, and TLR4 elicited similar induction of galectin-9 in activated PBMCs. Galectin-9 was not only upregulated intracellularly, but also released by MSCs in significant amounts into the supernatant after exposure to proinflammatory stimuli. In proliferation assays, MSCs with a galectin-9 knockdown lost a significant portion of their antiproliferative effects on T cells. In conclusion, we found that unlike constitutively expressed galectin-1, galectin-9 is induced by several proinflammatory stimuli and released by MSCs. Thus, galectin-9 contributes to the inducible immunomodulatory functions of MSCs. © 2013 WILEY-VCH Verlag GmbH & Co. KGaA, Weinheim.


Ringold S.,Seattle Childrens Hospital | Tzaribachev N.,Center for Rheumatic Disease | Cron R.Q.,University of Alabama at Birmingham
Pediatric Rheumatology | Year: 2012

Background: The temporomandibular (TMJ) is frequently involved in juvenile idiopathic arthritis (JIA), however little is known about management of this joint once a patient transitions from pediatric to adult care and about how rheumatologists approach TMJ involvement in rheumatoid arthritis (RA). The objective of this project was to describe adult rheumatologists' approaches to the diagnosis and treatment of TMJ arthritis in adults with JIA or RA.Findings: One hundred and eighteen rheumatologists responded to an online survey of adult rheumatologists in the United States and Canada. Respondents estimated that 1-25% of their patients with RA or JIA had TMJ arthritis. Respondents reported lower rates of MRI use (19%) and higher rates of use of splinting/functional devices (50%) than anticipated. Approximately 80% of respondents reported that their practice had a standardized approach to the evaluation of patients with TMJ arthritis. The most commonly used medical therapies were non-steroid anti-inflammatory drugs, anti-tumor necrosis factor alpha medications, and methotrexate.Conclusions: Despite the majority of respondents stating that their practices had a standardized approach to the diagnosis and treatment of TMJ disease, there nevertheless appeared to be a range of practices reported. Standardizing the evaluation and treatment of TMJ arthritis across practices may benefit both adult and pediatric patients. © 2012 Ringold et al.; licensee BioMed Central Ltd.


PubMed | Nizam's Institute of Medical Sciences, LTM Medical College & LTMG Hospital, Krishna Institute of Medical science, Shubhechha Multispecialty Hospital and 7 more.
Type: Journal Article | Journal: Clinical rheumatology | Year: 2016

The objective of this study was to assess the safety and efficacy of itolizumab with methotrexate in active rheumatoid arthritis (RA) patients who had inadequate response to methotrexate. In this open-label, phase 2 study, 70 patients fulfilling American College of Rheumatology (ACR) criteria and negative for latent tuberculosis were randomized to four arms: 0.2, 0.4, or 0.8mg/kg itolizumab weekly combined with oral methotrexate, and methotrexate alone (2:2:2:1). Patients were treated for 12weeks, followed by 12weeks of methotrexate alone during follow-up. Twelve weeks of itolizumab therapy was well tolerated. Forty-four patients reported adverse events (AEs); except for six severe AEs, all others were mild or moderate. Infusion-related reactions mainly occurred after the first infusion, and none were reported after the 11th infusion. No serum anti-itolizumab antibodies were detected. In the full analysis set, all itolizumab doses showed evidence of efficacy. At 12weeks, 50% of the patients achieved ACR20, and 58.3% moderate or good 28-joint count Disease Activity Score (DAS-28) response; at week 24, these responses were seen in 22 and 31 patients. Significant improvements were seen in Short Form-36 Health Survey and Health Assessment Questionnaire Disability Index scores. Overall, itolizumab in combination with methotrexate was well tolerated and efficacious in RA for 12weeks, with efficacy persisting for the entire 24-week evaluation period. (Clinical Trial Registry of India, http://ctri.nic.in/Clinicaltrials/login.php , CTRI/2008/091/000295).


PubMed | Center for Rheumatic Disease
Type: Case Reports | Journal: International journal of rheumatic diseases | Year: 2010

Several forms of arthritis and rheumatism can sometimes complicate leprosy. However, its presentation as an acute onset arthritis is unusual. We report two adult male nave patients who presented to our rheumatology outpatient clinic with acute onset inflammatory polyarthritis, skin rash and mild sensory neurodeficit. Borderline lepromatous leprosy (in type I lepra reaction) was diagnosed. We also refer to 19 case records of Hansen arthritis in the clinic database (1998-2007) from approximately 35,000 patients and a community study to highlight the missed diagnosis of Hansens disease and its unusual association with rheumatoid arthritis. In countries like India where leprosy is endemic, this disease also merits attention in rheumatology clinics.

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