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Total 23 results found since Jan 2013.
Janssen Presents Study Results Showing Clinical Efficacy for TREMFYA ® (guselkumab) and Long-Term Safety Profile for STELARA® (ustekinumab) for Patients Living with Inflammatory Bowel Disease at Digestive Disease Week® 2022
SPRING HOUSE, PENNSYLVANIA, May 24, 2022 – The Janssen Pharmaceutical Companies of Johnson & Johnson today announced new data from the Phase 2 GALAXI 1 clinical trial of TREMFYA® (guselkumab) in adult patients with moderately to severely active Crohn’s disease (CD), and from three separate long-term pooled analyses of adult patients with ulcerative colitis (UC) and CD treated with STELARA® (ustekinumab).1,2,3,4 These data are being presented as oral and poster presentations and are among 29 Janssen abstracts presented during the Digestive Disease Week® (DDW) meeting taking place in person and virtually in San Di...
Source: Johnson and Johnson - May 24, 2022 Category: Pharmaceuticals Source Type: news
Janssen Reports Positive Topline Week 48 Phase 2 Results for TREMFYA ® (guselkumab) in Adults With Moderately to Severely Active Crohn's Disease
SPRING HOUSE, PENNSYLVANIA, November 17, 2021 – The Janssen Pharmaceutical Companies of Johnson & Johnson today announced topline results from the Phase 2 GALAXI 1 clinical trial which showed rates of clinical remission (Crohn’s Disease Activity Index [CDAI]<150) previously reported at week 12 increased at week 48 among adults with moderately to severely active Crohn’s disease (CD) treated with TREMFYA® (guselkumab).1 At week 48, 65 percent of patients receiving TREMFYA achieved clinical remission. TREMFYA is under investigation and not currently approved for the treatment of CD in the U.S.2Janssen previously...
Source: Johnson and Johnson - November 17, 2021 Category: Pharmaceuticals Source Type: news
New Analyses Suggest Favorable Results for STELARA ® (ustekinumab) When Used as a First-Line Therapy for Bio-Naïve Patients with Moderately to Severely Active Crohn’s Disease and Ulcerative Colitis
SPRING HOUSE, PENNSYLVANIA, October 25, 2021 – The Janssen Pharmaceutical Companies of Johnson & Johnson today announced data from two new analyses of STELARA® (ustekinumab) for the treatment of adults with moderately to severely active Crohn’s disease (CD) and ulcerative colitis (UC).1,2 In a modelled analysisa focused on treatment sequencing using data from randomized controlled trials, network meta-analysis and literature, results showed patient time spent in clinical remission or response was highest when STELARA was used as a first-line advanced therapy for bio-naïve patients with moderately to severely acti...
Source: Johnson and Johnson - October 25, 2021 Category: Pharmaceuticals Tags: Innovation Source Type: news
Janssen Submits Application Seeking U.S. FDA Approval of STELARA ® (ustekinumab) for the Treatment of Pediatric Patients With Juvenile Psoriatic Arthritis
HORSHAM, PENNSYLVANIA, October 8, 2021 – The Janssen Pharmaceutical Companies of Johnson & Johnson today announced the submission of a supplemental Biologics License Application (sBLA) to the U.S. Food and Drug Administration (FDA) seeking expanded approval of STELARA® (ustekinumab) to treat pediatric patients ages 5 years and older with juvenile psoriatic arthritis (jPsA).The filing is supported by extrapolation of data from nine studies across both adult trials in active PsA and adult and pediatric studies in moderate to severe plaque psoriasis, totaling 3,997 patients evaluated across these closely associated dis...
Source: Johnson and Johnson - October 8, 2021 Category: Pharmaceuticals Tags: Innovation Source Type: news
New Analysis Presented by Janssen at United European Gastroenterology Week (UEGW) Demonstrates Long-Term Safety Profile for STELARA ® (ustekinumab) in Older Patients Across Approved Indications
SPRING HOUSE, PENNSYLVANIA, October 4, 2021 – Today, the Janssen Pharmaceutical Companies of Johnson & Johnson announced a new analysis of STELARA® (ustekinumab) pooled safety data from 13 clinical studies across approved indications, showing rates of key safety events among adults 60 years and older treated with STELARA for up to five yearsa were similar to rates observed with placebo during the control phase of these trials.1,b Approved indications included adults with moderately to severely active Crohn’s disease (CD), moderately to severely active ulcerative colitis (UC), moderate to severe plaque psoriasis (P...
Source: Johnson and Johnson - October 4, 2021 Category: Pharmaceuticals Tags: Innovation Source Type: news
STELARA ® (ustekinumab) Demonstrated Sustained Symptomatic and Corticosteroid-Free Remission Rates in Adults with Moderately to Severely Active Ulcerative Colitis at Nearly Three Years in Long-Term Extension of Phase 3 Trial
SPRING HOUSE, PENNSYLVANIA, July 9, 2021 – The Janssen Pharmaceutical Companies of Johnson & Johnson today announced new three-year data from the long-term extension (LTE) of the STELARA® (ustekinumab) Phase 3 UNIFI study. The data demonstrated the majority (55.2 percent) of adult patients with moderately to severely active ulcerative colitis (UC) who initially responded to treatment with STELARA sustained symptomatic remissiona rates at nearly three years (week 152).1 Furthermore, a majority (96.4 percent) of the patients in symptomatic remissiona at week 152 were corticosteroid-free. These data are being presented...
Source: Johnson and Johnson - July 9, 2021 Category: Pharmaceuticals Tags: Innovation Source Type: news
Janssen Presents Results of First Head-to-Head Study of Biologic Therapies in Patients with Moderate to Severe Crohn ’s Disease
SPRING HOUSE, PENNSYLVANIA, May 23, 2021 – The Janssen Pharmaceutical Companies of Johnson & Johnson today announced efficacy and safety data for STELARA® (ustekinumab) in Crohn’s disease (CD) and ulcerative colitis (UC),1-4including data from the SEAVUE study, the first head-to-head study of biologic therapies in patients with CD, presented in a Clinical Science Late-Breaking Abstract Plenary session.1 SEAVUE data showed treatment with STELARA demonstrated high rates of clinical remission, corticosteroid-free remission, clinical response and endoscopic response through one year in biologic-naïve patients with mo...
Source: Johnson and Johnson - May 24, 2021 Category: Pharmaceuticals Tags: Innovation Source Type: news
Janssen Announces Discontinuation of Phase 3 LOTUS Study Evaluating Ustekinumab in Systemic Lupus Erythematosus
SPRING HOUSE, PENNSYLVANIA, June 26, 2020 – The Janssen Pharmaceutical Companies of Johnson & Johnson announced today its decision to discontinue the Phase 3 LOTUS study of STELARA® (ustekinumab) in Systemic Lupus Erythematosus (SLE) due to lack of efficacy in SLE.The decision is based on data from a pre-planned interim efficacy analysis. Interim safety findings were consistent with the known safety profile of STELARA, and no new safety signals were identified. Investigators, study participants and health authorities have been informed of the decision. The company intends to thoroughly analyze the totality of the st...
Source: Johnson and Johnson - June 26, 2020 Category: Pharmaceuticals Tags: Innovation Source Type: news
Drug reactions in children with rheumatic diseases receiving parenteral therapies: 9 years ’ experience of a tertiary pediatric rheumatology center
In this study, drug side effects in patients who were followed up with a rheumatic disease and treated with parenteral administration methods were evaluated. The drug side effects in children who were followed up with a rheumatic disease and treated with parenteral treatments between 2010 and 2019 were recorded, retrospectively. All parenteral treatments are applied by a clinical nurse specialist (CNS) who is experienced in pediatric rheumatology for 10 years. Four hundred and thirteen patients were evaluated in this study. The mean age was 12.09 ± 5.05 years. Most of them were diagnosed with juvenile idiopathic art...
Source: Rheumatology International - December 20, 2019 Category: Rheumatology Source Type: research
Plant-Derived Alkaloids: The Promising Disease-Modifying Agents for Inflammatory Bowel Disease
Conclusion
This paper summarizes the current findings regarding the anti-colitis activity of plant-derived alkaloids and shows how these alkaloids exhibit significant and beneficial effects in alleviating colonic inflammation. These natural alkaloids are not only promising agents for IBD treatment but are also components for developing new wonder drugs. However, the underlying molecular mechanisms or toxicological evaluation of most plant-derived alkaloids still require much scientific research, and their actual efficacies for IBD patients have not been verified well in field research. Thus, further clinical trials to elu...
Source: Frontiers in Pharmacology - April 11, 2019 Category: Drugs & Pharmacology Source Type: research
Efficacy and safety of sarilumab monotherapy versus adalimumab monotherapy for the treatment of patients with active rheumatoid arthritis (MONARCH): a randomised, double-blind, parallel-group phase III trial
Conclusions
Sarilumab monotherapy demonstrated superiority to adalimumab monotherapy by improving the signs and symptoms and physical functions in patients with RA who were unable to continue MTX treatment. The safety profiles of both therapies were consistent with anticipated class effects.
Trial registration number
NCT02332590.
Source: Annals of the Rheumatic Diseases - April 6, 2017 Category: Rheumatology Authors: Burmester, G. R., Lin, Y., Patel, R., van Adelsberg, J., Mangan, E. K., Graham, N. M. H., van Hoogstraten, H., Bauer, D., Ignacio Vargas, J., Lee, E. B. Tags: Open access, Immunology (including allergy), Pain (neurology), Connective tissue disease, Degenerative joint disease, Musculoskeletal syndromes, Rheumatoid arthritis Clinical and epidemiological research Source Type: research
Cll, a rare but treatable cause of longitudinally extensive myelitis
A 65-year-old lady presented with a 1-year history of progressive sensory and motor symptoms in the the legs, back pain, pruritus and night sweats. Neurological examination of the cranial nerves and upper limbs was unremarkable. Lower limb examination revealed mild bilateral spastic paraparesis. Cervical, axillary and inguinal lymphadenopathy was noted. Bloods showed only a mild lymphopenia. MRI revealed symmetrically diffuse nodular enhancement in the brain and longitudinally extensive transverse myelitis in the cervical and thoracic spine with leptomeningeal enhancement. CSF analysis showed a protein of 1888 mg/L, W...
Source: Journal of Neurology, Neurosurgery and Psychiatry - November 14, 2016 Category: Neurosurgery Authors: Ahmed, W., Coe, J., Carroll, L., Vundavalli, S., Chevassut, T., Saha, R. Tags: Immunology (including allergy), Cranial nerves, Infection (neurology), Multiple sclerosis, Pain (neurology), Spinal cord, Radiology, Surgical diagnostic tests, Radiology (diagnostics) ABN Annual Meeting, 17-19 May 2016, The Brighton Centre, Brighton Source Type: research
Primary t-cell cns lymphoma mimicking vasculitis
A 29 year old male presented with headache and no neurological signs. MRI brain strongly suggested an aggressive primary brain tumour in the right frontal lobe but histopathology revealed a pleomorphic lymphoid infiltrate, necrosis and vague granulomata and vasculitis was diagnosed. There was aggressive clinico-radiological progression despite two debunking surgeries, corticosteroids and cyclophosphamide.
On review the following were noted: areas of necrosis and focal diffuse lymphoid infiltrate showing perivascular cuffing; the presence of granuloma formation and vascular necrosis was less certain; overwhelming predominan...
Source: Journal of Neurology, Neurosurgery and Psychiatry - November 14, 2016 Category: Neurosurgery Authors: Raheem, B., Khan, H., Scolding, N., Love, S., Al-Sarraj, S., Bhangoo, R., Devereaux, S., Rooney, N., Sutak, J., Moran, N. Tags: Genetics, Immunology (including allergy), Headache (including migraine), Pain (neurology), Drugs: musculoskeletal and joint diseases, Vascularitis, Surgical oncology ABN Annual Meeting, 17-19 May 2016, The Brighton Centre, Brighton Source Type: research
Separately tackling the development of erosions with denosumab: ultimately closing a gap in the treatment of patients with rheumatoid arthritis or trying too hard too late?
Patients with rheumatoid arthritis (RA) have benefited from an unprecedented treatment improvement over the last two decades. Taking the disease seriously, with earlier and more intensive treat-to-target strategies and new treatment options with biologicals, has led to a better long-term disease control. Classical antirheumatic therapies, primarily directed against the inflammatory/immunological processes that determine RA disease activity, are successfully improving pain and the severe clinical and functional burden patients are confronted with. Moreover, one of the most important previous hallmarks of this disease, sever...
Source: Annals of the Rheumatic Diseases - May 9, 2016 Category: Rheumatology Authors: Verschueren, P., Westhovens, R. Tags: Immunology (including allergy), Pain (neurology), Inflammation, Disability, Connective tissue disease, Degenerative joint disease, Musculoskeletal syndromes, Rheumatoid arthritis Editorials Source Type: research
Disease-modifying antirheumatic drug-free sustained remission in rheumatoid arthritis: an increasingly achievable outcome with subsidence of disease symptoms
Conclusions
More intensive treatment strategies increased the chance for DMARD-free sustained remission, indicating that RA chronicity can be influenced. Patients with RA achieving DMARD-free sustained remission have a normalised functional status.
Source: Annals of the Rheumatic Diseases - April 6, 2016 Category: Rheumatology Authors: Ajeganova, S., van Steenbergen, H. W., van Nies, J. A. B., Burgers, L. E., Huizinga, T. W. J., van der Helm-van Mil, A. H. M. Tags: Immunology (including allergy), Pain (neurology), Biological agents, Connective tissue disease, Degenerative joint disease, Drugs: musculoskeletal and joint diseases, Musculoskeletal syndromes, Rheumatoid arthritis Clinical and epidemiological research Source Type: research
