Pregnancy Outcomes and Disease Activity in Women with Axial Spondyloarthritis: A Systematic Literature Review A. Moltó, L. Gensler, M. Clowse, H. Marzo-Ortega, A. Artignan, D. Goff-Leggett, S. Leonard, H. Resemann, E. Thurtle, N. de Peyrecave, C. Ecoffet, F. Förger
- Date/Time: June 14, 2018: 11:45 - 13:30 CEST
UCB-sponsored Rheumatology Data:
Baseline Characteristics and Patient Satisfaction Data from Coach@Home: The German Support Program for Patients with Rheumatic Diseases Treated with Certolizumab Pegol, N. Böhme, A.-D. Holst, F. Dybowski, C. Volberg, H.-G. Pott, U. Lendl
- Date/Time: ePoster only
Barriers to Rheumatoid Arthritis Treatment Optimisation: Real-World Data from the ArthritisPower Registry, J. L. Stark, M. Yassine, W. B. Nowell, K. Gavigan, S. Ginsberg, M. S. Serna, J. R. Curtis
- Date/Time: June 14, 2018: 11:45 - 13:30 CEST
Do TNF Inhibitors Impact the Comorbidities and Extra-Articular Manifestations, and Thereby Alter the Natural History of Ankylosing Spondylitis? A. Deodhar, K. L. Winthrop, R. L. Bohn, B. K. Chan, R. Y. Suruki, J. L. Stark, H. Yun, S. A. R. Siegel, L. Chen, M. Yassine, J. R. Curtis
- Date/Time: June 16, 2018: 10:30 CEST
About Bimekizumab
Bimekizumab is a novel humanized monoclonal IgG1 antibody that potently and selectively neutralizes both IL-17A and IL-17F, two key cytokines driving inflammatory processes. IL-17A and IL-17F have overlapping pro-inflammatory functions and independently cooperate with other inflammatory mediators to drive chronic inflammation and damage across multiple tissues.
Previous early Phase clinical studies in psoriasis and psoriatic arthritis have suggested that neutralizing IL-17F in addition to IL-17A with bimekizumabmay provide a new targeted approach for the treatment of immune-mediated inflammatory diseases. Preclinical results in disease-relevant cells have shown that dual neutralization of both IL-17A and IL-17F reduces skin and joint inflammation, as well as pathological bone formation to an extent greater than inhibition of IL-17A or IL-17F alone.[i],[ii],[iii]
UCB is studying bimekizumab in psoriasis, psoriatic arthritis and ankylosing spondylitis. Bimekizumab is not approved by any regulatory authority worldwide.
About Romosozumab
Romosozumab is an investigational bone-forming monoclonal antibody and is not approved by any regulatory authority for the treatment of osteoporosis. It is designed to work by inhibiting the activity of sclerostin, which enables romosozumab to increase bone formation and reduce bone resorption simultaneously. Romosozumab is being studied for its potential to reduce the risk of fractures in an extensive global Phase 3 program. This program includes two large fracture trials comparing romosozumab to either placebo or active comparator in more than 11,000 postmenopausal women with osteoporosis. Amgen and UCB are co-developing romosozumab.
About CIMZIA(R) in the EU/EEA
In the EU, CIMZIA(R) in combination with methotrexate (MTX) is indicated for the treatment of moderate to severe active RA in adult patients inadequately responsive to disease-modifying anti-rheumatic drugs (DMARDs) including MTX.
CIMZIA can be given as monotherapy in case of intolerance to MTX or when continued treatment with MTX is inappropriate. CIMZIA in combination with MTX is also indicated for the treatment of severe, active and progressive RA in adults not previously treated with MTX or other DMARDs.
CIMZIA has been shown to reduce the rate of progression of joint damage as measured by X-ray and to improve physical function, when given in combination with MTX.
CIMZIA, in combination with MTX, is also indicated for the treatment of active psoriatic arthritis in adults when the response to previous DMARD therapy has been inadequate. CIMZIA can be given as monotherapy in case of intolerance to MTX or when continued treatment with MTX is inappropriate.
CIMZIA is also indicated in the EU for the treatment of adult patients with severe active axial spondyloarthritis (axSpA), comprising:
- Ankylosing spondylitis (AS) - adults with severe active AS who have had an inadequate response to, or are intolerant to non-steroidal anti-inflammatory drugs (NSAIDs). - Axial spondyloarthritis (axSpA) without radiographic evidence of AS - adults with severe active axSpA without radiographic evidence of AS but with objective signs of inflammation by elevated C-reactive protein (CRP) and/or Magnetic Resonance Imaging (MRI) who have had an inadequate response to, or are intolerant to NSAIDs.
Important Safety Information about CIMZIA(R) in the EU/EEA
CIMZIA(R) was studied in 4,049 patients with rheumatoid arthritis (RA) in controlled and open label trials for up to 92 months. The commonly reported adverse reactions (1-10%) in clinical trials with CIMZIA(R) and post-marketing were viral infections (includes herpes, papillomavirus, influenza), bacterial infections (including abscess), rash, headache (including migraine), asthaenia, leukopaenia (including lymphopaenia, neutropaenia), eosinophilic disorder, pain (any sites), pyrexia, sensory abnormalities, hypertension, pruritus (any sites), hepatitis (including hepatic enzyme increase), injection site reactions, and nausea. Serious adverse reactions include sepsis, opportunistic infections, tuberculosis, herpes zoster, lymphoma, leukaemia, solid organ tumours, angioneurotic oedema, cardiomyopathies (includes heart failure), ischemic coronary artery disorders, pancytopaenia, hypercoagulation (including thrombophlebitis, pulmonary embolism), cerebrovascular accident, vasculitis, hepatitis/hepatopathy (includes cirrhosis), and renal impairment/nephropathy (includes nephritis). In RA controlled clinical trials, 4.4% of patients discontinued taking CIMZIA(R) due to adverse events vs. 2.7% for placebo.
CIMZIA(R) is contraindicated in patients with hypersensitivity to the active substance or any of the excipients, active tuberculosis or other severe infections such as sepsis or opportunistic infections or moderate-to-severe heart failure.
Serious infections including sepsis, tuberculosis and opportunistic infections have been reported in patients receiving CIMZIA(R). Some of these events have been fatal. Monitor patients closely for signs and symptoms of infections including tuberculosis before, during, and after treatment with CIMZIA(R). Treatment with CIMZIA(R) must not be initiated in patients with a clinically important active infection. If an infection develops, monitor carefully and stop CIMZIA(R) if infection becomes serious. Before initiation of therapy with CIMZIA(R), all patients must be evaluated for both active and inactive (latent) tuberculosis infection. If active tuberculosis is diagnosed prior to or during treatment, CIMZIA(R) therapy must not be initiated and must be discontinued. If latent tuberculosis is diagnosed, appropriate anti-tuberculosis therapy must be started before initiating treatment with CIMZIA(R). Patients should be instructed to seek medical advice if signs/symptoms (e.g. persistent cough, wasting/weight loss, low grade fever, listlessness) suggestive of tuberculosis occur during or after therapy with CIMZIA(R).
Reactivation of hepatitis B has occurred in patients receiving a TNF-antagonist including CIMZIA(R) who are chronic carriers of the virus (i.e. surface antigen positive). Some cases have had a fatal outcome. Patients should be tested for HBV infection before initiating treatment with CIMZIA(R). Carriers of HBV who require treatment with CIMZIA(R) should be closely monitored and in the case of HBV reactivation CIMZIA(R) should be stopped and effective anti-viral therapy with appropriate supportive treatment should be initiated.
(CONTINUA)
