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	<title>Symptom Advice .com &#187; oxo</title>
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		<title>UCB : New study finds rheumatoid arthritis (RA) patients preferred ergonomically designed Cimzia (certolizumab pegol) syringe to conventional prefilled syringe</title>
		<link>http://symptomadvice.com/ucb-new-study-finds-rheumatoid-arthritis-ra-patients-preferred-ergonomically-designed-cimzia-certolizumab-pegol-syringe-to-conventional-prefilled-syringe/</link>
		<comments>http://symptomadvice.com/ucb-new-study-finds-rheumatoid-arthritis-ra-patients-preferred-ergonomically-designed-cimzia-certolizumab-pegol-syringe-to-conventional-prefilled-syringe/#comments</comments>
		<pubDate>Sat, 24 Sep 2011 04:51:15 +0000</pubDate>
		<dc:creator>Symptom Advice</dc:creator>
				<category><![CDATA[crohn s symptoms]]></category>
		<category><![CDATA[arthritis]]></category>
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		<guid isPermaLink="false">http://symptomadvice.com/ucb-new-study-finds-rheumatoid-arthritis-ra-patients-preferred-ergonomically-designed-cimzia-certolizumab-pegol-syringe-to-conventional-prefilled-syringe/</guid>
		<description><![CDATA[BRUSSELS, 21st September 2011, 07:00 CET? Results &#102;&#114;&#111;&#109; a study assessing the use of the OXO designed Cimzia? (certolizumab pegol) syringe &#115;&#104;&#111;&#119;&#101;&#100; patients &#119;&#105;&#116;&#104; rheumatoid arthritis (RA) rated &#105;&#116; higher on nineteen preference and performance-based scores, when compared to the conventional prefilled syringe used in the pivotal registration study RAPID 2.1, 2 Additionally, the results, [...]]]></description>
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<p>BRUSSELS, 21st September 2011, 07:00 CET? Results &#102;&#114;&#111;&#109; a study assessing the use of the OXO designed Cimzia? (certolizumab pegol) syringe &#115;&#104;&#111;&#119;&#101;&#100; patients &#119;&#105;&#116;&#104; rheumatoid arthritis (RA) rated &#105;&#116; higher on nineteen preference and performance-based scores, when compared to the conventional prefilled syringe used in the pivotal registration study RAPID 2.1, 2 Additionally, the results, &#114;&#101;&#099;&#101;&#110;&#116;&#108;&#121; published inApplied Ergonomics, &#115;&#104;&#111;&#119;&#101;&#100; that 77% of the patients involved in the study &#119;&#101;&#114;&#101; able to exert greater force when &#117;&#115;&#105;&#110;&#103; the OXO designed syringe compared &#119;&#105;&#116;&#104; the conventional prefilled syringe.1</p>
<p>?If untreated the effects of RA &#099;&#097;&#110; &#111;&#102;&#116;&#101;&#110; limit a patient?s hand strength and dexterity, which &#099;&#097;&#110; lead to difficulties in self-administering medication &#097;&#116; home,? &#115;&#097;&#105;&#100; Michael Schiff MD, University of Colorado, USA. ?The results &#102;&#114;&#111;&#109; &#116;&#104;&#105;&#115; study reinforce the importance of understanding the limitations RA &#099;&#097;&#110; impose on a person?s daily activity and the importance of providing solutions to patients that will improve the everyday management of their disease.? </p>
<p>The study assessed the effect of syringe design on the ability of RA patients to perform injections. Twenty-three RA patients participated in &#116;&#104;&#105;&#115; study to compare preferences and injection forces &#117;&#115;&#105;&#110;&#103; a conventional syringe and the OXO designed certolizumab pegol syringe. Injection force measurements &#119;&#101;&#114;&#101; collected in &#116;&#119;&#111; ways: (a) isometric forces, &#119;&#105;&#116;&#104; the syringes? plungers in fixed positions and (b) forces exerted &#100;&#117;&#114;&#105;&#110;&#103; injection of the medication. Subjects? grip and pinch strengths &#119;&#101;&#114;&#101; &#097;&#108;&#115;&#111; measured. &#117;&#115;&#105;&#110;&#103; a 7-point scale (1 &#119;&#097;&#115; the &#119;&#111;&#114;&#115;&#116; and 7 the best rating) a perception questionnaire gauged subjects? impressions and preferences. Injections &#119;&#101;&#114;&#101; performed &#117;&#115;&#105;&#110;&#103; simulated skin pads. &#111;&#110;&#101; syringe, referred to &#097;&#115; the RAPID 2 syringe, &#119;&#097;&#115; a standard pre-filled ?off-the-shelf? syringe. The second syringe &#119;&#097;&#115; the ergonomically designed syringe created &#098;&#121; Smart Design, OXO, and UCB. </p>
<p>As &#112;&#097;&#114;&#116; of the study, a patient questionnaire evaluated perceptions of the &#116;&#119;&#111; prefilled syringes and compared patient views on ease-of-use, physical characteristics and general preferences &#097;&#099;&#114;&#111;&#115;&#115; twenty different attributes. Of the twenty attributes, 15 &#119;&#101;&#114;&#101; statistically significant &#097;&#116; the 95% confidence level, and 16 &#119;&#101;&#114;&#101; statistically significant &#097;&#116; the 90% confidence level. Results &#115;&#104;&#111;&#119;&#101;&#100; that patients &#102;&#111;&#117;&#110;&#100; the OXO designed syringe more comfortable (6.0 (?1.0*)) &#118;&#115;. 4.2 (?1.7*)) and easier to inject (5.5 (?1.3*)) &#118;&#115;. 4.0 (?1.8*)) &#116;&#104;&#097;&#110; the traditional syringe.1 &#102;&#117;&#114;&#116;&#104;&#101;&#114;&#109;&#111;&#114;&#101;, patients agreed the OXO designed syringe provided more control (5.5 (?1.7*) &#118;&#115;. 4.4 (?2.0*)) and the larger design of the plunger made injections easier (5.7 (?1.7*) &#118;&#115;. 4.3 (?2.0*)).1</p>
<p>Designed in partnership &#119;&#105;&#116;&#104; OXO, the certolizumab pegol prefilled syringe incorporates several key features &#102;&#111;&#114; RA patients, including a non-slip finger grip, a finger loop on the needle shield and a larger &#116;&#104;&#097;&#110; usual plunger. Development of the syringe &#119;&#097;&#115; initiated when UCB patient research identified self-injection &#119;&#105;&#116;&#104; a conventional syringe &#097;&#115; a challenge &#102;&#111;&#114; many people &#119;&#105;&#116;&#104; RA. </p>
<p>UCB and OXO spent time discussing design features &#119;&#105;&#116;&#104; RA patients to establish their needs &#097;&#115; &#112;&#097;&#114;&#116; of the design process. The result &#119;&#097;&#115; a syringe designed specifically &#102;&#111;&#114; patients &#119;&#105;&#116;&#104; RA. In March 2011, the UCB/OXO prefilled syringe received the coveted GOOD DESIGNTM Award &#102;&#111;&#114; the patient-friendly design and packaging.3 The GOOD DESIGNTM Award is &#110;&#111;&#116; the &#102;&#105;&#114;&#115;&#116; that UCB has been recognised &#098;&#121; the design industry &#102;&#111;&#114; its Cimzia?4 2009 Silver Spark Award,5 2010 iF Product Design Award,6 2010 Universal Design Award,7 2010 Medical Design Excellence Award (MDEA),8 2010 Red Dot: Product Design Award.9</p>
<ol>
<li>Sheikhzadeh, A., Yoon, J., Formosa, D., Domanska, B., Morgan, D., Schiff, M. The effect of a new syringe design on the ability of rheumatoid arthritis patients to inject a biological medication, Applied Ergonomics (2011), doi:10.1016/j.apergo.2011.05.014 (in press) </li>
<li>Smolen, J. S., et al. Efficacy and Safety of Certolizumab Pegol Plus Methotrexate in Active Rheumatoid Arthritis: The RAPID 2 Study Annals of the Rheumatic Diseases;6-1-2009;68;6;797-804. </li>
</ol>
<p>For &#102;&#117;&#114;&#116;&#104;&#101;&#114; Information: Scott Fleming, Associate Director, Global Communications? ImmunologyT +44 770.277.7378, </p>
<p>About CIMZIA?Cimzia? is the &#111;&#110;&#108;&#121; PEGylated anti-TNF (Tumor Necrosis Factor). Cimzia? has a high affinity &#102;&#111;&#114; human TNF-alpha, selectively neutralizing the pathophysiological effects of TNF-alpha. Over the past decade, TNF-alpha has emerged &#097;&#115; a major target of basic research and clinical investigation. &#116;&#104;&#105;&#115; cytokine plays a key role in mediating pathological inflammation, and excess TNF-alpha production has been &#100;&#105;&#114;&#101;&#099;&#116;&#108;&#121; implicated in a wide variety of diseases. The U.S. Food and Drug Administration (FDA) has approved Cimzia? &#102;&#111;&#114; reducing signs and symptoms of Crohn&#8217;s disease and maintaining clinical response in adult patients &#119;&#105;&#116;&#104; moderately to severely active disease who &#104;&#097;&#118;&#101; &#104;&#097;&#100; &#097;&#110; inadequate response to conventional therapy and &#102;&#111;&#114; the treatment of adults &#119;&#105;&#116;&#104; moderately to severely active rheumatoid arthritis. Cimzia? in combination &#119;&#105;&#116;&#104; MTX, is approved in the EU &#102;&#111;&#114; the treatment of moderate to severe active RA in adult patients inadequately responsive to disease-modifying antirheumatic drugs (DMARDs) including MTX. Cimzia? &#099;&#097;&#110; be &#103;&#105;&#118;&#101;&#110; &#097;&#115; monotherapy in case of intolerance to MTX &#111;&#114; when continued treatment &#119;&#105;&#116;&#104; MTX is inappropriate. UCB is &#097;&#108;&#115;&#111; developing Cimzia? in other autoimmune disease indications. Cimzia? is a registered trademark of UCB PHARMA S.A.</p>
<p>CIMZIA? (certolizumab pegol) in European Union/ EEA important safety informationCimzia? &#119;&#097;&#115; studied in 2367 patients &#119;&#105;&#116;&#104; RA in controlled and open label trials &#102;&#111;&#114; up to 57 months. The commonly reported adverse reactions (1-10%) in clinical trials &#119;&#105;&#116;&#104; Cimzia? and post-marketing &#119;&#101;&#114;&#101; viral infections (includes herpes, papillomavirus, influenza), bacterial infections (including abscess), rash, headache (including migraine), asthenia, leukopaenia (including lymphopaenia, neutropaenia), eosinophilic disorder, pain (any sites), pyrexia, sensory abnormalities, hypertension, pruritis (any sites), hepatitis (including hepatic enzyme increase), injection site reactions. Serious adverse reactions include sepsis, opportunistic infections, tuberculosis, herpes zoster, lymphoma, leukaemia, solid organ tumours, angioneurotic edema, 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, 5% of patients discontinued taking Cimzia? due to adverse events &#118;&#115;. 2.5% &#102;&#111;&#114; placebo.Cimzia? is contraindicated in patients &#119;&#105;&#116;&#104; hypersensitivity to the active substance &#111;&#114; any of the excipients, active tuberculosis &#111;&#114; other severe infections &#115;&#117;&#099;&#104; &#097;&#115; sepsis &#111;&#114; opportunistic infections, moderate to severe heart failure.&#098;&#101;&#102;&#111;&#114;&#101; initiation of Cimzia?, evaluate patients &#102;&#111;&#114; both active &#111;&#114; inactive (latent) tuberculosis infection. Monitor patients &#102;&#111;&#114; the development of signs and symptoms of infection &#100;&#117;&#114;&#105;&#110;&#103; and after treatment &#119;&#105;&#116;&#104; Cimzia?. If &#097;&#110; infection develops, monitor carefully, and &#115;&#116;&#111;&#112; Cimzia? if infection becomes serious.TNF blockers including Cimzia? may increase the risk: of reactivation of Hepatitis B Virus (HBV) in patients who are chronic carriers of the virus; of new onset &#111;&#114; exacerbation of clinical symptoms and/or radiographic evidence of demyelinating disease; of formation of autoantibodies and uncommonly of the development of a lupus-like syndrome; of severe hypersensitivity reactions. If a patient develops any of &#116;&#104;&#101;&#115;&#101; adverse reactions, Cimzia? &#115;&#104;&#111;&#117;&#108;&#100; be discontinued and &#097;&#112;&#112;&#114;&#111;&#112;&#114;&#105;&#097;&#116;&#101; therapy instituted.&#119;&#105;&#116;&#104; the current knowledge, a &#112;&#111;&#115;&#115;&#105;&#098;&#108;&#101; risk &#102;&#111;&#114; the development of lymphomas, leukaemia &#111;&#114; other malignancies in patients treated &#119;&#105;&#116;&#104; a TNF antagonist &#099;&#097;&#110;&#110;&#111;&#116; be excluded. Rare cases of neurological disorders, including seizure disorder, neuritis and peripheral neuropathy, &#104;&#097;&#118;&#101; been reported in patients treated &#119;&#105;&#116;&#104; Cimzia?.Adverse reactions of the hematologic &#115;&#121;&#115;&#116;&#101;&#109;, including medically significant cytopenia, &#104;&#097;&#118;&#101; been infrequently reported &#119;&#105;&#116;&#104; Cimzia?. Advise &#097;&#108;&#108; patients to seek immediate medical attention if &#116;&#104;&#101;&#121; develop signs and symptoms suggestive of blood dyscrasias &#111;&#114; infection (e.g., persistent fever, bruising, bleeding, pallor) while on Cimzia?. &#099;&#111;&#110;&#115;&#105;&#100;&#101;&#114; discontinuation of Cimzia? therapy in patients &#119;&#105;&#116;&#104; confirmed significant haematological abnormalities.The use of Cimzia? in combination &#119;&#105;&#116;&#104; anakinra &#111;&#114; abatacept is &#110;&#111;&#116; recommended due to a potential increased risk of serious infections. &#097;&#115; &#110;&#111; data are &#097;&#118;&#097;&#105;&#108;&#097;&#098;&#108;&#101;, Cimzia? &#115;&#104;&#111;&#117;&#108;&#100; &#110;&#111;&#116; be administered concurrently &#119;&#105;&#116;&#104; live vaccines &#111;&#114; attenuated vaccines. The 14-day half-life of Cimzia? &#115;&#104;&#111;&#117;&#108;&#100; be taken &#105;&#110;&#116;&#111; consideration if a surgical procedure is &#112;&#108;&#097;&#110;&#110;&#101;&#100;. A patient who requires surgery while on Cimzia? &#115;&#104;&#111;&#117;&#108;&#100; be closely monitored &#102;&#111;&#114; infections.Please consult the full prescribing information in relation to other side effects, full safety and prescribing information. European SmPC date of revision February 2011. </p>
<p>About UCB UCB, Brussels, Belgium ( ) is a biopharmaceutical company dedicated to the research, development and commercialization of innovative medicines &#119;&#105;&#116;&#104; a focus on the fields of central nervous &#115;&#121;&#115;&#116;&#101;&#109; and immunology disorders. Employing more &#116;&#104;&#097;&#110; 9000 people in over 40 countries, UCB produced revenue of EUR 3.22 billion in 2010. UCB is listed on Euronext Brussels (symbol: UCB).UCB Forward-looking statementsThis press release &#099;&#111;&#110;&#116;&#097;&#105;&#110;&#115; forward-looking statements based on current plans, estimates and beliefs of management. &#097;&#108;&#108; statements, other &#116;&#104;&#097;&#110; statements of historical fact, are statements that &#099;&#111;&#117;&#108;&#100; be deemed forward-looking statements, including estimates of revenues, operating margins, capital expenditures, cash, other financial information, expected legal, political, regulatory &#111;&#114; clinical results and other &#115;&#117;&#099;&#104; estimates and results. &#098;&#121; their nature, &#115;&#117;&#099;&#104; forward-looking statements are &#110;&#111;&#116; guarantees of future performance and are subject to risks, uncertainties and assumptions which &#099;&#111;&#117;&#108;&#100; &#099;&#097;&#117;&#115;&#101; actual results to differ materially &#102;&#114;&#111;&#109; those that may be implied &#098;&#121; &#115;&#117;&#099;&#104; forward-looking statements contained in &#116;&#104;&#105;&#115; press release. Important factors that &#099;&#111;&#117;&#108;&#100; result in &#115;&#117;&#099;&#104; differences include: &#099;&#104;&#097;&#110;&#103;&#101;&#115; in general economic, business and competitive conditions, the inability to obtain &#110;&#101;&#099;&#101;&#115;&#115;&#097;&#114;&#121; regulatory approvals &#111;&#114; to obtain &#116;&#104;&#101;&#109; on acceptable terms, costs &#097;&#115;&#115;&#111;&#099;&#105;&#097;&#116;&#101;&#100; &#119;&#105;&#116;&#104; research and development, &#099;&#104;&#097;&#110;&#103;&#101;&#115; in the prospects &#102;&#111;&#114; products in the pipeline &#111;&#114; under development &#098;&#121; UCB, effects of future judicial decisions &#111;&#114; governmental investigations, product liability claims, challenges to patent protection &#102;&#111;&#114; products &#111;&#114; product candidates, &#099;&#104;&#097;&#110;&#103;&#101;&#115; in laws &#111;&#114; regulations, exchange rate fluctuations, &#099;&#104;&#097;&#110;&#103;&#101;&#115; &#111;&#114; uncertainties in tax laws &#111;&#114; the administration of &#115;&#117;&#099;&#104; laws and hiring and retention of its employees. UCB is providing &#116;&#104;&#105;&#115; information &#097;&#115; of the date of &#116;&#104;&#105;&#115; press release and expressly disclaims any duty to update any information contained in &#116;&#104;&#105;&#115; press release, &#101;&#105;&#116;&#104;&#101;&#114; to confirm the actual results &#111;&#114; to report a change in its expectations.There is &#110;&#111; guarantee that new product candidates in the pipeline will progress to product approval &#111;&#114; that new indications &#102;&#111;&#114; existing products will be developed and approved. Products &#111;&#114; potential products which are the subject of partnerships, joint ventures &#111;&#114; licensing collaborations may be subject to differences &#098;&#101;&#116;&#119;&#101;&#101;&#110; the partners. &#097;&#108;&#115;&#111;, UCB &#111;&#114; others &#099;&#111;&#117;&#108;&#100; discover safety, side effects &#111;&#114; manufacturing problems &#119;&#105;&#116;&#104; its products after &#116;&#104;&#101;&#121; are marketed.Moreover, sales may be impacted &#098;&#121; international and domestic trends toward managed care and health care cost containment and the reimbursement policies imposed &#098;&#121; third-party payers &#097;&#115; &#119;&#101;&#108;&#108; &#097;&#115; legislation affecting biopharmaceutical pricing and reimbursement.</p>
<p>About OXOFounded in 1990 on the concept of Universal Design, OXO&#8217;s mission is to &#099;&#114;&#101;&#097;&#116;&#101; consumer household products that ease the tasks of everyday life &#102;&#111;&#114; the widest range of users &#112;&#111;&#115;&#115;&#105;&#098;&#108;&#101;. Since the original 15 items &#119;&#101;&#114;&#101; introduced, the OXO collection has grown to more &#116;&#104;&#097;&#110; 800 strong covering areas &#102;&#111;&#114; cooking, cleaning, gardening, storing, organizing and lighting. Today OXO &#103;&#111;&#111;&#100; Grips? products are sold in 54 countries and are included in the permanent collections of numerous museums. The company has won more &#116;&#104;&#097;&#110; 100 design and business awards worldwide. OXO is &#118;&#101;&#114;&#121; frequently used &#097;&#115; a case study on how a well-executed Universal Design philosophy &#099;&#097;&#110; be a successful business strategy. OXO is owned &#098;&#121; Helen of Troy Limited, a leading designer, producer and global marketer of brand-name personal care and household consumer products. OXO? and &#103;&#111;&#111;&#100; Grips? are registered trademarks of Helen of Troy Limited.</p></p>
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