Journal of Gerontological Nursing

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Abstract

The addition of Cimzia® (certolizumab pegol) to current therapy was associated with a rapid clinical response, improved function, and reduced disease activity in a diverse group of adult rheumatoid arthritis (RA) patients, reflecting those seen in daily clinical practice (including those with prior use of anti-tumor necrosis factor [TNF] agents).

The data, presented during the American College of Rheumatology’s (ACR) annual Scientific Meeting, were from the REALISTIC (RA Evaluation in Subjects Receiving TNF Inhibitor Certolizumab Pegol) multicenter Phase IIIb study, which included a 12-week, randomized, double-blind, placebo-controlled phase followed by an open-label extension (≥16 weeks). REALISTIC was designed to investigate the safety and efficacy of Cimzia in a broad patient population with active RA more closely resembling routine clinical practice, versus the pivotal trials, including patients with/without prior TNF-inhibitor exposure; with/without concomitant use of methotrexate (Rheumatrex®) or other disease-modifying anti-rheumatic drugs; and varying lengths of disease duration.

The primary endpoint of an ACR 20 score at Week 12 was met. At that point, more than half (51.1%) of patients in the Cimzia treatment group achieved ACR 20 response versus the control group (25.9%). Additional efficacy evaluated in the trial included ACR 50/70 response rates, as well as the Disease Activity Score: C-reactive protein (DAS28[CRP]) and the Health Assessment Questionnaire-Disability Index (HAQ-DI) measuring physical function.

Clinical responses among patients in the Cimzia treatment group were rapid. ACR 20/50 responses were significantly superior to control (31.8% versus 8.5% and 9.6% versus 1.4%, p < 0.001 for both) from the first timepoint (Week 2) onward.

Significant improvements in DAS28[CRP] were reported among patients treated with Cimzia versus the placebo group. In addition, Cimzia patients reported rapid and significant improvements in HAQ-DI scores versus the placebo group at Week 2.

Similar ACR 20 responses were seen across the various patient populations, regardless of baseline disease duration or activity; baseline use of methotrexate; or prior use of TNF-inhibiting agents. ACR 50 and ACR 70 responses at Week 12 were 26.6% and 13% for patients treated with Cimzia compared with the placebo group (9.9% and 2.8%, respectively).

Cimzia is currently approved for the treatment of moderately to severely active rheumatoid arthritis in adults.

Also announced at the ACR meeting were data from magnetic resonance imaging (MRI) analyses from two Phase III clinical trials showing that subcutaneous injections of Simponi® (golimumab) 50 mg plus methotrexate once every 4 weeks resulted in statistically significant improvements in markers of inflammation and structural damage in patients with active RA compared with placebo plus methotrexate. Changes in disease activity were measured using the Rheumatoid Arthritis MRI Scoring (RAMRIS) system, which assesses three components: synovitis, bone edema, and bone erosions. Changes in RAMRIS scores were observed as early as Week 12 and continued through Week 24.

Investigators reported that at Week 24 of the GOlimumab Before Employing methotrexate as the First-line Option in the treatment of Rheumatoid arthritis of Early onset (GO-BEFORE) study (N = 637), patients with RA receiving Simponi 50 mg plus methotrexate showed significant improvements in synovitis, bone edema, and bone erosions (−2.2, p = 0.011; −2.5, p <0.001; and −0.7, p = 0.016, respectively), compared with patients receiving placebo plus methotrexate (−1.0, −0.3, and −0.2, respectively).

In a second study, GOlimumab FOR subjects With Active RA Despite methotrexate (GO-FORWARD) (N = 444), patients receiving Simponi 50 mg plus methotrexate experienced significant improvements in synovitis and bone edema (−1.9, p < 0.001 and −2.6, p < 0.001, respectively) at Week 24 when compared with the placebo plus methotrexate group (−0.4 and 0.7, respectively). Minimal changes in bone erosion across all treatment groups (mean change ranging from −1.1 to 0.4)…

New Data Released on Rheumatoid Arthritis Drugs

The addition of Cimzia® (certolizumab pegol) to current therapy was associated with a rapid clinical response, improved function, and reduced disease activity in a diverse group of adult rheumatoid arthritis (RA) patients, reflecting those seen in daily clinical practice (including those with prior use of anti-tumor necrosis factor [TNF] agents).

The data, presented during the American College of Rheumatology’s (ACR) annual Scientific Meeting, were from the REALISTIC (RA Evaluation in Subjects Receiving TNF Inhibitor Certolizumab Pegol) multicenter Phase IIIb study, which included a 12-week, randomized, double-blind, placebo-controlled phase followed by an open-label extension (≥16 weeks). REALISTIC was designed to investigate the safety and efficacy of Cimzia in a broad patient population with active RA more closely resembling routine clinical practice, versus the pivotal trials, including patients with/without prior TNF-inhibitor exposure; with/without concomitant use of methotrexate (Rheumatrex®) or other disease-modifying anti-rheumatic drugs; and varying lengths of disease duration.

The primary endpoint of an ACR 20 score at Week 12 was met. At that point, more than half (51.1%) of patients in the Cimzia treatment group achieved ACR 20 response versus the control group (25.9%). Additional efficacy evaluated in the trial included ACR 50/70 response rates, as well as the Disease Activity Score: C-reactive protein (DAS28[CRP]) and the Health Assessment Questionnaire-Disability Index (HAQ-DI) measuring physical function.

Clinical responses among patients in the Cimzia treatment group were rapid. ACR 20/50 responses were significantly superior to control (31.8% versus 8.5% and 9.6% versus 1.4%, p < 0.001 for both) from the first timepoint (Week 2) onward.

Significant improvements in DAS28[CRP] were reported among patients treated with Cimzia versus the placebo group. In addition, Cimzia patients reported rapid and significant improvements in HAQ-DI scores versus the placebo group at Week 2.

Similar ACR 20 responses were seen across the various patient populations, regardless of baseline disease duration or activity; baseline use of methotrexate; or prior use of TNF-inhibiting agents. ACR 50 and ACR 70 responses at Week 12 were 26.6% and 13% for patients treated with Cimzia compared with the placebo group (9.9% and 2.8%, respectively).

Cimzia is currently approved for the treatment of moderately to severely active rheumatoid arthritis in adults.

Also announced at the ACR meeting were data from magnetic resonance imaging (MRI) analyses from two Phase III clinical trials showing that subcutaneous injections of Simponi® (golimumab) 50 mg plus methotrexate once every 4 weeks resulted in statistically significant improvements in markers of inflammation and structural damage in patients with active RA compared with placebo plus methotrexate. Changes in disease activity were measured using the Rheumatoid Arthritis MRI Scoring (RAMRIS) system, which assesses three components: synovitis, bone edema, and bone erosions. Changes in RAMRIS scores were observed as early as Week 12 and continued through Week 24.

Investigators reported that at Week 24 of the GOlimumab Before Employing methotrexate as the First-line Option in the treatment of Rheumatoid arthritis of Early onset (GO-BEFORE) study (N = 637), patients with RA receiving Simponi 50 mg plus methotrexate showed significant improvements in synovitis, bone edema, and bone erosions (−2.2, p = 0.011; −2.5, p <0.001; and −0.7, p = 0.016, respectively), compared with patients receiving placebo plus methotrexate (−1.0, −0.3, and −0.2, respectively).

In a second study, GOlimumab FOR subjects With Active RA Despite methotrexate (GO-FORWARD) (N = 444), patients receiving Simponi 50 mg plus methotrexate experienced significant improvements in synovitis and bone edema (−1.9, p < 0.001 and −2.6, p < 0.001, respectively) at Week 24 when compared with the placebo plus methotrexate group (−0.4 and 0.7, respectively). Minimal changes in bone erosion across all treatment groups (mean change ranging from −1.1 to 0.4) precluded the adequate evaluation of the effects of Simponi on bone erosion, which is consistent with previously published radiographic data.

Simponi is approved for the treatment of moderately to severely active RA in combination with methotrexate, active psoriatic arthritis, and active ankylosing spondylitis.

Sources.“New Cimzia (Certolizumab Pegol) Data Show a Significant, Rapid Clinical Response and Reduced Disease Activity Among Diverse Patient Populations with Active Rheumatoid Arthritis (RA).” (2010, November 9). Retrieved November 23, 2010, from http://classic.cnbc.com/id/40087020.“New Magnetic Resonance Imaging (MRI) Data Show Efficacy of Simponi in Treatment of Rheumatoid Arthritis.” (2010, November 8). Retrieved November 23, 2010, from http://www.medicalnewstoday.com/articles/207089.php.

Tripod Canes Add Safe Spring to Step

Frustrated with his patients’ misuse of and complications with quadruped canes, physical therapist Randy Misenheimer spent years developing a new assistive device option—the Flex-Stick, a free-standing tripod based walking cane designed to enhance stability throughout the normal gait cycle.

What makes the Flex-Stick so unique is that its three spring-loaded legs are independently capable of reacting to changes in both the angle of the cane and also with uneven ground surfaces. The base and leg bodies are extremely lightweight (total weight = 14.2 ounces) and designed with both function and aesthetics in mind.

The canes retail for $69.95; visit http://www.ranjam.net for more information.

Source.RANjAM, LLC. (2010, November 10). RANjAM, LLC Announces Release of “Revolutionary Walking Cane” [Press release]. Grapevine, TX: Author.

Pain Med Pulled from Market

Darvon® and Darvocet®, the brand versions of the prescription pain medication propoxyphene, will be withdrawn from the U.S. market at the request of the U.S. Food and Drug Administration (FDA). The FDA has also contacted the generic manufacturers of propoxyphene-containing products and requested that they voluntarily remove their products as well.

In July 2009, the FDA required that a new boxed warning be added to the drug label alerting patients and health care professionals to the risk of a fatal overdose. In addition, the agency required the drug’s manufacturer, Xanodyne, to conduct a new safety study assessing unanswered questions about the effects of propoxyphene on the heart.

The FDA has reviewed the data from that study, which show that, even when taken at recommended doses, propoxyphene causes significant changes to the electrical activity of the heart. These changes, which can be seen on an electrocardiogram, can increase the risk for serious abnormal heart rhythms that have been linked to serious adverse effects, including sudden death. The available data also indicate that the risk of adverse events for any particular patient (even patients who have taken the drug for many years) is subject to change based on small changes in the health status of the patient, such as dehydration, a change in medications, or decreased kidney function. As a result of these data, combined with other information, the FDA concluded that the risks of the medication outweigh the benefits.

The FDA is advising health care professionals to stop prescribing propoxyphene to their patients, and patients who are currently taking the drug should contact their health care professional as soon as possible to discuss switching to another pain management therapy.

Source.“Xanodyne Agrees to Withdraw Propoxyphene From the U.S. Market.” (2010, November 19). Retrieved November 24, 2010, from http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm234350.htm.

Cymbalta Gets Clearance for Pain Indication

The U.S. Food and Drug Administration (FDA) has approved Cymbalta® (duloxetine hydrochloride) to treat chronic musculoskeletal pain, including discomfort from osteoarthritis and chronic lower back pain. Cymbalta was first approved in 2004 to treat major depressive disorder and has since been approved for the treatment of diabetic peripheral neuropathy, generalized anxiety disorder, maintenance treatment of major depression, and fibromyalgia.

The FDA assessed the efficacy of Cymbalta in chronic low back pain and osteoarthritis in four double-blind, placebo-controlled, randomized clinical trials. At the end of the study period, patients taking Cymbalta had a significantly greater pain reduction compared with placebo.

Source.“FDA Clears Cymbalta to Treat Chronic Musculoskeletal Pain.” (2010, November 5). Retrieved November 23, 2010, from http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm232708.htm.

10.3928/00989134-20110101-07

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