<?xml version="1.0" encoding="utf-8"?>
<recommendedContent xmlns="http://api.mspoke.com">
    <recommendedItem id="20100101_19_463"
                     title="AAPM: Online Program Helps Manage Pain (CME/CE)"
                     score="0.014"
                     href="http://www.medpagetoday.com/MeetingCoverage/AAPM/tb/18393?impressionId=1265800364095"
                     
      &lt;p&gt;SAN ANTONIO  --  A personalized, online self-management program helped patients with pain syndromes improve coping skills and reduce stress and depression in two studies reported here.&lt;/p&gt;
&lt;p&gt;Patients randomized to the self-management program demonstrated significant improvement in multiple social, emotional, and behavioral outcomes after six months (&lt;em&gt;P&lt;/em&gt;&amp;lt;0.05 to &lt;em&gt;P&lt;/em&gt;&amp;lt;0.01). Improvement in some parameters occurred within one month. A control group that was not exposed to the program showed no significant improvement.&lt;/p&gt;
&lt;p&gt;&quot;Our goal is to help people communicate better with providers, understand better how they can use social support, understand the comorbid conditions, like anxiety and depression, and develop cognitive skills to help get them through their pain episodes,&quot; said Emil Chiauzzi, PhD, of Inflexxion, the Newton, Mass. company that developed the program.&lt;/p&gt;
&lt;p&gt;Although the studies involved patients with migraine or low-back pain, programs are being developed for other types of pain condition, including several forms of neuropathic pain.&lt;/p&gt;
&lt;p&gt;The online program, demonstrated at &lt;a href=&quot;http://www.painACTION.com&quot; mce_href=&quot;http://www.painACTION.com&quot; target=&quot;_blank&quot;&gt;www.painACTION.com&lt;/a&gt;, employs patient-specific information to generate individualized self-management strategies.&lt;/p&gt;
&lt;p&gt;Patient responses to assessments are analyzed by a &quot;recommendation engine,&quot; which produces content recommendations designed to address each patient&apos;s informational and self-management needs.&lt;/p&gt;
&lt;p&gt;Elements on the Web site include multimedia education units, a pain inventory, interactive tools that provide information based on patient-provider communication, and medication risk management.&lt;/p&gt;
&lt;p&gt;&quot;The content on the Web site is focused on teaching people practical skills to manage the behavioral side of pain,&quot; Jonas Bromberg, PsyD, also of Inflexxion, said in an interview.&lt;/p&gt;
&lt;p&gt;Bromberg presented results of a randomized study involving 210 patients, all of whom met International Headache Society diagnostic criteria for migraine, with or without aura.&lt;/p&gt;
&lt;p&gt;Patients assigned to the online program completed at least eight 30-minute session during the first month of the study and at least five more 30-minute sessions during the five-month follow-up period. Patients in the control group continued to receive usual care without exposure to the Web site.&lt;/p&gt;
&lt;p&gt;Participants assigned to the online program had a minimum set of requirements for each session, which were provided at log-in. Follow-up assessments occurred at one, three, and six months.&lt;/p&gt;
&lt;p&gt;The two groups were balanced with respect to sex and headache frequency and severity, the researchers said.&lt;/p&gt;
&lt;p&gt;Bromberg reported that patients assigned to the self-management program demonstrated significant improvement in: &lt;ul&gt; &lt;li&gt;Headache self-efficacy (&lt;em&gt;P&lt;/em&gt;&amp;lt;0.01 compared with baseline)&lt;/li&gt; &lt;li&gt;Use of relaxation (&lt;em&gt;P&lt;/em&gt;&amp;lt;0.05 to &lt;em&gt;P&lt;/em&gt;&amp;lt;0.01)&lt;/li&gt; &lt;li&gt;Use of social support (&lt;em&gt;P&lt;/em&gt;&amp;lt;0.01)&lt;/li&gt; &lt;li&gt;Pain catastrophizing (&lt;em&gt;P&lt;/em&gt;&amp;lt;0.01)&lt;/li&gt; &lt;li&gt;Depression (&lt;em&gt;P&lt;/em&gt;&amp;lt;0.05 to &lt;em&gt;P&lt;/em&gt;&amp;lt;0.01)&lt;/li&gt; &lt;li&gt;Stress (&lt;em&gt;P&lt;/em&gt;&amp;lt;0.01)&lt;/li&gt; &lt;/ul&gt;&lt;/p&gt;
&lt;p&gt;Chiauzzi presented results from a randomized study of 209 patients with low-back pain. The design was similar to that of the migraine study, except results were analyzed for between-group differences.&lt;/p&gt;
&lt;p&gt;The results showed significant improvement in the study group versus control group with respect to: &lt;ul&gt; &lt;li&gt;Stress (&lt;em&gt;P&lt;/em&gt;&amp;lt;0.01)&lt;/li&gt; &lt;li&gt;Coping (&lt;em&gt;P&lt;/em&gt;&amp;lt;0.01)&lt;/li&gt; &lt;li&gt;Social supports (&lt;em&gt;P&lt;/em&gt;&amp;lt;0.05)&lt;/li&gt; &lt;/ul&gt;&lt;/p&gt;
&lt;p&gt;The data showed significant effects of both treatment (&lt;em&gt;P&lt;/em&gt;&amp;lt;0.01) and time (&lt;em&gt;P&lt;/em&gt;&amp;lt;0.01) favoring the Web site versus control. Chiauzzi said patients assigned to the Web site had greater mean improvement at posttest, three months, and six months.&lt;/p&gt;
&lt;p&gt;Qualitative analysis suggested that Web site participants had clinically meaningful improvement in depression, anxiety, and stress.&lt;/p&gt;
&lt;p&gt;Additionally, patients in the self-management program reported a 12.3% decrease in pain from baseline, versus 7% in the control group.&lt;/p&gt;
&lt;p&gt;Access to the Web site did not improve physical functioning.&lt;/p&gt;
&lt;div style=&quot;float:left;border-style:solid;border-width:1px;border-color:#8dabbc;font-family:arial;font-size:12px;background-color:#DBE9F2;padding:5px;&quot;&gt;&lt;p&gt;The studies were funded by the National Institutes of Health.&lt;/p&gt;&lt;p&gt;Chiauzzi and Bromberg are employees of Inflexxion, developer of the online program.&lt;/p&gt;&lt;/div&gt;&lt;div style=&quot;clear:both;&quot;&gt;&lt;/div&gt;
    </recommendedItem>
    <recommendedItem id="20100101_19_455"
                     title="Low Vitamin D Linked to Hip OA (CME/CE)"
                     score="0.013"
                     href="http://www.medpagetoday.com/Rheumatology/Arthritis/tb/18379?impressionId=1265800364095"
                     
      &lt;p&gt;Elderly men with low serum levels of vitamin D are at increased risk for developing hip osteoarthritis, a prospective cohort study found.&lt;/p&gt;
&lt;p&gt;Men whose levels of 25-hydroxyvitamin (OH)D were between 15.1 to 30 ng/mL had twice the likelihood of prevalent radiographic hip osteoarthritis than those whose levels were normal (OR 2.19, 95% CI 1.21 to 3.97), according to R. Krishna Chaganti, MD, of the University of California at San Francisco, and colleagues.&lt;/p&gt;
&lt;p&gt;Conversely, after adjusting for age, season at blood draw, and clinic site, higher vitamin D levels were associated with a lower prevalence of hip osteoarthritis (OR 1.39 per 1 SD decrease in 25(OH)D level, 95% CI 1.11 to 1.74), the researchers reported in the February issue of &lt;em&gt;Arthritis &amp;amp; Rheumatism&lt;/em&gt;.&lt;/p&gt;
&lt;p&gt;Because the role vitamin D may play in the pathogenesis and progression of osteoarthritis is unclear, Chaganti and colleagues analyzed data from the Osteoporotic Fractures in Men Study, which enrolled a large cohort of elderly men between 2000 and 2002 from six centers across the U.S.&lt;/p&gt;
&lt;p&gt;A total of 1,104 men whose mean age was 77.2 years had baseline measurements of serum vitamin D, and about 4.5 years later pelvic radiographs were obtained.&lt;/p&gt;
&lt;p&gt;Radiographs were scored to reflect joint space narrowing, osteophyte formation, cysts, subchondral sclerosis, and femoral head deformity.&lt;/p&gt;
&lt;p&gt;Vitamin D levels were categorized as deficiency (&amp;#8804;15 ng/mL), insufficiency (15.1 to 30 ng/mL), and sufficiency (&amp;gt;30 ng/mL).&lt;/p&gt;
&lt;p&gt;Mean vitamin D level was 23.38 ng/mL in men who had radiographic hip osteoarthritis, compared with 26.04 ng/mL in men without radiographic abnormalities (&lt;em&gt;P&lt;/em&gt;=0.0002).&lt;/p&gt;
&lt;p&gt;Men with hip osteoarthritis had a higher prevalence of both vitamin D insufficiency (77% versus 65%, &lt;em&gt;P&lt;/em&gt;=0.002) and deficiency (10.2% versus 7.5%, &lt;em&gt;P&lt;/em&gt;=0.012).&lt;/p&gt;
&lt;p&gt;Moreover, they had slower six-meter walking speed (&lt;em&gt;P&lt;/em&gt;&amp;lt;0.0001) and reported more hip pain (&lt;em&gt;P&lt;/em&gt;=0.0001).&lt;/p&gt;
&lt;p&gt;Men who were vitamin D deficient also tended to have an increased likelihood of hip osteoarthritis (OR 1.99, 95% CI 0.83 to 4.74), but after adjustment in multivariate models, statistical significance was lost with this level of the vitamin.&lt;/p&gt;
&lt;p&gt;&quot;The association of low 25(OH)D levels with prevalent radiographic hip [osteoarthritis] underscores the potentially important role of vitamin D in the pathogenesis of [osteoarthritis]. Vitamin D metabolites have been found to be associated with the regulation of the Wnt pathway, products of which play important roles in the development and maintenance of bone and cartilage,&quot; the investigators explained.&lt;/p&gt;
&lt;p&gt;Furthermore, in vitro studies have suggested that serum levels of 25-hydroxyvitamin D&lt;sub&gt;3&lt;/sub&gt; can affect the ratio of RANKL to osteoprotegerin and thereby influence bone deterioration and repair.&lt;/p&gt;
&lt;p&gt;Previous investigations have yielded conflicting results. One study found that low levels of vitamin D were not associated with worsening of knee osteoarthritis, as reflected in loss of articular cartilage on MRI.&lt;/p&gt;
&lt;p&gt;Another study, however, linked knee osteoarthritis with low vitamin D levels, particularly in patients who also had decreased bone mineral density in the lumbar spine.&lt;/p&gt;
&lt;p&gt;&quot;Vitamin D influences the mineralization of bone matrix, and low serum levels of vitamin D may result in poorly mineralized bone that might alter forces across the joint and reduce joint deterioration,&quot; the authors suggested.&lt;/p&gt;
&lt;p&gt;On the other hand, low levels may interfere with chondrocyte metabolism and thereby increase degeneration.&lt;/p&gt;
&lt;p&gt;Further studies will be needed to more fully clarify the effects of the vitamin on the development and progression of osteoarthritis, the investigators cautioned.&lt;/p&gt;
&lt;p&gt;Strengths of the study include the large cohort of participants, careful classification of radiographic osteoarthritis, and reliance on the gold standard of vitamin D measurement, the 25(OH)D level.&lt;/p&gt;
&lt;p&gt;Limitations include the cross-sectional design, precluding the inference of causality, and the gap in time between measurement of serum vitamin D and radiography.&lt;/p&gt;
&lt;p&gt;The authors concluded that therapeutic interventions to increase vitamin D serum levels in the elderly &quot;are warranted,&quot; with the goal of improving skeletal health in this vulnerable age group.&lt;/p&gt;
&lt;div style=&quot;float:left;border-style:solid;border-width:1px;border-color:#8dabbc;font-family:arial;font-size:12px;background-color:#DBE9F2;padding:5px;&quot;&gt;&lt;p&gt;The study was supported by the National Institute of Arthritis and Musculoskeletal and Skin Diseases, the National Institute on Aging, the National Center for Research Resources, and the NIH Roadmap for Medical Research.&lt;/p&gt;&lt;p&gt;The lead author was supported by a grant from the American College of Rheumatology Research and Education Foundation.&lt;/p&gt;&lt;/div&gt;&lt;div style=&quot;clear:both;&quot;&gt;&lt;/div&gt;
    </recommendedItem>
    <recommendedItem id="20100101_19_397"
                     title="AAPM: Nerve Growth Factor Antibody  May Reduce Pain (CME/CE)"
                     score="0.012"
                     href="http://www.medpagetoday.com/MeetingCoverage/AAPM/tb/18300?impressionId=1265800364095"
                     
      &lt;p&gt;SAN ANTONIO  --  A humanized monoclonal antibody against nerve growth factor provided relief in three chronic pain syndromes, according to a summary of small studies reported as an abstract here.&lt;/p&gt;
&lt;p&gt;Treatment with tanezumab led to statistically or clinically significant reductions in pain for patients with osteoarthritis, chronic lower back pain, and interstitial cystitis. The most common adverse events were transient abnormal peripheral sensations, which generally occurred only after the first infusion.&lt;/p&gt;
&lt;p&gt;&quot;Patients with these three different pain syndromes all had significant improvement when treated with tanezumab,&quot; Leslie Tive, PhD, of Pfizer, said in an interview at the American Academy of Pain Medicine meeting. &quot;The pain relief was sustained over time, and patient acceptance was good.&quot;&lt;/p&gt;
&lt;p&gt;&quot;Nerve growth factor is increased in many types of chronic pain and therefore represents an attractive target for therapy,&quot; she added. &quot;Tanezumab is being evaluated in some of these other conditions in ongoing studies.&quot;&lt;/p&gt;
&lt;p&gt;A small phase I study showed that the humanized monoclonal antibody resulted in significant pain improvement in patients with osteoarthritis (&lt;em&gt;Arthritis Rheum&lt;/em&gt; 2005; 52: S461). Tive presented data from a phase II trial involving 400 patients with osteoarthritis of the knee. They were randomized to placebo or to one of five tanezumab doses, administered on day one and day 56.&lt;/p&gt;
&lt;p&gt;All five doses of tanezumab resulted in significant reductions (&lt;em&gt;P&lt;/em&gt;&amp;lt;0.05) versus placebo after one week and were sustained through 16 weeks. As assessed by a visual analog scale, the mean change in pain on walking from baseline to week 16 ranged from 30 to 45 points (&lt;em&gt;P&lt;/em&gt;&amp;lt;0.0001), a two- to threefold difference compared with placebo.&lt;/p&gt;
&lt;p&gt;The trial in chronic low back pain involved 217 adults with Quebec Task Force on Spinal Disorders category 1 or 2 pain for at least three months. The primary location of the pain was between the 12th thoracic vertebra and the lower gluteal folds.&lt;/p&gt;
&lt;p&gt;Eligibility criteria included a score of at least 4 on an 11-point pain scale on at least four occasions in the five days before randomization, as indicated by entries in an electronic pain diary.&lt;/p&gt;
&lt;p&gt;Patients were randomized 2:2:1 to a single infusion of tanezumab, to oral naproxen, or to placebo. The primary endpoint was the change in mean Lower Back Pain Index score from baseline to six weeks, averaged over the last seven days.&lt;/p&gt;
&lt;p&gt;Beginning at week one and continuing through week six, patients who were randomized to either dose of tanezumab had significantly greater improvement in pain than those who took the placebo (&lt;em&gt;P&lt;/em&gt;&amp;lt;0.05 to &lt;em&gt;P&lt;/em&gt;&amp;lt;0.001), and compared with the naproxen group beginning at week two (&lt;em&gt;P&lt;/em&gt;&amp;lt;0.05 to &lt;em&gt;P&lt;/em&gt;&amp;lt;0.01).&lt;/p&gt;
&lt;p&gt;The interstitial cystitis study included 64 men and women who had a score &amp;#8805;13 on Pelvic Pain Symptom/Frequency questionnaire, &amp;#8805;7 score on the O&apos;Leary-Sant Interstitial Cystitis index, and micturition frequency &amp;#8805;8 times a day, as recorded in an electronic diary for at least five consecutive days prior to randomization.&lt;/p&gt;
&lt;p&gt;Patients were randomized to intravenous tanezumab or matching placebo. The primary efficacy endpoint was change from baseline to six weeks in the 11-point pain scale. A difference of at least one point from placebo was considered clinically significant. Statistical significance was not evaluated.&lt;/p&gt;
&lt;p&gt;The mean difference between tanezumab and placebo was -0.7 at week two, increasing to -1.1 at week four and -1.4 at week six. The advantage versus placebo was maintained at week 10 (-0.9) and week 16 (-0.5).&lt;/p&gt;
&lt;p&gt;Adverse events were evaluated for all patients combined in the three studies. Adverse events were reported by 66.3% of tanezumab patients, 61.4% of naproxen patients, and 59.3% of placebo patients. Serious and severe adverse events occurred in 1.6% to 3.4% of patients and 4.8% to 5.7%, respectively.&lt;/p&gt;
&lt;p&gt;Tive said 14.4% of tanezumab patients reported abnormal peripheral sensations, the most common being paresthesia (7.1%), hyperesthesia (4.1%), and hypoesthesia (3.9%).&lt;/p&gt;
&lt;div style=&quot;float:left;border-style:solid;border-width:1px;border-color:#8dabbc;font-family:arial;font-size:12px;background-color:#DBE9F2;padding:5px;&quot;&gt;&lt;p&gt;The studies included in the summary were funded by Pfizer.&lt;/p&gt;&lt;p&gt;Investigators included several Pfizer employees.&lt;/p&gt;&lt;/div&gt;&lt;div style=&quot;clear:both;&quot;&gt;&lt;/div&gt;
    </recommendedItem>
    <recommendedItem id="20100101_19_404"
                     title="Tailor Etanercept to Symptoms in Psoriasis and Psoriatic Arthritis (CME/CE)"
                     score="0.011"
                     href="http://www.medpagetoday.com/Rheumatology/Arthritis/tb/18309?impressionId=1265800364095"
                     
      &lt;p&gt;The decision to use once-weekly or twice-weekly etanercept (Enbrel) in patients with both psoriasis and psoriatic arthritis should be determined by the cutaneous and joint symptoms of the patient, researchers said.&lt;/p&gt;
&lt;p&gt;In a blinded, multicenter study, 46% of patients who received the drug twice a week had cleared or almost cleared their skin manifestations of psoriasis at week 12, compared with 32% of those who received the drug only once each week (&lt;em&gt;P&lt;/em&gt;&amp;lt;0.001), according to Wolfram Sterry, MD, of Charite University Medicine in Berlin, and colleagues.&lt;/p&gt;
&lt;p&gt;In contrast, there were no differences in response for arthritis symptoms, with 77% of those in the twice-weekly group and 76% of those in the once-weekly group meeting predetermined psoriatic arthritis response criteria at week 12, the researchers reported online in the &lt;em&gt;BMJ&lt;/em&gt;.&lt;/p&gt;
&lt;p&gt;An estimated 30% of patients with psoriasis have an arthritic component to their disease, manifesting as chronic inflammation of the joints and entheses.&lt;/p&gt;
&lt;p&gt;&quot;The challenge of treating patients with both active psoriasis and active psoriatic arthritis is to optimize the treatment of both disease manifestations to give the best overall outcome,&quot; the investigators wrote.&lt;/p&gt;
&lt;p&gt;Etanercept, a fully human tumor necrosis factor (TNF) inhibitor, is approved for use in both conditions based on findings showing that TNF and other cytokines are upregulated in both inflamed joint and skin tissues.&lt;/p&gt;
&lt;p&gt;To determine the efficacy of two different treatment regimens in patients who had not previously received a TNF inhibitor but had moderate-to-severe skin symptoms and active arthritis, Sterry and colleagues recruited 752 patients from 98 centers for PRESTA (Psoriasis Randomized Etanercept STudy in subjects with psoriatic Arthritis).&lt;/p&gt;
&lt;p&gt;They paired rheumatologists and dermatologists to cooperatively assess effects of the drug.&lt;/p&gt;
&lt;p&gt;Patients were randomized to receive subcutaneous etanercept, 50 mg once or twice weekly for 12 weeks, and for an additional 12 weeks both groups received 50 mg once weekly.&lt;/p&gt;
&lt;p&gt;To maintain blinding, the once-weekly group also received a placebo injection during the first 12 weeks.&lt;/p&gt;
&lt;p&gt;Participants&apos; mean age was 46.5 years. Mean duration of psoriasis was 18.9 years, and mean duration of arthritis was seven years. Most were white men.&lt;/p&gt;
&lt;p&gt;For the joint symptoms, the proportions of patients who achieved American College of Rheumatology (ACR) responses were similar at weeks 12 and 24 in the two groups.&lt;/p&gt;
&lt;p&gt;At week 12, 66.4% and 60.8% of patients in the twice- and once-weekly groups, respectively, had achieved ACR20 responses (representing a 20% improvement). At week 24, the corresponding proportions were 69% and 71.7%.&lt;/p&gt;
&lt;p&gt;At week 12, the percentage reductions in physician&apos;s global assessment of arthritis were 60% and 62% for the twice- and once-weekly groups (&lt;em&gt;P&lt;/em&gt;=0.823), and at week 24 the corresponding percentages were 73% and 74% (&lt;em&gt;P&lt;/em&gt;=0.760).&lt;/p&gt;
&lt;p&gt;At baseline, enthesitis was found in 287 patients and dactylitis in 318. These two symptoms decreased comparatively in both groups at weeks 12 and 24.&lt;/p&gt;
&lt;p&gt;Skin findings included the following for the twice-weekly and once-weekly groups, respectively: &lt;ul&gt; &lt;li&gt;Improvement in physician&apos;s global assessment at week 12, 52% versus 45%, &lt;em&gt;P&lt;/em&gt;&amp;lt;0.001&lt;/li&gt; &lt;li&gt;At week 24, 57% versus 55%, &lt;em&gt;P&lt;/em&gt;=0.420&lt;/li&gt; &lt;li&gt;Improvement in psoriasis area and severity index at week 12, 71% versus 62%, &lt;em&gt;P&lt;/em&gt;&amp;lt;0.001&lt;/li&gt; &lt;li&gt;At week 24, 78% versus 74%, &lt;em&gt;P&lt;/em&gt;=0.110&lt;/li&gt; &lt;li&gt;75% improvement in psoriasis area and severity index at week 12, 55% versus 36%, &lt;em&gt;P&lt;/em&gt;&amp;lt;0.001&lt;/li&gt; &lt;li&gt;At week 24, 70% versus 62%, &lt;em&gt;P&lt;/em&gt;&amp;lt;0.026&lt;/li&gt; &lt;/ul&gt;&lt;/p&gt;
&lt;p&gt;Clearly there were differences in the optimal dosages for the skin lesions at week 12, but when the dosage was decreased to once weekly for the two groups, improvements in both joint and skin symptoms continued to improve, and at week 24 the responses were similar in the two groups, the investigators observed.&lt;/p&gt;
&lt;p&gt;&quot;We found that initial treatment of the psoriasis with etanercept 50 mg twice weekly may allow for more rapid clearance of skin lesions than a 50 mg weekly regimen,&quot; they wrote, noting that the higher dose therefore may be preferable for patients with more severe cutaneous involvement.&lt;/p&gt;
&lt;p&gt;In contrast, at no time was the twice-weekly regimen more effective in treating the articular symptoms, so 50 mg once weekly is a sufficient dose for the treatment of joint symptoms alone, they concluded.&lt;/p&gt;
&lt;p&gt;There were no differences in safety between the regimens.&lt;/p&gt;
&lt;p&gt;It is not clear why the higher dose cleared the skin symptoms more rapidly than the low dose but did not have an additional benefit for the joint symptoms.&lt;/p&gt;
&lt;p&gt;&quot;These two different organ systems may have dissimilar autoimmune inflammatory environments, allowing for differences in local concentrations of tumor necrosis factor or in disease burdens or a subtle difference in tissue penetration of drug, although little information is available to support any particular mechanism,&quot; the researchers noted.&lt;/p&gt;
&lt;div style=&quot;float:left;border-style:solid;border-width:1px;border-color:#8dabbc;font-family:arial;font-size:12px;background-color:#DBE9F2;padding:5px;&quot;&gt;&lt;p&gt;Wyeth Research, which was acquired by Pfizer in October 2009, sponsored the trial.&lt;/p&gt;&lt;p&gt;Authors and sponsor were involved in study design, interpretation of data, manuscript preparation, and decision to publish.&lt;/p&gt;&lt;p&gt;Statistical analyses were done by the biostatistics department of Wyeth Research.&lt;/p&gt;&lt;p&gt;Several co-authors are employees of Pfizer, and others have received fees from multiple pharmaceutical companies including Wyeth.&lt;/p&gt;&lt;/div&gt;&lt;div style=&quot;clear:both;&quot;&gt;&lt;/div&gt;
    </recommendedItem>
    <recommendedItem id="20100101_19_283"
                     title="Antibodies Predict Response to Biologics in RA (CME/CE)"
                     score="0.003"
                     href="http://www.medpagetoday.com/Rheumatology/Arthritis/tb/18141?impressionId=1265800364095"
                     
      &lt;p&gt;Patients with rheumatoid arthritis who develop antibodies against the tumor necrosis factor (TNF) antagonist infliximab (Remicade) are also likely to develop antibodies against adalimumab (Humira), a Dutch cohort study found.&lt;/p&gt;
&lt;p&gt;During 28 weeks of follow-up, 33% of patients with anti-infliximab antibodies also developed anti-adalimumab antibodies, compared with only 18% of patients who had never received a TNF blocker (&lt;em&gt;P&lt;/em&gt;=0.039), according to Geertje M. Bartelds, MD, of the Jan van Breemen Institute in Amsterdam, and colleagues.&lt;/p&gt;
&lt;p&gt;Patients who developed antibodies to both TNF blockers also had a smaller decrease in their disease activity score compared with TNF-naive patients (1.1 versus 1.7 points, &lt;em&gt;P&lt;/em&gt;=0.007), a difference that persisted after adjustment for baseline disease activity (95% CI &amp;#8722;1.166 to &amp;#8722;0.351, &lt;em&gt;P&lt;/em&gt;&amp;lt;0.0001), the researchers reported online in the &lt;em&gt;Annals of the Rheumatic Diseases&lt;/em&gt;.&lt;/p&gt;
&lt;p&gt;Some 30% to 40% of patients with rheumatoid arthritis fail to respond to anti-TNF therapy. Some, though not all of this failure can be explained by immunogenic antibody responses to the drugs.&lt;/p&gt;
&lt;p&gt;When patients don&apos;t respond to one TNF antagonist, doctors frequently switch to another, the researchers noted, but the choice of drug is generally not evidence-based, and there is considerable variability in subsequent response.&lt;/p&gt;
&lt;p&gt;To investigate factors determining response after switching, Bartelds and colleagues prospectively followed a consecutive cohort of 235 patients with rheumatoid arthritis being treated with adalimumab.&lt;/p&gt;
&lt;p&gt;Mean age was 53 years and disease duration was about 10 years. About 80% were women. They had previously received a mean of four disease-modifying, anti-rheumatic drugs, and more than 80% also were receiving methotrexate.&lt;/p&gt;
&lt;p&gt;Baseline erythrocyte sedimentation rate (ESR) was approximately 30 mm/hour, and the mean disease activity score (DAS28) was 5.3. (A DAS28 of 3.2 or higher reflects active disease.)&lt;/p&gt;
&lt;p&gt;A total of 52 had previously received infliximab.&lt;/p&gt;
&lt;p&gt;In the overall cohort the mean DAS28 fell by 1.6 points during 28 weeks of follow-up.&lt;/p&gt;
&lt;p&gt;When responses were assessed according to the criteria used by the European League Against Rheumatism (EULAR), 24% were nonresponders, 43% were moderate responders, and 33% were good responders at 28 weeks.&lt;/p&gt;
&lt;p&gt;Among the TNF-naive patients, there were: &lt;ul&gt; &lt;li&gt;38% good responders&lt;/li&gt; &lt;li&gt;39% moderate responders &lt;/li&gt; &lt;li&gt;23% nonresponders&lt;/li&gt; &lt;/ul&gt;&lt;/p&gt;
&lt;p&gt;In contrast, among patients who had previously received infliximab, there were: &lt;ul&gt; &lt;li&gt;15% good responders&lt;/li&gt; &lt;li&gt;54% moderate responders&lt;/li&gt; &lt;li&gt;31% nonresponders&lt;/li&gt; &lt;/ul&gt;&lt;/p&gt;
&lt;p&gt;Post-hoc analysis determined that only the percentage of good responders differed significantly between the TNF-naive patients and the infliximab switchers (&lt;em&gt;P&lt;/em&gt;=0.002).&lt;/p&gt;
&lt;p&gt;Among the 20% of patients who developed anti-adalimumab antibodies, the mean decrease in DAS28 was 0.6 points, compared with 1.8 points in those without the antibodies (&lt;em&gt;P&lt;/em&gt;&amp;lt;0.0001). That difference remained significant after adjustment for baseline ESR (95% CI &amp;#8722;1.797 to &amp;#8722;0.908, &lt;em&gt;P&lt;/em&gt;&amp;lt;0.0001).&lt;/p&gt;
&lt;p&gt;Previous studies have suggested that there may be differences between patients who are primary nonresponders and secondary nonresponders (who initially improve with treatment).&lt;/p&gt;
&lt;p&gt;In primary nonresponders, who never responded to anti-TNF therapy, TNF may not be the crucial cytokine responsible for the initiating events in rheumatoid arthritis, the investigators hypothesized.&lt;/p&gt;
&lt;p&gt;The findings of this study suggest that nonresponders could be treated according to their antibody status, with antibody-positive patients likely deriving greater benefit from switching to a less immunogenic drug acting on the same principle, or from optimizing concomitant methotrexate therapy.&lt;/p&gt;
&lt;p&gt;In nonresponders without antibodies, it may be more useful and cost-effective to try a drug with a different mechanism of action, they suggested.&lt;/p&gt;
&lt;p&gt;The study was limited by the small number of patients and the observational cohort design. The patient population also had severe, longstanding rheumatoid arthritis, which might have made it difficult to detect treatment effects.&lt;/p&gt;
&lt;p&gt;&quot;To our knowledge, this is the first study providing more information on the underlying mechanisms contributing to the possible success of switching,&quot; they wrote.&lt;/p&gt;
&lt;p&gt;More research will be needed, however, to provide conclusive data on how immunogenicity could aid in clinical decision-making for individual patients.&lt;/p&gt;
&lt;div style=&quot;float:left;border-style:solid;border-width:1px;border-color:#8dabbc;font-family:arial;font-size:12px;background-color:#DBE9F2;padding:5px;&quot;&gt;&lt;p&gt;The study was funded by Abbott, Wyeth, and the Netherlands Organization for Health Research and Development.&lt;/p&gt;&lt;p&gt;One co-author has served as consultant to Abbott, Amgen, Centocor, Schering-Plough, UCB, and Wyeth, and several others also are members of the advisory board of Abbott and have received honoraria for lectures.&lt;/p&gt;&lt;/div&gt;&lt;div style=&quot;clear:both;&quot;&gt;&lt;/div&gt;
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