<?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="0.013"
                     href="http://www.medpagetoday.com/MeetingCoverage/AAPM/tb/18393?impressionId=1265784242497"
                     
      &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_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=1265784242497"
                     
      &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_415"
                     title="AAPM: Drug for Fibromyalgia Boosts Multiple Outcomes (CME/CE)"
                     score="0.011"
                     href="http://www.medpagetoday.com/MeetingCoverage/AAPM/tb/18327?impressionId=1265784242497"
                     
      &lt;p&gt;SAN ANTONIO  --  The fibromyalgia drug milnacipran (Savella) achieved clinically meaningful reductions in pain throughout almost four months of randomized therapy, a post-hoc analysis of daily pain control showed.&lt;/p&gt;
&lt;p&gt;Half of patients treated with the serotonin/norepinephrine reuptake inhibitor had at least a 30% improvement in pain scores at 15 weeks, and 35% to 40% had at least a 50% improvement, according to analyses reported here at the American Academy of Pain Medicine meeting.&lt;/p&gt;
&lt;p&gt;Two different doses of milnacipran led to at least 30% improvement in pain on almost half of the days during the randomized trial. Patients treated with milnacipran had at least 50% improvement during 30% of the days.&lt;/p&gt;
&lt;p&gt;&quot;A 30% improvement in pain is clinically significant, and half the patients treated with milnacipran attained that level of pain relief,&quot; Aroon Datta, MD, of Forest Laboratories in Jersey City, N.J., said in an interview. &quot;Even when the more stringent criteria of 50% improvement were applied, significantly more patients in the milnacipran groups achieved that threshold compared with placebo.&quot;&lt;/p&gt;
&lt;p&gt;&quot;By any measure, it is fair to say that patients treated with milnacipran had significantly better pain control,&quot; he added.&lt;/p&gt;
&lt;p&gt;Milnacipran is chemically similar to the antidepressant venlafaxine (Effexor). However, milnacipran has three times the power to inhibit norepinephrine reuptake. The drug was approved in 2009 for treatment of fibromyalgia.&lt;/p&gt;
&lt;p&gt;Datta reported results of a post-hoc analysis of data from two randomized, placebo-controlled clinical trials. One lasted 27 weeks, and the other had a 15-week follow-up.&lt;/p&gt;
&lt;p&gt;In the 27-week trial, approximately 900 patients were randomized 1:1:2 to placebo, milnacipran 100 mg/d (50 mg BID), or milnacipran 200 mg/d (100 mg BID). In the 15-week trial, 1,200 patients were randomized in equal proportion to placebo and the two doses of milnacipran.&lt;/p&gt;
&lt;p&gt;Patients recorded their pain level several times a day by means of an electronic diary. They rated their pain according to a visual analog scale (VAS) with a range of 0 to 100.&lt;/p&gt;
&lt;p&gt;The post-hoc analysis centered on outcomes at 15 weeks in both trials. The primary outcomes were change from baseline in weekly 24-hour VAS pain score, the proportion of patients who achieved &amp;#8805;30% and &amp;#8805;50% improvement in the VAS pain score, and the proportion of days with &amp;#8805;30% and &amp;#8805;50% improvement in pain.&lt;/p&gt;
&lt;p&gt;In the longer trial, the change in the weekly average of 24-hour recall of VAS scores differed significantly in both milnacipran groups within two weeks, and the difference was maintained through 15 weeks (&lt;em&gt;P&lt;/em&gt;&amp;lt;0.05 to &lt;em&gt;P&lt;/em&gt;&amp;lt;0.001).&lt;/p&gt;
&lt;p&gt;Significant differences emerged within the first week in the second trial and persisted through week 15 (&lt;em&gt;P&lt;/em&gt;&amp;lt;0.05 to &lt;em&gt;P&lt;/em&gt;&amp;lt;0.001).&lt;/p&gt;
&lt;p&gt;In both trials, 52% of patients assigned to 100 mg of milnacipran and 56% of those assigned to 200 mg had &amp;#8805;30% improvement in pain scores, compared with 40% to 42% of placebo-treated patients (&lt;em&gt;P&lt;/em&gt;&amp;lt;0.05 to &lt;em&gt;P&lt;/em&gt;&amp;lt;0.001).&lt;/p&gt;
&lt;p&gt;When the more stringent criterion of &amp;#8805;50% improvement was used, 31% to 35% of the 100-mg milnacipran patients achieved that goal, as did 36% to 37% of patients treated with 200 mg.&lt;/p&gt;
&lt;p&gt;About 25% of placebo patients had &amp;#8805;50% improvement. Only the 200-mg dose differed significantly from placebo (&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;A similar pattern emerged in evaluation of the proportion of days with threshold pain reductions. Milnacipran-treated patients had &amp;#8805;30% improvement on 44% to 47% of days in the trial and &amp;#8805;50% improvement on 25% to 30% of days.&lt;/p&gt;
&lt;p&gt;For both thresholds, milnacipran was significantly better than placebo, whose patients had &amp;#8805;30% pain improvement on about a third of days and &amp;#8805;50% improvement on fewer than 20% of days (&lt;em&gt;P&lt;/em&gt;&amp;lt;0.01 to &lt;em&gt;P&lt;/em&gt;&amp;lt;0.001).&lt;/p&gt;
&lt;p&gt;Datta also reported findings from a randomized, placebo-controlled clinical trial evaluating the pain relief afforded by the 100-mg daily dose of milnacipran. The study involved 1,025 patients with fibromyalgia randomized to placebo or active therapy.&lt;/p&gt;
&lt;p&gt;The trial had two principal 12-week efficacy outcomes: the composite of &amp;#8805;30% improvement in pain and the Patient Global Impression of Change (PGIC), and the composite of the same two outcomes plus improvement &amp;#8805;6 points on the physical function component of the SF-36 health assessment survey.&lt;/p&gt;
&lt;p&gt;The principal efficacy analysis used baseline observation carried forward (BOCF) for patients with missing data. By that statistical method, 29% of milnacipran patients were responders compared with 18% of the placebo group (&lt;em&gt;P&lt;/em&gt;&amp;lt;0.001).&lt;/p&gt;
&lt;p&gt;An analysis that employed last observation carried forward (LOCF) showed response rates of 33% with milnacipran and 19&lt;strong&gt;%&lt;/strong&gt; with placebo (&lt;em&gt;P&lt;/em&gt;&amp;lt;0.001).&lt;/p&gt;
&lt;p&gt;An analysis of observed cases resulted in response rates of 42% versus 26% (&lt;em&gt;P&lt;/em&gt;&amp;lt;0.001).&lt;/p&gt;
&lt;p&gt;Similar results emerged from analyses of the three-measure outcome. Milnacipran led to significantly higher (&lt;em&gt;P&lt;/em&gt;&amp;lt;0.001) response rates by BOCF (20% versus 11%), by LOCF (28% versus 12%), and by observed cases (30% versus 16%).&lt;/p&gt;
&lt;p&gt;Milnacipran therapy also led to significantly higher (&lt;em&gt;P&lt;/em&gt;&amp;lt;0.001) response rates for each component of the composite outcomes: &amp;#8805;30% improvement in pain (45% versus 31%), PGIC (42% versus 26%), and &amp;#8805;6-point improvement in physical function (40% versus 31%).&lt;/p&gt;
&lt;p&gt;The results indicate that milnacipran 100 mg (50 mg BID) could offer an alternative for patients who cannot tolerate the FDA-approved 200-mg dose, said Datta. If physicians choose to start patients on 100 mg and then titrate up to the approved dose, that also would appear feasible, he said.&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 supported by Forest Laboratories and Cypress Bioscience.&lt;/p&gt;&lt;p&gt;All but two of the authors are employees of the study sponsors.&lt;/p&gt;&lt;/div&gt;&lt;div style=&quot;clear:both;&quot;&gt;&lt;/div&gt;
    </recommendedItem>
    <recommendedItem id="20100101_19_350"
                     title="Leflunomide Equal to Methotrexate in Anti-TNF Combo for RA Treatment (CME/CE)"
                     score="0.008"
                     href="http://www.medpagetoday.com/Rheumatology/Arthritis/tb/18231?impressionId=1265784242497"
                     
      &lt;p&gt;Treatments combining leflunomide (Arava) with an antitumor necrosis factor (TNF) agent were as effective in rheumatoid arthritis as regimens combining methotrexate with the biologics, a randomized Italian study found.&lt;/p&gt;
&lt;p&gt;After 24 weeks of therapy, patients receiving a methotrexate-based regimen achieved a mean Disease Activity Score (DAS)28 of 3.3, while those receiving leflunomide-based treatment had a mean DAS28 of 3.5, according to Renato De Stefano, MD, and colleagues from the Siena (Italy) University Hospital.&lt;/p&gt;
&lt;p&gt;Remission was achieved by 21.6% of patients in the methotrexate group and 16.6% of those in the leflunomide group. Neither of these differences was statistically significant, the investigators reported online in &lt;em&gt;Clinical Rheumatology&lt;/em&gt;.&lt;/p&gt;
&lt;p&gt;Multiple clinical trials have now demonstrated the efficacy of TNF blocking agents in combination with methotrexate for rheumatoid arthritis, but some patients can&apos;t tolerate or don&apos;t respond to methotrexate.&lt;/p&gt;
&lt;p&gt;Some data suggested leflunomide as an alternative to methotrexate, particularly if the TNF blocker is not begun for at least 12 weeks after the initiation of leflunomide.&lt;/p&gt;
&lt;p&gt;The mechanism of action of leflunomide is not fully understood, but it may be related to its ability to inhibit de novo pyrimidine biosynthesis through the inhibition of the enzyme dihydroorotate dehydrogenase, researchers say. Laboratory studies have demonstrated that it also affects stimulated T cells.&lt;/p&gt;
&lt;p&gt;So De Stefano and colleagues undertook a prospective trial that included 120 patients whose disease activity was high (DAS28 &amp;gt;5.1) despite treatment with methotrexate at 15 mg/week or leflunomide at 20 mg/day.&lt;/p&gt;
&lt;p&gt;These two groups of 60 patients each were then divided into three subgroups, with patients being randomized to receive etanercept (Enbrel), 25 mg twice weekly, adalimumab (Humira), 40 mg every two weeks, or infliximab (Remicade) at 5 mg/kg/week at baseline, weeks two and six, and every six to eight weeks thereafter.&lt;/p&gt;
&lt;p&gt;Treatment was discontinued in patients whose DAS28 score did not change more than 1.2 points or if they had an insufficient ACR20 response (20% improvement on American College of Rheumatology criteria) by 12 weeks.&lt;/p&gt;
&lt;p&gt;Most patients were women, with an average age of 52.&lt;/p&gt;
&lt;p&gt;In the methotrexate group, therapy was discontinued prematurely in 30%. The reasons were lack of efficacy in 18.3% and serious adverse effects in 11.6%.&lt;/p&gt;
&lt;p&gt;Serious adverse effects associated with methotrexate use included vasculitis in a patient receiving etanercept, elevated liver enzymes in one patient receiving etanercept and another receiving infliximab, and a diffuse rash in one patient on etanercept and in another on adalimumab.&lt;/p&gt;
&lt;p&gt;In the leflunomide group, therapy was discontinued in 30%, in 15% because of lack of efficacy and in 15% because of adverse effects.&lt;/p&gt;
&lt;p&gt;Serious adverse events in the leflunomide patients included one case each of thrombocytopenia and leukopenia in patients receiving etanercept, and diffuse rash in one patient on infliximab and in another on adalimumab.&lt;/p&gt;
&lt;p&gt;Mild adverse events, such as nausea and arthromyalgia, occurred much more frequently in the methotrexate group (43.3% versus 20%, &lt;em&gt;P&lt;/em&gt;=0.032), the investigators reported.&lt;/p&gt;
&lt;p&gt;By week 24, antinuclear antibodies had appeared in titers exceeding 1:160 in seven patients undergoing methotrexate treatment and in five taking leflunomide.&lt;/p&gt;
&lt;p&gt;In one patient taking leflunomide in combination with etanercept, anticardiolipid and anti-SS-A antibodies also appeared, but no patients developed clinical signs of connective tissue disease.&lt;/p&gt;
&lt;p&gt;Efficacy was similar among all groups. At week 24, methotrexate patients in the three coordinated-drug subgroups had these DAS28 scores: &lt;ul&gt; &lt;li&gt;Etanercept, 2.93&lt;/li&gt; &lt;li&gt;Adalimumab, 3.2&lt;/li&gt; &lt;li&gt;Infliximab, 3.7&lt;/li&gt; &lt;/ul&gt;&lt;/p&gt;
&lt;p&gt;Leflunomide patients had these scores: &lt;ul&gt; &lt;li&gt;Adalimumab, 3.3&lt;/li&gt; &lt;li&gt;Infliximab, 3.6&lt;/li&gt; &lt;li&gt;Etanercept, 3.7&lt;/li&gt; &lt;/ul&gt;&lt;/p&gt;
&lt;p&gt;There were no significant differences in DAS28 scores between the leflunomide and methotrexate groups or in the six subgroups.&lt;/p&gt;
&lt;p&gt;At week 24, the ACR responses in the methotrexate group were: &lt;ul&gt; &lt;li&gt; ACR20, 63.3%&lt;/li&gt; &lt;li&gt;ACR50, 51.2%&lt;/li&gt; &lt;li&gt;ACR70, 32.1%&lt;/li&gt; &lt;/ul&gt;&lt;/p&gt;
&lt;p&gt;Corresponding responses in the leflunomide group were &lt;ul&gt; &lt;li&gt;ACR20, 66.6%&lt;/li&gt; &lt;li&gt;ACR50, 47.4%&lt;/li&gt; &lt;li&gt;ACR70, 26.3%&lt;/li&gt; &lt;/ul&gt;&lt;/p&gt;
&lt;p&gt;Differences in ACR scores were not significant between the leflunomide and methotrexate groups, or in the six subgroups.&lt;/p&gt;
&lt;p&gt;Improvements in health assessment questionnaire scores, reflecting levels of disability, were seen throughout the study for both groups, and by week 24 (&lt;em&gt;P&lt;/em&gt;&amp;lt;0.0001) were most pronounced for the methotrexate-etanercept subgroup (median 0.11) and for the leflunomide-etanercept subgroup (median 0.3).&lt;/p&gt;
&lt;p&gt;The results of the study seem to confirm that TNF-blocker combination therapy with leflunomide is associated with a similar likelihood of achieving significant clinical response as with methotrexate, and without a significantly greater risk of adverse effects.&lt;/p&gt;
&lt;p&gt;In fact, treatment with leflunomide was more readily tolerated, lacking the minor dyspeptic and arthromyalgic side effects associated with methotrexate.&lt;/p&gt;
&lt;p&gt;That tolerability, and the fact that the drug can be administered orally, &quot;undoubtedly represent points in its favor as far as patients are concerned,&quot; the investigators noted.&lt;/p&gt;
&lt;p&gt;However, leflunomide is much more expensive than methotrexate, they pointed out.&lt;/p&gt;
&lt;p&gt;They called for further research on the use of leflunomide in this context, with greater numbers of patients and longer duration to better assess the persistence of efficacy, potential safety concerns with long-term use, and effects on structural joint damage.&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 authors disclosed no conflicts of interest.&lt;/p&gt;&lt;/div&gt;&lt;div style=&quot;clear:both;&quot;&gt;&lt;/div&gt;
    </recommendedItem>
    <recommendedItem id="20100101_19_269"
                     title="Close Relationships Influence RA Inflammation (CME/CE)"
                     score="0.001"
                     href="http://www.medpagetoday.com/Rheumatology/Arthritis/tb/18125?impressionId=1265784242497"
                     
      &lt;p&gt;Women with rheumatoid arthritis whose close relationships are marked by mutuality  --  the reciprocal sharing of thoughts and feelings  --  have lower levels of inflammation, a prospective study found.&lt;/p&gt;
&lt;p&gt;After controlling for the effects of factors such as disease flares and the use of anti-inflammatory and disease-modifying drugs, mutuality accounted for 9% of the difference in levels of an inflammatory marker at six months, and an additional 12.5% at 12 months, according to Shelley Kasle, PhD, of the University of Arizona, Tucson.&lt;/p&gt;
&lt;p&gt;In contrast, levels of the marker (erythrocyte sedimentation rate, or ESR) had no effect on subsequent mutuality, suggesting that while mutuality influences inflammation, the reverse is not the case, the investigators reported in the Jan. 15 &lt;em&gt;Arthritis Care &amp;amp; Research&lt;/em&gt;.&lt;/p&gt;
&lt;p&gt;Social relationships exert benefits on health through both biological and behavioral pathways. The impact of social relationships may be particularly great in patients with rheumatoid arthritis because they have been shown to be psychologically and physiologically reactive to interpersonal stressors.&lt;/p&gt;
&lt;p&gt;Previous studies have shown that heightened interpersonal stress in patients with rheumatoid arthritis led to increases in clinical disease activity and cellular inflammation.&lt;/p&gt;
&lt;p&gt;Specific aspects of close social relationships, such as marital status and quality, are also known to influence rheumatoid arthritis outcomes, with single patients becoming disabled more quickly than those who are married or partnered.&lt;/p&gt;
&lt;p&gt;Some researchers believe that mutuality, unlike similar constructs such as intimacy and emotional responsiveness, are important for women&apos;s psychological and physical health because mutuality emphasizes equal empowerment of both parties through empathic exchanges.&lt;/p&gt;
&lt;p&gt;To see whether mutuality simply correlates with health in patients with rheumatoid arthritis or has a possible causal role, Kasle and colleagues recruited 70 women with rheumatoid arthritis who completed questionnaires at baseline, six months, and 12 months, detailing demographics, medical history, and medications.&lt;/p&gt;
&lt;p&gt;In addition, couple mutuality was measured according to the Mutual Psychological Development Questionnaire.&lt;/p&gt;
&lt;p&gt;Their mean age was 57 years, mean disease duration was five years, and relationship duration was 24 years.&lt;/p&gt;
&lt;p&gt;Four regression analyses examined the cross-lagged effects of mutuality and other factors on ESR, as well as the possible effects of ESR on mutuality over two time spans  --  baseline to six months, and six months to 12 months.&lt;/p&gt;
&lt;p&gt;Variables included C-reactive protein, the use of disease-modifying anti-rheumatic drugs, nonsteroidal anti-inflammatory agents, and biologic response modifiers, arthritis disease flares, and negative affect.&lt;/p&gt;
&lt;p&gt;Mutuality remained constant across the two time spans, whereas mean ESR fell from 20.32 mm/hour at baseline to 13.32 mm/hour at 12 months.&lt;/p&gt;
&lt;p&gt;In step 1 of the regression predicting six-month ESR, baseline controls explained 42.7% of variance, with baseline ESR being the only significant predictor (&lt;em&gt;P&lt;/em&gt;&amp;lt;0.001).&lt;/p&gt;
&lt;p&gt;In step 2 of this analysis, baseline mutuality demonstrated an inverse lagged effect on six-month ESR (&lt;em&gt;P&lt;/em&gt;=0.008), explaining 9% of the additional variance in ESR during that time span.&lt;/p&gt;
&lt;p&gt;In step 1 of the regression predicting 12 month ESR, six-month control variables accounted for 36.7% of variance, with six-month ESR and disease flares being marginally significant predictors.&lt;/p&gt;
&lt;p&gt;In step 2, six-month mutuality exerted an inverse lagged effect on 12-month ESR (&lt;em&gt;P&lt;/em&gt;&amp;lt;0.02), explaining an additional 12.5% of the variance in ESR at that time point.&lt;/p&gt;
&lt;p&gt;Then, in a regression analysis predicting six-month mutuality, baseline mutuality was the only significant predictor in both steps 1 and 2 (&lt;em&gt;P&lt;/em&gt;&amp;lt;0.001 for both), with negative affect being marginally significant.&lt;/p&gt;
&lt;p&gt;In step 2, baseline ESR failed to exert any lagged effect on six-month mutuality.&lt;/p&gt;
&lt;p&gt;In the regression analysis predicting 12-month mutuality, baseline mutuality again was the only significant predictor in steps 1 and 2 of the model (&lt;em&gt;P&lt;/em&gt;&amp;lt;0.001 for both).&lt;/p&gt;
&lt;p&gt;And in step 2, six-month ESR failed to exert any lagged effect on 12-month mutuality.&lt;/p&gt;
&lt;p&gt;&quot;The current study provides initial evidence that the relational behaviors measured as mutuality (engaged, authentic, empathic, and validating responses) exert a beneficial effect relative to inflammation for female patients with [rheumatoid arthritis], suggesting their potential usefulness as therapeutic targets,&quot; the investigators wrote.&lt;/p&gt;
&lt;p&gt;For instance, developing interventions to enhance couple mutuality could contribute to the maintenance of health and quality of life for these patients.&lt;/p&gt;
&lt;p&gt;The study findings also suggest that exclusive reliance on pharmacotherapy may represent less than optimal care, particularly since many of the disease modifying drugs and biologic response modifiers have potentially serious adverse effects and are not effective in all patients.&lt;/p&gt;
&lt;p&gt;Strengths of the study include its prospective design and replication of findings over two time spans, the authors reported.&lt;/p&gt;
&lt;p&gt;&quot;In addition, the linkage of a self-report measure of relationship quality with an objective medical measure of inflammation argues persuasively for the importance of psychosocial factors for physical health.&quot;&lt;/p&gt;
&lt;p&gt;Study limitations were inherent in its design, wherein cross-lagged effects provide a starting point for determining causality, but effects must then be tested experimentally.&lt;/p&gt;
&lt;p&gt;Moreover, other factors, such as personality traits and disease severity, and other disease measures, such as disability and pain, were not accounted for.&lt;/p&gt;
&lt;p&gt;Nonetheless, the investigators concluded, &quot;Our findings join an accumulating body of evidence linking social relationships with health.&quot;&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 lead investigator was supported by a grant from the Arthritis Foundation.&lt;/p&gt;&lt;/div&gt;&lt;div style=&quot;clear:both;&quot;&gt;&lt;/div&gt;
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