Difference In Remission Rates Research Articles

Technology-enhanced maintenance of treatment gains in eating disorders: Efficacy of an intervention delivered via text messaging.

Given the lack of maintenance interventions for eating disorders, a program delivered via the short message service (SMS) and text messaging was developed to support patients after their discharge from inpatient treatment. The efficacy of the intervention was studied in a randomized controlled trial. Additionally, its impact on the utilization of outpatient treatment during follow-up was investigated. One hundred sixty-five female patients with bulimia nervosa or a related eating disorder not otherwise specified were randomly assigned to a control group (treatment as usual; TAU) or an intervention group (SMS-based maintenance intervention; SMS). After hospital discharge, participants in the intervention group submitted a weekly symptom report via text message for 16 weeks and received tailored feedback. Primary outcome was the rate of partial remission 8 months after discharge from inpatient treatment. The difference in remission rates reached significance in the intent-to-treat analyses (SMS = 51.2%; TAU = 36.1%), χ²(1) = 3.81, p = .05, and approached significance in the completer analysis (SMS = 59.2%; TAU = 43.5%), χ²(1) = 3.44, p = .06. There were no differences in the utilization of outpatient treatment. Remission rates between the intervention and control groups were not significantly different among patients who used outpatient treatment (63.2% vs. 55.6%), χ²(1) = 0.44, p = .51. A significant difference was found in those who did not utilize such treatment (54.5% vs. 30.3%), χ²(1) = 3.97, p = .046. The aftercare intervention was efficacious in enhancing treatment outcome after discharge from inpatient treatment.

BMI Guidelines for Bariatric Surgery in Diabetes: How Low Can We Go?

The benefit of weight loss on glycemic control in type 2 diabetes is well known; weight management is foundational to good diabetes care. Intensive lifestyle intervention, which produces modest (5–10%) weight loss can produce durable (demonstrated up to 4 years) improvement in HbA1c and some cardiovascular risk factors (1,2). As for bariatric surgery, a recent systematic review and meta-analysis (3) of 621 bariatric surgery studies (>135,000 patients) reported that diabetes “improved or resolved” in 84%. Thus, there is a growing appreciation for the role of bariatric surgery as a tool in diabetes management. The appreciation that bariatric surgery might yield remission of diabetes stimulated the American Diabetes Association (ADA) to convene a consensus committee to define the terms “partial remission,” “complete remission,” and “durable remission\x{201d} (4). This is an important step because slight variation in definition can yield significant differences in remission rates (5). If we are to be able to develop evidence to support recommendations for this procedure in diabetes, we must be able to compare results across studies. Surgery for obesity has typically been reserved for patients with more severe obesity, and current guidelines (6) for the diagnosis and management of obesity indicate bariatric surgical procedures for patients with BMI ≥40 kg/m2 or for patients with a serious comorbidity (such as type 2 diabetes) and BMI ≥35 kg/m2. These BMI cut points are drawn from observations of large populations that show …

P352 Need for infliximab dose intensification in patients with Crohn's disease and ulcerative colitis

ation, endoscopic remission and need of colectomy. Results: Eighty-two patients (30 male; median age 39 years, IQR 32-48) have been enrolled. Main indications for ADA treatment were steroid-dependency (45%), steroid-resistance (23%) and extraintestinal manifestations (15%). Most of patients (78%) received previous infliximab treatment. Median partial Mayo score at baseline was 6 (IQR 4-7). ADA induction regimen was 160/80 mg (88%) or 80/40 mg (12%) and maintenance treatment was 40 mg every other week for a median time of 11 months (IQR 4-17). During follow up 30% of patients required dose-escalation. Clinical remission at 4, 12, 24 and 54 weeks was achieved in 13/82 (16%), 20/78 (27%), 26/75 (35%) and 24/60 (42%) patients, respectively. Sustained clinical remission at 12, 24 and 54 weeks was achieved in 10/60 (17%) patients. Thirty-three of 55 patients (60%) receiving corticosteroids at baseline were able to discontinue them. Forty-seven patients underwent baseline and follow-up endoscopy after a median of 11 months (IQR 3-13). Endoscopic remission was achieved in 21/47 patients (45%). During the study period, 18 patients (22%) underwent colectomy after a median of 5.5 months (IQR 2-14). No significant differences in remission rates at 4, 12, 24 and 54 weeks and colectomy rates were observed between anti-TNF alpha naive and non-naive patients. Conclusions: In this large “real-life” experience ADA appeared to be effective in active UC. One fourth of patients achieved clinical remission within three months. In patients receiving scheduled maintenance treatment for one year the remission rate was about 40%. Although ADA shows a steroid-sparing effect, the probability of colectomy for treatment failure is high.

Value of acute-phase reactants in monitoring disease activity and treatment response in idiopathic retroperitoneal fibrosis

Prospective evaluation of the value of erythrocyte sedimentation rate (ESR) and C-reactive protein (CRP) levels in monitoring disease activity and treatment response in patients with idiopathic retroperitoneal fibrosis (RPF). This study included 57 patients with idiopathic RPF receiving tamoxifen monotherapy with at least 8 months follow-up. Clinical, laboratory and radiological investigation was performed at presentation and at repeated follow-up. Remission was defined as significant clinical improvement within 6 weeks of treatment together with stable or decreasing mass size on follow-up computed tomography (CT) scanning at 4 months and definitive decrease in mass size on follow-up CT scanning at 8 months. ESR and CRP levels at presentation and their respective decreases over time correlated strongly with each other (P<0.001). Baseline ESR and CRP levels correlated with visual analogue scale (VAS) score for pain (ESR, P<0.01; CRP, P<0.001); baseline ESR levels also correlated with VAS score for discomfort (P<0.001). Short-term decreases in ESR or CRP levels at 6 weeks follow-up did not correlate with subsequent mass regression but decrease in ESR at 4 months and decrease in CRP at 4 and 8 months follow-up correlated with mass regression. Kaplan-Meier analysis showed no difference in remission rate between patients with normal or elevated baseline ESR or CRP (log-rank P=0.22/P=0.88) or between patients with or without (near-)normalization of ESR or CRP in first 6 weeks of treatment (log-rank P=0.12/P=0.32). Patients with idiopathic RPF who have elevated acute-phase reactant levels are more symptomatic. Neither acute-phase reactant levels or their initial changes can be taken as a major predictor for treatment success.

Combined Treatments for Depression as for Other Medical Disorders

Back to table of contents Previous article Next article Communications and UpdatesFull AccessCombined Treatments for Depression as for Other Medical DisordersPierre Blier, M.D., Ph.D.Pierre BlierOttawaSearch for more papers by this author, M.D., Ph.D.Published Online:1 Jan 2012https://doi.org/10.1176/appi.ajp.2011.11071055AboutSectionsPDF/EPUB ToolsAdd to favoritesDownload CitationsTrack Citations ShareShare onFacebookTwitterLinked InEmail To the Editor: We read with great interest the article by Dr. Rush et al. on the Combining Medications to Enhance Depression Outcomes (CO-MED) study (1) and the editorial by Dr. Coryell (2) in the July 2011 issue of the Journal. The overall result of this large-scale trial is that a single antidepressant produced the same remission results as did combinations started 1 week after treatment initiation. Our main issue with CO-MED, apart from its not being a double-blind study, is the dosing of the antidepressants. The CO-MED study did not adhere to an important rule of combination treatment in medicine: use similar and/or effective dosages of both agents. For instance, when treating asthma, physicians should administer standard doses of both a β2-adrenergic agonist and an inhaled steroid, not lower doses. Physicians were aware of the dosages used throughout the study, and despite the use of a decision tree involving tolerability and response for titration, the dose of escitalopram was near the maximum in the monotherapy arm and was significantly lower when combined with bupropion. Consequently, the dosage issue has not been “credibly dismissed” in the CO-MED study (2).One possible explanation for the identical remission rates in the venlafaxine-mirtazapine arm and the escitalopram arm is that the combination arm was again underdosed. Several studies supporting the superiority of this combination consistently used higher dosages. The mean of the daily doses of mirtazapine was only 20 mg in the CO-MED study, which is below its minimal effective daily dose of 30 mg. The mean of the daily doses of venlafaxine was 192 mg, which is below its noradrenergic range of 225 mg/day (3). Rush et al. (1) point out that no difference in remission rates was observed between the 86 patients who reached the daily regimen of 225 mg of venlafaxine and 30 mg of mirtazapine and those who were in the escitalopram arm. However, the authors indicate that this regimen was achieved “at any time during treatment.” It is unclear how long these dosages were maintained. In two double-blind studies (4, 5), we doubled the remission rates using adequately dosed combinations of mirtazapine and other antidepressants, and the dropout rates were below 15%; no patients in the fixed venlafaxine (225 mg) and mirtazapine (30 mg) group dropped out because of side effects. The double-blind structure of our studies likely contributed to patients tolerating side effects because neither they nor the investigators knew if a dosage titration was used. On the one hand, the CO-MED study results may reflect the underdosing that can happen in a community sample. On the other hand, this approach limits our ability to validate the superiority of the venlafaxine-mirtazapine combination because most patients were on a dosage of venlafaxine that did not inhibit norepinephrine reuptake and a sedative/non-antidepressant dosage of mirtazapine during the trial.More studies on combining antidepressant drugs from treatment initiation are needed, especially those that keep in mind the above-mentioned pitfalls. Nevertheless, a crucial take-home message from the CO-MED study is that if patients are treated with a combination of antidepressants, they should be receiving adequate dosages because a single medication may do just as well.OttawaDr. Blier has received investigator-initiated research grants and/or honoraria for participating in advisory boards and delivering lectures from AstraZeneca, Biovail, Bristol-Myers Squibb, Eli Lilly, Euthymics, Janssen, Labopharm, Lundbeck, Merck, Organon, Pfizer, Pierre Fabre Medicaments, Takeda, and Wyeth.Accepted for publication in October 2011.

Effects of Race and Ethnicity on Depression Treatment Outcomes: The CO-MED Trial

The investigators examined whether outcomes differ by race-ethnicity for patients with major depressive disorder in acute- (12 weeks) and continuation-phase (weeks 12-28) treatment with one of two antidepressant combinations or one selective serotonin reuptake inhibitor. This single-blind, seven-month prospective, randomized trial enrolled 352 non-Hispanic white (59%), 169 black (28%), and 79 white Hispanic (13%) participants from six primary and nine psychiatric care U.S. sites. Patients had nonpsychotic chronic or recurrent major depressive disorder (or both) of at least moderate severity. Escitalopram plus placebo, bupropion sustained-release plus escitalopram, or venlafaxine extended-release plus mirtazapine were delivered according to measurement-based care. The primary outcome was remission (last two consecutive 16-item Quick Inventory of Depressive Symptomatology-Self-Report ratings <8 and <6); secondary outcomes included side effects, adverse events, quality of life, function, and attrition. Black participants had greater baseline psychiatric and medical comorbidity. Baseline depression severity did not significantly differ between groups. In both phases more blacks than those in other groups exited the trial early. There were only minor differences in side effects, no significant differences in remission rates, and no significant differences between groups in other outcomes for each treatment. Despite differences in sociodemographic characteristics and comorbidities, when measurement-based care was used, members of different minority groups had similar outcomes when treated with one antidepressant or a combination of two antidepressants. Black participants had the highest attrition rate, an important issue to address in clinical care.

Effects of Race and Ethnicity on Depression Treatment Outcomes: The CO-MED Trial

Objective: The investigators examined whether outcomes differ by race-ethnicity for patients with major depressive disorder in acute- (12 weeks) and continuation-phase (weeks 12–28) treatment with one of two antidepressant combinations or one selective serotonin reuptake inhibitor. Methods: This single-blind, seven-month prospective, randomized trial enrolled 352 non-Hispanic white (59%), 169 black (28%), and 79 white Hispanic (13%) participants from six primary and nine psychiatric care U.S. sites. Patients had nonpsychotic chronic or recurrent major depressive disorder (or both) of at least moderate severity. Escitalopram plus placebo, bupropion sustained-release plus escitalopram, or venlafaxine extended-release plus mirtazapine were delivered according to measurement-based care. The primary outcome was remission (last two consecutive 16-item Quick Inventory of Depressive Symptomatology-Self-Report ratings <8 and <6); secondary outcomes included side effects, adverse events, quality of life, function, and attrition. Results: Black participants had greater baseline psychiatric and medical comorbidity. Baseline depression severity did not significantly differ between groups. In both phases more blacks than those in other groups exited the trial early. There were only minor differences in side effects, no significant differences in remission rates, and no significant differences between groups in other outcomes for each treatment. Conclusions: Despite differences in sociodemographic characteristics and comorbidities, when measurement-based care was used, members of different minority groups had similar outcomes when treated with one antidepressant or a combination of two antidepressants. Black participants had the highest attrition rate, an important issue to address in clinical care. (Psychiatric Services 62:1167–1179, 2011)

Do Children With IBD Really Respond Better Than Adults to Thiopurines?

Children and adolescents with inflammatory bowel disease (IBD) have more extensive and severe disease than adults. Despite a lack of comparative studies, thiopurines are frequently cited as being more efficacious in children. To test this assertion, we compared the efficacy of thiopurines in children with IBD with that in adults matched for disease phenotype. Fifty paediatric and adult patients with IBD started on a thiopurine were matched for sex, disease type, and extent. Retrospective data were obtained by electronic case note review, and corticosteroid-free clinical remission and tolerance rates at 6 months as well as relapse rates during the subsequent year were recorded. Adverse effects caused discontinuation of thiopurines in 1 of 50 children and 16% (8/50) of adults (P < 0.05). At 6 months, steroid-free remission was achieved in 30% (15/50) of children and 38% (19/50) of adults (P = 0.53). No differences in remission rates were seen according to disease type. At the end of the following year, 73% (11/15) of children and 68% (13/19) of adults remained in remission (P = 1). Thiopurines are tolerated better by children. When phenotype is matched, there is no difference in the therapeutic response to thiopurines between children and adults with IBD.

Can thoracoscopic Heller’s myotomy give equivalent results to the more usual laparoscopic Heller’s myotomy in the treatment of achalasia?: Table 1

A best evidence topic in thoracic surgery was written according to a structured protocol. The question addressed was 'Can thoracoscopic Heller's myotomy (THM) give equivalent results to the more usual laparoscopic Heller's myotomy (LHM) in the treatment of achalasia?' Altogether, more than 478 papers were found using the reported search, of which eight represented the best evidence to answer the clinical question. The authors, journal, date and country of publication, patient group studied, study type, relevant outcomes and results of these papers are tabulated. THM and LHM are two recognised approaches to the performance of a distal oesophageal myotomy in the treatment of achalasia. Of the two meta-analyses on this subject, Campos et al. [Campos GM, Vittinghoff E, Rabl C, Takata M, Gadenstätter M, Lin F, Ciovica R. Endoscopic and surgical treatments for achalasia: a systematic review and meta-analysis. Ann Surg 2009;249:45-57] illustrated improved symptom control in LHM compared with THM. Wang et al. [Wang L, Li Y, Li L, Yu C. A systematic review and meta-analysis of the Chinese literature for the treatment of achalasia. World J Gastroenterol 2008;14:5900-5906], however, observed no difference in remission rates following either approach. Close scrutiny of comparison studies revealed superiority in long-term outcomes and symptoms following LHM in three studies. There were, however, studies that illustrated comparable outcome results for THM in both resolution of dysphagia and reflux. Morbidity rates following THM were noted to be similar to or slightly higher than those following LHM in five studies, but no statistically significant difference was illustrated in these studies. Operating time and length of stay were noted to be significantly shorter in LHM when compared with THM in three studies, although there were exceptions to this, with two studies illustrating shorter or equal operating times for THM. However, LHM operating times have been shown to improve with experience gained. We conclude that there is good evidence demonstrating the effectiveness and safety of LHM, and it has come to be regarded as the gold standard treatment of achalasia. When THM is compared with LHM, the long-term results approach parity on occasion but not consistently. The overall postoperative morbidity of THM is not significantly different from that of LHM. An advantage of LHM over THM that is demonstrated is that LHM offers a shorter hospital stay and reduced operative time.

Prognostic Impact of Helicobacter pylori Infection and Eradication Therapy in Gastric Mucosa-associated Lymphoid Tissue Lymphoma

Gastric mucosa-associated lymphoid tissue (MALT) lymphoma is associated with Helicobacter pylori infection and H. pylori eradication is used as its first-line therapy. However, controversies exist about the prognostic value of H. pylori infection in these patients. We evaluated the prognostic impact of H. pylori infection and eradication therapy in gastric MALT lymphoma. A total of 292 patients diagnosed with MALT lymphoma since 2000 were analysed. MALT lymphoma was diagnosed with tissue biopsy and H. pylori infection was diagnosed with hematoxylin-eosin and additional Warthin-Starry stains on tissue sections. Clinical variables such as bone marrow (BM) involvement, multiorgan involvement, tumor stage at diagnosis, and remission were obtained with retrospective review of electronic medical records. Non-gastric MALT lymphoma patients showed higher multiorgan involvement rates (26.6% vs. 9.6%, P<0.001) and higher proportion of stage ≥ 3 (27.7% vs. 16.7%, P=0.029) than gastric cases. Regarding gastric MALT lymphoma, patients with H. pylori infection at diagnosis showed significantly less BM (2.1% vs. 21.8%, P<0.001) and multiorgan involvement rates (6.3% vs. 18.2%, P=0.011) than those without infection. But there was no significant difference in remission rates between them. In contrast, those with successful H. pylori eradication therapy showed significantly higher remission rates (81.0% vs. 30.8%, P<0.001) than those with failure. Non-gastric MALT lymphoma patients showed worse prognosis compared to gastric cases. As for remission rates in patients with gastric MALT lymphoma, successful H. pylori eradication therapy could be a good prognostic factor even if H. pylori infection was present at diagnosis.

Testing anxious depression as a predictor and moderator of symptom improvement in major depressive disorder during treatment with escitalopram

The purpose of this analysis was to explore the potential role of anxious MDD as a treatment predictor and moderator in major depressive disorder (MDD) using a large escitalopram clinical trial dataset. Individual patient-level data from 13 double-blinded, randomized, controlled trials in patients with MDD were pooled. Both univariate, last observation carried forward (LOCF) analyses and repeated measurements analyses without imputation (MMRM) were carried out for change in symptom scores, response and remission rates. Of 3,919 patients, 48.0% were classified as having anxious MDD depression (HAMD) somatization/anxiety subscale score ≥7 at baseline. Patients with anxious MDD were less likely to report symptom improvement on some outcome measures than patients without anxious MDD (predictor analysis). Specifically, the difference in response rates for patients with vs. patients without anxious MDD according to the MADRS (55.6% vs. 57.7%, respectively) was not statistically different. However, the difference in remission rates for patients with versus without anxious MDD according to the MADRS (37.6% vs. 44.1%, respectively) was statistically significant. Escitalopram was more effective than placebo, and as effective as the SSRIs and SNRIs, in the treatment of anxious MDD. The present analysis provides some evidence that the presence of an anxious MDD subtype is a predictor of poor response. There was no difference in the response to treatment of patients with or without anxious MDD to escitalopram, SSRIs, or SNRIs. The present analysis did not support the notion that SNRIs are more effective than escitalopram in the treatment of anxious MDD, nor was there evidence to support treatment moderating effects for anxious MDD.

Consequent and intensified relapse therapy improved survival in pediatric AML: results of relapse treatment in 379 patients of three consecutive AML-BFM trials

Relapse remains the major cause of treatment failure in pediatric acute myeloid leukemia (AML). We analyzed the clinical characteristics, treatment response to relapse treatment and overall survival (OS) of 379 children with AML relapse treated according to three consecutive frontline protocols of the AML-Berlin/Frankfurt/Muenster study group (AML-BFM-87/-93/-98). Of 313 treated patients with data on remission status, 198 children (63%) achieved a second complete remission (CR2). There were no significant differences in remission rates and OS for the intensive reinduction treatment schedules used. The 5-year OS rate was 23% for the total group and 29% for patients treated with curative intent. OS rates increased with study periods from 18 to 34% (P(log rank)=0.012), whereas the proportion of patients receiving only palliative treatment decreased from 23 to 11% (P(CMH)=0.005). Late relapse, no allogeneic stem cell transplantation (SCT) in CR1, age <10 years and favorable cytogenetics were independent favorable prognostic factors for survival. Achievement of CR2 was the most important prognostic factor (OS 44 vs 3%; P(log rank)<0.0001). Overall, one-third of children with relapsed AML can be cured today. SCT in CR2 is recommended for most patients, although its impact on CR2 is discussed.

Reboxetine for acute treatment of major depression: systematic review and meta-analysis of published and unpublished placebo and selective serotonin reuptake inhibitor controlled trials

Objectives To assess the benefits and harms of reboxetine versus placebo or selective serotonin reuptake inhibitors (SSRIs) in the acute treatment of depression, and to measure the impact of potential...

How Much Rituximab Do We Need: A Multicenter, Randomized Trial Comparing 1, 3 or 6 Infusions of Rituximab Combined with 6 Cycles of CHOP Chemotherapy in Untreated Patients with Advanced Follicular Lymphoma (HD2000-Trial).

Abstract 2687Poster Board II-663 Background:The addition of Rituximab to standard chemotherapy has substantially improved the prognosis of NHL. Over the last years, a trend towards intensified protocols with multiple applications of Rituximab has been observed. We are able to report a unique cohort that has also been treated with only 1 or 3 courses of Rituximab within a prospective randomized phase II trial, contrasting current standard procedures. Patients and Methods:Between 2000 and 2005, 126 patients (pts) with stage III/ IV CD20+ follicular lymphoma (FL) were randomized in a prospective multicenter trial to receive 1, 3 or 6 courses Rituximab with 6 courses standard CHOP chemotherapy. The primary endpoint was to compare the three treatment arms with regards to molecular remission rates (mRR) among pts with positive PCR at diagnosis. Secondary endpoints were clinical remission rates, progression-free (PFS) and overall-survival (OS) and toxicity. After screening failure (n = 21) or protocol violation (n = 6) had occurred, 99 pts form the base for this analysis. Among those, only 28 pts were PCR positive at start of treatment and met the criteria for inclusion into the primary endpoint analysis. Results:Due to a limited number of evaluable pts, mRR and duration of molecular remission could not be analyzed. Among 99 pts eligible for the secondary endpoint analysis, 31 received 1 course of Rituximab (arm A), 36 received 3 courses (arm B) and 32 received 6 (arm C). 42% were male. The median age at diagnosis was 56 years (range 23–79). Histological grade was 1 in 49%, 2 in 35% and 3 in 12%. Stage according to Ann Arbor was 3 in 30% and 4 in 70% of pts. B symptoms were present in 36%. According to FLIPI, 21% were classified as low risk (0–1), 39% as intermediate risk (2), and 39% as high risk (3–5). At least one extranodal manifestation was detected in 81 pts, with over 60% of extranodal manifestations being located in the bone marrow. Bulky disease was detected in 57 pts. Following immunochemotherapy, 37% received consolidating involved-field radiotherapy. There was no difference between the three treatment arms with regards to presenting or demographic characteristics (p>.05). Treatment was terminated prematurely in 19 pts due to protocol violation (n = 10), stable disease/ disease progression (n=5), pts′ preference (n = 3) or death (n = 1). After completion of immunochemotherapy, 29 of 99 pts had achieved CR and 58 PR; no or minimal response or progression was observed in 6 pts, and 6 pts were not evaluable. There was no statistically significant difference of clinical remission status between pts in arm A and B compared to those in arm C (p = .66), and between pts in arm B and C compared to arm A (p = .07). There was no trend in clinical remission rates through different courses of Rituximab (p = .09). However, 3 courses were not inferior to 6 courses with regards to clinical remission rate. After a median follow-up of 60 months (range 4–90) 94% of pts in each arm had achieved at least PR. Relapse occurred in 36 pts, with no significant difference in remission duration between the three arms (p = .28). In comparison to 1 course, multiple courses did not significantly prolong the duration of remission (p = .12). 6-year PFS was 45% in arm A, 60% in arm B and 65% in arm C, with no difference between the three arms (p = .35). Neither 3 (p = .29) nor 6 courses (p = .18) did significantly alter PFS compared to 1 course. The difference in PFS between 1 course vs. 3 or 6 courses was not significant (p =.16). 6-year OS was 72% in arm A, 82% in arm B and 80% in arm C, with no significant difference between the three arms (p = .46). Neither 3 (p = .26) nor 6 courses (p = .36) significantly altered OS when compared to 1 course. The difference in OS between 1 course vs. 3 or 6 courses was also not significant (p = .22). Toxicities most frequently observed were grade 3/4 leucopenia. There was no difference with regards to infections (p = .67) and allergic reactions (p = .70). Death occurred in 18 pts. Conclusion:There was no difference in remission rates, remission duration, PFS and OS between pts treated with different courses of Rituximab, with more frequent applications not differing from less frequent applications. In this study, a non-inferiority of fewer applications of Rituximab could not be detected. Therefore, the advantage of multiple courses of Rituximab remains uncertain. To our knowledge, this is the first study that randomized pts to receive fewer doses of Rituximab than currently applied in standard protocols. Disclosures:No relevant conflicts of interest to declare.

Clinical Outcome of Patients with Follicular Lymphoma and Bulky Disease After Rituximab-CHOP Immunochemotherapy with and without Consolidating Radiotherapy.

Abstract 2722Poster Board II-698 Background:As the clinical management of patients with bulky disease remains challenging, many centres apply involved-field radiotherapy (IF-RT) after completion of immunochemotherapy. This strategy remains controversial. Patients and Methods:To evaluate the benefit of consolidating IF-RT in addition to immunochemotherapy, we retrospectively analyzed relapse patterns and survival of patients presenting with bulky follicular lymphoma (FL). Bulky disease was defined as abdominal/ mediastinal lymphoma mass >7.5 cm and/ or peripheral lymphoma mass >5 cm. All patients were treated within a prospective randomized trial on 126 patients with FL with six cycles of standard CHOP-chemotherapy in combination with 1, 3 or 6 cycles of Rituximab, followed by consolidating IF-RT in patients with bulky disease. 42 eligible patients with bulky disease were identified and form the foundation of this analysis, of which 26 were irradiated and 16 were not, violating the protocol. Results:With the exception of number of affected nodal regions, there was no significant difference between the irradiated and the non-irradiated group with regards to presenting characteristics (p > .05). Among all patients, bulks were located below the diaphragm in 91%. A second tumour bulk was present in 9 patients (22%). Female to male ratio was 1.3:1, and the median age at diagnosis was 54 years (range 23–73). According to FLIPI, 10% were classified as low risk (0–1), 45% as intermediate risk (2), and 45% as high risk (3–5). B symptoms were absent in 69%. Eleven patients (26 %) had received one course of Rituximab, 17 (41%) three courses and 14 (33%) six courses. There was no significant difference between the irradiated and the non-irradiated group with regards to previous exposure to immunochemotherapy (p = .628). After a median follow-up of 60 months, a total of 21 patients (50%) had progressed or relapsed and 9 patients (21%) had died. With the exception of one patient who died from congestive heart failure following chemotherapy-related cardiomyopathy, the main cause of death was disease progression or relapse. Highly malignant transformation into diffuse large B-cell lymphoma was observed in 5 cases. In the irradiated group, relapse occurred in 12 of 26 patients. Half of these relapses were located within the original bulk or within the bulk plus a new location, and 50% at a new location altogether; 42% occurred within the previously irradiated area. In the non-irradiated group, 9 of 16 patients relapsed. The corresponding rates regarding relapse location were 67% for original plus new location and 33% for new location only. There was no statistically significant difference between exposure to radiotherapy after immunochemotherapy and the likelihood of a relapse per se (p = .751) or at a specific location (p = .66). At the last follow-up, 31% of irradiated patients had achieved CR and 23% PR. Among the non-irradiated group, the corresponding rates were 25% and 19%. There was no significant difference in remission rates at any staging examination throughout the clinical trial between the two treatment groups (p > .05). 6-year progression-free- and overall survival rates were 52% and 80% after IF-RT and 48% and 73% without IF-RT (p = 1.00, p = .68 respectively). Conclusion:In this analysis, there was no difference in relapse rate, relapse location, PFS and OS between patients with bulky FL treated with and without consolidating IF-RT. Although patient numbers are limited, this is the first analysis of its kind conducted in the Rituximab era. Disclosures:No relevant conflicts of interest to declare.

The use of exclusive enteral nutrition for induction of remission in children with Crohn’s disease demonstrates that disease phenotype does not influence clinical remission

Exclusive enteral nutrition (EEN) achieves variable remission rates in patients with Crohn's disease (CD). To describe our experience of treating CD with an 8-week course of primary EEN and to study factors affecting treatment outcome. All CD patients treated with EEN in our centre between 2004 and 2007 were included in the study. Remission was determined by a combination of clinical parameters. Disease phenotype was assigned using published classifications. Inflammatory markers and anthropometry (Z-scores) were calculated before and after treatment. A total of 114 children were treated (four were excluded). Median age at diagnosis was 11.6 years. Fifty-seven (51.8%) were fed orally whilst 53 (48.2%) were fed by tube. Eighty-eight (80%) achieved remission with consequent reductions in erythrocyte sedimentation rate and C-reactive protein (P < 0.001). Patients in remission had comparative improvements in weight (-1.04 cf. -0.40) and BMI Z-scores (-0.98 cf. -0.03) by the end of treatment (P < 0.001). Individuals with isolated terminal ileal disease (n = 4) had lower remission rates than other locations (P = 0.02). No other significant differences in remission rates for any other disease locations were found. Exclusive enteral nutrition induces clinical remission, normalization of inflammatory markers and improves weight/BMI Z-scores in most patients. This study demonstrates that disease phenotype should not influence clinicians when commencing patients on EEN.

Comparison of SSRIs and SNRIs in major depressive disorder: a meta-analysis of head-to-head randomized clinical trials

Controversy exists whether serotonin-norepinephrine reuptake inhibitors (SNRIs) have improved efficacy compared with selective serotonin reuptake inhibitors (SSRIs). To compare clinical outcomes of adults treated with SSRIs or SNRIs for major depressive disorder (MDD) under ideal clinical condition, research design, and outcome measure. Electronic databases searched were Medline, Embase and Cochrane Library from inception to July 2007. Included studies were those head-to-head randomized trials comparing remission (HAMD-17 <or=7-8, MADRS <or=10-12) after 8-12 weeks of therapeutic doses of SSRIs or SNRIs in patients diagnosed with MDD were targeted for analysis. Reviews, letters, commentaries, economic studies, etc. were excluded. Studies were reviewed by two independent researchers. Where disagreements occurred in study selection, a consensus approach was used. Targeted outcome data included number of patients achieving remission, withdrawing from therapy due to lack of efficacy (LoE) and/or adverse drug reactions (ADRs), and total patients in trial. A random effects model combined intent-to-treat (ITT) and per-protocol (PP) odds ratio (OR), and remission and dropout rates. Chi-square assessed heterogeneity. Quality assessment was done using Downs-Black checklist. Thirty-three studies were identified; 18 were rejected (patients had co-morbidities in 7, outcomes differed in 5, different follow-up in 3, and three reviews). Fifteen head-to-head trials of 3094 patients, average age was 41.9 +/- 11.9 years (for SNRIs) and 41.6 +/- 12.1 years (for SSRIs), P = 0.941. All analyses displayed non-heterogeneity (P > 0.05). The OR (under ITT) was 1.27 (1.06-1.52 95% CI) favoring SNRIs. Meta-analytic remission rates were 48.5 +/- 3.2% and 41.9 +/- 4.2% for SNRIs and SSRIs, respectively. The meta-analytic difference in remission rates between drugs was 5.7% (P = 0.007). Dropout rates due to ADRs were higher with SNRIs than SSRIs (3.2% difference, P < 0.001). Dropout rates due to LoE were non-significant between studied groups (P > 0.05). Serotonin and norepinephrine reuptake inhibitors showed statistical but not clinical significance when compared with SSRIs in treating MDD.

A comparison of a standard-dose prednisone regimen and mycophenolate mofetil combined with a lower prednisone dose in chinese adults with idiopathic nephrotic syndrome who were carriers of hepatitis B surface antigen: A prospective cohort study

Background: When receiving immunosuppressive therapy, patients with idiopathic nephrotic syndrome who are also carriers of hepatitis B virus (HBV) surface antigen (HBsAg) are at risk for reactivation of HBV.Objective: This study compared the effectiveness and tolerability of a standard-dose prednisone regimen with those of the combination of mycophenolate mofetil (MMF) and a lower prednisone dose for the treatment of idiopathic nephrotic syndrome characterized by minimal-change nephropathy or slight mesangial proliferative glomerulonephritis in Chinese adults who were also carriers of HBsAg, a combination here termed MSNS-HBV.Methods: This was a prospective, open-label cohort study in Chinese adults with MSNS-HBV. Patients were self-assigned to 1 of 2 treatment groups: the standard prednisone regimen of 1 mg/kg daily or oral MMF 0.5 to 1.0 g BID combined with the lower pred-nisone dose of 0.5 mg/kg daily. The planned duration of treatment was 36 weeks, with an additional 60 weeks of follow-up. The primary outcome measures were rates of complete remission of idiopathic nephrotic syndrome (a decrease in daily proteinuria to within the normal range [<0.3 g]) and rates of HBV reactivation (detectable serum HBV DNA). Secondary outcome measures included relapse rates (>1+ albuminuria on dipstick urinalysis on 3 consecutive days), alanine ami-notransferase (ALT) elevations (>50 U/L), use of la-mivudine 100 mg/d (added if HBV DNA titers reached ≥105 copies/mL), and adverse effects.Results: The intent-to-treat population included 41 patients (22 prednisone, 19 MMF). In patients who completed the study, rates of complete remission after 24 weeks of treatment were 78.9% (15/19) in the prednisone group and 76.5% (13/17) in the MMF group; 2 and 3 patients in the respective groups had a partial remission, and 2 and 1 patient had no response. HBV reactivation occurred in 63.6% (14/22) and 36.8% (7/19) of patients (P = 0.047). The only significant difference in the study was in the probability of HBV reactivation between groups (P = 0.043, log-rank test). During follow-up, at least 1 relapse occurred in 46.7% (7/15) and 30.8% (4/13) of patients. Elevations in ALT were observed in 36.4% (8/22) and 26.3% (5/19) of patients, and the addition of lamivu-dine was required in 40.9% (9/22) and 21.1% (4/19) of patients. The most frequent adverse effects in both groups were infections (27.3% and 26.3%), followed by gastrointestinal symptoms (13.6% and 21.1%). Two MMF patients developed leukopenia. One patient in the prednisone group discontinued treatment because of severe hepatitis, and 1 patient in the MMF group discontinued because of severe pulmonary infection.Conclusions: Among the adult Chinese patients with MSNS-HBV who completed this study, there were no significant differences in remission rates of idiopathic nephrotic syndrome between the standard prednisone regimen and the combination of MMF and a reduced prednisone dose. Rates of HBV reactivation, however, were significantly lower in the combination-therapy group.

Differential effects of venlafaxine in the treatment of major depressive disorder according to baseline severity

In this meta-analysis, we compare the relative efficacy of venlafaxine to selective serotonin reuptake inhibitors (SSRIs) in patients with major depressive disorder classified according to baseline disease severity. Data from 31 double-blind randomised clinical trials comparing venlafaxine and SSRIs (intent-to-treat n = 6,492) were pooled. For this secondary analysis, patients were stratified into groups based on baseline HAM-D(17) total score (>or=30, <30, >or=25, and <25). Remission rates (HAM-D(17) < 8) were analyzed for each subgroup using Fisher's exact test to compare treatment effects between venlafaxine and SSRIs; last observation carried forward (LOCF) and observed cases (OC) data were analyzed. The number needed to treat (NNT) to benefit was determined for each analysis. Statistically significant remission rate differences, favoring venlafaxine, were seen in LOCF and OC analyses for each subgroup. In patients with baseline HAM-D(17) < 25 (n = 3,928) the differences were (LOCF) 7.3 [P < 0.001; NNT = 14] and (OC) 6.2 [P = 0.003; NNT = 16], and in patients with baseline HAM-D(17) >or= 25 (n = 2,564) were (LOCF) 5.7 [P = 0.002; NNT = 17] and (OC) 6.7 [P = 0.009; NNT = 15]. In patients with baseline HAM-D(17) < 30 (n = 5,836) the differences were (LOCF) 6.4 [P < 0.001; NNT = 16] and (OC) 5.5 [P = 0.001; NNT = 18], and in patients with baseline HAM-D(17) >or= 30 (n = 656) were (LOCF) 8.9 [P = 0.015; NNT = 11] and (OC) 14.8 [P = 0.003; NNT = 7]. In conclusion, these analyses demonstrate that venlafaxine may be superior to SSRIs in achieving remission in both mild/moderate and severely depressed patients. The greater difference in remission rates among patients with baseline HAM-D(17) >or= 30 suggests a more pronounced clinical benefit that may be achieved with venlafaxine in severely depressed patients.

Remission and Recovery in the Treatment for Adolescents With Depression Study (TADS): Acute and Long-Term Outcomes

ObjectiveWe examine remission rate probabilities, recovery rates, and residual symptoms across 36 weeks in the Treatment for Adolescents with Depression Study (TADS). MethodThe TADS, a multisite clinical trial, randomized 439 adolescents with major depressive disorder to 12 weeks of treatment with fluoxetine, cognitive–behavioral therapy, their combination, or pill placebo. The pill placebo group, treated openly after week 12, was not included in the subsequent analyses. Treatment differences in remission rates and probabilities of remission over time are compared. Recovery rates in remitters at weeks 12 (acute phase remitters) and 18 (continuation phase remitters) are summarized. We also examined whether residual symptoms at the end of 12 weeks of acute treatment predicted later remission. ResultsAt week 36, the estimated remission rates for intention-to-treat cases were as follows: combination, 60%; fluoxetine, 55%; cognitive–behavioral therapy, 64%; and overall, 60%. Paired comparisons reveal that, at week 24, all active treatments converge on remission outcomes. The recovery rate at week 36 was 65% for acute phase remitters and 71% for continuation phase remitters, with no significant between-treatment differences in recovery rates. Residual symptoms at the end of acute treatment predicted failure to achieve remission at weeks 18 and 36. ConclusionsMost depressed adolescents in all three treatment modalities achieved remission at the end of 9 months of treatment.