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T1050 Impact of Anti-Tumor Necrosis Factor Therapies On Absence from Work Among Employees with Inflammatory Bowel Disease
T1050
AGA Abstracts
Impact of Anti-Tumor Necrosis Factor Therapies On Absence from Work Among Employees with Inflammatory Bowel Disease Heidi C. Waters, Nathan L. Kleinman, Spencer Borden, Wendy D. Lynch, Harold H. Gardner, Mirza I. Rahman Purpose:To investigate the effect of persistence with anti-tumor necrosis factor (anti-TNF) therapy on work related absences for employees with inflammatory bowel disease (IBD). Methods: A retrospective analysis using the HCMS Research Reference Database (RRDb) containing claims from large employers in the United States between January 1, 2001 and September 30, 2006 was conducted. Employees with IBD were identified using ICD-9 codes for Crohn's disease (555.xx) and ulcerative colitis (556.xx). The first diagnosis found in the data was defined as the index diagnosis date, and employees were required to have ≥12 months continuous enrollment following the index date. Anti-TNF treatment was identified based on the presence of medication J-Codes (J1745 infliximab; J1438 etanercept; J0135 adalimumab) or prescription pharmacy claims for these medications. Results: A total of 294,983 employees without IBD and 1,380 employees with IBD were analyzed. Employees with IBD who were treated for less than 48 weeks of TNF treatment had more total healthrelated absence days (22.5) than those with at least 48 weeks of TNF treatment (10.3). This was true for sick leave days (4.8 vs. 2.3; P=0.44) and short-term disability days (17.6 vs. 8.0; P=0.67). Conclusions: Persistence with anti-TNF treatment is associated with a trend toward reduced work absence, including sick leave and STD. These indirect costs must be taken into account when considering treatment options available to patients with IBD.
T1048 No New Safety Signals Identified in Crohn's Disease Patients Treated with Infliximab in An Interim Review of the ENCORE Registry Jean-Frédéric Colombel, Cosimo Prantera, Paul J. Rutgeerts, Julian Panes, Wolfgang E. Fleig, Geert D'Haens, Bernd Bokemeyer, Usha Barai, Maria Wiekowski BACKGROUND: Infliximab (IFX), a monoclonal antibody to TNFα, with potent anti-inflammatory effects, is approved in Europe to treat patients with refractory luminal and/or fistulizing Crohn's disease. METHODS: A prospective, observational, non-randomized, parallelgroup, post-marketing safety surveillance registry (ENCORE) was launched in 8 European countries to collect long-term (5-year) safety data in patients with Crohn's Disease treated with IFX or Non-Biologic therapies. Additionally, data on efficacy and health economics were also obtained. RESULTS: As of May 2007, 842 patients (61% F/39% M; mean age 37.5 years ± 12.67) received Non-Biologic Therapy, and 1166 (63% F/37% M; mean age 36.4 years ± 12.89) received IFX with median follow-up of 12.7 and 13.2 months, respectively. A total of 122 subjects switched from Non-Biologic therapy to IFX therapy. Follow-up patient years were 1016 for patients on Non-Biologic therapy and 1506 for patients on IFX therapy. Mean disease time since first diagnosis was 8 years for patients in the Non-Biologic therapy group and 9.1 years in the IFX group. The number of hospitalizations, need for narcotic analgesics, and treatment with methotrexate and azathioprine were greater at baseline for patients in the IFX group. More corticosteroids, sulfasalazine/5-ASA, and other Crohn's disease medications were used in the Non-Biologic Therapy group at baseline. Patients placed in the IFX group initially had a higher mean Harvey-Bradshaw severity score (8.4 compared to 6.3 in the Non-Biologic therapy group), more infections requiring antibiotics, and/or (draining) fistulae. This indicates that patients in the IFX group had more active and severe disease at baseline compared to those on Non-Biologic treatment. The incidence of overall adverse events was 53.7% in the IFX group compared to 41.2% in the Non-Biologic therapy group and the occurrence of Crohn's Disease related AEs was higher in the IFX group than in Non-Biologic group (12.9% vs. 8.05%). As previously shown, the incidence of serious infections (infections that were serious or considered severe) was slightly higher in the IFX group than in the Non-Biologic therapy group (2.8% vs. 1.7 % or 21.9 vs. 13.8 based on 1000 patient years of follow-up). Events like congestive heart failure, malignancies, and death were observed at an event rate of less than 1 percent, and treatment with IFX was not a predictor of risk for these events. CONCLUSION: In this interim data analysis of the 5 year ENCORE registry, long-term follow-up on approximately 2000 Crohn's Disease patients presented no new safety signals in those treated with IFX.
T1051 Clinical Efficacy of Infliximab in the Management of Postsurgical Recurring Crohn's Disease Naoki Yoshimura, Takaaki Kawaguchi, Minako Sako, Masakazu Takazoe BACKGROUND & OBJECTIVE: The postsurgical recurrence of Crohn's disease (CD) is a frequent event and most patients have several operations during their CD life. Hence, minimizing recurrence in the clinical management of postoperative CD is a major therapeutic objective. The anti-TNF-α, infliximab has efficacy in inducing and maintaining remission in patients with CD, but there is inadequate clinical data on its efficacy and safety in postsurgical CD. The objective of this investigation was to assess the efficacy of infliximab against recurring CD after surgery. METHODS: Between 2002 and 2007, we retrospectively investigated 280 patients with a CD activity index (CDAI) score of at least 150 points. Of 280 patients, 164 were non- operative and 116 were postoperative who had received iv infliximab (10mg/kg) at week 0 or at weeks 0, 2, 6. Clinical response was defined as a ≥70 point reduction in CDAI or CDAI below 150 points. Response rates at weeks 4 to 6 after initial infusion in the postoperative group were compared with those of the control group (non-operative). Additionally, the responders in the postoperative group were followed for at least 12 months by episodic (infusion of infliximab at every recurrences) or scheduled (infusion of infliximab every 8 weeks) as maintenance therapy together with 5-aminosalicylate and an immunomodulator (azathioprine). Long-term outcomes in both groups were evaluated by Kaplan-Meier survival analysis. RESULTS: Of 164 patients in the control group, 139 (84.8%) achieved remission vs 75 of 116 patients (64.7%) in the postoperative group. Further, 34 of 42 patients (81.0%) who received infliximab within a year after intestinal resection achieved remission vs 41 of 74 patients (55.4%) who received beyond one year (P<0.05). Similarly, 51 of 76 patients (67.1%) who underwent only one intestinal resection before infliximab therapy achieved remission vs 15 of 23 (65.2%) patients who underwent twice, and 9 of 17 (52.9%) who had more than 3 times resections. As the number of intestinal resections increased, the efficacy of infliximab appeared to decrease. Of the 75 responders in the postoperative group, 32 (16 episodic and 16 scheduled) were observed for more than 12 months in maintenance therapy. Ten of 16 patients (62.5%) in the episodic group underwent reoperation due to recurrence vs 2 of 16 (12.5%) patients in the scheduled group (P<0.01). Serious adverse events were not observed. CONCLUSIONS: In the management of postoperative CD, infliximab given at recurrence is effective in inducing remission and the scheduled maintenance therapy is superior to the episodic maintenance therapy for maintaining long-term remission.
T1049 A Survey Evaluating Patterns of Infliximab Use Amongst Canadian Gastroenterologists: Utilization of the Tailored Design Method Jennifer Jones, Remo Panaccione, Margaret Russell, Robert J. Hilsden Background: Physician response rates to surveys have been observed to be consistently low, but the surveys have frequently not used evidence-based methods to maximize response. Objectives: To evaluate physician response to a nationally administered, postal questionnaire designed in accordance to Dillman's Tailored Design methodology (TDM). A comprehensive, systematic review of the literature was also performed. Methods shown to increase odds of response to postal questionnaires by more than 25 percent were identified and incorporated into the study design. Methods: A nationally distributed, postal questionnaire, designed in accordance with TDM, was distributed to all practicing gastroenterologists captured in the 2007 membership of the Canadian Association of Gastroenterology. A pre-notice letter preceded the first questionnaire mail out and each physician was contacted up to a maximum of three times. A non-conditional $15 gift certificate for Chapters bookstore was included with the first questionnaire distribution. All questionnaires were accompanied by an abbreviated non-responder form, as well as a self-addressed, postage-affixed return envelope. Results: 336/466 persons responded (72%). 292/336 (63 percent) of respondents had completed questionnaires and 44 (13 percent) returned a non-responder form. Analysis of response rate by mail out was 57 percent (190/336) for the first contact, 23 percent (76/336) for the second contact and 20 percent (68/336) for the third contact. A greater proportion of nonresponders than responders were over 60 years of age, did not use Infliximab and had a practice profile of less than 30% of patient visits for inflammatory bowel disease. Conclusions: The TDM is an effective strategy for increasing physician response rates to self-administered questionnaires. Key design elements including the pre-notification letter, multiple contacts, and the inclusion of a non-conditional monetary incentive are essential components of this design method. TDM should be applied to future surveys targeting physicians.
AGA Abstracts
T1052 Endoscopic Balloon Dilation of Crohn's Strictures: Does the Need of Surgery Depend On Their Location? Thomas Müller, Bernd Rieder, Albrecht Pfeiffer BACKGROUND: Recently we demonstrated that endoscopic balloon dilation of Crohn`s strictures is safe and effective. Surgery may be avoided or at least postponed. Aim of the present study was to evaluate whether the location of the stricture effects the need of surgery. MATERIAL AND METHODS: Between Feb. 1999 and Nov. 2007 50 patients (20 males, 30 females, 41 (15-71) years) underwent 85 ballon dilations for 65 symptomatic strictures which were located as follows: colonic (15), ileocoecal valve (7), terminal ileum (26), ileocolonic anastomosis (17) and duodenum (1). Hydrostatic through the scope balloons were used with a diameter of 18 mm on inflation (Microvasive Rigiflex Ballons, Boston Scientific, Boston, MA, USA). RESULTS: In 47 (94%) out of the 50 patients, balloon dilation was technically successfull. 12 (24%) patients needed surgery within a median period of 1,5 (0-20) months. Indications were procedure related perforation of the terminal ileum (1, uneventfull recovery), technical failure of the procedure (2), persistent or recurrent obstructive symptoms (4), newly developped enteroenteric or enterovesical fistula during follow-up
A-472
AGA Abstracts
Impact of Anti-Tumor Necrosis Factor Therapies On Absence from Work Among Employees with Inflammatory Bowel Disease Heidi C. Waters, Nathan L. Kleinman, Spencer Borden, Wendy D. Lynch, Harold H. Gardner, Mirza I. Rahman Purpose:To investigate the effect of persistence with anti-tumor necrosis factor (anti-TNF) therapy on work related absences for employees with inflammatory bowel disease (IBD). Methods: A retrospective analysis using the HCMS Research Reference Database (RRDb) containing claims from large employers in the United States between January 1, 2001 and September 30, 2006 was conducted. Employees with IBD were identified using ICD-9 codes for Crohn's disease (555.xx) and ulcerative colitis (556.xx). The first diagnosis found in the data was defined as the index diagnosis date, and employees were required to have ≥12 months continuous enrollment following the index date. Anti-TNF treatment was identified based on the presence of medication J-Codes (J1745 infliximab; J1438 etanercept; J0135 adalimumab) or prescription pharmacy claims for these medications. Results: A total of 294,983 employees without IBD and 1,380 employees with IBD were analyzed. Employees with IBD who were treated for less than 48 weeks of TNF treatment had more total healthrelated absence days (22.5) than those with at least 48 weeks of TNF treatment (10.3). This was true for sick leave days (4.8 vs. 2.3; P=0.44) and short-term disability days (17.6 vs. 8.0; P=0.67). Conclusions: Persistence with anti-TNF treatment is associated with a trend toward reduced work absence, including sick leave and STD. These indirect costs must be taken into account when considering treatment options available to patients with IBD.
T1048 No New Safety Signals Identified in Crohn's Disease Patients Treated with Infliximab in An Interim Review of the ENCORE Registry Jean-Frédéric Colombel, Cosimo Prantera, Paul J. Rutgeerts, Julian Panes, Wolfgang E. Fleig, Geert D'Haens, Bernd Bokemeyer, Usha Barai, Maria Wiekowski BACKGROUND: Infliximab (IFX), a monoclonal antibody to TNFα, with potent anti-inflammatory effects, is approved in Europe to treat patients with refractory luminal and/or fistulizing Crohn's disease. METHODS: A prospective, observational, non-randomized, parallelgroup, post-marketing safety surveillance registry (ENCORE) was launched in 8 European countries to collect long-term (5-year) safety data in patients with Crohn's Disease treated with IFX or Non-Biologic therapies. Additionally, data on efficacy and health economics were also obtained. RESULTS: As of May 2007, 842 patients (61% F/39% M; mean age 37.5 years ± 12.67) received Non-Biologic Therapy, and 1166 (63% F/37% M; mean age 36.4 years ± 12.89) received IFX with median follow-up of 12.7 and 13.2 months, respectively. A total of 122 subjects switched from Non-Biologic therapy to IFX therapy. Follow-up patient years were 1016 for patients on Non-Biologic therapy and 1506 for patients on IFX therapy. Mean disease time since first diagnosis was 8 years for patients in the Non-Biologic therapy group and 9.1 years in the IFX group. The number of hospitalizations, need for narcotic analgesics, and treatment with methotrexate and azathioprine were greater at baseline for patients in the IFX group. More corticosteroids, sulfasalazine/5-ASA, and other Crohn's disease medications were used in the Non-Biologic Therapy group at baseline. Patients placed in the IFX group initially had a higher mean Harvey-Bradshaw severity score (8.4 compared to 6.3 in the Non-Biologic therapy group), more infections requiring antibiotics, and/or (draining) fistulae. This indicates that patients in the IFX group had more active and severe disease at baseline compared to those on Non-Biologic treatment. The incidence of overall adverse events was 53.7% in the IFX group compared to 41.2% in the Non-Biologic therapy group and the occurrence of Crohn's Disease related AEs was higher in the IFX group than in Non-Biologic group (12.9% vs. 8.05%). As previously shown, the incidence of serious infections (infections that were serious or considered severe) was slightly higher in the IFX group than in the Non-Biologic therapy group (2.8% vs. 1.7 % or 21.9 vs. 13.8 based on 1000 patient years of follow-up). Events like congestive heart failure, malignancies, and death were observed at an event rate of less than 1 percent, and treatment with IFX was not a predictor of risk for these events. CONCLUSION: In this interim data analysis of the 5 year ENCORE registry, long-term follow-up on approximately 2000 Crohn's Disease patients presented no new safety signals in those treated with IFX.
T1051 Clinical Efficacy of Infliximab in the Management of Postsurgical Recurring Crohn's Disease Naoki Yoshimura, Takaaki Kawaguchi, Minako Sako, Masakazu Takazoe BACKGROUND & OBJECTIVE: The postsurgical recurrence of Crohn's disease (CD) is a frequent event and most patients have several operations during their CD life. Hence, minimizing recurrence in the clinical management of postoperative CD is a major therapeutic objective. The anti-TNF-α, infliximab has efficacy in inducing and maintaining remission in patients with CD, but there is inadequate clinical data on its efficacy and safety in postsurgical CD. The objective of this investigation was to assess the efficacy of infliximab against recurring CD after surgery. METHODS: Between 2002 and 2007, we retrospectively investigated 280 patients with a CD activity index (CDAI) score of at least 150 points. Of 280 patients, 164 were non- operative and 116 were postoperative who had received iv infliximab (10mg/kg) at week 0 or at weeks 0, 2, 6. Clinical response was defined as a ≥70 point reduction in CDAI or CDAI below 150 points. Response rates at weeks 4 to 6 after initial infusion in the postoperative group were compared with those of the control group (non-operative). Additionally, the responders in the postoperative group were followed for at least 12 months by episodic (infusion of infliximab at every recurrences) or scheduled (infusion of infliximab every 8 weeks) as maintenance therapy together with 5-aminosalicylate and an immunomodulator (azathioprine). Long-term outcomes in both groups were evaluated by Kaplan-Meier survival analysis. RESULTS: Of 164 patients in the control group, 139 (84.8%) achieved remission vs 75 of 116 patients (64.7%) in the postoperative group. Further, 34 of 42 patients (81.0%) who received infliximab within a year after intestinal resection achieved remission vs 41 of 74 patients (55.4%) who received beyond one year (P<0.05). Similarly, 51 of 76 patients (67.1%) who underwent only one intestinal resection before infliximab therapy achieved remission vs 15 of 23 (65.2%) patients who underwent twice, and 9 of 17 (52.9%) who had more than 3 times resections. As the number of intestinal resections increased, the efficacy of infliximab appeared to decrease. Of the 75 responders in the postoperative group, 32 (16 episodic and 16 scheduled) were observed for more than 12 months in maintenance therapy. Ten of 16 patients (62.5%) in the episodic group underwent reoperation due to recurrence vs 2 of 16 (12.5%) patients in the scheduled group (P<0.01). Serious adverse events were not observed. CONCLUSIONS: In the management of postoperative CD, infliximab given at recurrence is effective in inducing remission and the scheduled maintenance therapy is superior to the episodic maintenance therapy for maintaining long-term remission.
T1049 A Survey Evaluating Patterns of Infliximab Use Amongst Canadian Gastroenterologists: Utilization of the Tailored Design Method Jennifer Jones, Remo Panaccione, Margaret Russell, Robert J. Hilsden Background: Physician response rates to surveys have been observed to be consistently low, but the surveys have frequently not used evidence-based methods to maximize response. Objectives: To evaluate physician response to a nationally administered, postal questionnaire designed in accordance to Dillman's Tailored Design methodology (TDM). A comprehensive, systematic review of the literature was also performed. Methods shown to increase odds of response to postal questionnaires by more than 25 percent were identified and incorporated into the study design. Methods: A nationally distributed, postal questionnaire, designed in accordance with TDM, was distributed to all practicing gastroenterologists captured in the 2007 membership of the Canadian Association of Gastroenterology. A pre-notice letter preceded the first questionnaire mail out and each physician was contacted up to a maximum of three times. A non-conditional $15 gift certificate for Chapters bookstore was included with the first questionnaire distribution. All questionnaires were accompanied by an abbreviated non-responder form, as well as a self-addressed, postage-affixed return envelope. Results: 336/466 persons responded (72%). 292/336 (63 percent) of respondents had completed questionnaires and 44 (13 percent) returned a non-responder form. Analysis of response rate by mail out was 57 percent (190/336) for the first contact, 23 percent (76/336) for the second contact and 20 percent (68/336) for the third contact. A greater proportion of nonresponders than responders were over 60 years of age, did not use Infliximab and had a practice profile of less than 30% of patient visits for inflammatory bowel disease. Conclusions: The TDM is an effective strategy for increasing physician response rates to self-administered questionnaires. Key design elements including the pre-notification letter, multiple contacts, and the inclusion of a non-conditional monetary incentive are essential components of this design method. TDM should be applied to future surveys targeting physicians.
AGA Abstracts
T1052 Endoscopic Balloon Dilation of Crohn's Strictures: Does the Need of Surgery Depend On Their Location? Thomas Müller, Bernd Rieder, Albrecht Pfeiffer BACKGROUND: Recently we demonstrated that endoscopic balloon dilation of Crohn`s strictures is safe and effective. Surgery may be avoided or at least postponed. Aim of the present study was to evaluate whether the location of the stricture effects the need of surgery. MATERIAL AND METHODS: Between Feb. 1999 and Nov. 2007 50 patients (20 males, 30 females, 41 (15-71) years) underwent 85 ballon dilations for 65 symptomatic strictures which were located as follows: colonic (15), ileocoecal valve (7), terminal ileum (26), ileocolonic anastomosis (17) and duodenum (1). Hydrostatic through the scope balloons were used with a diameter of 18 mm on inflation (Microvasive Rigiflex Ballons, Boston Scientific, Boston, MA, USA). RESULTS: In 47 (94%) out of the 50 patients, balloon dilation was technically successfull. 12 (24%) patients needed surgery within a median period of 1,5 (0-20) months. Indications were procedure related perforation of the terminal ileum (1, uneventfull recovery), technical failure of the procedure (2), persistent or recurrent obstructive symptoms (4), newly developped enteroenteric or enterovesical fistula during follow-up
A-472