- Email: [email protected]
W1239 Efficacy of Methotrexate in Ulcerative Colitis
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35.7 years (yrs). Median disease duration was 12.8 yrs. Twenty-five pts (21.2%) had a draining fistula at the time of first dose. All but five pts (96%) had received prior infliximab, and 51 were on systemic corticosteroids at the time of first dose (43%). Median length of follow-up after first dose was 13.7 months (mos). Induction strategies included 160/80 mg in 37 pts (31%), 80/40 mg in 49 pts (42%), and no induction in 24 pts (20%). The cumulative probability (cumprob) of any response (CR+PR) was 82% at 1 yr. CR was achieved in 49 pts, PR occurred in 46 pts, and 21 had NR. Maintenance dose escalation to 40 mg weekly was utilized in 59 pts (1 yr cumprob 54%). Among those with CR, 19 lost response during follow-up (1 yr cumprob 24.9%), though 2 pts regained CR after dose escalation. Of 25 pts with a baseline fistula, 9 had complete closure (36%). Among 51 patients on steroids at baseline, median daily dose was 20 mg, which decreased to a median of 0 mg during treatment. Fifty-eight pts required additional CD medications (1 yr cumprob 52%), 34 underwent surgery (1 yr cumprob 27%), and 25 experienced a CD complication (1 yr cumprob 18%) while on ADA. Sixty-four pts (54%) had a total of 117 AEs. Thirteen pts (11%) had 15 serious AEs, including 6 bacteremias, 2 deaths (suicide, PE), 1 suicide attempt, 1 basal cell carcinoma, and 4 other infections. Overall, 16 pts (14%) discontinued ADA due to an AE. Eighty pts (68%) remained on ADA at last follow-up (median duration, 11.3 mos). Conclusions: ADA was both effective and well-tolerated for the treatment of CD in this tertiary practice with a high prevalence of previous infliximab exposure.
AGA Abstracts
The Remitrac Infusion Registry: Safety and Management of Infliximab Infusions in a Real-Life Setting Rafat Faraawi, Majed Khraishi, Denis Choquette, William Bensen, Francois Nantel Objective and Method: RemiTRAC INFUSION is a Canadian registry in which patients receiving Infliximab (IFX) are followed prospectively to document medication use, adverse events, infusion reactions and management of infusion reactions. The registry started in August 2005. Results: After 2 years, 383 patients were enrolled of whom 192 (54%) were at their first IFX infusion. A total of 2519 infusions were recorded with a mean of 6.7 ± 4.1 infusions per patient representing 282.3 years of exposure. The majority of patients (n = 205, 54%) had rheumatoid arthritis (RA) whereas 10% of the patients had Crohn's disease (CD, n=39). Interim results show that the incidence of infusion reactions in all patients was low (56/2519 or 2.22%) and almost all reactions were mild to moderate in severity (52/ 56). No serious infusion reactions were recorded in the study. The rate of infusion reactions was similar between CD patients (4/191 infusions or 2.1%) and RA patients (44/1548 infusions or 2.8%). Pre-treatment data show that a high proportion of IFX infusions in patients with CD were administered with antihistamines (42%), steroids (62%) or acetaminophen (19%). However, in patients with RA, a much smaller proportion of IFX infusions were administered with antihistamines (20%), steroids (10%) or acetaminophen (5%). In all patients, most infusion reactions were managed by slowing the infusion rate (30%), infusing saline (71%) and/or by treatment with anti-histamines (70%), steroids (29%) or acetaminophen (13%). The majority of patients (>70%) with infusion reactions were subsequently pre-treated with anti-histamines, steroids or acetaminophen. However, only acetaminophen appeared to decrease the overall incidence of infusion reactions. Patients who were on immunosuppressive drugs upon study entry did not appear to have more infusion reactions (30/1770 or 2.2%) than those who were not (17/749 or 2.3%). Patients who were on corticosteroids upon study entry had a 4% incidence of infusion reaction (26/655) in contrast to only 1.6% (30/1864) in subjects who were not. Serious adverse events were reported in 45 patients and included diarrhea, pneumonia, cellulitis, tachycardia and urinary tract infections. There were 2 malignancies, one breast cancer and a fibroma of the uterus. Conclusions: This registry shows that, in a real-life setting, infusion reactions to Infliximab occur at a low incidence, are mainly mild to moderate in severity and are easily managed by health care professionals.
W1241 Does Immunogenicity Play a Role in Adalimumab Treatment for Crohn's Disease? Rachel L. West, Zuzana Zelinkova, Gertjan Wolbink, E. J. Kuipers, Pieter C. Stokkers, Christien J. van der Woude Purpose: Infliximab, a chimeric monoclonal antibody to TNF, is an effective treatment for patients with Crohn's disease (CD). Chimeric antibodies like infliximab lead to antibody formation. Subsequently these antibodies to infliximab (ATIs) can lead to allergic reactions and to loss of efficacy. Adalimumab, a recombinant fully humanized monoclonal antibody has also found to be effective in CD. Little is known about the effect of ATIs and antibodies to adalimumab (ATAs) on adalimumab treatment outcome in CD patients previously treated with infliximab. The aim of this study was to assess whether ATAs or ATIs affect the efficacy of adalimumab therapy in CD patients. Methods: Patients with active luminal or fistulizing CD who failed to respond or were intolerant to infliximab were treated with adalimumab. The following subcutaneous regimen was used: 160 mg at week 0, 80 mg at week 2 and 40 mg every 2 weeks. Clinical response and side effects were assessed. The serum ATAs and ATIs levels were determined by a radioimmunoassay (cut-off values 12.4 AE/mL) during and prior to adalimumab treatment. Results: In total 36 patients (M/F (9/27), median age 35 yrs, range 21-73) were included: 24 with luminal and 12 with fistulizing CD. Infliximab treatment was stopped due to a failed response (6/36), intolerance (25/36) and unknown reasons (5/36). Median adalimumab treatment duration was 313 days (range 71-632). Clinical response was 72% (responders (R): 26, non-responders (NR): 10) and side effects were observed in 42% (15/36) of patients. In 25 (19 R/6 NR) patients ATAs were assessed, of which 5 (20%) had positive ATAs. Of the 20 patients with negative ATAs; 18 (90%) were responders. The presence of ATAs was related to non-response to adalimumab (OR 12.7; CI: 1.7-92.6; p=0.05). ATIs were positive in 18 of 36 patients (50%), the mean ATIs level was 270.6±86.4 (SEM) AE/ml. ATIs levels were significantly increased in adalimumab non-responders (R vs.NR: 597.4±261.0 vs. 144.9±52.6 AE/mL, p<0.01). No relationship between the presence of ATIs and ATAs was observed. Conclusions: Immunogenicity negatively influences response to adalimumab treatment due to the development of antibodies to adalimumab. In addition, high levels of antibodies to infliximab resulting from previous treatment may have an impact on therapeutic outcome of adalimumab.
W1239 Efficacy of Methotrexate in Ulcerative Colitis Mahmood Wahed, John R. Louis-Auguste, Louisa M. Baxter, Jimmy K. Limdi, Sara McCartney, Stuart L. Bloom, James O. Lindsay Introduction: The use of thiopurine therapy in the management of ulcerative colitis (UC) is widespread. In those patients who fail to respond or are intolerant of thiopurines, management remains a challenge. Data on the use of methotrexate in ulcerative colitis is limited to a negative, inappropriately dosed, randomised controlled trial and small case series (1). Aims and Methods: The aim of this study was to investigate the efficacy and safety profile of methotrexate in UC. Patients at the IBD clinics of University College London Hospital and Barts and the London NHS trust were identified using the units' databases. Retrospective data was obtained by case note review. Clinical response (defined as steroid withdrawal, normalisation of previously raised C reactive protein (CRP), or physician's clinical assessment of improvement) was assessed at 6 months. Results: Between 2001 and September 2007, 32 patients (median (range) age 43 (22-88)) with UC were treated with methotrexate. The duration of disease prior to methotrexate was 72 (range 12-290) months. All had previously been on a thiopurine for a median duration of 28 (2-468) weeks. These were discontinued due to lack of response in 9 (28%) and intolerance in 23 (72%). The median (range) induction dose of methotrexate (combination of oral and parenteral) used was 25 (10-25) mg/ week followed by a maintenance dose of 20 (10-25) mg/week. Methotrexate was continued for 55 (2 - 290) weeks. Clinical response assessed at 6 months was achieved in 22/32 (68%), this included 7/9 (78%) in the thiopurine refractory group and 14/21 (63%) in the intolerant group. Steroid withdrawal was possible in 7 out of 16 patients on steroids at baseline, and a normalisation of previously raised C reactive protein (CRP) in 4 out of the 15 patients. Side effects: bone marrow suppression; abnormal liver function tests (LFTs); nausea and vomiting; and hair loss occurred in 5 (16%), but only warranted discontinuation in 3(9.3%) (abnormal LFTs (n=1), nausea and vomiting (1), hair loss (1)). Conclusion: Methotrexate appears effective in ulcerative colitis in patients who either fail to respond or are intolerant to a thiopurines. It is also well tolerated in the majority of patients. Reference: [1] Oren R et al. Methotrexate in chronic active ulcerative colitis: A double-blind, randomized, Israeli multicenter trial. Gastroenterology. 1996 May; 110(5):1416-21
W1242 Patient Preferences for Subcutaneous Versus Intravenous Formulations of Anti-TNF Agents for Treatment of Inflammatory Bowel Disease Suresh Pitchumoni, Ellen J. Scherl, Brian P. Bosworth, Thomas C. Lee, Michael A. Poles Background: Biologic therapies, especially anti-TNF agents, are increasingly recognized as early as early interventions in patients with inflammatory bowel disease (IBD). All data, thus far, suggests similar efficacy and toxicity for infliximab, adalimumab, and certolizumab pegol. The greatest difference between these medications is therefore their mode of delivery, their schedule of administration and adherence. We therefore sought to determine the proportion of patients with IBD who prefer subcutaneous (SQ) versus intravenous (IV) formulations of ant-TNF agents, and to determine predictors of a strong preference for these formulations. Methods: An anonymous survey was conducted among IBD patients visiting GI outpatient clinics at the Manhattan VA Hospital, Bellevue Hospital, NYU Medical Center, and the Roberts IBD Center of Cornell University. Patients were asked about their demographics, attitudes and preferences towards anti-TNF agents and their mode and schedule of delivery. Results: The survey was completed by 50 patients, of which 27 were diagnosed with CD, 20 with UC, and 3 with indeterminate colitis. While 54.3% of patients expressed a preference for the SQ route of therapy, 56% of those who preferred SQ therapy, rated this preference as strong. In comparison, of the 45.7% of patients expressed a preference for IV therapy, only 28.6% of such patients rated this preference as strong. Among subjects who are presently receiving IV therapy, 67% expressed a preference for IV therapy, while 100% of subjects receiving SQ therapy and 100% who have experienced both routes of delivery of anti-TNF agents prefer the SQ route. Multiple factors were significantly associated with a strong preference for SQ and for IV therapies, the top four for each are presented in the table. Conclusions: While a slightly greater percentage of patients expressed a preference for the SQ route of delivery of anti-TNF therapies, they were more likely to express a strong preference, compared to those who preferred intravenous therapies. Present use of SQ or IV therapy predicted current preferences, though patients who had experienced both routes preferred the SQ administration. The impact of patient preferences in selecting anti-TNF agents, as well as on patient adherence, requires further study.
W1240 Adalimumab for Crohn's Disease in Clinical Practice At An Academic Medical Center: the First 118 Patients Jason M. Swoger, Edward V. Loftus, Darrell S. Pardi, Sunanda V. Kane, William J. Tremaine, Yuning Xiong, Karen A. Hanson, William S. Harmsen, Alan R. Zinsmeister, William J. Sandborn Background: Adalimumab (ADA) was approved for the treatment of rheumatoid arthritis in 2003, and for induction and maintenance of remission in moderate to severe Crohn's disease (CD) in 2007. Our practice has been prescribing ADA for CD since 2003. Aims: To assess the efficacy and safety of ADA for CD in our referral-based practice. Methods: We conducted an electronic search of all clinical notes from 2003-2007. Notes were searched for ‘adalimumab' or ‘Humira'. Records of all patients (pts) identified through this search were reviewed to ensure they received at least one ADA dose. The primary outcome was clinical response to ADA for CD (complete response [CR], partial response [PR], or no response [NR]). Secondary outcomes included steroid sparing, maintenance of response, and occurrence of adverse events (AEs). Results: A total of 118 pts were prescribed ADA for CD between 1/ 1/03 and 7/1/07. Seventy-three pts were female (62%), and median age at first dose was
AGA Abstracts
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35.7 years (yrs). Median disease duration was 12.8 yrs. Twenty-five pts (21.2%) had a draining fistula at the time of first dose. All but five pts (96%) had received prior infliximab, and 51 were on systemic corticosteroids at the time of first dose (43%). Median length of follow-up after first dose was 13.7 months (mos). Induction strategies included 160/80 mg in 37 pts (31%), 80/40 mg in 49 pts (42%), and no induction in 24 pts (20%). The cumulative probability (cumprob) of any response (CR+PR) was 82% at 1 yr. CR was achieved in 49 pts, PR occurred in 46 pts, and 21 had NR. Maintenance dose escalation to 40 mg weekly was utilized in 59 pts (1 yr cumprob 54%). Among those with CR, 19 lost response during follow-up (1 yr cumprob 24.9%), though 2 pts regained CR after dose escalation. Of 25 pts with a baseline fistula, 9 had complete closure (36%). Among 51 patients on steroids at baseline, median daily dose was 20 mg, which decreased to a median of 0 mg during treatment. Fifty-eight pts required additional CD medications (1 yr cumprob 52%), 34 underwent surgery (1 yr cumprob 27%), and 25 experienced a CD complication (1 yr cumprob 18%) while on ADA. Sixty-four pts (54%) had a total of 117 AEs. Thirteen pts (11%) had 15 serious AEs, including 6 bacteremias, 2 deaths (suicide, PE), 1 suicide attempt, 1 basal cell carcinoma, and 4 other infections. Overall, 16 pts (14%) discontinued ADA due to an AE. Eighty pts (68%) remained on ADA at last follow-up (median duration, 11.3 mos). Conclusions: ADA was both effective and well-tolerated for the treatment of CD in this tertiary practice with a high prevalence of previous infliximab exposure.
AGA Abstracts
The Remitrac Infusion Registry: Safety and Management of Infliximab Infusions in a Real-Life Setting Rafat Faraawi, Majed Khraishi, Denis Choquette, William Bensen, Francois Nantel Objective and Method: RemiTRAC INFUSION is a Canadian registry in which patients receiving Infliximab (IFX) are followed prospectively to document medication use, adverse events, infusion reactions and management of infusion reactions. The registry started in August 2005. Results: After 2 years, 383 patients were enrolled of whom 192 (54%) were at their first IFX infusion. A total of 2519 infusions were recorded with a mean of 6.7 ± 4.1 infusions per patient representing 282.3 years of exposure. The majority of patients (n = 205, 54%) had rheumatoid arthritis (RA) whereas 10% of the patients had Crohn's disease (CD, n=39). Interim results show that the incidence of infusion reactions in all patients was low (56/2519 or 2.22%) and almost all reactions were mild to moderate in severity (52/ 56). No serious infusion reactions were recorded in the study. The rate of infusion reactions was similar between CD patients (4/191 infusions or 2.1%) and RA patients (44/1548 infusions or 2.8%). Pre-treatment data show that a high proportion of IFX infusions in patients with CD were administered with antihistamines (42%), steroids (62%) or acetaminophen (19%). However, in patients with RA, a much smaller proportion of IFX infusions were administered with antihistamines (20%), steroids (10%) or acetaminophen (5%). In all patients, most infusion reactions were managed by slowing the infusion rate (30%), infusing saline (71%) and/or by treatment with anti-histamines (70%), steroids (29%) or acetaminophen (13%). The majority of patients (>70%) with infusion reactions were subsequently pre-treated with anti-histamines, steroids or acetaminophen. However, only acetaminophen appeared to decrease the overall incidence of infusion reactions. Patients who were on immunosuppressive drugs upon study entry did not appear to have more infusion reactions (30/1770 or 2.2%) than those who were not (17/749 or 2.3%). Patients who were on corticosteroids upon study entry had a 4% incidence of infusion reaction (26/655) in contrast to only 1.6% (30/1864) in subjects who were not. Serious adverse events were reported in 45 patients and included diarrhea, pneumonia, cellulitis, tachycardia and urinary tract infections. There were 2 malignancies, one breast cancer and a fibroma of the uterus. Conclusions: This registry shows that, in a real-life setting, infusion reactions to Infliximab occur at a low incidence, are mainly mild to moderate in severity and are easily managed by health care professionals.
W1241 Does Immunogenicity Play a Role in Adalimumab Treatment for Crohn's Disease? Rachel L. West, Zuzana Zelinkova, Gertjan Wolbink, E. J. Kuipers, Pieter C. Stokkers, Christien J. van der Woude Purpose: Infliximab, a chimeric monoclonal antibody to TNF, is an effective treatment for patients with Crohn's disease (CD). Chimeric antibodies like infliximab lead to antibody formation. Subsequently these antibodies to infliximab (ATIs) can lead to allergic reactions and to loss of efficacy. Adalimumab, a recombinant fully humanized monoclonal antibody has also found to be effective in CD. Little is known about the effect of ATIs and antibodies to adalimumab (ATAs) on adalimumab treatment outcome in CD patients previously treated with infliximab. The aim of this study was to assess whether ATAs or ATIs affect the efficacy of adalimumab therapy in CD patients. Methods: Patients with active luminal or fistulizing CD who failed to respond or were intolerant to infliximab were treated with adalimumab. The following subcutaneous regimen was used: 160 mg at week 0, 80 mg at week 2 and 40 mg every 2 weeks. Clinical response and side effects were assessed. The serum ATAs and ATIs levels were determined by a radioimmunoassay (cut-off values 12.4 AE/mL) during and prior to adalimumab treatment. Results: In total 36 patients (M/F (9/27), median age 35 yrs, range 21-73) were included: 24 with luminal and 12 with fistulizing CD. Infliximab treatment was stopped due to a failed response (6/36), intolerance (25/36) and unknown reasons (5/36). Median adalimumab treatment duration was 313 days (range 71-632). Clinical response was 72% (responders (R): 26, non-responders (NR): 10) and side effects were observed in 42% (15/36) of patients. In 25 (19 R/6 NR) patients ATAs were assessed, of which 5 (20%) had positive ATAs. Of the 20 patients with negative ATAs; 18 (90%) were responders. The presence of ATAs was related to non-response to adalimumab (OR 12.7; CI: 1.7-92.6; p=0.05). ATIs were positive in 18 of 36 patients (50%), the mean ATIs level was 270.6±86.4 (SEM) AE/ml. ATIs levels were significantly increased in adalimumab non-responders (R vs.NR: 597.4±261.0 vs. 144.9±52.6 AE/mL, p<0.01). No relationship between the presence of ATIs and ATAs was observed. Conclusions: Immunogenicity negatively influences response to adalimumab treatment due to the development of antibodies to adalimumab. In addition, high levels of antibodies to infliximab resulting from previous treatment may have an impact on therapeutic outcome of adalimumab.
W1239 Efficacy of Methotrexate in Ulcerative Colitis Mahmood Wahed, John R. Louis-Auguste, Louisa M. Baxter, Jimmy K. Limdi, Sara McCartney, Stuart L. Bloom, James O. Lindsay Introduction: The use of thiopurine therapy in the management of ulcerative colitis (UC) is widespread. In those patients who fail to respond or are intolerant of thiopurines, management remains a challenge. Data on the use of methotrexate in ulcerative colitis is limited to a negative, inappropriately dosed, randomised controlled trial and small case series (1). Aims and Methods: The aim of this study was to investigate the efficacy and safety profile of methotrexate in UC. Patients at the IBD clinics of University College London Hospital and Barts and the London NHS trust were identified using the units' databases. Retrospective data was obtained by case note review. Clinical response (defined as steroid withdrawal, normalisation of previously raised C reactive protein (CRP), or physician's clinical assessment of improvement) was assessed at 6 months. Results: Between 2001 and September 2007, 32 patients (median (range) age 43 (22-88)) with UC were treated with methotrexate. The duration of disease prior to methotrexate was 72 (range 12-290) months. All had previously been on a thiopurine for a median duration of 28 (2-468) weeks. These were discontinued due to lack of response in 9 (28%) and intolerance in 23 (72%). The median (range) induction dose of methotrexate (combination of oral and parenteral) used was 25 (10-25) mg/ week followed by a maintenance dose of 20 (10-25) mg/week. Methotrexate was continued for 55 (2 - 290) weeks. Clinical response assessed at 6 months was achieved in 22/32 (68%), this included 7/9 (78%) in the thiopurine refractory group and 14/21 (63%) in the intolerant group. Steroid withdrawal was possible in 7 out of 16 patients on steroids at baseline, and a normalisation of previously raised C reactive protein (CRP) in 4 out of the 15 patients. Side effects: bone marrow suppression; abnormal liver function tests (LFTs); nausea and vomiting; and hair loss occurred in 5 (16%), but only warranted discontinuation in 3(9.3%) (abnormal LFTs (n=1), nausea and vomiting (1), hair loss (1)). Conclusion: Methotrexate appears effective in ulcerative colitis in patients who either fail to respond or are intolerant to a thiopurines. It is also well tolerated in the majority of patients. Reference: [1] Oren R et al. Methotrexate in chronic active ulcerative colitis: A double-blind, randomized, Israeli multicenter trial. Gastroenterology. 1996 May; 110(5):1416-21
W1242 Patient Preferences for Subcutaneous Versus Intravenous Formulations of Anti-TNF Agents for Treatment of Inflammatory Bowel Disease Suresh Pitchumoni, Ellen J. Scherl, Brian P. Bosworth, Thomas C. Lee, Michael A. Poles Background: Biologic therapies, especially anti-TNF agents, are increasingly recognized as early as early interventions in patients with inflammatory bowel disease (IBD). All data, thus far, suggests similar efficacy and toxicity for infliximab, adalimumab, and certolizumab pegol. The greatest difference between these medications is therefore their mode of delivery, their schedule of administration and adherence. We therefore sought to determine the proportion of patients with IBD who prefer subcutaneous (SQ) versus intravenous (IV) formulations of ant-TNF agents, and to determine predictors of a strong preference for these formulations. Methods: An anonymous survey was conducted among IBD patients visiting GI outpatient clinics at the Manhattan VA Hospital, Bellevue Hospital, NYU Medical Center, and the Roberts IBD Center of Cornell University. Patients were asked about their demographics, attitudes and preferences towards anti-TNF agents and their mode and schedule of delivery. Results: The survey was completed by 50 patients, of which 27 were diagnosed with CD, 20 with UC, and 3 with indeterminate colitis. While 54.3% of patients expressed a preference for the SQ route of therapy, 56% of those who preferred SQ therapy, rated this preference as strong. In comparison, of the 45.7% of patients expressed a preference for IV therapy, only 28.6% of such patients rated this preference as strong. Among subjects who are presently receiving IV therapy, 67% expressed a preference for IV therapy, while 100% of subjects receiving SQ therapy and 100% who have experienced both routes of delivery of anti-TNF agents prefer the SQ route. Multiple factors were significantly associated with a strong preference for SQ and for IV therapies, the top four for each are presented in the table. Conclusions: While a slightly greater percentage of patients expressed a preference for the SQ route of delivery of anti-TNF therapies, they were more likely to express a strong preference, compared to those who preferred intravenous therapies. Present use of SQ or IV therapy predicted current preferences, though patients who had experienced both routes preferred the SQ administration. The impact of patient preferences in selecting anti-TNF agents, as well as on patient adherence, requires further study.
W1240 Adalimumab for Crohn's Disease in Clinical Practice At An Academic Medical Center: the First 118 Patients Jason M. Swoger, Edward V. Loftus, Darrell S. Pardi, Sunanda V. Kane, William J. Tremaine, Yuning Xiong, Karen A. Hanson, William S. Harmsen, Alan R. Zinsmeister, William J. Sandborn Background: Adalimumab (ADA) was approved for the treatment of rheumatoid arthritis in 2003, and for induction and maintenance of remission in moderate to severe Crohn's disease (CD) in 2007. Our practice has been prescribing ADA for CD since 2003. Aims: To assess the efficacy and safety of ADA for CD in our referral-based practice. Methods: We conducted an electronic search of all clinical notes from 2003-2007. Notes were searched for ‘adalimumab' or ‘Humira'. Records of all patients (pts) identified through this search were reviewed to ensure they received at least one ADA dose. The primary outcome was clinical response to ADA for CD (complete response [CR], partial response [PR], or no response [NR]). Secondary outcomes included steroid sparing, maintenance of response, and occurrence of adverse events (AEs). Results: A total of 118 pts were prescribed ADA for CD between 1/ 1/03 and 7/1/07. Seventy-three pts were female (62%), and median age at first dose was
AGA Abstracts
A-662