BMC Gastroenterology. 2010;10:26
Abstract
Background: The effect of thiopurine immunomodulators on health-related quality of life (HRQoL) in patients with inflammatory bowel disease (IBD) has been controversial. The aims were to evaluate the HRQoL in patients with IBD treated with thiopurines and assess the short- and long-term impacts of the treatment on HRQoL.
Methods: Ninety-two consecutive patients who started treatment with thiopurines were prospectively included. Evaluation of HRQoL was performed at months 0, 6, and 12 using two questionnaires, the Short-Form Health Survey (SF-36) and the Inflammatory Bowel Disease Questionnaire (IBDQ).
Results: Baseline score of IBDQ was 4,6, range (2,31–6,84), with an impairment of the five dimensions of HRQoL compared with inactive patients. Results obtained in 8 dimensions of SF-36 showed worse HRQoL than Spanish general population. At 6 months patients had a significant improvement in overall IBDQ score -5,8 (1,58 -6,97)- and also in all IBDQ dimensions. All the 8 dimensions of SF-36 obtained a significant improvement. At twelve months score of IBDQ was 6,1, range (2,7–6,98), with improvement in all dimensions compared with baseline and 6 months. SF-36 showed a similar significant improvement in all subscales.
Conclusions: Thiopurine immunomodulators alone or with other treatments have a positive and long lasting impact on HRQoL of IBD patients.
Abstract
Background: The effect of thiopurine immunomodulators on health-related quality of life (HRQoL) in patients with inflammatory bowel disease (IBD) has been controversial. The aims were to evaluate the HRQoL in patients with IBD treated with thiopurines and assess the short- and long-term impacts of the treatment on HRQoL.
Methods: Ninety-two consecutive patients who started treatment with thiopurines were prospectively included. Evaluation of HRQoL was performed at months 0, 6, and 12 using two questionnaires, the Short-Form Health Survey (SF-36) and the Inflammatory Bowel Disease Questionnaire (IBDQ).
Results: Baseline score of IBDQ was 4,6, range (2,31–6,84), with an impairment of the five dimensions of HRQoL compared with inactive patients. Results obtained in 8 dimensions of SF-36 showed worse HRQoL than Spanish general population. At 6 months patients had a significant improvement in overall IBDQ score -5,8 (1,58 -6,97)- and also in all IBDQ dimensions. All the 8 dimensions of SF-36 obtained a significant improvement. At twelve months score of IBDQ was 6,1, range (2,7–6,98), with improvement in all dimensions compared with baseline and 6 months. SF-36 showed a similar significant improvement in all subscales.
Conclusions: Thiopurine immunomodulators alone or with other treatments have a positive and long lasting impact on HRQoL of IBD patients.
Methods
Study Population
Participants were recruited from a single Spanish hospital. The diagnoses of IBD were made according to the Lennard-Jones criteria[30] and patients were classified in accordance with the Montreal classification.[31] In patients with CD, age at diagnosis, lesion location (ileum, colon, ileum and colon or upper gastrointestinal tract), disease behavior (stricturing, penetrating or nonstricturing and nonpenetrating) and the presence of perianal disease were recorded to classify the subjects. UC was classified into three subgroups: ulcerative proctitis; left-sided UC (distal UC); and extensive UC (pancolitis).
We prospectively and consecutively studied all adult subjects with IBD either attending as outpatients or during hospital admission who started treatment with thiopurines. The indications to initiate thiopurines in both CD and UC were steroid dependency, induction of remission, and maintenance treatment after a severe flare. In patients with CD, thiopurines were additionally used to treat perianal disease, to treat extensive disease, and to prevent postsurgical recurrence.
All patients who underwent surgery were endoscopically evaluated after 12 months, recurrence in the neoterminal ileum was defined by a Rutgeerts score > = 1. In case of recurrence, patients were started with Azathioprine. The patients who started thiopurines immediately after surgery were not eligible for the study.
Induction treatment with infliximab, at three doses of 5 mg/Kg, was allowed at the beginning of the study, those patients who received maintenance treatment with infliximab were excluded. The treatment was considered as failure if the patient required infliximab or surgery during the follow up.
Treatment
All patients were treated initially with azathioprine. Although the enzyme activity of thiopurine methyltransferase (TPMT) was measured at the beginning of treatment, AZA was started at 50 mg daily and was increased to a target dose of 2.5 mg/kg within the first month of follow up.[32]
HRQoL Assessment
Prospective evaluation of HRQoL was performed at months 0, 6, and 12 using two questionnaires, the Medical Outcomes Study 36-Item Short-Form Health Survey (SF-36) and the Inflammatory Bowel Disease Questionnaire (IBDQ). The SF-36 is a generic questionnaire containing 36 items.[33] Thirty-five of the items are grouped into eight multi-item scales. The eight domains of the SF-36 are as follows: physical function (10 items); social function (two items); role limitations due to physical problems (four items); role limitations due to emotional problems (three items); energy/vitality (four items); mental health (five items); bodily pain (two items); and general health perception (five items). In addition, it contains a one-item measure of self-evaluated change in health status (health transition) over the previous year. For each question, the raw score was coded and transformed into a percentage on a scale of 0 to 100, with 0 indicating the least favorable possible health status and 100 indicating the most favorable. The questionnaire has been translated into Spanish and validated.[34] The disease-specific questionnaire used, the IBDQ, was the 36-item version by Love et al,[2] a self-administered questionnaire that has been previously validated for use in Spain.[35] The 36 items are grouped into five domains of health: bowel symptoms; systemic symptoms; functional impairment; social impairment; and emotional function. Responses are scored on a 7-point Likert scale, in which 7 corresponds to the highest level of functioning. The instrument produces five dimension scores and an overall IBDQ score ranging from 1 to 7, where a higher score reflects better HRQoL.
Assessment of Clinical Activity and Definitions of Remission
Disease activity was assessed with the Crohn's Disease Activity Index (CDAI) in patients with CD and with Mayo Clinic Score or the Disease Activity Index (CAI) in patients with UC.[36,37] Eight variables determine the CDAI score: the number of liquid stools; the extent of abdominal pain; general well-being; the occurrence of extraintestinal symptoms; the need for antidiarrheal drugs; the presence of abdominal masses; hematocrit; and body weight. In order to calculate the CDAI, the patient completed a symptom diary for the seven days before each visit. Remission was defined as defined by a CDAI score < 150. The Mayo Score consists of four items: stool frequency; rectal bleeding; findings of flexible proctosigmoidoscopy; and the Physician Global Assessment. Scores range from 0 to 12 points. Complete response (remission) is defined as complete resolution of (1) stool frequency (normal stool frequency), (2) rectal bleeding (no rectal bleeding), and (3) patient's functional assessment score (generally well). If colonoscopy was available, normal endoscopy findings were also required. The patients should be free of steroids to be considered in remission.
Study Design and Follow up
Patients were enrolled prospectively. Demographic data were recorded during the first visit. Blood samples were taken before starting on AZA, and TPMT activity was measured. Patients were clinically evaluated at baseline, at two, four and 12 weeks, and then every three months until the end of the study. HRQoL assessment was performed at the beginning and after six and 12 months of therapy. Patients were also evaluated throughout the study period whenever they had a medical problem. At each visit, a complete physical exam was performed and patients were asked about symptoms and any systemic manifestations of the disease or its treatment. Scores of activity were calculated. Data on the use of steroids and other concomitant treatments were obtained. Those patients who discontinued their medication because of adverse events or reactions were followed in the same way as those who continued to receive therapy. In cases of treatment failure, HRQoL assessment was performed before new treatment was administered.
Abstract
Background: The effect of thiopurine immunomodulators on health-related quality of life (HRQoL) in patients with inflammatory bowel disease (IBD) has been controversial. The aims were to evaluate the HRQoL in patients with IBD treated with thiopurines and assess the short- and long-term impacts of the treatment on HRQoL.
Methods: Ninety-two consecutive patients who started treatment with thiopurines were prospectively included. Evaluation of HRQoL was performed at months 0, 6, and 12 using two questionnaires, the Short-Form Health Survey (SF-36) and the Inflammatory Bowel Disease Questionnaire (IBDQ).
Results: Baseline score of IBDQ was 4,6, range (2,31–6,84), with an impairment of the five dimensions of HRQoL compared with inactive patients. Results obtained in 8 dimensions of SF-36 showed worse HRQoL than Spanish general population. At 6 months patients had a significant improvement in overall IBDQ score -5,8 (1,58 -6,97)- and also in all IBDQ dimensions. All the 8 dimensions of SF-36 obtained a significant improvement. At twelve months score of IBDQ was 6,1, range (2,7–6,98), with improvement in all dimensions compared with baseline and 6 months. SF-36 showed a similar significant improvement in all subscales.
Conclusions: Thiopurine immunomodulators alone or with other treatments have a positive and long lasting impact on HRQoL of IBD patients.
Abstract
Background: The effect of thiopurine immunomodulators on health-related quality of life (HRQoL) in patients with inflammatory bowel disease (IBD) has been controversial. The aims were to evaluate the HRQoL in patients with IBD treated with thiopurines and assess the short- and long-term impacts of the treatment on HRQoL.
Methods: Ninety-two consecutive patients who started treatment with thiopurines were prospectively included. Evaluation of HRQoL was performed at months 0, 6, and 12 using two questionnaires, the Short-Form Health Survey (SF-36) and the Inflammatory Bowel Disease Questionnaire (IBDQ).
Results: Baseline score of IBDQ was 4,6, range (2,31–6,84), with an impairment of the five dimensions of HRQoL compared with inactive patients. Results obtained in 8 dimensions of SF-36 showed worse HRQoL than Spanish general population. At 6 months patients had a significant improvement in overall IBDQ score -5,8 (1,58 -6,97)- and also in all IBDQ dimensions. All the 8 dimensions of SF-36 obtained a significant improvement. At twelve months score of IBDQ was 6,1, range (2,7–6,98), with improvement in all dimensions compared with baseline and 6 months. SF-36 showed a similar significant improvement in all subscales.
Conclusions: Thiopurine immunomodulators alone or with other treatments have a positive and long lasting impact on HRQoL of IBD patients.
Methods
Study Population
Participants were recruited from a single Spanish hospital. The diagnoses of IBD were made according to the Lennard-Jones criteria[30] and patients were classified in accordance with the Montreal classification.[31] In patients with CD, age at diagnosis, lesion location (ileum, colon, ileum and colon or upper gastrointestinal tract), disease behavior (stricturing, penetrating or nonstricturing and nonpenetrating) and the presence of perianal disease were recorded to classify the subjects. UC was classified into three subgroups: ulcerative proctitis; left-sided UC (distal UC); and extensive UC (pancolitis).
We prospectively and consecutively studied all adult subjects with IBD either attending as outpatients or during hospital admission who started treatment with thiopurines. The indications to initiate thiopurines in both CD and UC were steroid dependency, induction of remission, and maintenance treatment after a severe flare. In patients with CD, thiopurines were additionally used to treat perianal disease, to treat extensive disease, and to prevent postsurgical recurrence.
All patients who underwent surgery were endoscopically evaluated after 12 months, recurrence in the neoterminal ileum was defined by a Rutgeerts score > = 1. In case of recurrence, patients were started with Azathioprine. The patients who started thiopurines immediately after surgery were not eligible for the study.
Induction treatment with infliximab, at three doses of 5 mg/Kg, was allowed at the beginning of the study, those patients who received maintenance treatment with infliximab were excluded. The treatment was considered as failure if the patient required infliximab or surgery during the follow up.
Treatment
All patients were treated initially with azathioprine. Although the enzyme activity of thiopurine methyltransferase (TPMT) was measured at the beginning of treatment, AZA was started at 50 mg daily and was increased to a target dose of 2.5 mg/kg within the first month of follow up.[32]
HRQoL Assessment
Prospective evaluation of HRQoL was performed at months 0, 6, and 12 using two questionnaires, the Medical Outcomes Study 36-Item Short-Form Health Survey (SF-36) and the Inflammatory Bowel Disease Questionnaire (IBDQ). The SF-36 is a generic questionnaire containing 36 items.[33] Thirty-five of the items are grouped into eight multi-item scales. The eight domains of the SF-36 are as follows: physical function (10 items); social function (two items); role limitations due to physical problems (four items); role limitations due to emotional problems (three items); energy/vitality (four items); mental health (five items); bodily pain (two items); and general health perception (five items). In addition, it contains a one-item measure of self-evaluated change in health status (health transition) over the previous year. For each question, the raw score was coded and transformed into a percentage on a scale of 0 to 100, with 0 indicating the least favorable possible health status and 100 indicating the most favorable. The questionnaire has been translated into Spanish and validated.[34] The disease-specific questionnaire used, the IBDQ, was the 36-item version by Love et al,[2] a self-administered questionnaire that has been previously validated for use in Spain.[35] The 36 items are grouped into five domains of health: bowel symptoms; systemic symptoms; functional impairment; social impairment; and emotional function. Responses are scored on a 7-point Likert scale, in which 7 corresponds to the highest level of functioning. The instrument produces five dimension scores and an overall IBDQ score ranging from 1 to 7, where a higher score reflects better HRQoL.
Assessment of Clinical Activity and Definitions of Remission
Disease activity was assessed with the Crohn's Disease Activity Index (CDAI) in patients with CD and with Mayo Clinic Score or the Disease Activity Index (CAI) in patients with UC.[36,37] Eight variables determine the CDAI score: the number of liquid stools; the extent of abdominal pain; general well-being; the occurrence of extraintestinal symptoms; the need for antidiarrheal drugs; the presence of abdominal masses; hematocrit; and body weight. In order to calculate the CDAI, the patient completed a symptom diary for the seven days before each visit. Remission was defined as defined by a CDAI score < 150. The Mayo Score consists of four items: stool frequency; rectal bleeding; findings of flexible proctosigmoidoscopy; and the Physician Global Assessment. Scores range from 0 to 12 points. Complete response (remission) is defined as complete resolution of (1) stool frequency (normal stool frequency), (2) rectal bleeding (no rectal bleeding), and (3) patient's functional assessment score (generally well). If colonoscopy was available, normal endoscopy findings were also required. The patients should be free of steroids to be considered in remission.
Study Design and Follow up
Patients were enrolled prospectively. Demographic data were recorded during the first visit. Blood samples were taken before starting on AZA, and TPMT activity was measured. Patients were clinically evaluated at baseline, at two, four and 12 weeks, and then every three months until the end of the study. HRQoL assessment was performed at the beginning and after six and 12 months of therapy. Patients were also evaluated throughout the study period whenever they had a medical problem. At each visit, a complete physical exam was performed and patients were asked about symptoms and any systemic manifestations of the disease or its treatment. Scores of activity were calculated. Data on the use of steroids and other concomitant treatments were obtained. Those patients who discontinued their medication because of adverse events or reactions were followed in the same way as those who continued to receive therapy. In cases of treatment failure, HRQoL assessment was performed before new treatment was administered.
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