Generate Real World Data On Tofacitinib Induction Therapy and Changes In Clinical and Patient Reported Outcomes.

Clinical remission was defined as PMS of <= 2 with no subscore >1. PMS consisted of 3 components: rectal bleeding, stool frequency, and physician global assessment of disease activity. Each sub score ranged from 0 (normal) to 3 (extreme severity). These sub scores were summed up to give a total score range of 0 (normal) to 9 (extreme severity), where higher scores indicated more disease severity.

Clinical response was defined as a reduction in the PMS from baseline of >=2 points or achieving clinical remission. Clinical remission was defined as PMS of <= 2 with no subscore >1. PMS consisted of 3 components: rectal bleeding, stool frequency, and physician global assessment of disease activity. Each sub score ranged from 0 (normal) to 3 (extreme severity). These sub scores were summed up to give a total score range of 0 (normal) to 9 (extreme severity), where higher scores indicated more disease severity.

Clinical remission was defined as PMS of <= 2 with no subscore >1. PMS consisted of 3 components: rectal bleeding, stool frequency, and physician global assessment of disease activity. Each sub score ranged from 0 (normal) to 3 (extreme severity). These sub scores were summed up to give a total score range of 0 (normal) to 9 (extreme severity), where higher scores indicated more disease severity.

IBDQ remission was defined as an IBDQ score >= 170. The IBDQ was a 32-item questionnaire grouped into four dimensions: bowel symptoms, systemic symptoms, emotional function and social function, where range was as follows: bowel symptoms: 10 to 70; systemic symptoms: 5 to 35; emotional function: 12 to 84 and social function: 5 to 35. The total IBDQ score ranged from 32 to 224. For the total score and each domain, a higher score indicated better quality of life.

IBDQ remission was defined as an IBDQ score >= 170. The IBDQ was a 32-item questionnaire grouped into four dimensions: bowel symptoms, systemic symptoms, emotional function and social function, where range was as follows: bowel symptoms: 10 to 70; systemic symptoms: 5 to 35; emotional function: 12 to 84 and social function: 5 to 35. The total IBDQ score ranged from 32 to 224. For the total score and each domain, a higher score indicated better quality of life.

IBDQ response was defined as an IBDQ score >=16 points higher than IBDQ baseline score. The IBDQ was a 32-item questionnaire grouped into four dimensions: bowel symptoms, systemic symptoms, emotional function and social function, where range was as follows: bowel symptoms: 10 to 70; systemic symptoms: 5 to 35; emotional function: 12 to 84 and social function: 5 to 35. The total IBDQ score ranged from 32 to 224. For the total score and each domain, a higher score indicated better quality of life.

IBDQ response was defined as an IBDQ score >=16 points higher than IBDQ baseline score. The IBDQ was a 32-item questionnaire grouped into four dimensions: bowel symptoms, systemic symptoms, emotional function and social function, where range was as follows: bowel symptoms: 10 to 70; systemic symptoms: 5 to 35; emotional function: 12 to 84 and social function: 5 to 35. The total IBDQ score ranged from 32 to 224. For the total score and each domain, a higher score indicated better quality of life.

Biochemical remission was defined as a fecal calprotectin (fCAL) concentration <=250 micrograms per gram (mcg/g). fCAL is a small anti-microbial protein detected in stool that constitutes approximately 60% of neutrophil cytoplasm. As migration of neutrophils into the intestinal mucosa is a hallmark of active intestinal inflammation, fCAL serves as a non-invasive biomarker for intestinal inflammation.

Biochemical remission was defined as a fCAL concentration <=250 mcg/g. fCAL is a small anti-microbial protein detected in stool that constitutes approximately 60% of neutrophil cytoplasm. As migration of neutrophils into the intestinal mucosa is a hallmark of active intestinal inflammation, fCAL serves as a non-invasive biomarker for intestinal inflammation.

The stool frequency patient reported outcome (PRO) was assessed with one question about the number of stools on a given day. The Mayo Score stool frequency subscore was used for scoring. Scores ranged from 0 to 3 (0= normal number of stools; 1= 1-2 stools more than normal; 2= 3-4 stools more than normal and 3= 5 or more stools than normal) where higher scores indicated more severe disease activity.

The rectal bleeding PRO was assessed with one question about most severe rectal bleeding on a given day. The Mayo Score rectal bleeding subscore was used for scoring. Scores ranged from 0 to 3 (0= no blood seen; 1= streaks of blood with stool less than half the time; 2= obvious blood with stool most of the time and 3= blood alone passes) where higher scores indicated more severe bleeding of the day.

The urgency of defecation was assessed with the urgency NRS. Scoring was done on a 11-point NRS. Participant provided a score from 0 (no urgency) to 10 (worst possible urgency). Higher scores indicated more severe urgency.

The abdominal pain was assessed with the pain NRS. Scoring was done on a 10-point horizontal NRS. Participant provided a score from 1 (none) to 10 (very severe). Higher scores indicated more severe pain.

The quality of sleep was assessed with a question from the sleep quality visual analogue scale survey. Scoring was done on a 11 NRS. Participant provided a score from 0 (very bad) to 10 (great). Higher scores indicated better quality of sleep.

The daily fatigue was assessed with the fatigue NRS. Scoring was done on a 11-point NRS. Participant provided a score from 0 (no fatigue) to 10 (as bad as you can imagine). Higher scores indicated more severe fatigue.

The weekly fatigue was assessed with 13 questions from the functional assessment of chronic illness therapy - fatigue (FACIT-F) version (v)4. Participants rated the intensity of their fatigue symptoms on a scale of 0 (not at all) to 4 (very much) for each 13 questions. Total score ranged from 0 to 52, with higher scores representing lower fatigue.

The IBDQ was a 32-item questionnaire grouped into four dimensions: bowel symptoms, systemic symptoms, emotional function and social function, where range was as follows: bowel symptoms: 10 to 70; systemic symptoms: 5 to 35; emotional function: 12 to 84 and social function: 5 to 35. The total IBDQ score ranged from 32 to 224. For the total score and each domain, a higher score indicated better quality of life.

fCAL is a small anti-microbial protein detected in stool that constitutes approximately 60% of neutrophil cytoplasm. As migration of neutrophils into the intestinal mucosa is a hallmark of active intestinal inflammation, fCAL serves as a non-invasive biomarker for intestinal inflammation.

Correlation between PMS and IBDQ score was assessed by Spearman correlation coefficient. PMS consisted of 3 components: rectal bleeding, stool frequency, and physician global assessment of disease activity. Each sub score ranged from 0 (normal) to 3 (extreme severity). These sub scores were summed up to give a total score range of 0 (normal) to 9 (extreme severity), where higher scores indicated more disease severity. The IBDQ was a 32-item questionnaire grouped into four dimensions: bowel symptoms, systemic symptoms, emotional function and social function, where range was as follows: bowel symptoms: 10 to 70; systemic symptoms: 5 to 35; emotional function: 12 to 84 and social function: 5 to 35. The total IBDQ score ranged from 32 to 224. For the total score and each domain, a higher score indicated better quality of life.

Correlation between PMS and fCAL concentration was assessed by Spearman correlation coefficient. PMS consisted of 3 components: rectal bleeding, stool frequency, and physician global assessment of disease activity. Each sub score ranged from 0 (normal) to 3 (extreme severity). These sub scores were summed up to give a total score range of 0 (normal) to 9 (extreme severity), where higher scores indicated more disease severity. fCAL is a small anti-microbial protein detected in stool that constitutes approximately 60% of neutrophil cytoplasm. As migration of neutrophils into the intestinal mucosa is a hallmark of active intestinal inflammation, fCAL serves as a non-invasive biomarker for intestinal inflammation.

Correlation between stool frequency PRO and fCAL concentration was assessed by Spearman correlation coefficient. The stool frequency PRO was assessed with one question about the number of stools on a given day. The mayo score stool frequency subscore was used for scoring. Scores ranged from 0 to 3 (0= normal number of stools; 1= 1-2 stools more than normal; 2= 3-4 stools more than normal and 3= 5 or more stools than normal) where higher scores indicated more severe disease activity. fCAL is a small anti-microbial protein detected in stool that constitutes approximately 60% of neutrophil cytoplasm. As migration of neutrophils into the intestinal mucosa is a hallmark of active intestinal inflammation, fCAL serves as a non-invasive biomarker for intestinal inflammation.

Correlation between rectal bleeding PRO and fCAL concentration was assessed by Spearman correlation coefficient. The rectal bleeding PRO was assessed with one question about most severe rectal bleeding on a given day. The Mayo Score rectal bleeding subscore was used for scoring. Scores ranged from 0 to 3 (0= no blood seen; 1= streaks of blood with stool less than half the time; 2= obvious blood with stool most of the time and 3= blood alone passes) where higher scores indicated more severe bleeding of the day. fCAL is a small anti-microbial protein detected in stool that constitutes approximately 60% of neutrophil cytoplasm. As migration of neutrophils into the intestinal mucosa is a hallmark of active intestinal inflammation, fCAL serves as a non-invasive biomarker for intestinal inflammation.

Correlation between urgency of defecation and fCAL concentration was assessed by Spearman correlation coefficient. The urgency of defecation was assessed with the urgency NRS. Scoring was done on a 11-point NRS. Participant provided a score from 0 (no urgency) to 10 (worst possible urgency). Higher scores indicated more severe urgency. fCAL is a small anti-microbial protein detected in stool that constitutes approximately 60% of neutrophil cytoplasm. As migration of neutrophils into the intestinal mucosa is a hallmark of active intestinal inflammation, fCAL serves as a non-invasive biomarker for intestinal inflammation.

Correlation between abdominal pain and fCAL was assessed by Spearman correlation coefficient. The abdominal pain was assessed with the pain NRS. Scoring was done on a 10-point horizontal NRS. Participant provided a score from 1 (none) to 10 (very severe). Higher scores indicated more severe pain. fCAL is a small anti-microbial protein detected in stool that constitutes approximately 60% of neutrophil cytoplasm. As migration of neutrophils into the intestinal mucosa is a hallmark of active intestinal inflammation, fCAL serves as a non-invasive biomarker for intestinal inflammation.

Correlation between quality of sleep and fCAL concentration was assessed by Spearman correlation coefficient. The quality of sleep was assessed with a question from the sleep quality visual analogue scale survey. Scoring was done on a 11-point NRS. Participant provided a score from 0 (very bad) to 10 (great). Higher scores indicated better quality of sleep. fCAL is a small anti-microbial protein detected in stool that constitutes approximately 60% of neutrophil cytoplasm. As migration of neutrophils into the intestinal mucosa is a hallmark of active intestinal inflammation, fCAL serves as a non-invasive biomarker for intestinal inflammation.

Correlation between daily fatigue and fCAL concentration was assessed by Spearman correlation coefficient. The daily fatigue was assessed with the fatigue NRS. Scoring was done on a 11-point NRS. Participant provided a score from 0 (no fatigue) to 10 (as bad as you can imagine). Higher scores indicated more severe fatigue. fCAL is a small anti-microbial protein detected in stool that constitutes approximately 60% of neutrophil cytoplasm. As migration of neutrophils into the intestinal mucosa is a hallmark of active intestinal inflammation, fCAL serves as a non-invasive biomarker for intestinal inflammation.

Correlation between weekly fatigue and fCAL concentration was assessed by Spearman correlation coefficient. The weekly fatigue was assessed with 13 questions from the FACIT-F v4. Participants rated the intensity of their fatigue symptoms on a scale of 0 (not at all) to 4 (very much) for each 13 questions. Total score ranged from 0 to 52, with higher scores representing lower fatigue. fCAL is a small anti-microbial protein detected in stool that constitutes approximately 60% of neutrophil cytoplasm. As migration of neutrophils into the intestinal mucosa is a hallmark of active intestinal inflammation, fCAL serves as a non-invasive biomarker for intestinal inflammation.

Correlation between IBDQ score and fCAL concentration was assessed by Spearman correlation coefficient. The IBDQ was a 32-item questionnaire grouped into four dimensions: bowel symptoms, systemic symptoms, emotional function and social function, where range was as follows: bowel symptoms: 10 to 70; systemic symptoms: 5 to 35; emotional function: 12 to 84 and social function: 5 to 35. The total IBDQ score ranged from 32 to 224. For the total score and each domain, a higher score indicated better quality of life. fCAL is a small anti-microbial protein detected in stool that constitutes approximately 60% of neutrophil cytoplasm. As migration of neutrophils into the intestinal mucosa is a hallmark of active intestinal inflammation, fCAL serves as a non-invasive biomarker for intestinal inflammation.

Correlation between stool frequency PRO and IBDQ score was assessed by Spearman correlation coefficient. The stool frequency PRO was assessed with one question about the number of stools on a given day. The Mayo Score stool frequency subscore was used for scoring. Scores ranged from 0 to 3 (0= normal number of stools; 1= 1-2 stools more than normal; 2= 3-4 stools more than normal and 3= 5 or more stools than normal) where higher scores indicated more severe disease activity. The IBDQ was a 32-item questionnaire grouped into four dimensions: bowel symptoms, systemic symptoms, emotional function and social function, where range was as follows: bowel symptoms: 10 to 70; systemic symptoms: 5 to 35; emotional function: 12 to 84 and social function: 5 to 35. The total IBDQ score ranged from 32 to 224. For the total score and each domain, a higher score indicated better quality of life.

Correlation between rectal bleeding PRO and IBDQ score was assessed by Spearman correlation coefficient. The rectal bleeding PRO was assessed with one question about most severe rectal bleeding on a given day. The Mayo Score rectal bleeding subscore was used for scoring. Scores ranged from 0 to 3 (0= no blood seen; 1= streaks of blood with stool less than half the time; 2= obvious blood with stool most of the time and 3= blood alone passes) where higher scores indicated more severe bleeding of the day. The IBDQ was a 32-item questionnaire grouped into four dimensions: bowel symptoms, systemic symptoms, emotional function and social function, where range was as follows: bowel symptoms: 10 to 70; systemic symptoms: 5 to 35; emotional function: 12 to 84 and social function: 5 to 35. The total IBDQ score ranged from 32 to 224. For the total score and each domain, a higher score indicated better quality of life.

Correlation between urgency of defecation and IBDQ score was assessed by Spearman correlation coefficient. The urgency of defecation was assessed with the urgency NRS. Scoring was done on a 11-point NRS. Participant provided a score from 0 (no urgency) to 10 (worst possible urgency). Higher scores indicated more severe urgency. The IBDQ was a 32-item questionnaire grouped into four dimensions: bowel symptoms, systemic symptoms, emotional function and social function, where range was as follows: bowel symptoms: 10 to 70; systemic symptoms: 5 to 35; emotional function: 12 to 84 and social function: 5 to 35. The total IBDQ score ranged from 32 to 224. For the total score and each domain, a higher score indicated better quality of life.

Correlation between abdominal pain and IBDQ score was assessed by Spearman correlation coefficient. The abdominal pain was assessed with the pain NRS. Scoring was done on a 10-point horizontal NRS. Participant provided a score from 1 (none) to 10 (very severe). Higher scores indicated more severe pain. The IBDQ was a 32-item questionnaire grouped into four dimensions: bowel symptoms, systemic symptoms, emotional function and social function, where range was as follows: bowel symptoms: 10 to 70; systemic symptoms: 5 to 35; emotional function: 12 to 84 and social function: 5 to 35. The total IBDQ score ranged from 32 to 224. For the total score and each domain, a higher score indicated better quality of life.

Correlation between quality of sleep and IBDQ score was assessed by Spearman correlation coefficient. The quality of sleep was assessed with a question from the sleep quality visual analogue scale survey. Scoring was done on a 11-point NRS. Participant provided a score from 0 (very bad) to 10 (great). Higher scores indicated better quality of sleep. The IBDQ was a 32-item questionnaire grouped into four dimensions: bowel symptoms, systemic symptoms, emotional function and social function, where range was as follows: bowel symptoms: 10 to 70; systemic symptoms: 5 to 35; emotional function: 12 to 84 and social function: 5 to 35. The total IBDQ score ranged from 32 to 224. For the total score and each domain, a higher score indicated better quality of life.

Correlation between daily fatigue and IBDQ score was assessed by Spearman correlation coefficient. The daily fatigue was assessed with the fatigue NRS. Scoring was done on a 11-point NRS. Participant provided a score from 0 (no fatigue) to 10 (as bad as you can imagine). Higher scores indicated more severe fatigue. The IBDQ was a 32-item questionnaire grouped into four dimensions: bowel symptoms, systemic symptoms, emotional function and social function, where range was as follows: bowel symptoms: 10 to 70; systemic symptoms: 5 to 35; emotional function: 12 to 84 and social function: 5 to 35. The total IBDQ score ranged from 32 to 224. For the total score and each domain, a higher score indicated better quality of life.

Correlation between weekly fatigue and IBDQ score was assessed by Spearman correlation coefficient. The weekly fatigue was assessed with 13 questions from the FACIT-F v4. Participants rated the intensity of their fatigue symptoms on a scale of 0 (not at all) to 4 (very much) for each 13 questions. Total score ranged from 0 to 52, with higher scores representing lower fatigue. The IBDQ was a 32-item questionnaire grouped into four dimensions: bowel symptoms, systemic symptoms, emotional function and social function, where range was as follows: bowel symptoms: 10 to 70; systemic symptoms: 5 to 35; emotional function: 12 to 84 and social function: 5 to 35. The total IBDQ score ranged from 32 to 224. For the total score and each domain, a higher score indicated better quality of life.

Correlation between PMS and stool frequency PRO was assessed by Spearman correlation coefficient. PMS consisted of 3 components: rectal bleeding, stool frequency, and physician global assessment of disease activity. Each sub score ranged from 0 (normal) to 3 (extreme severity). These sub scores were summed up to give a total score range of 0 (normal) to 9 (extreme severity), where higher scores indicated more disease severity. The stool frequency PRO was assessed with one question about the number of stools on a given day. The Mayo Score stool frequency subscore was used for scoring. Scores ranged from 0 to 3 (0= normal number of stools; 1= 1-2 stools more than normal; 2= 3-4 stools more than normal and 3= 5 or more stools than normal) where higher scores indicated more severe disease activity.

Correlation between PMS and rectal bleeding PRO was assessed by Spearman correlation coefficient. PMS consisted of 3 components: rectal bleeding, stool frequency, and physician global assessment of disease activity. Each sub score ranged from 0 (normal) to 3 (extreme severity). These sub scores were summed up to give a total score range of 0 (normal) to 9 (extreme severity), where higher scores indicated more disease severity. The rectal bleeding PRO was assessed with one question about most severe rectal bleeding on a given day. The Mayo Score rectal bleeding subscore was used for scoring. Scores ranged from 0 to 3 (0= no blood seen; 1= streaks of blood with stool less than half the time; 2= obvious blood with stool most of the time and 3= blood alone passes) where higher scores indicated more severe bleeding of the day.

Correlation between PMS and urgency of defecation was assessed by Spearman correlation coefficient. PMS consisted of 3 components: rectal bleeding, stool frequency, and physician global assessment of disease activity. Each sub score ranged from 0 (normal) to 3 (extreme severity). These sub scores were summed up to give a total score range of 0 (normal) to 9 (extreme severity), where higher scores indicated more disease severity. The urgency of defecation was assessed with the urgency NRS. Scoring was done on a 11-point NRS. Participant provided a score from 0 (no urgency) to 10 (worst possible urgency). Higher scores indicated more severe urgency.

Correlation between PMS and abdominal pain was assessed by Spearman correlation coefficient. PMS consisted of 3 components: rectal bleeding, stool frequency, and physician global assessment of disease activity. Each sub score ranged from 0 (normal) to 3 (extreme severity). These sub scores were summed up to give a total score range of 0 (normal) to 9 (extreme severity), where higher scores indicated more disease severity. The abdominal pain was assessed with the pain NRS. Scoring was done on a 10-point horizontal NRS. Participant provided a score from 1 (none) to 10 (very severe). Higher scores indicated more severe pain.

Correlation between PMS and quality of sleep was assessed by Spearman correlation coefficient. PMS consisted of 3 components: rectal bleeding, stool frequency, and physician global assessment of disease activity. Each sub score ranged from 0 (normal) to 3 (extreme severity). These sub scores were summed up to give a total score range of 0 (normal) to 9 (extreme severity), where higher scores indicated more disease severity. The quality of sleep was assessed with a question from the sleep quality visual analogue scale survey. Scoring was done on a 11-point NRS. Participant provided a score from 0 (very bad) to 10 (great). Higher scores indicated better quality of sleep.

Correlation between PMS and daily fatigue was assessed by Spearman correlation coefficient. PMS consisted of 3 components: rectal bleeding, stool frequency, and physician global assessment of disease activity. Each sub score ranged from 0 (normal) to 3 (extreme severity). These sub scores were summed up to give a total score range of 0 (normal) to 9 (extreme severity), where higher scores indicated more disease severity. The daily fatigue was assessed with the fatigue NRS. Scoring was done on a 11-point NRS. Participant provided a score from 0 (no fatigue) to 10 (as bad as you can imagine). Higher scores indicated more severe fatigue.

Correlation between PMS and weekly fatigue was assessed by Spearman correlation coefficient. PMS consisted of 3 components: rectal bleeding, stool frequency, and physician global assessment of disease activity. Each sub score ranged from 0 (normal) to 3 (extreme severity). These sub scores were summed up to give a total score range of 0 (normal) to 9 (extreme severity), where higher scores indicated more disease severity. The weekly fatigue was assessed with 13 questions from the FACIT-F v4. Participants rated the intensity of their fatigue symptoms on a scale of 0 (not at all) to 4 (very much) for each 13 questions. Total score ranged from 0 to 52, with higher scores representing lower fatigue.

Clinical remission was defined as PMS of <= 2 with no subscore >1. Partial mayo score consisted of 3 components: rectal bleeding, stool frequency, and physician global assessment of disease activity. Each sub score ranged from 0 (normal) to 3 (extreme severity). These sub scores were summed up to give a total score range of 0 (normal) to 9 (extreme severity), where higher scores indicated more disease severity. In this outcome measure, fCAL concentration are reported at specified time points in those participants who had clinical remission at Week 8 and in those participants who did not have clinical remission at Week 8.

Clinical remission was defined as PMS of <= 2 with no subscore >1. Partial mayo score consisted of 3 components: rectal bleeding, stool frequency, and physician global assessment of disease activity. Each sub score ranged from 0 (normal) to 3 (extreme severity). These sub scores were summed up to give a total score range of 0 (normal) to 9 (extreme severity), where higher scores indicated more disease severity. In this outcome measure, fCAL concentration are reported at specified time points in those participants who had clinical remission at Week 16 and in those participants who did not have clinical remission at Week 16.

Clinical response was defined as a reduction in the PMS from baseline of >=2 points or achieving clinical remission. Clinical remission was defined as PMS of <= 2 with no subscore >1. PMS consisted of 3 components: rectal bleeding, stool frequency, and physician global assessment of disease activity. Each sub score ranged from 0 (normal) to 3 (extreme severity). These sub scores were summed up to give a total score range of 0 (normal) to 9 (extreme severity), where higher scores indicated more disease severity. In this outcome measure, fCAL concentration are reported at specified time points in those participants who had clinical response at Week 8 and in those participants who did not have clinical response at Week 8.

Clinical response was defined as a reduction in the PMS from baseline of >=2 points or achieving clinical remission. Clinical remission was defined as PMS of <= 2 with no subscore >1. PMS consisted of 3 components: rectal bleeding, stool frequency, and physician global assessment of disease activity. Each sub score ranged from 0 (normal) to 3 (extreme severity). These sub scores were summed up to give a total score range of 0 (normal) to 9 (extreme severity), where higher scores indicated more disease severity. In this outcome measure, fCAL concentration are reported at specified time points in those participants who had clinical response at Week 16 and in those participants who did not have clinical response at Week 16.