AIM To evaluate the real-world effectiveness of golimumab in ulcerative colitis(UC) and to identify predictors of response.METHODS We conducted an observational, prospective and multi-center study in UC patients treat...AIM To evaluate the real-world effectiveness of golimumab in ulcerative colitis(UC) and to identify predictors of response.METHODS We conducted an observational, prospective and multi-center study in UC patients treated with golimumab, from September 2014 to September 2015. Clinical activity was assessed at wk 0 and 14 with the physician's global clinical assessment(PGA) and the partial Mayo score. Colonoscopies and blood tests were performed, following daily-practice clinical criteria, and the results were recorded in an SPSS database.RESULTS Thirty-three consecutive patients with moderately to severely active UC were included. Among them, 54.5% were female and 42 years was the average age. Thirty percent had left-sided UC(E2) and 70% had extensive UC(E3). All patients had an endoscopic Mayo score of 2 or 3 at baseline. Twenty-seven point three percent were anti-tumor necrosis factor(TNF) treatment na?ve, whereas 72.7% had previously received infliximab and/or adalimumab. Sixty-nine point seven percent showed clinical response and were steroid-free at wk 14(a decrease from baseline in the partial Mayo score of at least 3 points). Based on PGA, the clinical remission and clinical response rates were 24% and 55% respectively. Withdrawal of corticosteroids was observed in 70.8% of steroid-dependent patients at the end of the study. Three out of 10 clinical non-responders needed a colectomy. Mean fecal calprotectin value at baseline was 300 μg/g, and 170.5 μg/g at wk 14. Being anti-TNF treatment na?ve was a protection factor, which was related to better chances of reaching clinical remission. Twenty-seven point three percent of the patients required treatment intensification at 14 wk of followup. Only three adverse effects(AEs) were observed during the study; all were mild and golimumab was not interrupted.CONCLUSION This real-life practice study endorses golimumab's promising results, demonstrating its short-term effectiveness and confirming it as a safe drug during the induction phase.展开更多
BACKGROUND The introduction of biologics has revolutionized the management of the chronic inflammatory bowel disease,ulcerative colitis(UC),with many patients experiencing significant improvements not only in their sy...BACKGROUND The introduction of biologics has revolutionized the management of the chronic inflammatory bowel disease,ulcerative colitis(UC),with many patients experiencing significant improvements not only in their symptoms but in other outcomes relevant to individuals and society as a whole.In Germany,there are no prospective data>3 mo that assess the work productivity,daily activities and quality of life(QoL)of patients with moderate-to-severe UC treated with golimumab.AIM To assess change in work productivity,capacity for daily activities and QoL in UC patients treated with golimumab in Germany.METHODS The validated Work Productivity Activity Impairment(WPAI)Questionnaire was used to analyze the change in work productivity,the capacity for daily activities after three months(primary endpoint)and disease specific and health related QoL(HRQoL)up to 1 year(secondary endpoints).The changes in work productivity and activity impairment were evaluated every three months until month twelve compared to baseline.Disease-specific and health-related QoL were assessed with the inflammatory bowel disease questionnaire and with the short-form 12 health survey questionnaire(SF-12).RESULTS This prospective non-interventional study included 287 patients.The analysis population was comprised of 282 patients who had completed at least two visits.At baseline,61%of patients had moderate UC and 18%had severe UC.Furthermore,75%of patients worked full-time or part-time at baseline.A total of 212 patients who were employed at the start of the study(employed population)were evaluated for the primary endpoint.Golimumab significantly reduced all WPAI sub-scores compared to baseline after three,six,nine and twelve months after the start of treatment(P<0.0001).In addition,disease-specific QoL and HRQoL,as measured by the SF-12 questionnaire,improved significantly with golimumab at all evaluation times(P<0.0001 in each case vs baseline).CONCLUSION Treatment of moderate-to-severe UC with golimumab leads to significant improvements in patient´s work productivity,daily activity and QoL over twelve months.展开更多
Background: Ankylosing spondylitis (AS) is a chronic inflammatory disease which is characterized by the involvement of the sacroiliac joint and the spine, the main therapy includes biological agents, which may increas...Background: Ankylosing spondylitis (AS) is a chronic inflammatory disease which is characterized by the involvement of the sacroiliac joint and the spine, the main therapy includes biological agents, which may increase the risk of tumor and infection in long term application. Case Presentation: A fifty-year- old man was diagnosed of AS. He received the therapy of golimumab 50 mg once every one month subcutaneously. After receiving this treatment for two years and eight months, the patient had an elevated level of IgA. The monoclonal protein was finally identified as the type of IgA-kappa from the immunofixation study. Bone marrow aspirate smear revealed infiltration by plasma cells (5%) and immunophenotyping was positive for CD27, CD28, CD38, CD45, CD138 and cKappa, which was finally diagnosed of MGUS. Conclusion: This case demonstrates that golimumab may increase the risk of premalignant disease in patients with AS. With our case report, we also like to highlight that patients with AS may have increased risk of plasma cell malignancies.展开更多
文摘AIM To evaluate the real-world effectiveness of golimumab in ulcerative colitis(UC) and to identify predictors of response.METHODS We conducted an observational, prospective and multi-center study in UC patients treated with golimumab, from September 2014 to September 2015. Clinical activity was assessed at wk 0 and 14 with the physician's global clinical assessment(PGA) and the partial Mayo score. Colonoscopies and blood tests were performed, following daily-practice clinical criteria, and the results were recorded in an SPSS database.RESULTS Thirty-three consecutive patients with moderately to severely active UC were included. Among them, 54.5% were female and 42 years was the average age. Thirty percent had left-sided UC(E2) and 70% had extensive UC(E3). All patients had an endoscopic Mayo score of 2 or 3 at baseline. Twenty-seven point three percent were anti-tumor necrosis factor(TNF) treatment na?ve, whereas 72.7% had previously received infliximab and/or adalimumab. Sixty-nine point seven percent showed clinical response and were steroid-free at wk 14(a decrease from baseline in the partial Mayo score of at least 3 points). Based on PGA, the clinical remission and clinical response rates were 24% and 55% respectively. Withdrawal of corticosteroids was observed in 70.8% of steroid-dependent patients at the end of the study. Three out of 10 clinical non-responders needed a colectomy. Mean fecal calprotectin value at baseline was 300 μg/g, and 170.5 μg/g at wk 14. Being anti-TNF treatment na?ve was a protection factor, which was related to better chances of reaching clinical remission. Twenty-seven point three percent of the patients required treatment intensification at 14 wk of followup. Only three adverse effects(AEs) were observed during the study; all were mild and golimumab was not interrupted.CONCLUSION This real-life practice study endorses golimumab's promising results, demonstrating its short-term effectiveness and confirming it as a safe drug during the induction phase.
基金Supported by MSD Sharp and Dohme GmbH,Haar,Germany。
文摘BACKGROUND The introduction of biologics has revolutionized the management of the chronic inflammatory bowel disease,ulcerative colitis(UC),with many patients experiencing significant improvements not only in their symptoms but in other outcomes relevant to individuals and society as a whole.In Germany,there are no prospective data>3 mo that assess the work productivity,daily activities and quality of life(QoL)of patients with moderate-to-severe UC treated with golimumab.AIM To assess change in work productivity,capacity for daily activities and QoL in UC patients treated with golimumab in Germany.METHODS The validated Work Productivity Activity Impairment(WPAI)Questionnaire was used to analyze the change in work productivity,the capacity for daily activities after three months(primary endpoint)and disease specific and health related QoL(HRQoL)up to 1 year(secondary endpoints).The changes in work productivity and activity impairment were evaluated every three months until month twelve compared to baseline.Disease-specific and health-related QoL were assessed with the inflammatory bowel disease questionnaire and with the short-form 12 health survey questionnaire(SF-12).RESULTS This prospective non-interventional study included 287 patients.The analysis population was comprised of 282 patients who had completed at least two visits.At baseline,61%of patients had moderate UC and 18%had severe UC.Furthermore,75%of patients worked full-time or part-time at baseline.A total of 212 patients who were employed at the start of the study(employed population)were evaluated for the primary endpoint.Golimumab significantly reduced all WPAI sub-scores compared to baseline after three,six,nine and twelve months after the start of treatment(P<0.0001).In addition,disease-specific QoL and HRQoL,as measured by the SF-12 questionnaire,improved significantly with golimumab at all evaluation times(P<0.0001 in each case vs baseline).CONCLUSION Treatment of moderate-to-severe UC with golimumab leads to significant improvements in patient´s work productivity,daily activity and QoL over twelve months.
文摘Background: Ankylosing spondylitis (AS) is a chronic inflammatory disease which is characterized by the involvement of the sacroiliac joint and the spine, the main therapy includes biological agents, which may increase the risk of tumor and infection in long term application. Case Presentation: A fifty-year- old man was diagnosed of AS. He received the therapy of golimumab 50 mg once every one month subcutaneously. After receiving this treatment for two years and eight months, the patient had an elevated level of IgA. The monoclonal protein was finally identified as the type of IgA-kappa from the immunofixation study. Bone marrow aspirate smear revealed infiltration by plasma cells (5%) and immunophenotyping was positive for CD27, CD28, CD38, CD45, CD138 and cKappa, which was finally diagnosed of MGUS. Conclusion: This case demonstrates that golimumab may increase the risk of premalignant disease in patients with AS. With our case report, we also like to highlight that patients with AS may have increased risk of plasma cell malignancies.
