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Improving patients' QoL: how the success of treatment can improve workability
Crohn’s Disease: Achieving Patients’ Benefits / Digestive and Liver Disease Supplements 2 (2008) 3–26
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Improving patients’ QoL: how the success of treatment can improve workability M. Cottone, A. Orlando, F. Mocciaro Dipartimento di Medicina, Pneumologia e Fisiologia della Nutrizione Umana, Università di Palermo Palermo, Italy
Crohn’s disease (CD) is a chronic, relapsing inflammatory disease of the gastrointestinal tract. Rarely fatal, its young age of onset and the morbidity associated with the disease and its therapies have the potential to profoundly affect patients, not only physically, but also through limitations in social, educational, professional and emotional activities. The impact of Crohn’s disease upon these factors can be quantified using formalized studies of the health-related quality of life (HRQOL). The four major components of HRQOL are physical function, emotional/social function, ability to work productively and absence of specific disease-related symptoms. There are many characteristics of CD that make HRQOL measurements of particular importance in this entity, such as the young age of onset, impact on productivity and the recurrent nature of the disease. Previous investigations have shown that traditional measurements of disease activity correlate poorly with patient assessment in Crohn’s disease. Due to the importance of HRQOL in Crohn’s disease, formal HRQOL questionnaires are often included as secondary outcomes in clinical trials. The three key characteristics of HRQOL questionnaires are validity, reliability and responsiveness. The degree of impairment depends on disease activity but seems independent of the type of disease, UC and CD. Quality of life, a subjective index of health perception and function embraces physical, social and emotional performance but has not had a prominent role in clinical trials of inflammatory bowel disease. The IBDQ, a disease specific QOL index, is a valid reliable assessment tool that reflects important changes in the health status of patients with IBD. The IBDQ is a robust measure of therapeutic efficacy and has been used recently in clinical trials mainly on IBD and also in observational studies. In Crohn’s disease in the ACCENT 1 trial the efficacy and safety of long term dosing of infliximab compared to a single dose was evaluated in 573 pts. At baseline patients had a severely impaired quality of life and a high unemployment rate (38%). Among the group of patients who were unemployed at baseline, 31% of those patients who achieved CDAI remission at wk 54 were employed compared to 16% who were not in CDAI remission at week 54 (P < 0.05). Physical component summary (PCS) and
mental component summary scores of patients in CDAI remission at wk 54 were significantly higher indicating better and physical functioning. In the ACCENT I trial, assessing the benefit of maintenance infliximab therapy in patients with active CD who respond to a single infusion of infliximab, the drug improved significantly the quality of life in comparison to placebo-treated group. The CHARM trial evaluated the efficacy and safety of adalimumab in the maintenance of response and remission in patients with moderate to severe CD. IBDQ was evaluated as secondary end point. Mean IBDQ scores improved to a greater extent over time among adalimumab treated patients. In particular, patients with draining enterocutaneous or perianal fistulas had rapid and meaningful (≥16 points) improvements in the total IBDQ with adalimumab induction therapy. These improvements were sustained with adalimumab every other week and weekly maintenance therapy compared with placebo. Furthemore, from week 12 through week 56, the IBDQ total score was significantly higher in the adalimumab maintenance groups than in the induction-only group, with significant reductions in patientreported symptoms of fatigue, depression, and abdominal pain. In the PRECISE 2 study, 140 of 331 in the certolizumab group (42%) had an IBDQ response at week 26, as compared with 108 of 328 in the placebo group (33%, P = 0.01). The mean (± SD) increase in IBDQ total scores for all patients from baseline to week 26 was 26.4 ± 35.1 points in the certolizumab group and 20.5 ± 33.1 points in the placebo group (P = 0.03). Ankylosing Spondylitis (AS) is a cause of disability and loss from work. Recently in a randomised trial the daily productivity of pts with active AS was significantly associated with functional impairment and disease activity. Infliximab treatment significantly improved productivity and reduced workday loss among employed patients with AS. Impairment of health related quality of life, employment and productivity has been documented in patients with moderate to severe ulcerative colitis. In ACT 1 and 2 trial at weeks 30 improvements from baseline in productivity and both actual and fully productive hours worked per week were greater for patients in remission.
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Crohn’s Disease: Achieving Patients’ Benefits / Digestive and Liver Disease Supplements 2 (2008), 3–26
In conclusion, quality of life is improved if patients with IBD reach long term remission. Biological therapies, if applied according to the guidelines, have a role in improving working ability of patients with IBD. Essential references [1] Cohen RD. The quality of life in patients with Crohn’s disease. Aliment Pharmacol Ther 2002;16:1603–9. [2] Hanauer SB, Feagan BG, Lichtenstein GR, Mayer LF, Schreiber S,
Colombel JF et al. Maintenance Infliximab for Crohn’s disease: the ACCENT I randomised trial. Lancet 2002;359:1541–9. [3] Rutgeerts P, Sandborn WJ, Feagan BG, Reinisch W, Olson A, Johanns J et al. Infliximab for induction and maintenance therapy for ulcerative colitis. N Engl J Med 2005;353:2462–76. [4] Colombel JF, Sandborn WJ, Rutgeerts P, Enns R, Hanauer SB, Panaccione R et al. Adalimumab for maintenance of clinical response and remission in patients with Crohn’s disease: the CHARM trial. Gastroenterology 2007 Jan;132:52–65. [5] Schreiber S, Khaliq-Kareemi M, Lawrance IC, Thomsen OØ, Hanauer SB, McColm J et al. Maintenance therapy with certolizumab pegol for Crohn’s disease. N Engl J Med 2007;357:239–50.
17
Improving patients’ QoL: how the success of treatment can improve workability M. Cottone, A. Orlando, F. Mocciaro Dipartimento di Medicina, Pneumologia e Fisiologia della Nutrizione Umana, Università di Palermo Palermo, Italy
Crohn’s disease (CD) is a chronic, relapsing inflammatory disease of the gastrointestinal tract. Rarely fatal, its young age of onset and the morbidity associated with the disease and its therapies have the potential to profoundly affect patients, not only physically, but also through limitations in social, educational, professional and emotional activities. The impact of Crohn’s disease upon these factors can be quantified using formalized studies of the health-related quality of life (HRQOL). The four major components of HRQOL are physical function, emotional/social function, ability to work productively and absence of specific disease-related symptoms. There are many characteristics of CD that make HRQOL measurements of particular importance in this entity, such as the young age of onset, impact on productivity and the recurrent nature of the disease. Previous investigations have shown that traditional measurements of disease activity correlate poorly with patient assessment in Crohn’s disease. Due to the importance of HRQOL in Crohn’s disease, formal HRQOL questionnaires are often included as secondary outcomes in clinical trials. The three key characteristics of HRQOL questionnaires are validity, reliability and responsiveness. The degree of impairment depends on disease activity but seems independent of the type of disease, UC and CD. Quality of life, a subjective index of health perception and function embraces physical, social and emotional performance but has not had a prominent role in clinical trials of inflammatory bowel disease. The IBDQ, a disease specific QOL index, is a valid reliable assessment tool that reflects important changes in the health status of patients with IBD. The IBDQ is a robust measure of therapeutic efficacy and has been used recently in clinical trials mainly on IBD and also in observational studies. In Crohn’s disease in the ACCENT 1 trial the efficacy and safety of long term dosing of infliximab compared to a single dose was evaluated in 573 pts. At baseline patients had a severely impaired quality of life and a high unemployment rate (38%). Among the group of patients who were unemployed at baseline, 31% of those patients who achieved CDAI remission at wk 54 were employed compared to 16% who were not in CDAI remission at week 54 (P < 0.05). Physical component summary (PCS) and
mental component summary scores of patients in CDAI remission at wk 54 were significantly higher indicating better and physical functioning. In the ACCENT I trial, assessing the benefit of maintenance infliximab therapy in patients with active CD who respond to a single infusion of infliximab, the drug improved significantly the quality of life in comparison to placebo-treated group. The CHARM trial evaluated the efficacy and safety of adalimumab in the maintenance of response and remission in patients with moderate to severe CD. IBDQ was evaluated as secondary end point. Mean IBDQ scores improved to a greater extent over time among adalimumab treated patients. In particular, patients with draining enterocutaneous or perianal fistulas had rapid and meaningful (≥16 points) improvements in the total IBDQ with adalimumab induction therapy. These improvements were sustained with adalimumab every other week and weekly maintenance therapy compared with placebo. Furthemore, from week 12 through week 56, the IBDQ total score was significantly higher in the adalimumab maintenance groups than in the induction-only group, with significant reductions in patientreported symptoms of fatigue, depression, and abdominal pain. In the PRECISE 2 study, 140 of 331 in the certolizumab group (42%) had an IBDQ response at week 26, as compared with 108 of 328 in the placebo group (33%, P = 0.01). The mean (± SD) increase in IBDQ total scores for all patients from baseline to week 26 was 26.4 ± 35.1 points in the certolizumab group and 20.5 ± 33.1 points in the placebo group (P = 0.03). Ankylosing Spondylitis (AS) is a cause of disability and loss from work. Recently in a randomised trial the daily productivity of pts with active AS was significantly associated with functional impairment and disease activity. Infliximab treatment significantly improved productivity and reduced workday loss among employed patients with AS. Impairment of health related quality of life, employment and productivity has been documented in patients with moderate to severe ulcerative colitis. In ACT 1 and 2 trial at weeks 30 improvements from baseline in productivity and both actual and fully productive hours worked per week were greater for patients in remission.
18
Crohn’s Disease: Achieving Patients’ Benefits / Digestive and Liver Disease Supplements 2 (2008), 3–26
In conclusion, quality of life is improved if patients with IBD reach long term remission. Biological therapies, if applied according to the guidelines, have a role in improving working ability of patients with IBD. Essential references [1] Cohen RD. The quality of life in patients with Crohn’s disease. Aliment Pharmacol Ther 2002;16:1603–9. [2] Hanauer SB, Feagan BG, Lichtenstein GR, Mayer LF, Schreiber S,
Colombel JF et al. Maintenance Infliximab for Crohn’s disease: the ACCENT I randomised trial. Lancet 2002;359:1541–9. [3] Rutgeerts P, Sandborn WJ, Feagan BG, Reinisch W, Olson A, Johanns J et al. Infliximab for induction and maintenance therapy for ulcerative colitis. N Engl J Med 2005;353:2462–76. [4] Colombel JF, Sandborn WJ, Rutgeerts P, Enns R, Hanauer SB, Panaccione R et al. Adalimumab for maintenance of clinical response and remission in patients with Crohn’s disease: the CHARM trial. Gastroenterology 2007 Jan;132:52–65. [5] Schreiber S, Khaliq-Kareemi M, Lawrance IC, Thomsen OØ, Hanauer SB, McColm J et al. Maintenance therapy with certolizumab pegol for Crohn’s disease. N Engl J Med 2007;357:239–50.