To nie takie proste
Clinical trials were reviewed and summarized. Results: Four controlled clinical trials of infliximab in the treatment of steroid-refractory UC were found and assessed. In a double-blind, randomized, controlled trial in 43 patients with moderately severe, glucocorticoid-resistant UC, infliximab and placebo were not significantly different with respect to clinical and sigmoidoscopic remission or quality of life 2 and 6 weeks after infliximab treatment. In a multicenter, randomized, double-blind, placebo-controlled study in 45 patients with moderately severe to severe glucocorticoid-resistant UC, infliximab was associated with a significantly reduced need for colectomy compared with placebo (29% vs 67%; P=0.017). The Active Ulcerative Colitis Trials (ACT) 1 and 2 together included 728 patients with moderate to severe glucocorticoid-resistant UC. The primary outcome, the rate of clinical response at 8 weeks, was significantly higher with infliximab compared with placebo (5 mg/kg: ACT 1, 69.4%, ACT 2, 64.5%; 10 mg/kg: ACT 1, 61.5%, ACT 2, 69.2%; placebo: ACT 1, 37.2%;, ACT 2, 29.3%; all, P < 0.001 vs placebo). Based on the data from ACT 1 and 2, infliximab was associated with improved health-related quality-of-life (HRQOL) scores based on the Inflammatory Bowel Disease Questionnaire and the 36-item Short Form Health Survey. Conclusions: Current data suggest that infliximab is an effective alternative treatment option for patients with moderate to severe UC with an inadequate response to conventional glucocorticoid treatment. Further trials are needed to assess infliximab's impact on the treatment and progression of UC, the HRQL of patients with UC, and the economic impact on the health care system.
oraz ostatnia
RESULTS:: Eighty-seven percent (630 of 728) of patients had complete colectomy follow-up; 13% (98 of 728) of patients had a median follow-up of 6.2 months. The cumulative incidence of colectomy through 54 weeks was 10% for infliximab and 17% for placebo (p=0.02) yielding an absolute risk reduction of 7%. Compared with placebo, fewer ulcerative colitis-related hospitalizations and surgeries/procedures per 100 patient-years of treatment occurred with infliximab therapy, 40 versus 20 (p=0.003) and 34 versus 21 (p=0.03), respectively. Serious adverse events occurring in infliximab-treated patients included serious infections, tuberculosis, histoplasmosis, listeriosis, and malignancy.
I płatnik liczy - nie tylko w Polsce, ale wszędzie na świecie ile kosztuje rok przeżycia lub podniesienie jakości życia i co się społeczeństwu opłaca. Wiem, że takie rozumowanie z punktu pojedynczego pacjenta jest nieludzkie, ale z drugiej strony jeśli poprawa jakości życia, bez szansy na wyleczenie, jednego pacjenta kosztuje kilkaset tysięcy złotych rocznie to zadać trzeba sobie pytanie czy nas na to stać. Tych pieniędzy zabraknie na leczenie innych chorych.
Nie twierdzę, że przy CU nie należy leczyć biologicznie, ale patrzeć na to zagadnienie spokojnie. CU i CD to są różne choroby i skuteczność dostępnego leczenia biologicznego jest także rożna.
