A Chrissafidou1, M Malek, E Musch. 1. Marienhospital Bottrop, Abteilung für Innere Medizin, Bottrop, Germany. achrissaf@web.de
Abstract
INTRODUCTION: Treatment of Crohn's disease is based on anti-inflammatory and immunosuppressive therapy. Over time, however, approx. 20 % of patients develop steroid resistance. In these cases, alternative treatment methods are required. Short-term application of intravenous immunoglobulin (IVIg) may serve as an additional alternative. PATIENTS AND METHODS: In 19 steroid-resistant patients (case collection over 15 years) suffering from Crohn's disease (mean CDAI 284.1 +/- 149.8), IVIg therapy with Venimmun, Gamimmun, Octagam, respectively (7 days 10 g/day i. v.) or Sandoglobin (total dose: 72 g or 90 g i. v., respectively, over a period of 8 or 10 days) was applied in addition to basic medication (5-ASA/SASP plus corticosteroids). CDAI according to Best was assessed on a weekly basis starting 3 weeks prior to and ending 4 weeks after completion of therapy. 8 patients could be followed for a longer period. RESULTS: All patients benefited from this treatment and the effectiveness of IVIg therapy could not only be observed during therapy, but also during the four consecutive weeks after therapy. At 4 weeks after therapy, a total of 14 patients (73.7%) reached a clinical remission (CDAI < 150) and 14 patients (73.7%) showed a CDAI decrease of > 100 points. In the 8 patients who could be followed over a longer period of time, a mean remission duration of 20.6 months was observed. Apart from a slight rise in temperature in one patient, no significant side effects occurred. CONCLUSION: In patients suffering from Crohn's disease, IVIg therapy may be applied effectively and with few side effects, however, not as remission maintenance, but as a stopgap treatment during an acute attack with steroid resistance, e. g., until therapy with other immunosuppressive agents becomes effective. To validate our presented results, a prospective, randomised, placebo-controlled trial has to be proposed.
RCT Entities:
INTRODUCTION: Treatment of Crohn's disease is based on anti-inflammatory and immunosuppressive therapy. Over time, however, approx. 20 % of patients develop steroid resistance. In these cases, alternative treatment methods are required. Short-term application of intravenous immunoglobulin (IVIg) may serve as an additional alternative. PATIENTS AND METHODS: In 19 steroid-resistant patients (case collection over 15 years) suffering from Crohn's disease (mean CDAI 284.1 +/- 149.8), IVIg therapy with Venimmun, Gamimmun, Octagam, respectively (7 days 10 g/day i. v.) or Sandoglobin (total dose: 72 g or 90 g i. v., respectively, over a period of 8 or 10 days) was applied in addition to basic medication (5-ASA/SASP plus corticosteroids). CDAI according to Best was assessed on a weekly basis starting 3 weeks prior to and ending 4 weeks after completion of therapy. 8 patients could be followed for a longer period. RESULTS: All patients benefited from this treatment and the effectiveness of IVIg therapy could not only be observed during therapy, but also during the four consecutive weeks after therapy. At 4 weeks after therapy, a total of 14 patients (73.7%) reached a clinical remission (CDAI < 150) and 14 patients (73.7%) showed a CDAI decrease of > 100 points. In the 8 patients who could be followed over a longer period of time, a mean remission duration of 20.6 months was observed. Apart from a slight rise in temperature in one patient, no significant side effects occurred. CONCLUSION: In patients suffering from Crohn's disease, IVIg therapy may be applied effectively and with few side effects, however, not as remission maintenance, but as a stopgap treatment during an acute attack with steroid resistance, e. g., until therapy with other immunosuppressive agents becomes effective. To validate our presented results, a prospective, randomised, placebo-controlled trial has to be proposed.