Octapharma News November 4, 2005

November 4, 2005

The GAMPP Study: Investigation of IVIG for the Management of Multiple Sclerosis after Pregnancy

While pregnancy is not regarded to have an overall effect on the long-term disease course of Multiple Sclerosis, research has shown that patients with relapsing-remitting multiple sclerosis have an 1.7 increased risk of exacerbation during the first three months after delivery compared to untreated patients in the pre-pregnancy period.

Disease modifying drugs licensed for this condition are contra indicated or should be avoided during breastfeeding. Thus most breastfeeding patients are without therapy during this period of elevated relapse risk. Several clinical trials have provided evidence for intravenous immunoglobulin (IVIG) to have a beneficial effect on relapse activity during the course of RR-MS.


	Principle Investigator for GAMPP, Prof. J. Haas

Under the auspices of the European Charcot Foundation the GAMmaglobulin Post Partum study (GAMPP study) was initiated in order to investigate the efficacy of two IVIG dosing regimens on the postpartum relapse activity of MS patients during 3 months postpartum. The first results of the GAMPP study were presented at ECTRIMS Congress in Vienna 2004 during the satellite symposium of the European Charcot Foundation. At this year’s ECTRIMS/ACTRIMS congress at Thessaloniki , Greece, further results of the GAMPP study, including analysis of patient subgroups, were presented during a poster session.

The GAMPP study was the first clinical trial study where the mean annualized relapse rate during the first 3 months postpartum did not exceed the pre-pregnancy relapse activity. There was no significant difference between the different dosage regimens tested.

Out of 173 enrolled patients. 163 patients (Group I: 82; Group II: 81) could be evaluated for efficacy during 3 months postpartum. Group II was slightly but not significantly better than Group I in terms of relapse free patients during the 1st trimester postpartum (Group I: 75.6 %, Group II: 81.5 %). The study treatment resulted in a limitation of the 3 months postpartum ARR to a mean rate of 0.9 ± 1.8 which was slightly below the pre-pregnancy ARR of 1.0 ± 0.7 (seen in above chart).

There was no difference of ARR for patients who had only 1 relapse during 2 years before pregnancy. However, patients who reported 2 (preP ARR=1) or more relapses (preP ARR>1) during the 2 pre-pregnancy years and receiving the booster dose had a slightly lower risk of exacerbation during the first 3 months of puerperium than Group I patients. Patients who did not breastfeed due to different reasons had a higher risk of exacerbation compared to patients breastfeeding for at least 3 months. The relapse risk for non-breastfeeding patients was slightly lower when treated in Group II. Combining both treatment groups (Group I and Group II) there was a mean 19.3 % difference of relapse free patients between the non-breastfeeding group and the group breastfeeding for more than 3 months.

ECTRIMS 2005 Poster: Management of Multiple Sclerosis after pregnancy: The GAMPP Study

Summary

	The GAMPP study is the first randomised confirmatory clinical trial considering the efficacy of IVIG on the postpartum relapse risk of patients with RR-MS.
	The study compares two IVIG dosage regimen.
	The ratio of relapse free patients during 3 months postpartum is similar in both dosage groups.
	For the first time the postpartum relapse rate does not exceed the pre-pregnancy relapse activity.
	A higher ratio of breastfeeding patients remained relapse free compared to non-breastfeeding patients.
	Patients with a higher pre-pregnancy relapse activity might have a benefit of the booster dose.