P181
Increasing use and efficacy of Rituximab for currently non-commissioned indications
Morlidge C, Loudon K, Mathavakkannan S, Thompson BC
Lister Renal Unit, East and North Herts NHS Trust
Introduction: In April 2013 rituximab (RTX) funding for the treatment of refractory ANCA
vasculitis and systemic lupus erythematosus (SLE) was removed from local agreement, to being
commissioned by NHS England (NHSE). Experience and evidence for the use of RTX in noncommissioned indications,such as membranous glomerulonephritis (MGN) and minimal change
disease (MCD), is growing. Over a two year period (2012-2014) we haveadministered RTX to a
total to 45 patients – 19 (44.4%) of these have been for non-commissioned indications.
Method:Retrospective analysis of RTX in 19 unfunded cases. Review of clinical
indication,previous immunosuppressive therapies, RTX dosing regimes, clinical outcome
(complete remission, partial remission or no response) and time to first relapse after RTX.
Hepatitis B status, CD19 level and immunoglobulins were measured.
Results: RTX achieved CR in 8 patients with MCD – see Table
MCD
1
2
3
4
Previous
immunosuppression
Prednisolone (pred),
tacrolimus (tac), ciclosporin
(CyA) and
mycophenolatemofetil
(MMF)
Pred, CyAand MMF
Pred and CyA
Pred, CyA, Tac, MMF and
Cyclophosphamide
(Pontecelli)
Pred and Tac
RTX dosing
Time to
CD19 = 0
Time from RTX dose
to first relapse
1g x 2 plus 1g at
6and12 months
9 months
16 months (no relapse)
1g x 2
375mg/m2 x 2
10 days
6 weeks
4 months (no relapse)
1 month (no relapse)
1g x 1
-
12 months (no relapse)
1g x 2
12 months (no relapse)
1gx2 plus; 1g at
Pred, CyAand Tac
10 days
16 months (no relapse)
6
6and12months
Prednisolone
1g x 2
1 month (no relapse)
7
2
Pred, Tacand MMF
375mg/m x 4
19 months
8
Complete remission wasseen in isolated cases ofrelapsing polyarteritisnodosa, hepatitis C
associated membranoproliferative glomerulonephritis and de novo focal segmental
glomerulosclerosis (FSGS) post transplantation. Partial remission was seen in 4 out of 6
patients with MGN. No remission was seen in single cases ofprimary FSGS; MGN
andfibrillaryglomerulonephritis.CD19 results were incomplete but suggest early B-cell
depletion may justify a single 1g dose. The cost of a single 1gRTX is £2136.34.
5
Conclusion: Our results contribute to the emergingevidence that RTX is efficacious in
refractory cases of MCD, MGN and other isolated conditions. These situations are currently
unfunded by NHSE. The cost of a single dose is offset by considerable gains in avoidance of
steroid or other immunosuppression; reduced clinic reviews and improved quality of life.
Funding to support RTX requires urgent review by NICE and NHSE.