11 Pons-Estel GJ et al. Protective
effect of hydroxychloroquine on
renal damage in patients with
lupus nephritis: LXV, data from a
multiethnic US cohort. Arthritis
Rheum 2009;61:830–9.
12 Hench PS et al. The
effects of the adrenal cortical
hormone 17-hydroxy-11-
dehydrocorticosterone
(Compound E) on the acute phase
of rheumatic fever; preliminary
report. Proc Staff Meet Mayo Clin
1949;24:277–97.
13 Apostolopoulos D, Morand EF.
It hasn’t gone away: the problem
of glucocorticoid use in lupus
remains. Rheumatology (Oxford)
2017;56(suppl_1):i114-i122.
14 Bertsias G et al. EULAR
recommendations for the
management of systemic lupus
erythematosus. Report of a Task
Force of the EULAR Standing
Committee for International
Clinical Studies Including
Therapeutics. Ann Rheum Dis
2008;67:195–205.
15 Barile-Fabris L et al.
Controlled clinical trial of IV
cyclophosphamide versus IV
methylprednisolone in severe
neurological manifestations in
systemic lupus erythematosus.
Ann Rheum Dis 2005;64:620–5.
16 Contreras G et al.
Maintenance therapies for
proliferative lupus nephritis:
mycophenolate mofetil,
azathioprine and intravenous
cyclophosphamide. Lupus
2005;14 Suppl 1:s33–8.
17 Houssiau FA et al.
Immunosuppressive therapy
in lupus nephritis: the Euro-
Lupus Nephritis Trial, a
randomized trial of low-dose
versus high-dose intravenous
cyclophosphamide. Arthritis
Rheum 2002;46:2121–31.
18 Boumpas DT et al. Controlled
trial of pulse methylprednisolone
versus two regimens of pulse
cyclophosphamide in severe
lupus nephritis. Lancet
1992;340:741–5.
19 Austin HA 3rd et al. Therapy
of lupus nephritis. Controlled
trial of prednisone and
cytotoxic drugs. N Engl J Med
1986;314:614–19.
20 Gourley MF et al.
Methylprednisolone and
cyclophosphamide, alone or in
combination, in patients with
lupus nephritis. A randomized,
controlled trial. Ann Intern Med
1996;125:549–57.
21 Houssiau FA. Therapy of lupus
nephritis: lessons learned from
clinical research and daily care
of patients. Arthritis Res Ther
2012;14:202.
22 Gunnarsson I et al.
Histopathologic and clinical
outcome of rituximab
treatment in patients with
cyclophosphamide-resistant
proliferative lupus nephritis.
Arthritis Rheum 2007;56:
1263–72.
23 Mok CC. Pro: The use of
calcineurin inhibitors in the
treatment of lupus nephritis.
Nephrol Dial Transplant
2016;31:1561–6.
24 Fei Y et al. Low-dose
tacrolimus in treating lupus
nephritis refractory to
cyclophosphamide: a prospective
cohort study. Clin Exp Rheumatol
2013;31:62–8.
25 Li X et al. Mycophenolate
mofetil or tacrolimus
compared with intravenous
cyclophosphamide in the
induction treatment for active
lupus nephritis. Nephrol Dial
Transplant 2012;27:1467–72.
26 Hannah J, Casian A, D’Cruz
D. Tacrolimus use in lupus
nephritis: A systematic review
and meta-analysis. Autoimmun
Rev 2016;15:93–101.
27 Alexander T et al. The
proteasome inhibitor
bortezomib depletes plasma
cells and ameliorates clinical
manifestations of refractory
systemic lupus erythematosus.
Ann Rheum Dis 2015;74:1474–8.
28 Monneaux F et al. T cell
recognition and therapeutic effect
of a phosphorylated synthetic
peptide of the 70K snRNP protein
administered in MR/lpr mice. Eur
J Immunol 2003;33:287–96.
29 Monneaux F et al.
Intramolecular T cell spreading
in unprimed MRL/lpr mice:
importance of the U1-70k protein
sequence 131-151. Arthritis
Rheum 2004;50:3232–8.
30 Monneaux F et al. Selective
modulation of CD4+ T cells from
lupus patients by a promiscuous,
protective peptide analog. J
Immunol 2005;175:5839–47.
31 Monneaux F et al. Importance
of spliceosomal RNP1 motif
for intermolecular T-B cell
spreading and tolerance
restoration in lupus. Arthritis Res
Ther 2007;9:R111.
32 Page N et al. The
spliceosomal phosphopeptide
P140 controls the lupus disease
by interacting with the HSC70
protein and via a mechanism
mediated by gammadelta T cells.
PLoS One 2009;4:e5273.
33 Page N et al. HSC70 blockade
by the therapeutic peptide P140
affects autophagic processes and
endogenous MHCII presentation
in murine lupus. Ann Rheum Dis
2011;70:837–43.
34 Zimmer R et al. Lupuzor/
P140 peptide in patients with
systemic lupus erythematosus:
a randomised, double-blind,
placebo-controlled phase IIb
clinical trial. Ann Rheum Dis
2013;72:1830–5.
35 Navarra SV et al. Efficacy and
safety of belimumab in patients
with active systemic lupus
erythematosus: a randomised,
placebo-controlled, phase 3 trial.
Lancet 2011;377:721–31.
36 Furie R et al. A phase
III, randomized, placebo-
controlled study of belimumab,
a monoclonal antibody that
inhibits B lymphocyte stimulator,
in patients with systemic lupus
erythematosus. Arthritis Rheum
2011;63:3918–30.
37 Baker KP et al. Generation
and characterization of
LymphoStat-B, a human
monoclonal antibody that
antagonizes the bioactivities of B
lymphocyte stimulator. Arthritis
Rheum 2003;48:3253–65.
38 Terrier B et al. Safety and
efficacy of rituximab in systemic
lupus erythematosus: results
from 136 patients from the
French AutoImmunity and
Rituximab registry. Arthritis
Rheum 2010;62:2458–66.
39 Diaz-Lagares C et al. Efficacy
of rituximab in 164 patients with
biopsy-proven lupus nephritis:
pooled data from European
cohorts. Autoimmun Rev
2012;11:357–64.
40 Boletis JN et al. Rituximab
and mycophenolate mofetil
for relapsing proliferative
lupus nephritis: a long-term
prospective study. Nephrol Dial
Transplant 2009;24:2157–60.
36 | Issue 90 | 2018 | hospitalpharmacyeurope.com
41 Jonsdottir T et al. Clinical
improvements in proliferative
vs membranous lupus nephritis
following B-cell depletion:
pooled data from two cohorts.
Rheumatology (Oxford)
2010;49:1502–4.
42 Jonsdottir T et al. Rituximab-
treated membranous lupus
nephritis: clinical outcome
and effects on electron dense
deposits. Ann Rheum Dis
2011;70:1172–3.
43 Li EK et al. Is combination
rituximab with cyclophosphamide
better than rituximab alone
in the treatment of lupus
nephritis? Rheumatology (Oxford)
2009;48:892–8.
44 Pepper R et al. Rituximab is
an effective treatment for lupus
nephritis and allows a reduction
in maintenance steroids. Nephrol
Dial Transplant 2009;24:3717–23.
45 Sfikakis PP et al. Remission
of proliferative lupus nephritis
following B cell depletion therapy
is preceded by down-regulation
of the T cell costimulatory
molecule CD40 ligand: an
open-label trial. Arthritis Rheum
2005;52:501–13.
46 Vigna-Perez M et al. Clinical
and immunological effects
of Rituximab in patients with
lupus nephritis refractory
to conventional therapy: a
pilot study. Arthritis Res Ther
2006;8:R83.
47 Leandro MJ et al. An open
study of B lymphocyte depletion
in systemic lupus erythematosus.
Arthritis Rheum 2002;46:2673–7.
48 Looney RJ et al. B cell
depletion as a novel treatment for
systemic lupus erythematosus:
a phase I/II dose-escalation trial
of rituximab. Arthritis Rheum
2004;50:2580–9.
49 Leandro MJ et al. B-cell
depletion in the treatment
of patients with systemic
lupus erythematosus: a
longitudinal analysis of 24
patients. Rheumatology (Oxford)
2005;44:1542–5.
50 Ng KP et al. Repeated B
cell depletion in treatment
of refractory systemic lupus
erythematosus. Ann Rheum Dis
2006;65:942–5.
51 Jonsdottir T et al. Treatment
of refractory SLE with rituximab
plus cyclophosphamide: clinical
effects, serological changes,
and predictors of response. Ann
Rheum Dis 2008;67:330–4.
52 Jonsdottir T et al. Long-term
follow-up in lupus nephritis
patients treated with rituximab
– clinical and histopathological
response. Rheumatology (Oxford)
2013;52:847–55.
53 van Vollenhoven RF et
al. Biopsy-verified response
of severe lupus nephritis to
treatment with rituximab (anti-
CD20 monoclonal antibody) plus
cyclophosphamide after biopsy-
documented failure to respond to
cyclophosphamide alone. Scand J
Rheumatol 2004;33:423–7.
54 Rovin BH et al. Efficacy and
safety of rituximab in patients
with active proliferative lupus
nephritis: the Lupus Nephritis
Assessment with Rituximab
study. Arthritis Rheum
2012;64:1215–26.
55 Merrill JT et al. Efficacy and
safety of rituximab in moderately-
to-severely active systemic lupus
erythematosus: the randomized,
double-blind, phase II/III
systemic lupus erythematosus
evaluation of rituximab trial.
Arthritis Rheum 2010;62:222–33.
56 Bertsias GK et al. Joint
European League Against
Rheumatism and European
Renal Association-European
Dialysis and Transplant
Association (EULAR/ERA-
EDTA) recommendations for
the management of adult and
paediatric lupus nephritis. Ann
Rheum Dis 2012;71:1771–82.
57 Hahn BH et al. American
College of Rheumatology
guidelines for screening,
treatment, and management of
lupus nephritis. Arthritis Care
Res (Hoboken) 2012;64:797–808.
58 Ramos-Casals M et al.
Off-label use of rituximab
in 196 patients with severe,
refractory systemic autoimmune
diseases. Clin Exp Rheumatol
2010;28:468–76.
59 Witt M et al. Clinical outcomes
and safety of rituximab treatment
for patients with systemic lupus
erythematosus (SLE) – results
from a nationwide cohort
in Germany (GRAID). Lupus
2013;22:1142–9.
60 Ryden-Aulin M et al. Off-label
use of rituximab for systemic
lupus erythematosus in Europe.
Lupus Sci Med 2016;3:e000163.
61 van Vollenhoven RF et
al. Atacicept in patients with
rheumatoid arthritis and
an inadequate response to
methotrexate: results of a
phase II, randomized, placebo-
controlled trial. Arthritis Rheum
2011;63:1782–92.
62 Ginzler EM et al. Atacicept
in combination with MMF and
corticosteroids in lupus nephritis:
results of a prematurely
terminated trial. Arthritis Res
Ther 2012;14:R33.
63 Furie RA et al. A phase 2,
randomised, placebo-controlled
clinical trial of blisibimod, an
inhibitor of B cell activating
factor, in patients with
moderate-to-severe systemic
lupus erythematosus, the
PEARL-SC study. Ann Rheum Dis
2015;74:1667–75.
64 Isenberg DA et al. Efficacy
and safety of subcutaneous
tabalumab in patients with
systemic lupus erythematosus:
results from ILLUMINATE-1, a
52-week, phase III, multicentre,
randomised, double-blind,
placebo-controlled study. Ann
Rheum Dis 2016;75:323–31.
65 Merrill JT et al. Efficacy
and safety of subcutaneous
tabalumab, a monoclonal
antibody to B-cell activating
factor, in patients with systemic
lupus erythematosus: results
from ILLUMINATE-2, a 52-
week, phase III, multicentre,
randomised, double-blind,
placebo-controlled study. Ann
Rheum Dis 2016;75:332–40.
66 Gatto M et al. Success and
failure of biological treatment in
systemic lupus erythematosus:
A critical analysis. J Autoimmun
2016;74:94-105.
67 Houssiau FA, Doria A.
Targeting BAFF/BLyS in lupus: is
the glass half-full or half-empty?
Ann Rheum Dis 2016;75:321–2.
68 Wallace DJ et al. Efficacy and
safety of epratuzumab in patients
with moderate/severe flaring
systemic lupus erythematosus:
results from two randomized,
double-blind, placebo-controlled,
multicentre studies (ALLEVIATE)
and follow-up. Rheumatology
(Oxford) 2013;52:1313–22.
69 Wallace DJ et al. Efficacy and
safety of epratuzumab in patients
with moderate/severe active
systemic lupus erythematosus:
results from EMBLEM, a phase
IIb, randomised, double-blind,
placebo-controlled, multicentre
study. Ann Rheum Dis
2014;73:183–90.
70 Clowse MEB et al. Efficacy
and safety of epratuzumab in
patients with moderate-to-severe
systemic lupus erythematosus:
Results from two phase 3
randomized, placebo-controlled
trials [abstract]. Arthritis
Rheumatol 2015;67.
71 Liang B et al. Anti-
interleukin-6 monoclonal
antibody inhibits autoimmune
responses in a murine model of
systemic lupus erythematosus.
Immunology 2006;119:296–305.
72 Kiberd BA. Interleukin-6
receptor blockage ameliorates
murine lupus nephritis. J Am Soc
Nephrol 1993;4:58–61.
73 Rovin BH et al. A Multicenter,
randomized, double-blind,
placebo-controlled study to
evaluate the efficacy and safety of
treatment with sirukumab (CNTO
136) in patients with active lupus
nephritis. Arthritis Rheumatol
2016;68:2174–83.
74 Illei GG et al. Tocilizumab in
systemic lupus erythematosus:
data on safety, preliminary
efficacy, and impact on
circulating plasma cells from
an open-label phase I dosage-
escalation study. Arthritis Rheum
2010;62:542–52.
75 Ronnblom L, Pascual V. The
innate immune system in SLE:
type I interferons and dendritic
cells. Lupus 2008;17:394–9.
76 Khamashta M et al.
Sifalimumab, an anti-interferon-
alpha monoclonal antibody, in
moderate to severe systemic
lupus erythematosus: a
randomised, double-blind,
placebo-controlled study. Ann
Rheum Dis 2016;75:1909–16.
77 Kalunian KC et al. A Phase
II study of the efficacy and
safety of rontalizumab (rhuMAb
interferon-alpha) in patients with
systemic lupus erythematosus
(ROSE). Ann Rheum Dis
2016;75:196–202.
78 Furie R et al. Anifrolumab,
an anti-interferon alpha
receptor monoclonal antibody,
in moderate to severe systemic
lupus erythematosus (SLE)
[abstract]. Arthritis Rheumatol
2015;67.
79 Merrill JT et al. The efficacy
and safety of abatacept
in patients with non-life-
threatening manifestations of
systemic lupus erythematosus:
results of a twelve-month,
multicenter, exploratory, phase
IIb, randomized, double-blind,
placebo-controlled trial. Arthritis
Rheum 2010;62:3077-87.
80 van Vollenhoven RF, Parodis
I, Levitsky A. Biologics in SLE:
towards new approaches. Best
Pract Res Clin Rheumatol
2013;27:341–9.
81 Furie R et al. Efficacy and
safety of abatacept in lupus
nephritis: a twelve-month,
randomized, double-blind
study. Arthritis Rheumatol
2014;66:379–89.
82 Wofsy D, Hillson JL, Diamond
B. Abatacept for lupus nephritis:
alternative definitions of
complete response support
conflicting conclusions. Arthritis
Rheum 2012;64:3660–5.