Lupus

Lupus is associated with multisystemic inflammation

resulting from abnormal immunological function. The
four main types of lupus are:
1. NLE (Neonatal and pediatric Lupus Erythematosus)
2. DLE (Discoid Lupus Erythematosus)
3. DIL (Drug Induced Lupus)
4. SLE (Systemic Lupus Erythematosus)

2
 NLE
10%

SL
DLE
10%

DIL
10%

E
7
0
%
3
 Who is at risk for SLE?
SLE can affect people of all ages, including children.
However, women of childbearing ages—15 to
44 years—are at greatest risk of developing SLE.

According
4
to:
 What causes SLE?
The causes of SLE are unknown, but are believed to
be linked to
• Environmental
• Genetic
• Hormonal factors

According
5
to:
 Signs and Symptoms
Rashes:
butterfly shaped rash over the cheeks-referred as malar
rash
red rash with raised round or oval patches-known as
discoid rash
rash on skin exposed to the sun
 Mouth sores:
sores in the mouth or nose lasting from a few days to
more than a month

According
to:
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 Signs and Symptoms (cont.)
Arthritis:
tenderness and swelling lasting for a week in two or
more joints
Lung or heart inflammation:
swelling of the tissue lining the lungs (referred to as
pleuritis) or the heart (pericarditis), which can cause
chest pain when breathing deeply
Kidney problem:
blood or protein in the urine or tests that suggest poor
kidney function

According
to:
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 Signs and Symptoms (cont.)
Neurologic problems:
seizures, strokes or psychosis (a mental health problem)
Abnormal blood test result such as:
low blood cell counts: anemia, low white blood cells, or
low platelets
positive antinuclear antibodies (ANA) result: antibodies
that can cause the body to begin attacking itself that are
present in nearly all lupus patients
certain abnormal antibodies: anti-double-strand DNA
(called anti-dsDNA), anti-Smith (referred to as anti-Sm),
or antiphospholipid antibodies

According
to:
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Signs and Symptoms (cont.)
Fever
Fatigue
Sensitivity to sun
Weight loss
Blood clots
Hair loss
Raynaud’s Phenomenon
Poor blood circulation to the fingers and toes

According
to:
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 How is SLE treated?
There is no cure for lupus, as it is a chronic
disease. The treatment goals are to suppress the
overactive immune system and ultimately induce
remission and prevent permanent organ damage.
Common treatment options include: Antimalarial drugs
(Hydroxychloroquine), Corticosteroids and Immune
suppressants (Aazathioprine, Mycophenolate Mofetil,
Methotrexate, Cyclophosphamide), NSAIDs (to help in
controlling pain) etc.

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 Hydroxychloroquine (HCQ)
Used in the United States and
more than 50 other
countries for more than 50
years as the first line
treatment option to treat
SLE.

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Recommendation for HCQ in
SLE

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To treat SLE effectively

SQUARE offers

Quinivir ™
Hydroxychloroquine Sulfate USP 200 mg tablet

The first line treatment option for

Systemic Lupus Erythematosus

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 Indication
• Systemic Lupus Erythematosus (SLE)
• Rheumatoid Arthritis (RA)
• Chronic Idiopathic Urticaria (CIU)
• Malaria

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 Dosage and Administration
• Systemic Lupus Erythematosus: 200-400 mg daily
PO as a single daily dose or in two divided doses
with meal (but not exceeding 6.5 mg/kg daily based
on ideal body-weight)
• Acute & chronic Rheumatoid Arthritis: 400-600 mg
daily with meal. When good response is obtained
(usually 4 to 8 weeks), dose can be reduced to 50%
and continue maintenance dose of 200-400 mg/day
PO as once or twice daily
• Chronic Idiopathic Urticaria: 200g bid for at least 3
months
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 Side effects
Hydroxychloroquine typically is very well tolerated.
Serious side effects are rare.
Most common side effects are:
• Nausea
• Diarrhea

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Use in pregnancy & Lactation
US FDA pregnancy category: Not formally assigned to
a pregnancy category.
However, in 2004, during the “4th International Conference
of Sex Hormones, Pregnancy and the Rheumatic Diseases”,
international experts concluded that:
• HCQ is the drug of choice in fertile women in need of
treatment
• HCQ is compatible with breast-feeding
• During pregnancy and breast-feeding, HCQ continuation is
not only allowed but also recommended

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 Use in children
For Juvenile Rheumatoid Arthritis (JRA) or Systemic
Lupus Erythematosus (SLE):
3 - 5 mg/kg/day divided into 1 - 2 doses (maximum
400 mg/day, not to exceed 7 mg/kg/day).

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Clinical Studies

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 Efficacy results of HCQ from LUMINA (LXXV) study
(Systemic lupus erythematosus in a multiethnic, multi-center cohort)

patients had decreased

62.86% SLAM-R scores

(SLAM-R = Systemic Lupus Activity Measure Revised)

It measures clinical disease activity in Systemic Lupus
Erythematosus. It includes 23 clinical manifestations in 9
organs/systems.
A decrease in the score means a total decrease in disease
activity.

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 Efficacy results of HCQ from LUMINA (LXXV) study
(Systemic lupus erythematosus in a multiethnic, multi-center cohort)

decrease in sCD40L
59.30% sCD40L = soluble CD40 Ligand, a proinflammatory cytokine

45.80% decrease in IL-6

IL-6 = Interleukin-6, a proinflammatory cytokine

decrease in IFN & IFN inducible

33.50% cytokines IFN = Interferon and Interferon
inducible chemokine/cytokine

33.50% decrease in IL-8

IL-8 = Interleukin-8, a proinflammatory cytokine

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 Efficacy results of HCQ from LUMINA (LXXV) study
(Systemic lupus erythematosus in a multiethnic, multi-center cohort)

Finally this study concludes that HCQ

• Significantly reduces disease activity in SLE patients
• Reduces the risk of irreversible organ damage
• Improved survival rate in SLE patients

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 QUINIVIR
Shows significant clinical improvement in SLE patients
Decreases disease activity levels in SLE patients
Improves survival rate in SLE patients
Greatly reduces the risk of irreversible organ damage
Inexpensive and safe treatment option for SLE patients
Not only allowed but also recommended for SLE
affected pregnant and breast-feeding women

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Thanks for your
attention

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