Journal club 2 16 august

JournAl club 2
16/8/2019
Dr Ashishkumar Baheti
JR 1 ,MD Pharmacology
MGIMS , Sevagram

A STUDY OF THE USE OF DRUGS
IN PATIENTS SUFFERING FROM
PSORIASIS AND THEIR IMPACT
ON QUALITY OF LIFE
V. V. Karamata, A. M. Gandhi, P. P. Patel, A. Sutaria , M. K. Desai
Departments of pharmacology and skin and venereal disease,
B.J. Medical college, ahmedabad, gujarat, india
Indian Journal of Pharmacology - Volume 49 | Issue 1 | January 2017

Introduction
 Psoriasis is a common
chronic inflammatory,
immune -mediated disease
that predominantly
affects the skin and joints.
 Psoriasis may affect patients’ life adversely, for
example, emotional status, psychological stress,
self-esteem, relationships, work, social activities,
financial burden, and even physical function,
particularly in patients with psoriasis arthritis.

 In addition to disease itself, drugs used for the
treatment of psoriasis may cause adverse drug
reaction(s) (ADRs).
 These factors affect the quality of life (QOL).
 The World Health Organization (WHO) defines
QOL as “Individual perception of their position
in life in the context of the culture and value
systems in which they live and in relation to their
goals, expectations, standards and concerns.”

 Data regarding the efficacy of drugs used for
the treatment of psoriasis and its effect on QOL
for psoriasis are not available from western part
of India.
 Hence, this study was designed to study the use
of drugs in patients suffering from psoriasis and
their impact on QOL.

Materials and Methods
 After taking permission from the Institutional
Ethics Committee (EC/Approval/35/14) and Head
of Department of Skin and Venereal diseases, this
prospective, observational, single-center study was
carried out at Department of Pharmacology and
Outpatient Department of Skin and Venereal
diseases of a tertiary care teaching hospital of
Ahmedabad for duration of 18 months.
 Written informed consent was taken
 Diagnosis of psoriasis was done by dermatologist.

Inclusion criteria
 more than 18 years of age,
 of either gender,
 newly diagnosed patient of psoriasis with
moderate severity,
 as well as willing to participate in the study
Patients who could not comprehend the
questionnaires were excluded from the study

Group A Clobetasol propionate (0.05%) + salicylic acid (3%) lotion
for scalp application and betamethasone valerate (0.05%)
cream for body surface application.
Group B Tablet methotrexate (7.5 mg/week) along with topical
treatment; clobetasol propionate (0.05%) + salicylic acid
(3%) lotion for scalp application and betamethasone valerate
(0.05%) cream for body surface application.
Group C Capsule cyclosporine (100 mg 2 times a day) along with
topical treatment; clobetasol propionate (0.05%) + salicylic
acid (3%) lotion for scalp application and betamethasone
valerate (0.05%) cream for body surface application.
Based on prescribed treatment, patients were grouped
as:

Parameters Observed
 The baseline data including demographic details,
clinical history, details of lesions, and details of the
drug treatment were recorded in prevalidated case
record form.
 The efficacy of drug was measured using Psoriasis
Area Severity Index (PASI).
 PASI is a validated objective measurement of
psoriasis severity which ranges from 0 to 72.
 Higher the score more will be severity of psoriasis.

 QOL was measured using Psoriasis Disability Index (PDI).
 The score in each question ranges from 0 to 3, and total
score ranges from 0 to 45.
 A Higher score indicates greater impairment of QOL.
 All the recruited patients were followed up at 1 month (1st
follow-up) and 6 months (2nd follow-up) of treatment.
 At each follow-up visit, presenting complaints, any change
in drug treatment, PASI score, and QOL were recorded and
analyzed at the end of the study.
 Detail of the ADR was also recorded and analyzed.

Statistical Analysis
P < 0.05 was considered statistically significant.
Intragroup comparison was done between baseline and at
each follow-up visits by repeated measure analysis of
variance (ANOVA) test, followed by post hoc analysis using
Tukey–Kramer multiple comparison test.
Intergroup comparison was done between Group A, B, and
C by one-way ANOVA test, followed by post hoc analysis
using Tukey–Kramer multiple comparison test.
Correlation between PASI score and QOL was made using
Pearson parametric correlation test.

Results
A total of 126 patients were enrolled during the
study period of 18 months, out of which 114 patients
completed the study while 12 patients were lost to
follow-up.
The mean age of the total patient was 41.07 ± 1.05
There was no significant difference in mean age
between all three groups.
It was reported that most common exacerbating
factors for psoriasis were seasonal weather changes,
especially in winter (71 [62.2%]), followed by stress
(49 [42.9%]) and irregular sleep habit (24 [21%]).

Past history of hypertension and diabetes was
reported in 15 (13.1%) and 6 (5.2%) patients,
respectively.
Concomitant diabetes and hypertension were present
in 13 (11.4%) patients.
Two (1.75%) patients had a history of bronchial
asthma.
It was observed that 50 (43.86%) patients had
disturbed sleep, history of alcohol intake - 18
(15.79%) patients, and smoking - 23 (20.17%)
patients. 25 (22%) patients reported a family history
of psoriasis.

Baseline mean Mean difference
PASI score of PASI scores
Group A 11.59 ± 0.14 4.60 ± 0.33,
Group B 12.35 ± 0.34 7.18 ± 0.37,
Group C 12.72 ± 0.20 7.37 ± 0.28.
To compare the efficacy of Group A, B, and C, the mean
difference of the baseline and 2nd follow-up data was
calculated and measured for each group.
Mean difference of PASI score was significantly (P < 0.001)
higher in Group B and C as compared to Group A.

Figure 2: Improvement in severity of symptoms in Group A, B, and C.
Group A: topical treatment (betamethasone
valerate and [clobetasol propionate + salicylic
acid]): (a) baseline (before) and (b) 6 months
(after).
Group B: methotrexate + topical
treatment (betamethasone valerate and
[clobetasol propionate + salicylic acid]):
(c) baseline (before) and (d) 6 months
(after).
Group C: cyclosporine + topical treatment (betamethasone valerate and [clobetasol propionate
+ salicylic acid]): (e) baseline (before) and (f) 6 months (after)

To compare the change in QOL score between Group
A, B, and C, the difference of QOL between baseline
and 2nd follow-up data was calculated.
The mean value of the difference was measured for
each treatment group.
(P < 0.001) higher in Group B and C
Mean difference of total QOL scores
Group A 0.56 ± 0.18
Group B 6.53 ± 0.46
Group C 7.18 ± 0.47.

Correlation between PASI Score and Quality of
Life
Correlation between PASI score and QOL was
carried out using Pearson parametric correlation
test.
Correlation coefficient (r) value
Group A 0.07
Group B 0.29
Group C 0.13
The correlation was not significant in any of the
treatment group (P > 0.05).

Figure 3:
(a)Correlation of PASI score with
QOL in Group A (n = 52): topical
treatment (betamethasone
valerate and [clobetasol
propionate + salicylic acid]). r =
0.07 (little or no correlation
between PASI and QOL).
(b) Correlation of PASI score with
QOL in Group B (n = 32):
methotrexate + topical treatment
(betamethasone valerate and
[clobetasol propionate + salicylic
acid]). r = 0.29 (weak
positive correlation between
Psoriasis Area Severity Index and
quality of life).

(c) Correlation of PASI score with quality of life in
Group C (n = 30):
cyclosporine + topical treatment (betamethasone
valerate and [clobetasol propionate + salicylic acid]).
r = 0.13 (weak positive correlation between Psoriasis
Area Severity Index and quality of life)

Adverse Drug Reactions -- 22 ADRs
Group A - 7 ADRs were reported itching (2), dryness of
Skin (2),redness of skin (3).
Group B - 8 ADRs were reported itching (3), nausea (4),
abdominal discomfort (1).
Group C - 7 ADRs were reported headache (1), tiredness (2),
nausea (3), itching (1).
According to the WHO UMCscale, causality assessment in
Group A showed that all the ADRs had possible causal relation with the
suspect drug, i.e., betamethasone valerate and clobetasol propionate +
salicylic acid.
Group B, abdominal discomfort and remaining 7 ADRs were possible
with the suspect drug methotrexate.
Group C, possible causal relation with suspect drug cyclosporine.

Discussion
Present study correlated efficacy and QOL in a newly
diagnosed patient suffering from psoriasis on different
treatments.
Reduction of PASI score in each treatment group
indicates that there was a decrease in severity of the
disease at each follow-up visit. This finding is similar
to a study carried out at Punjab,India.
However, when intergroup comparison was done, it
was observed that combination of topical therapy with
methotrexate and cyclosporine is more efficacious
than topical therapy alone.

In intergroup comparison, It was observed that mean
difference of QOL score was significantly higher in
Group B and C as compared to Group A which
suggest that there was a significant reduction of QOL
score in Group B and Group C as compared to Group
A.
It was also observed that there was no significant
difference in reduction of QOL score between Group
B (methotrexate with topical therapy) and Group C
(cyclosporine with topical therapy) which is similar
to a study carried out in the Netherlands where
SF-36 QOL questionnaire was used to compare QOL
between treatment groups, and topical treatment was
not used along with systemic drug.

It was also observed that there was no significant
correlation between PASI score and QOL in any of the
treatment group which is similar to study carried out
by Yang et al.
Correlation of efficacy and QOL was not observed in
our study which may be because QOL is a subjective
parameter, and apart from the disease severity, QOL
also depends on the other factors including age,
day-to-day activities, cosmetic effect, and
relationships with family members and friends.
In addition,the chronic nature, irritation due to lesion,
and disease affecting visible parts of the body are
associated with psychological stress.

Hence, emotional burden of disease itself has a
negative impact on QOL.
This study highlights that there was a reduction in
severity score (PASI) in each treatment group, but
QOL was improved only up to some extent
Limitation of the study includes the fact that this in
an observational study in a small sample of patients.
Furthermore, a longer duration of evaluation may
give a better idea of the impact of drug therapy on
QOL.

Conclusion
Combination therapy (topical + systemic) is more efficacious
than topical therapy alone.
Patients treated with combined topical and systemic therapy
(methotrexate and cyclosporine) demonstrate a better
improvement in QOL as compared to those receiving topical
therapy alone.
Methotrexate and cyclosporine are equally efficacious in
treating and improving QOL in patients of psoriasis.
Financial Support and Sponsorship
Nil.
Conflicts of Interest
There are no conflicts of interest.

Criticism
1) Title – Informative, doesn’t mention type of study
Abstract – provided detaied information regarding
methods, results, and conclusions
2) Introduction
Scientific background and explanation of rationale was
provided

3) Methods
 Eligibility criteria for participants was mentioned .
 The interventions for each group was decided,
 informed written consent was taken
 Institutional ethics committee approval was taken
 Statistical methods used were described in detail.

4)Results
 Results were documented with proper tables,
graphs but no use of flow chart
 For each group, the numbers of participants who
were assigned, intended treatment, and loss to
follow up was mentioned
 Dates defining the periods of recruitment and
follow-up were mentioned
 Adverse drug reactions were mentioned

Discussion
study limitations were mentioned by the authors.
Interpretation were consistent with results.

Table 2. WHO-UMC Causality Categories Causality term and Assessment criteria*
Certain • Event or laboratory test abnormality, with plausible time relationship to drug intake •
Cannot be explained by disease or other drugs • Response to withdrawal plausible
(pharmacologically, pathologically) • Event definitive pharmacologically or phenomenologically
(i.e. an objective and specific medical disorder or a recognised pharmacological phenomenon) •
Rechallenge satisfactory, if necessary
Probable / Likely • Event or laboratory test abnormality, with reasonable time relationship to
drug intake •Unlikely to be attributed to disease or other drugs • Response to withdrawal
clinically reasonable • Rechallenge not required
Possible • Event or laboratory test abnormality, with reasonable time relationship to drug intake
• Could also be explained by disease or other drugs • Information on drug withdrawal may be
lacking or unclear
Unlikely • Event or laboratory test abnormality, with a time to drug intake that makes a
relationship improbable (but not impossible) • Disease or other drugs provide plausible
explanations
Conditional / Unclassified • Event or laboratory test abnormality • More data for proper
assessment needed, or • Additional data under examination
Unassessable / Unclassifiable • Report suggesting an adverse reaction • Cannot be judged
because information is insufficient or contradictory • Data cannot be supplemented or verified

Journal club 2 16 august

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