Received: 18 February 2019 Revised: 29 July 2019 Accepted: 5 August 2019

DOI: 10.1111/dth.13057

ORIGINAL PAPER

Methylprednisolone pulse therapy plus adjuvant therapy for

pemphigus vulgaris: an analysis of 10 years' experience on
312 patients

Mehdi Gheisari | Zahra Faraji | Mohammad S. Dadras | Soheila Nasiri |

Reza M. Robati | Hamideh Moravvej | Zohreh Tehranchinia |
Fariba Ghalamkarpour | Nastaran Namazi | Niloufar N. Nobari

Skin Research Center, Shahid Beheshti

University of Medical Sciences, Tehran, Iran
Correspondence
Mehdi Gheisari, Skin Research Center, Shahid
Beheshti University of Medical Sciences,
Tehran, Iran.
Email: mgheisari@sbmu.ac.ir
Abstract
Steroid pulse therapy has shown satisfactory efficacy and safety in treating pemphi-
gus vulgaris (PV). However, there is a paucity of data about the efficacy and safety of
methylprednisolone, despite its frequent administration. The aim of this study is to
evaluate the efficacy and safety of steroid pulse therapy in treating PV. In this
10-year retrospective cohort study, 312 patients with PV, who had received methyl-
prednisolone pulse therapy, were included. Data of pulse therapy sessions, adjuvant
medications, dosages, remission rates, complications, and mortalities were collected
from all patients. A total of 276 patients out of 312 underwent the final follow-up at
least 6 months after the last session of pulse therapy. Complete remission off therapy
was achieved in 83 patients (30%), and 152 patients (55%) had complete remission
on therapy. About 29 (10.5%) patients had lesions of pemphigus at the time of the
study follow-up, and 26.8% of remained patients were on the minimal therapy. Meth-
ylprednisolone pulse therapy could be considered as an option for proper control of
PV in severe cases. It might lead to shorter periods of hospitalization and reduce the
need to take long-term high-dose oral steroid therapy.

KEYWORDS
methylprednisolone, pemphigus vulgaris, steroid pulse therapy

1 | I N T RO D UC T I O N Systemic steroids have been considered as the mainstay PV treat-

Pemphigus vulgaris (PV) is an autoimmune bullous disease with a
chronic, relapsing course (Shahidi Dadras, Qeisari, & Givrad, 2009;
Toossi, Kani, Qeisari, & Namazi, 2012). PV treatment is always chal-
lenging and despite the availability of various therapeutic options,
there is no global consensus, regarding the PV treatment due to the
paucity of large, high-quality clinical trials comparing the various treat-
ments (Feldman-Billard, Lissak, Kassaei, Benrabah, & Héron, 2005;
Mimouni et al., 2003).
ment for decades (Pishgahi et al., 2018; Werth, 1993). Although
rituximab has been introduced as the first-line therapy for the pem-
phigus treatment in recent years, its costs and the needs for mainte-
nance therapy were still an issue, as well as its lack of efficacy when
has been used as a single agent (Joly et al., 2017; Murrell et al.,
2018). The conventional management of PV by steroids has been the
intake of high dose of daily oral steroid. Intravenous steroid pulse
therapy is an alternative method that has been administered by many
dermatologists worldwide and it is turned as a proper treatment for

Dermatologic Therapy. 2019;32:e13057. wileyonlinelibrary.com/journal/dth © 2019 Wiley Periodicals, Inc. 1 of 6

https://doi.org/10.1111/dth.13057
2 of 6
severe or resistant PV cases (Mignogna et al., 2002). The two agents
most commonly used for corticosteroid pulse therapy are methyl-
prednisolone with the dose of 20–30 mg kg–1 per pulse for 3–5 con-
secutive days, and also dexamethasone with the dose of 4–5 mg kg–1
per pulse (Chryssomallis, Dimitriades, Chaidemenos, Panagiotides, &
Karakatsanis, 1995).
Although several studies have investigated the efficacy and side
effects of dexamethasone pulse therapy in PV, the data regarding fea-
tures of methylprednisolone are still limited (Gupta, Gupta, & Gupta,
2015; Kanwar, Kaur, & Thami, 2002; Kaur & Kanwar, 1990; Sethy,
Khandpur, & Sharma, 2009). This study aimed to investigate the effi-
cacy and safety of methylprednisolone pulse therapy in PV patients
treated with this method.
2 | PATI ENT S AND M ET HODS
2.1 | Patient characteristics
This study is a 10-year and two-centric retrospective survey on
312 patients with PV who were admitted in Loghman Hakim and
Shohada-e-Tajrish hospitals from January 2006 to January 2016. A
total of 184 (59%) patients were admitted in Shohada-e-Tajrish Hos-
pital and 128 (41%) patients were admitted in Loghman-Hakim hospi-
tal. The following treatment and follow-up protocols were identical in
both centers.
All of the included patients had biopsy-proven PV, which was con-
firmed by using immunofluorescence examination of the skin or
mucosal surfaces. Data were obtained from the medical records of
these two hospitals and included sex, age, the duration between dis-
ease onset and clinical diagnosis, localization of the lesions, the per-
centage of body surface involvement, medications, treatment efficacy,
side effects, and recurrence(s). All of the patients were called up for
another visit during the time of data collection and were visited and
also evaluated for the recent disease condition, medications, and their
dosages as well as the treatment complications and mortality. This
follow-up visit was at least 6 months after the last session of pulse
therapy.
Most of the patients had received pulse therapy by methylpred-
nisolone as the first-line treatment. The contraindications for pulse
therapy included age below 18 and above 80 years, pregnancy and
lactation, known hypersensitivity to the steroid preparation, systemic
infections, sepsis, uncontrolled hypertension or severe uncontrolled
diabetes mellitus, moderate-to-severe heart failure, and arrhythmia.
2.2 | Pulse therapy protocol
After a complete physical examination, the laboratory works up
had been carried out including complete blood cell counts, levels
of blood sugar, erythrocyte sedimentation rate, liver and renal
function tests, stool exam, total serum albumin and protein and
β-HCG (in childbearing women), Hepatitis B, Hepatitis C, and HIV
serology, skin tuberculin test, chest X-ray, electrocardiogram
(EKG), and bone mass densitometry. The patients who had positive
GHEISARI ET AL.
results for skin tuberculin test, evidence of latent tuberculosis on
chest X-ray, and positive viral markers including Hepatitis B,
Hepatitis C, and HIV did not receive steroid pulse therapy and
were referred for proper evaluation. Elderly patients and patients
with any record of abnormal EKG, and also the history of cardio-
vascular problems were examined by a cardiologist before the initi-
ation of treatment.
Methylprednisolone (as sodium succinate) has been administrated
at a dose of 20–30 mg kg–1 day–1 (maximum dose of 1 g for 4 consec-
utive days) which was dissolved in 200 ml of 5% dextrose and infused
intravenously, slowly during 2–3 hr. The patients had been monitored
closely by a physician and their heart rates, respiratory rates, and
blood pressure were recorded every 15 min during the infusion, and
every 6 hours after the termination of treatment during the first
24 hr. The infusion was discontinued in the case of arrhythmia or
hypertension. After cardiologist consultation and correction of the
hemodynamic abnormalities, the infusion was restarted at a much
slower rate. Laboratory tests including complete blood cell counts,
levels of blood sugar, liver and renal function tests, and EKG were
checked 6 hr after pulse therapy.
On the following day, patients were reexamined. If new lesions
ceased to form and established lesions began to heal (control of dis-
ease activity), then oral prednisolone (0.5 mg kg–1 day–1) and azathio-
prine (1–1.5 mg kg–1day–1) were administered and the patient was
discharged after some days in cases that there was reassurance about
complications. The patients, who had recalcitrant or new lesions,
received another course of pulse therapy every month. At the end of
each consecutive session of pulse therapy, the dose of maintenance
daily oral of prednisolone had been reduced by 5 mg.
Monthly pulse therapy sessions had been discontinued in some
cases that patients were in complete remission (absence of new lesion
and healing of established lesions by 80%). It took a minimum of one
and maximum of six sessions commonly. The oral prednisolone had
been tapered to 20–30 mg day–1 by this time. After the monthly pulse
therapy termination, the patients' further follow-ups had been per-
formed in the outpatient clinic. Patients had been visited every month
and oral prednisolone had been tapered as follows: the dosage of
more than 20 mg was decreased by 5 mg monthly. Then the dose was
reduced by 2.5 mg every month to reach the total daily dose of 5 mg
(in the case of complete remission); only then, at this time the adju-
vant drug had been tapered off. If there had been any relapse in
monthly follow-ups, the adjuvant dosage increased or further pulses
were performed until complete remission was achieved, and then
tapering was resumed.
To taper off the adjuvant (after the patient had reached oral pred-
nisolone of 5 mg daily), the dosage of the adjuvant drug decreased
monthly to the half of the last dosage, and was discontinued during
about 2 months. Once the patient has been receiving oral predniso-
lone without adjuvant just 5 mg per day (about 1 year since the first
session of treatment), treatment was discontinued based on the neg-
ative direct immunofluorescence or normal titer of serum
desmogleins.
GHEISARI ET AL. 3 of 6

2.3 | Treatment failure
Pulse therapy discontinued if the new lesions were still developing or
the established lesions did not begin to improve after one session of
pulse therapy. In these patients, oral prednisolone was prescribed at a
–1
dose of 1.5 mg kg day–1 along with azathioprine. The high dose of
oral prednisolone was prescribed until no new lesion develops for
2 weeks or 80% of established lesions healed (The end of the consoli-
dation phase), which took approximately from 4 to 6 weeks. At this
time, the patient discharged with oral prednisolone (0.5 mg kg–1) and
the following treatment was similar to the steps noted above.
(47%), and lower extremities (36%). Gingiva was the most common
location of resistant lesions in mucosal surfaces (77%) followed by
genital (53%), eye (52%), and nasal mucosa (41%). The occurrences of
resistant lesions were slightly higher in the mucosal areas (59%) than
the cutaneous areas (56%).
Methylprednisolone pulse therapy was the first-line treatment on
268 (86%) patients and classic oral steroid therapy was administered
for 44 (14%) cases. Pulse therapy failure was the reason for oral ste-
roid administration in 27 (8.6%) patients. The mean of the involved
cutaneous area was 27% in the first session of pulse therapy, and
67.3% of the patients had mucosal involvement. The skin involvement
had been documented in ad 55.6% of the patients who had received

2.4 | Final follow-up
At the time of final follow-up (which was at least 6 months after the
last session of admission), patients were divided into groups based on
their disease status definition; complete remission off therapy, com-
plete remission on therapy, partial remission on minimal therapy,
relapse/flare, and failure of therapy regarding the presence of new or
established lesions (Murrell et al., 2008).
Relapse/flare was defined as the presence of ≥3 new lesions dur-
ing a month that does not heal within 1 week spontaneously, or as
the extension of established lesions, in a patient who has achieved
disease control. The failure of therapy was defined as if there is the
continued development of new lesions, continued extension of old
lesions, or failure of established lesions to begin to heal despite
3 weeks of therapy on 1.5 mg kg–1 day–1 prednisone with or without
adjuvant drugs (Murrell et al., 2008).
2.5 | Statistical analysis
All statistical analyses were done using the SPSS, version 17.0
(Chicago, IL). According to the descriptive design of this study,
descriptive statistics including mean, SD, median, minimum, maximum,
numbers, and percentage rate were calculated.
3 | RESULTS
classic oral therapy ultimately, and mucosal involvement also existed
in 76.7% of these patients. Table 1 shows the most common adverse
effects, which were hyperlipidemia, hypertension, and diabetes
mellitus with approximately similar prevalence during steroid therapy.
The most frequent used adjuvant drug at the beginning of the
treatment was azathioprine (dose of 1–1.5 mg kg–1day–1, 50–150 mg
daily) (93.5%). Other adjuvants included cyclophosphamide (dose of
1–1.5 mg kg–1day–1, 50–100 mg daily) (1.4%), and mycophenolate
mofetil (dose of 30 mg kg–1day–1, 1,500–2000 mg daily) (0.3%). By
the time of last follow-ups, azathioprine (79%) was still the most
administrated immunosuppressive drug, followed by mycophenolate
mofetil (15%), and cyclophosphamide (4%).
During the treatment, nearly 16% of patients changed their immu-
nosuppressive medication to another, due to adverse effects on 12%
and unresponsiveness on 4% of them. In the case of azathioprine side
effects, the alternative drug was mycophenolate mofetil and if the dis-
ease could not be controlled by azathioprine or mycophenolate
mofetil, cyclophosphamide was the alternative adjuvant. In recalci-
trant cases, the third line of adjuvant therapy had been administrated
included: intravenous immunoglobulin (IVIg) (for eight cases), plasma-
pheresis (for one case), or rituximab. The administration of rituximab
was limited to persistent disease (16% of the cases) before 2015;
T A B L E 1 Adverse effects of steroid therapy and
immunosuppressive medications
Steroid therapy Adjuvant medications

From 312 PV patients of this study, 167 (54%) cases were female and Hyperlipidemia 46 (14.7%) Gastrointestinal 47 (15%)
145 (46%) patients were male. Mean age at the time of diagnosis was involvement

43.7 years old and the mean duration between disease onset and the Diastolic 44 (14%) Elevated liver enzymes 42 (13.5%)
hypertension
diagnosis was 4.9 months. Mucocutaneous lesions had been docu-
Diabetes mellitus 43 (13.8%) Hemorrhagic cystitis 5 (1.6%)
mented in 191 cases (61.2%). Pure mucosal lesions were found in
Systolic 31 (10%) Cytopenia 4 (1.3%)
79 patients (25.3%), and also pure cutaneous involvement had been
hypertension
observed in 42 patients (13.4%).
Osteoporosis 12 (3.8%) Hypersensitivity 3 (1%)
The most common locations of cutaneous involvement included
Cataract 7 (2.2%) Infertility 1 (0.3%)
trunk (56%) followed by the head and neck (47%), upper extremities
Osteonecrosis 4 (1.6%)
(28%), lower extremities (25%), genital (15%), and palms and soles
(3%), respectively. The locations of mucosal involvement were oral Sepsis 3 (1%)

mucosa (83%), gingiva (11%), genital (6%), nasal (4%), and also eyes Glaucoma 3 (1%)

(3%). The resistant lesions most located on the palms and soles (70%) Peptic ulcer 2 (0.6%)
diseases
followed by head and neck (66%), trunk (59%), upper extremities
4 of 6
FIGURE 1 Percentage of clinical outcomes
however, this rate increased to 35% of cases subsequently, and it was
used even as the first-line therapy for some cases in our centers. In
5% of the cases, no adjuvant drug was used. The two most frequent
documented side effects of immunosuppressive drugs included gas-
trointestinal dysfunction and elevated liver enzymes (Table 1).
From 312 patients with PV in our study, 276 cases were available
for the last follow-up, which was at least 6 months after the last ses-
sion of admission. At this time, 83 (30%) patients were in complete
remission off therapy achieved by the average of three sessions of
steroid pulse therapy (minimum one and maximum five sessions). In
152 (55%) patients, complete remission had been achieved on ther-
apy; these patients had received an average of 4.3 sessions of methyl-
prednisolone pulse therapy. In patients with complete remission
(85%), the mean duration of remission was 47.4 month (Figure 1).
Only 29 patients (10.5%) had active lesions. We had documented per-
sistent or new lesions in spite of receiving more than 10 mg of daily
oral prednisolone in 3.2% of these patients. Figure 1 shows that the
other patients (26.8%) were on minimal therapy. The mortality
occurred in 12 patients (4%): three patients due to infection or sepsis,
and nine patients due to other comorbidities, PV, or medication
adverse effects.
4 | DISCUSSION
The traditional treatment for PV is intaking systemic steroids with two
most known administration routes including high dose of oral prednis-
olone, and intravenous pulse therapy (Santoro, Stoopler, & Werth,
2013; Werth, 1993). Steroid pulse therapy might show an encourag-
ing risk–benefit ratio with less toxicity than conventional daily oral of
prednisone. Uddin, Islam, Ali, Wahab, and Khondker (2013) showed
that the most common side effects were obesity, diabetes, puffy face,
and hypertension, which were significantly higher in oral prednisolone
group.
The last guideline by the British Association of Dermatologists has
considered pulse therapy as a very useful option for rapid control of
pemphigus in patients with severe disease. The indication for steroid
GHEISARI ET AL.
pulse therapy included the need for >1 mg kg–1 oral prednisolone in
order to disease remission induction or as initial treatment in severe
disease followed by 1 mg kg–1day–1 oral prednisolone (Harman et al.,
2017). The first agent that was considered for pulse therapy in pem-
phigus was methylprednisolone. Subsequently, the combination of dexa-
methasone and cyclophosphamide has been introduced as pulse therapy
dexamethasone cyclophosphamide pulse therapy (DCP) in some coun-
tries, due to its lower cost and better availability (Chryssomallis et al.,
1995; Gupta et al., 2015). However, this combination could be associ-
ated with other major side effects especially related to long-term cyclo-
phosphamide administration. Considering these problems with DCP
method, and easy availability of methylprednisolone, and also negligible
concern about its cost in our country, we prefer methylprednisolone for
pulse therapy similar to pioneer study in this regard.
In our previous study on 123 patients with PV, we compared
methylprednisolone pulse therapy to the conventional method using
oral prednisolone. There were no significant differences between two
groups in terms of response to the treatment of skin and mucosal
lesions, rate of complete remission and relapse but cumulative dose of
steroid, weight gain and duration of admission were significantly low
in pulse therapy after 1 year. The results of this study motivated us to
use pulse therapy as the first-line method of systemic steroid adminis-
tration, especially regarding the lower total dosage of prednisolone
which could prevent long-term complications (Shahidi-Dadras, Karami,
Toosy, & Shafiyan, 2007).
In our study, we evaluated the efficacy of methylprednisolone
pulse therapy in the treatment of 312 PV patients, and about 85% of
all the patients showed complete remission. While 10.5% of all the
patients had partial remission on minimal therapy or relapse/flare
and mortality rate recorded in 4%. Our result was comparable to Pas-
richa et al.'s study. Both studies prescribed steroid pulse therapy in
about 300 PV patients and reported remission in about 80% of
patients with a low mortality rate as 4% in both studies, and low
recurrence rate (10.5 vs. 19.6%), and minimal steroid side effects
(Pasricha, Khaitan, Raman, & Chandra, 1995). However, we have cho-
sen oral azathioprine instead of cyclophosphamide in order to reach
a better safety profile and avoid the possible cyclophosphamide side
effects. Therefore, our study suggests methylprednisolone pulse
therapy as a proper method of systemic steroid administration in PV
patients with considerable efficacy, reasonable flare rate, and low
mortality.
Azathioprine was the most frequently prescribed adjuvant drug in
our study, due to its high efficacy, low cost, and proper safety profile.
The limited number of using the other adjuvants like cyclophospha-
mide or mycophenolate mofetil might be given to the high efficacy of
methylprednisolone pulse therapy plus azathioprine for our patients.
Other studies have also considered azathioprine as superior to
mycophenolate mofetil and cyclophosphamide (Chams-Davatchi et al.,
2007; Sethy et al., 2009).
Recently, rituximab has also been presented as the first-line treat-
ment alongside systemic steroids in new-onset moderate-to-severe
disease and/or for patients who do not respond to systemic steroids,
especially, and/or other immunosuppressive adjuvants (Joly et al.,
GHEISARI ET AL.
2017; Murrell et al., 2018). In our study, rituximab prescription has
been increased progressively from 16% in early years of study in
patients with severe life-threatening disease and resistant to pulse
therapy plus other adjuvant drugs especially, to about 35% in the last
year of the study, even it was the first choice of adjuvant therapy,
but not as monotherapy. Primarily, this was due to less availability
and the cost of the original brand of drug. However, after launching
the rituximab biosimilar (Zytux™, AryoGen Pharmed) in Iran, its usage
has significantly increased, even as the first choice of adjuvant
therapy.
However, our study has some limitations, due to its retrospective
nature, mainly. There were some missing data about our patient
records, especially those who admitted and treated before the year
2006. It leads to their exclusion from the study and we select the
year 2006 as our starting point to include the patients in the study.
Moreover, no clinical score, such as the pemphigus disease area
index, and the autoantibody titers have been recorded or measured
in many patients due to restricted facilities in our centers. Other
important information about specific timely follow-up sessions on
9 months, 1 year or 2 years after treatment or timelines for the
healing of skin or mucosa were also not properly recorded in the
patients' profiles, due to our restricted facilities for the patients' data
registry. Therefore, we could not express these data in our study.
Considering these measurements in future studies could be more
beneficial to elucidate the efficacy of any suggested treatment of
pemphigus-like steroid pulse therapy. In conclusion, steroid pulse
therapy could be considered as a good option for proper control of
PV, specifically in severe cases with the possibility of a shorter stay
period of hospital admission. It could also reduce the need to take
long-term high-dose oral steroid therapy in pemphigus patients.
However, future controlled studies are needed to clarify these possi-
ble benefits of pulse steroid therapy in the management of PV more
definitely.
CONF LICT OF IN TE RE ST
The authors declare no potential conflict of interest.
ORCID
Mehdi Gheisari https://orcid.org/0000-0003-1268-7412
Reza M. Robati https://orcid.org/0000-0002-7947-8642
Fariba Ghalamkarpour https://orcid.org/0000-0002-2119-8082
Nastaran Namazi https://orcid.org/0000-0002-5411-8122
Niloufar N. Nobari https://orcid.org/0000-0002-4245-1980
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