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  IN THIS Article
 ::  Abstract
 ::  Introduction
 ::  Materials and Me...
 ::  Results
 ::  Discussion
 ::  Acknowledgement
 ::  References
 ::  Article Figures
 ::  Article Tables

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  Table of Contents     
ORIGINAL ARTICLE
Year : 2011  |  Volume : 57  |  Issue : 2  |  Page : 115-119

Drug-induced Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), and SJS-TEN overlap: A multicentric retrospective study


1 Department of Pharmacology, Government Medical College, Bhavnagar, India
2 Department of Dermatology, Venerology and Leprosy, Sir Takhtsinhji General Hospital and Government Medical College, Bhavnagar, Gujarat, India

Date of Submission11-Oct-2010
Date of Decision10-Dec-2010
Date of Acceptance03-Jan-2011
Date of Web Publication4-Jun-2011

Correspondence Address:
C Tripathi
Department of Pharmacology, Government Medical College, Bhavnagar
India
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Source of Support: None, Conflict of Interest: None


DOI: 10.4103/0022-3859.81865

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 :: Abstract 

Background : Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN) are rare immune-mediated severe cutaneous adverse reactions with incidence rate of 0.05 to 2 persons per million populations per year. Drugs are the most commonly implicated in 95% of cases. Aims : To audit the causative drugs, clinical outcome, and cost of management in SJS, TEN, and SJS-TEN overlap. Setting and Design: Tertiary care hospitals-based multicentric retrospective study (case series). Materials and Methods : Indoor case papers of SJS, TEN, and SJS-TEN overlap admitted between January 2006 and December 2009 in four tertiary care hospitals of Gujarat were scrutinized. Data were collected for demographic information, causative drugs, investigations, treatment given, duration of hospital stay, time interval between onset of symptoms and drug intake, clinical outcome, and complications. Data were analyzed to find out proportion of individual drugs responsible, major complications, and clinical outcome in SJS, TEN, and SJS-TEN overlap. Total cost of management was calculated by using cost of drugs, investigations, and consumables used during entire hospital stay. Statistical Analysis : One-way Analysis of Variance followed by Tukey-Kramer multiple comparison test was used for comparison of incubation period, duration of hospital stay, and cost of management. Results : Antimicrobials (50%), nonsteroidal anti-inflammatory drugs (22.41%), and antiseizure drugs (18.96%) were the most commonly associated groups. Nevirapine (28.12%) was the most common drug. Antiseizure drugs were more often associated with serious form of adverse reaction (TEN: 81.8%) than other drugs. Duration of hospital stay (20.6 vs 9.7 days) and cost of management (Rs 7 910/- vs Rs 2 460/-) were significantly higher in TEN than SJS (P=0.020 and P<0.001, respectively). Time duration between drug intake and onset of symptoms (17.7 vs 27.5 days) was nonsignificantly lower in TEN as compared with SJS. Secondary infection (28.12%) was the most common complication noted. Mortality rate was 15.6% among all cases; 9% in SJS and 26.7% in TEN. Conclusion : Antimicrobial drugs are the most commonly implicated drugs and cost of managing these adverse drug reactions is higher than other serious ADRs.


Keywords: Adverse drug reaction, Stevens-Johnson syndrome, toxic epidermal necrolysis


How to cite this article:
Barvaliya M, Sanmukhani J, Patel T, Paliwal N, Shah H, Tripathi C. Drug-induced Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), and SJS-TEN overlap: A multicentric retrospective study. J Postgrad Med 2011;57:115-9

How to cite this URL:
Barvaliya M, Sanmukhani J, Patel T, Paliwal N, Shah H, Tripathi C. Drug-induced Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), and SJS-TEN overlap: A multicentric retrospective study. J Postgrad Med [serial online] 2011 [cited 2017 Oct 20];57:115-9. Available from: http://www.jpgmonline.com/text.asp?2011/57/2/115/81865



 :: Introduction Top


Adverse drug reactions (ADRs) hold special importance in healthcare as they account for 6% of total hospital admissions, increase in economic burden on healthcare system, withdrawal of drugs from market, and death. [1],[2],[3] Among the various ADRs, cutaneous adverse reactions like skin rashes, urticaria, itching, fixed drug eruption, angioedema, erythema multiforme,  Stevens-Johnson syndrome More Details (SJS), and toxic epidermal necrolysis (TEN) are the common ones. [4],[5] In this wide spectrum of cutaneous reactions, SJS and TEN are rare but serious form of ADRs affecting patient's life. [4] SJS and TEN are immune-mediated reactions, due to various etiological factors like drugs, infections, malignancy, and radiation therapy. [5] Drugs are the most commonly implicated in 95% of cases. [5] Incidence of SJS and TEN is 0.05 to 2 persons per million populations per year. [6],[7] Incidence is higher in HIV patients than general population. [8] Clinically, SJS and TEN are characterized by polymorphic lesions like erythematous macules, papules, plaque, vesicles, and bullae predilected to distal extremities with Nikolsky's sign positive. "Target" lesion with bull's eye appearance is characteristic of SJS and TEN. Oral, genital, and conjunctival mucosa is often involved in the form of erosion or ulceration. [9] The basic difference between SJS and TEN is the percentage of body surface area (BSA) involved: <10% in SJS; >30% in TEN; 10 to 30% in SJS-TEN overlap. [5],[9] No confirmatory in vivo or in vitro tests are available for identifying offending agents in SJS and TEN. [9] Moreover, a rechallenge in a case is not ethically justified as these are the life-threatening reactions. So, to identify the drugs associated with risk of causing severe skin reactions, retrospective epidemiological data are required. This study was aimed to audit the causative drugs, clinical outcome, and economic burden due to these serious ADRs. This study also helped us to know the changing pattern of most common causative agents for SJS and TEN.


 :: Materials and Methods Top


This multicentric study was started after approval from Institutional Review Board, Government Medical College, Bhavnagar, Gujarat. Permission for data collection at other centers was taken from the head of the respective institutions. Indoor case papers of SJS, TEN, and SJS-TEN overlap admitted between January 2006 and December 2009 in Sir Takhtsinhji General Hospital, Bhavnagar; Pandit Deendayal Upadhyay Civil Hospital, Rajkot; New Civil Hospital, Surat; and Sir Sayaji General Hospital, Vadodara were scrutinized. Data were collected for demographic information, causative drugs, time duration between drug intake and onset of symptoms, BSA involvement, duration of hospital stay, treatment given, complications, and clinical outcome. Cases with doubtful diagnosis and insufficient data were excluded from the study. Data were analyzed to find out the proportion of individual drugs involved, major complications, and cost of management for SJS, TEN, and SJS-TEN overlap. Total cost of management was calculated by using cost of drugs (average cost of drugs from IDR-triple i Drug Compendium), investigations, and consumables used during entire hospital stay. [10] Ward and nursing charges were not included in the management cost. SCORTEN score was calculated for each case at the time of admission and its relation with mortality was compared in the study. [11]

Results are expressed as percentages and mean (95% confidence interval [CI]). Comparisons between the three groups were performed by using One-way Analysis of Variance (ANOVA) followed by Tukey-Kramer multiple comparison test. A P value of less than 0.05 was considered significant. All statistical analyses were performed with GraphPad InStat 3 (demo version).


 :: Results Top


Of the 46 cases scrutinized, 32 cases were included in the study, whereas 14 cases were excluded from the study. Among the 32 cases, we found 11 cases of SJS, 15 cases of TEN, and 6 cases of SJS-TEN otverlap. Of the 32, 17 patients were male and 15 were female between age group of 7 to 60 years. Total 58 drugs were found as suspected causative agent. In 20 cases, multiple drugs were suspected, whereas in 12 cases, single drug was implicated. In all the 32 cases, drugs were the "probable" cause of eruptions, as determined by Naranjo's algorithm. [12] Antimicrobials (50%) were the most commonly associated group followed by nonsteroidal anti-inflammatory drugs (NSAIDs) (22.41%) and antiseizure drugs (18.96%) [Table 1]. Nevirapine (9 of 32 cases), paracetamol (8 of 32 cases), cotrimoxazole (7 of 32 cases), and phenytoin (7 of 32 cases) were found to be the most commonly associated drugs. Phenytoin (4 of 12 cases) was the most common drug among the single drug culprit cases. Associated diseases were present in 13 cases (HIV infection - 12 cases [37.5%] and malignancy - 1 case [3.1%]). In 12 HIV patients, nevirapine (9 of 12 cases), cotrimoxazole (6 of 12 cases), zidovudine (1 of 12 cases), and stavudine (1 of 12 cases) were found responsible for causing this reaction. Antiseizure drugs were more often associated with serious form of adverse reaction (TEN: 81.8%) than other drugs. Time duration between drug intake and onset of symptoms was 27.5 days (95% CI: 9.5-45.3) in SJS, 17.7 days (95% CI: 10.2-25.1) in TEN, and 15.3 days (95% CI: 3.1-27.5) in SJS-TEN overlap. In treatment, systemic steroids were given in 8 of 11 cases of SJS, 12 of 15 cases of TEN, and 5 of 6 cases of SJS-TEN overlap, whereas intravenous immunoglobulin (IVIG) was given in 1 of 6 cases of SJS-TEN overlap. Duration of hospital stay was 9.7 days (95% CI: 5.8-13.6) in SJS, 20.6 days (95% CI: 14.4-26.8) in TEN, and 16.1 days (95% CI: 5.0-27.4) in SJS-TEN overlap, while cost of management was ` 2 460/- (95% CI: 1 762-3 158) in SJS, ` 7 910/-(95% CI: 5 672-10 147) in TEN, and ` 4 857/- (95% CI: 2 118-7 597) in SJS-TEN overlap. Duration of hospital stay and cost of management were significantly higher in TEN than in SJS (P=0.020 and P<0.001, respectively) [Table 2]. Various complications noted in cases of SJS, TEN, and SJS-TEN overlap were secondary infection, septicemia, altered liver function test, electrolytes imbalance, leucocytosis, leucopoenia, thrombocytopenia, hyperglycemia, respiratory distress, and acute renal failure. Secondary infection was the most common complication (9 of 32 cases) noted [Figure 1]. Mortality rate was 15.6% among all cases; 9% in SJS and 26.7% in TEN. Higher mortality rate was noticed in patients with higher SCORTEN score at the time of admission [Table 3].
Table 1: Drug groups and individual drugs responsible for SJS, TEN, and SJS-TEN overlap


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Table 2: Comparison of incubation period, duration of hospital stay, and cost of management between SJS, TEN, and SJS-TEN overlap


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Table 3: Comparison between SCORTEN score, mortality rate in present study, and expected mortality rate


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Figure 1: Complications noted in SJS, TEN, and SJS-TEN overlap (SJS: Stevens-Johnson syndrome; TEN: Toxic epidermal necrolysis; LFT: Liver function test)

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 :: Discussion Top


We had male preponderance (53.1% male and 46.9% female), unlike female preponderance in earlier studies. [13],[14],[15] All the cases had same frequency of occurrence throughout the year, no seasonal variation was noted. [16] Three most common groups of drugs causing eruptions were antimicrobials, NSAIDs, and antiseizure drugs. This is in agreement with the previous reports. [13],[14],[17] Nevirapine (28.1%) was the most commonly associated drug in our study, as against phenytoin and carbamazepine which have been mentioned in previous study. [14],[15] Antiseizure drugs were the most common drugs causing TEN in our study. They had the higher chance (81.8%) of causing severe eruption, that is, TEN than NSAIDs (53.84%) and antimicrobials (34.48%). This is higher as compared with the previous report (70%). [14] Average number of drugs to be found as causative for SJS, TEN, and SJS-TEN overlap was 1.81. Though antimicrobials have been the most common group of drugs involved, there has been change in the individual drugs involved. Nevirapine and cotrimoxazole are the most common antimicrobial associated as compared with cephalosporins in an earlier study. [14] In all, 37.5% patients were HIV positive, which indicates increase in incidence of SJS and TEN in HIV patients, which was 7.3% in European study. [18] Nevirapine was the most common causative drug among the HIV patients as compared with the cotrimoxazole. [8] However, of 7 culprit cases with cotrimoxazole, 6 patients were HIV positive. This shows higher incidence of SJS and TEN with cotrimoxazole in HIV-positive patients than in general populations. [8] In last few years, HIV infection might have changed the trend of antimicrobials causing SJS, TEN, and SJS-TEN overlap. In 4 HIV cases, reaction appeared after change in regimen of antiretroviral therapy from ZLE (Zidovudine, Lamivudine, Efavirenz) to ZLN (Zidovudine, Lamivudine, Nevirapine). Arrival of new drugs like nevirapine and lamotrigine have changed current scenario of causative drugs for SJS, TEN, and SJS-TEN overlap and risk of severe skin reaction increases with use of these drugs. [19] However, we did not have lamotrigine as culprit in our study. This may be due to its limited utilization or different environmental or genomic factors in our population. However, highest occurrence with nevirapine suggests the requirement of monitoring the newer drugs for such type of severe reactions. [19]

Among NSAIDs, paracetamol was the most common to cause the reaction in our study and as described in other Indian study. [14] We did not find any oxicam derivative as culprit which is mentioned as the most commonly responsible among NSAIDs in American study. [20] This may be due to different genomic factors or drug utility pattern influencing both the populations.

Duration of hospital stay in TEN is higher than in SJS, which is same as in previous study. [21] The risk of SJS, TEN, and SJS-TEN overlap appears to be greater in the first month of initiation of treatment as revealed by incubation period. Incubation period is nonsignificantly lower in the TEN as compared with SJS and SJS-TEN overlap. In our study, majority of cases were treated with systemic steroids, and mortality rate was found similar to previous study in which patients were treated with steroids. [14] Though the role of steroids is controversial in treatment of SJS and TEN, beneficial effect may be there if steroids are started early in treatment with proper dose. [22] IVIG was given in one patient with SCORTEN score 2 and had recovered within 8 days. We could not make any conclusion about the use of IVIG in treatment of SJS and TEN as it was used only in one patient in our study. Complications were seen more frequently in TEN group (63.4%), the most common being secondary infection (28.1%). One patient died in SJS group, whereas no mortality was noted in SJS-TEN overlap. Mortality rate in TEN group was 26.66%, which is equal to earlier study (26%). [14] Our study showed that mortality rate was higher in patients with higher SCORTEN score, which shows importance of SCORTEN score as an important tool for predicting the clinical outcome in patients of SJS, TEN, and SJS-TEN overlap. [11] Average cost of management of SJS (Rs 2 460/-) is nearly equal to average cost of management of other severe ADRs in India (Rs 2 820/-), but the cost of management of SJS-TEN overlap (Rs 4 857/-) and TEN (Rs 7 910/-) is much higher. [10]

Being retrospective in nature, we were not able to calculate direct nonmedical and indirect costs. Thirty percent cases have been excluded from the study due to insufficient data or improper records. Proper record keeping is required for such type of study involving disease of low incidence rate.

In conclusion, SJS, TEN, and SJS-TEN overlap are serious cutaneous adverse reactions most commonly caused by antimicrobials, NSAIDs, and antiseizure drugs. Their cost of management is higher than other serious ADRs.


 :: Acknowledgement Top


Our sincere thanks to Dr. Neela Bhuptani, Professor and Head, Department of Dermatology, Venerology and Leprosy and

Dr. R.B.Deshmukh, Medical Superintendent (P.D.U. Civil Hospital and Medical College, Rajkot); Dr. N.D.Kanthariya, Professor and Head, Department of Pharmacology and Dr. M.K.Vadel, Medical Superintendent (Government Medical College and New Civil Hospital, Surat) and Dr. Yogesh Marfatiya, Professor and Head, Department of Dermatology, Venerology and Leprosy and Dr. R.N. Deveshvar, Medical Superintendent (Medical College and S.S.G. Civil Hospital, Vadodara) for giving permission for the data collection at their respective centers.

 
 :: References Top

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    Figures

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    Tables

  [Table 1], [Table 2], [Table 3]

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26 Diclofenac-induced Stevens-Johnson syndrome: A case report
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Barvaliya, M.J. and Patel, M.K. and Patel, T.K. and Tripathi, C.B.
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30 Dermatologic emergencies: Rapid response by the Pharmacist
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31 Drug-induced Stevens-Johnson syndrome: Case series from tertiary care centre in Gujarat
Bang, D. and Shah, T. and Thakker, D. and Shah, Y. and Raval, A.D.
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32 Severe antiretroviral therapy-induced toxic epidermal necrolysis in a child
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Online since 12th February '04
© 2004 - Journal of Postgraduate Medicine
Official Publication of the Staff Society of the Seth GS Medical College and KEM Hospital, Mumbai, India
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