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Table of Contents   
ORIGINAL RESEARCH  
Year : 2021  |  Volume : 32  |  Issue : 2  |  Page : 192-198
Hydroxychloroquine- A new treatment option for erosive oral lichen planus


1 Department of Periodontics, S.C.B Dental College and Hospital, Cuttack, Odisha, India
2 Department of Prosthodontics and Crown and Bridge, S.C.B Dental College and Hospital, Cuttack, Odisha, India
3 Department of Pedodontics and Preventive Dentistry, S.C.B Dental College and Hospital, Cuttack, Odisha, India

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Date of Submission28-Sep-2020
Date of Decision04-Jul-2021
Date of Acceptance22-Jul-2021
Date of Web Publication22-Nov-2021
 

   Abstract 


Context: Oral Lichen planus (OLP) is a chronic, debilitating, immune-mediated disease whose management is considered a challenge in medical science. Aims: To quantitatively evaluate the effect of administration of enteral hydroxychloroquine (HCQS) as a monotherapy for six months on the extent and severity of erosive OLP using reticular score, erythema score and ulcerative score (REU score), and to subjectively evaluate the success of HCQS as a therapeutic drug for OLP-e using Tel Aviv-San Francisco Scale, visual analogue scale (VAS) and severity of burning sensation (BURN score). Settings and Design: Prospective clinical trial. Methods and Material: A total of 45 subjects received 200 mg of HCQS bid for six months. REU, VAS, BURN scores and Tel Aviv-San Francisco Scale readings were taken at the beginning of the study (baseline) and three- and six-month intervals post administration of enteral HCQS. Subjects were examined for any adverse drug outcomes for one year after the cessation of enteric HCQS therapy. Data were analysed with SPSS version 25. Results: There was a stark reduction in REU, VAS and BURN scores during the study period, with a statistically significant reduction (P < 0.05) seen at three- and six-month time intervals as compared to baseline. Further, the mean of change in R, E and U scores showed a statistically significant difference, with the highest reduction seen at baseline to six-month time interval. The Tel Aviv-San Francisco Scale showed 70%–100% remission in disease in more than 70% of subjects. Conclusions: Enteral HCQS can be considered a viable treatment option for the enigma that is erosive OLP.

Keywords: Erosive oral lichen planus, hydroxychloroquine, REU score

How to cite this article:
Raj SC, Baral D, Garhnayak L, Mahapatra A, Patnaik K, Tabassum S, Dash JK. Hydroxychloroquine- A new treatment option for erosive oral lichen planus. Indian J Dent Res 2021;32:192-8

How to cite this URL:
Raj SC, Baral D, Garhnayak L, Mahapatra A, Patnaik K, Tabassum S, Dash JK. Hydroxychloroquine- A new treatment option for erosive oral lichen planus. Indian J Dent Res [serial online] 2021 [cited 2021 Dec 8];32:192-8. Available from: https://www.ijdr.in/text.asp?2021/32/2/192/330867



   Introduction Top


Lichen planus is a T-cell mediated autoimmune disease of the skin and mucous membrane resulting in erythema, atrophy and ulceration, which leads to significant morbidity affecting roughly 1-2% of the world population.[1],[2],[3] Lesions occurring in the oral cavity are called oral lichen planus (OLP), predominantly found on the buccal mucosa and tongue, less frequently on the gingiva and labial mucosa, and rarely on the palate and floor of the mouth. OLP found on gingiva is classified as non-plaque-induced gingival lesion.[4],[5],[6] Erosive lichen planus is associated with erythema (atrophic) and ulceration in varying degrees and is associated with intense pain and burning sensation with a reported 1% potential of malignant transformation.[7],[8] So far, the management of this condition is mostly palliative, with most reliable results with the use of topical or systemic corticosteroids. However, a rise in secondary candidiasis and recalcitrant forms has led to a search for newer molecules and strategies to tackle this predicament.[9] Hydroxychloroquine (HCQS) is a wonder drug that was developed shortly before World War II as an anti-malarial agent.[10] Its immunomodulatory action was a chance finding following which it was most widely used in autoimmune diseases, such as lupus,[11] and chronic inflammatory diseases, such as arthritis. It was used as a monotherapy for the treatment of OLP for the first time in 1993 and was reported to have favourable results, especially in reducing erosion and alleviating pain.[10] There are several reports of the benefits of this line of treatment for OLP. However, so far, there is no consensus regarding its efficacy or superiority.

The aim of our study was to quantitatively evaluate the effect of administration of HCQS as a monotherapy for six months on the extent and severity of erosive OLP using the reticular score, erythema score and ulcerative score (REU score),[12] and to subjectively evaluate the success of HCQS as a therapeutic drug for erosive OLP using Tel Aviv-San Francisco Scale,[13] visual analogue scale (VAS) and severity of burning sensation (BURN score).


   Subjects and Methods Top


This study was approved by the Institutional Ethical committee before its commencement and was conducted in accordance with the declaration of Helsinki of 1975, as revised in 2000. This was a prospective clinical trial performed from February 2018 to December 2019 in our department. Written informed consent was obtained from all the participants after they received a written and oral explanation of the study's objectives, risks and benefits. Approval from Institutional Ethical Committee obtained dated 16-01-2018.

As determined in a sample of patients attending the out-patient department, at least 30 subjects were required to detect a variation of 1-unit increase or decrease in the REU score with a 5% significance level and a power of 80%. Anticipating attrition of 20%, 45 subjects, aged 18 to 45 years with good oral hygiene (plaque scores of <1),[14] with the chief complain of painful burning sensation in the oral cavity were enrolled in the study from February 2018 to June 2019 based on pre-decided criteria [Figure 1]. Inclusion criteria: 1) clinically active erosive OLP confirmed by a supportive biopsy report within 12 months of commencement of the study,[15] 2) no history of use of any pharmacotherapeutic agent for the treatment of the lesion within six months of the study, 3) otherwise systemically healthy as elicited by thorough medical history, physical examination, cardiovascular evaluation, ophthalmologic evaluation (to rule out cataract, diabetic retinopathy, glaucoma and macular degeneration) along with the relevant biochemical examination of blood and urine (routine ECG, complete blood cell count, blood urea nitrogen, serum creatinine level, ALT, AST, LDH, bilirubin, alkaline phosphatase and G6PD test). Exclusion criteria: 1) pregnancy or lactation, 2) use of tobacco in any form, 3) history of long-term non-steroidal anti-inflammatory drug therapy or antibiotic prophylaxis within 6 months of study, 4) presence of amalgam restoration adjacent to the lesion, 5) known hypersensitivity to HCQS, 6) lichen planus in any region other than oral cavity. All patients underwent a complete cardiovascular and ophthalmological evaluation at baseline which was repeated every four to five months.
Figure 1: Study flowchart. N: Number of subjects.

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During the first visit (baseline), demographic and clinical information was recorded. Each subject was asked to score pain on a 0-to-10 VAS, 0 representing the absence of pain and 10 representing the worst possible pain. The severity of burning sensation (BURN) was recorded on a scale of 0 to 4 by the patient,[16] (0: no burning, 1: mild/occasional, 2: moderate while eating spicy food, 3: severe while eating any food, 4: an intolerable burning sensation that is always present). Using a flexible transparent grid with 1 × 1 mm2 smallest dimension, the number of units of reticulation (R), erythema (E) or ulceration (U) was counted for every lesion(s) [Figure 2]a and [Figure 2]b. The severity was estimated by calculating the REU score using the formula, R + 1.5 E + 2 U,[12] by an investigator (DB).
Figure 2: Calculation of REU score. (a) Flexible transparent grid used for measuring the number of units of reticulation (R), erythma (E) or ulceration (U). (b) Placement of grid on lesion.

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On the same day, the subjects were prescribed oral 200 mg of HCQS (IPCA Lab, India) tablet twice daily for six months and instructed to stop the medication immediately and report to the dental office at the earliest in case of any severe adverse reaction to the drug.

To ensure optimum oral hygiene, vital for management of erosive OLP, all the participants underwent a full-mouth supragingival scaling by an operator (DB) using ultrasonic scalers (NSK, Nakanishi Inc, USA) at the onset of the trial and a 4-week interval, each visit lasting for 30–45 min. Each of them was given a standardised set of oral hygiene instructions, both verbally as well as in written format.

All the evaluation done at baseline [Figure 3]a and [Figure 3]b was repeated at the end of three and six months [Figure 4]a and [Figure 4]b of the drug therapy. Based on the comparison of the REU score and the symptoms at baseline and subsequent visits, the success of HCQS as a therapeutic drug for OLP was evaluated using Tel Aviv-San Francisco Scale[13] of −1 to 4 (−1: deterioration or regression, 0: little improvement (less than 20%), 1: moderate recovery (approximately 30%–50%), 2: marked improvement (50%–70%) treatment still required, 3: almost complete (70%–80%) treatment not required, 4: absolute remission). This scoring was done by a single examiner (SCR) calibrated up to a precision of 0.5.[10],[13] All the patients were followed up for one year after cessation of medication to monitor recurrence of the lesion, if any, and checked for any delayed side effects of the monotherapy.
Figure 3: Evaluation of lesion at baseline. (a) Erosive lesion seen at right buccal mucosa. (b) Erosive lesion seen at left buccal mucosa.

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Figure 4: Evaluation of lesion at six months post administration of enteral HCQS. (a) Lesion at right buccal mucosa shows resolution of erythema. (b) Lesion at left buccal mucosa shows complete absence of reddish erythematous component.

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Statistical analysis

The statistical analysis was done using statistical software [SPSS version 25]. Statistical significance was defined as P < 0.05. The normality of the data was tested using the Shapiro-Wilk test. One-way repeated measure ANOVA was carried out to compare the mean REU, VAS and BURN scores at the pre-defined time interval. One-way ANOVA was done to compare the mean change R, E and U score at different time intervals.


   Results Top


[Table 1] shows the descriptive data and mean REU, VAS and BURN scores. [Figure 5] shows the reduction in mean REU, VAS and BURN scores over six months. One-way repeated measure ANOVA was carried out to compare the mean of REU, VAS and BURN at three- and six-month intervals [Table 2]. The results showed a significant reduction in REU, VAS and BURN scores after administration of HCQS at baseline when compared at three- and six-month intervals. [Table 3] shows the result of one-way ANOVA comparing mean of change in R, E and U scores at defined time intervals, i.e., baseline to three months, baseline to six months and three months to six months. At P < 0.05, there was a significant difference between the mean values of independent variables at all time intervals. Mean of change in R, E and U scores are also depicted in [Table 3] and [Figure 6], with maximum reduction in parameters seen after six months. Among the parameters measured, U and E exhibit a maximum degree of resolution after the administration of HCQS. According to the scores of Tel Aviv-San Francisco Scale at the end of three months, REU showed slight improvement at the end of 3 months and significant improvement at the end of 6 months. VAS and BURN score began showing marked improvement at the end of 3 months. Marked improvement in REU was seen at the end of six months (score 3, 4) [Table 4].
Table 1: Descriptive data and Mean REU, VAS and BURN

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Table 2: One-way repeated ANOVA measurements for comparison of mean REU, VAS and BURN at various time intervals

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Table 3: Results of ANOVA comparing mean change in R, E and U scores and Mean value of change in R, E and U scores at different time intervals

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Figure 5: Graph showing a reduction in REU, VAS and BURN scores during treatment.

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Figure 6: Graph showing mean values of change in R, E and U scores at different time intervals.

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Table 4: Global Physician Assessment using REU score

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   Discussion Top


It is widely claimed that a permanent cure is not available for OLP,[17] and the management aims at symptomatic control and reducing the frequency of exacerbations.[18],[19],[20] In our study, the use of enteral HCQS resulted in significant resolution (>70% of the lesions exhibited 70-100% remission and did not require any further treatment). Further, none of them reported any episodic outbursts during the study. To the best of our knowledge, this is the first of its kind study to quantitatively evaluate the effect of systemic HCQS on OLP-e over six months. However, there are previous reports of favourable results, six months and 12 months after using enteral HCQS for lichen planopilaris and cicatricial pemphigoid.[21] An OLP lesion has six clinical variants: papular, reticular, erosive, atrophic, bullous and plaque-like.[22] Most of the lesions are a combination of two or more histologic variants.[22],[23] The three major clinical features of a lesion are reticulation, erythema and ulceration (erosion), present alone or in combination. Hence, quantifying these components of a lesion helps us to diagnose the severity of the disease more definitively. One such scale is the REU scale proposed by Piboonniyom et al.[12] in 2005. In 2012, Park et al.[24] reported a highly significant correlation between the REU score and the pain in OLP cases. In our study, we assessed the severity of the lesion by REU scoring and found a significant reduction in all three components with a significant reduction in E and U scores. This is reflected directly in the drastic reduction in the burning sensation and pain scores.

OLP is one of the most challenging ailments to cure since 1866 when it was reported for the first time as a white papular eruption in the buccal mucosa.[25] Typically, it manifests as periods of exacerbations and remissions. Depending on the histopathological nature of the lesion, it may be asymptomatic or may be associated with severe burning sensation, pain and discomfort.[2],[3],[4],[26] We have included subjects having erosive OLP with the chief complain of pain, burning sensation and discomfort. As the pathogenesis is mostly immuno-inflammatory, the management usually aims at alleviating the painful symptoms and resolution of the inflammation, rather than being curative.[3],[4],[17],[18],[19],[20] Over the years, several treatment modalities have been put forth, both pharmacological as well as surgical. However, the rate of recurrence is notably high, making the morbidity associated with surgical methods undesirable. Some nonsurgical therapies include photochemotherapy with 8-methoxypsoralen and long-wave ultraviolet light (PUVA therapy), Photodynamic therapy (PDT) and laser therapy.[26] However, the data available is limited and inconclusive.

The mainstay treatment of erosive OLP remains corticosteroids.[27] The rationale behind their usage is the ability of steroids to modulate the immunological as well as the inflammatory response by stabilising the lysosomal membrane and reducing the lymphocytic exudates.[28] The commonest corticosteroids used for erosive OLP are triamcinolone acetonide, fluocinonide acetonide and disodium betamethasone phosphate. The newest molecule of this category is clobetasol, which shows promising results.[29] The biggest disadvantage of topical corticosteroid is its inability to adhere to the mucosa for a sufficient length of time. It is reported that the use of adhesive bases as a vehicle for the medicament results in faster resolution of symptoms. However, for lesions in the buccal or labial mucosa, tongue, floor of the mouth or vestibular depth, the efficacy of topical corticosteroids is considerably compromised. Further, prolonged use of corticosteroids leads to secondary candidiasis, tachyphylaxis and even adrenal insufficiency.[27],[28],[29],[30] Hence, there is a lookout for other therapeutic agents. Immunosuppressants such as dapsone, retinoids and recombinant monoclonal antibodies are the newer agents reported to have promising results in OLP.[26],[31] Topical calcineurin inhibitors such as cyclosporine and tacrolimus have considerable therapeutic benefits, tacrolimus being 10–100 times more potent than cyclosporine. The newest molecule in the series is pimecrolimus.[31] However, the burning sensation, the cost and the difficulty in application compromise patient compliance. Moreover, the clinical superiority of these agents over clobetasol is not yet conclusively established.[17]

Hydroxychloroquine is an anti-lymphocytic, anti-malarial drug that has been widely used since the 1950s for a range of dermatologic conditions, including lupus erythematosus, porphyria cutanea tarda, polymorphous light eruption, dermatomyositis, cutaneous sarcoidosis, granuloma annulare and lichen planus.[21],[32],[33],[34] The anti-inflammatory effect is attributed to the stabilisation of lysosomal membrane and the inhibition of prostaglandin synthesis. It interferes with complement-dependent antigen-antibody reactions and suppresses the in vitro lymphocyte transformation.[32],[33] The drug is generally well tolerated with minor gastrointestinal symptoms (nausea, vomiting and diarrhoea) and neuromuscular symptoms (headaches, myalgia and fatigue).[21],[32],[33],[34] Some of the infrequent adverse effects of long-term monotherapy are reversible agranulocytosis, headaches due to neuropathy, retinopathy, toxic psychosis and cutaneous pigmentation. In the course of our study, two patients developed severe headache, three patients developed nausea and vomiting resulting in withdrawal from the study at two months of prescription after which the headache, nausea and vomiting resolved but the lesions reappeared within four weeks. One patient developed blue-black skin pigmentation after four months of the therapy, resulting in withdrawal. He did not report the reappearance of OLP within the period of the study. In our study, we used 200 mg of HCQS twice daily as a monotherapy for six months and found marked remission in almost all patients. In a previous study, the use of 400 mg/day of HCQS for six months resulted in a significant remission in six out of 10 subjects whereas use of 200 mg/day resulted in acute exacerbations within six months of the therapy. They reported that attaining 96% of steady-state levels of hydroxychloroquine with a once-daily oral dosage of 400 mg required a six-month regimen.[33]

In 2012, Bendas[35] reported the use of topical HCQS that resulted in remission of OLP in the first two weeks of application; however, by the end of six weeks, some of the symptoms reappeared. However, they have not mentioned the histological variant they have conducted their study on. In a previous study conducted over six weeks, enteral HCQS was reported to give better results as compared to topical HCQS. However, the interpretation was based on subjective clinical assessment and small sample size.[33]

We found that ulcerative and erythematous components of the lesion responded extremely well to the monotherapy, and at the end of six months, all lesions showed 70%–100% remission. The possible explanation could be the mechanism of action of HCQS that interferes with the cytokine-mediated immune-inflammatory cascade.

However, indiscriminate use of any pharmaco-therapeutic agent is fraught with significant health risks and hence calls for appropriate caution. We followed up on all the cases for one year post the cessation of monotherapy. There was no recurrence of any of the erosive OLP lesions [Figure 7]a and [Figure 7]b or any incidence of adverse systemic side effects as monitored by regular cardiovascular and ophthalmologic examinations, blood and urine analysis.
Figure 7: (a, b) Follow-up of erosive OLP in right and left buccal mucosa respectively after one year of cessation of monotherapy showing complete remission.

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   Conclusion Top


Within the limitations of our study, we have reached the conclusion that HCQS monotherapy using a daily dosage of 400 mg/day for six months may be a promising curative treatment for OLP-e as no significant adverse outcomes or recurrences of the lesion were reported in the one year follow-up. One limitation of our study could be that only the ulcerative variant of OLP was included, while the other forms are equally elusive to treatment. In the future, studies could be designed to evaluate the effectiveness of HCQS on other forms of OLP. However, repeated CVS and ophthalmologic evaluations are vital, and HCQS therapy must be stopped if symptoms developed.

Declaration of patient consent

The authors certify that they have obtained all appropriate patient consent forms. In the form, the patient(s) has/have given his/her/their consent for his/her/their images and other clinical information to be reported in the journal. The patients understand that their names and initials will not be published and due efforts will be made to conceal their identity, but anonymity cannot be guaranteed.


   Acknowledgements Top


Department of Oral Medicine and Radiology, S.C.B Dental College and Hospital, Cuttack, Odisha, India.

Financial support and sponsorship

Nil.

Conflicts of interest

There are no conflicts of interest.



 
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Correspondence Address:
Dr. Subash Chandra Raj
Department of Periodontics, S.C.B Dental College and Hospital, Cuttack - 753007, Odisha
India
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Source of Support: None, Conflict of Interest: None


DOI: 10.4103/ijdr.IJDR_943_20

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