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A NEW STUDY PROVIDES CONCRETE EVIDENCE FOR THE EFFECTIVENESS OF TOPICAL TACROLIMUS IN ORAL LICHEN PLANUS

Author: Medical Team (Alniche Life Sciences)

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Background

A recent study discussing the long-term treatment protocol for Oral lichen planus (OLP) with tacrolimus after the failure of initial treatment with topical corticosteroids was published in the Journal of the European Academy of Dermatology and Venereology.

The clinical effectiveness of topical tacrolimus has been demonstrated in numerous previous studies. However, this research provided detailed data to prove the beneficial effects of tacrolimus with long-term usage which was not done in established literature where the follow-up was too short.

Therefore, this study can be established as a relevant piece of literature to prove the clinical efficacy and safety of tacrolimus as a second line of therapy for the treatment of Oral lichen planus (OLP) in patient’s refractory to topical steroids.

 

About Oral lichen planus

Lichen planus is a mucocutaneous inflammatory disorder primarily affecting the skin and the oral mucosa where the appearance of symptoms in the oral mucosa precedes the appearance of lesions at other locations. The Etiology of lichen planus is unknown but currently it has been linked to an autoimmune disorder.

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

About the study

The primary objective of the study was to develop an optimal therapeutic application scheme for the use of oral tacrolimus in the treatment of Oral lichen planus as well as its use-associated side effects.

To attain this objective all the patients diagnosed with OLP and failed treatment with topical corticosteroids were prescribed oral tacrolimus solution (0.03%) as 5-min mouthwash between January 2015 to October 2020. A 4 – point scale (complete remission, major remission, partial remission and no response) was used to evaluate the clinical remission. Additionally, subjective impairment was evaluated on the basis of a 3- point scale (severe, moderate and no impairment).

Key findings from the study:

• A total no. of 57 patients with 42 females and 15 males were included in the study. Majority of the patients i.e., 46 had a combination of hyperkeratotic & erosive lesions predominantly in the buccal and gingival mucosa. All the patients except 1 were previously treated with corticosteroids and doxycycline. Patients characteristics and detailed data on clinical response to the tacrolimus are provided in the table 1.

 

 

The key findings from the study are summarized in the table given below:

N	57
Sex	Male: 15 Female: 4
Predominant form	Only hyperkeratotic: 7 Patients Erosive lesions: 4 Patients Combination of hyperkeratotic & Erosive lesions: 46 patients
Localization	Buccal mucosa: 52 patients Gingiva: 42 patients Tongue: 22 patients Lips: 9 patients Palate: 7 patients
Previous treatment	Topical steroids (Betamethasone dihydrogen phosphate-disodium water-soluble tablets 0.5 mg in 1 dL water) / fluocinonide gel 0.05%: 56 patients Systemic corticosteroids: 3 patients Doxycycline: 1 patients
Duration of therapy with follow up	4 & 19.6 months
CLINICAL RESPONSE TO TREATMENT
Time period	3 months	6 months	12 months	24 months
Objective remission	16 patients	33 patients	44 patients	47 patients
Complete remission	0 patients	6 patients	4 patients	4 patients
Relapse	-	7 patients	12 patients	15 patients
Subjective remission (no impairment)	9 patients	26 patients	37 patients	42 patients

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

• At the end of the treatment overall 56/57 patients reported initial improvement with treatment with tacrolimus as initial therapy.
• Treatment frequency decreased from twice daily to once daily in 28%, 61%, 78%, and 87%  patients after 3, 6, 12 and 24 months respectively.
• During the study 4 patients with a median age of 80 years were diagnosed with squamous cell carcinoma (SCC) of the oral mucosa. Mild side effects were observed in a very small no. of patients.

 

Conclusion

The study investigators recommended the use of Tacrolimus (b.i.d) as a second-line treatment for Oral lichen planus refractory to the topical steroids.

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References

Primary study

•  Utz S, Suter V, Cazzaniga S. et al. Outcome and long‐term treatment protocol for topical tacrolimus in oral lichen planus. Journal of the European Academy of Dermatology and Venereology. 2022

Additional Reference

• Gupta S, Jawanda M. Oral lichen planus: An update on etiology, pathogenesis, clinical presentation, diagnosis and management. Indian Journal of Dermatology. 2015;60(3):222.