Azathioprine weekly pulse versus methotrexate for the treatment of chronic plaque psoriasis: A randomized controlled trial.

BACKGROUND: Methotrexate is the most commonly used drug in the treatment of psoriasis with good efficacy and safety. Recently, weekly azathioprine pulse has been shown to be effective in this disease. AIM: The aim of this study is to compare the effectiveness and safety of weekly pulse doses of azathioprine and methotrexate for the treatment of chronic plaque psoriasis. METHODS: In this randomized controlled trial, 80 patients with chronic plaque psoriasis were recruited. After detailed clinical and laboratory evaluation, patients were randomized to 2 groups to receive either weekly 300 mg azathioprine (n = 40) or 15 mg methotrexate every week (n = 40) for 20 weeks, following which the response to treatment and adverse effects were assessed. The patients were then followed up every 4 weeks for 3 months to determine any relapse. RESULTS: Overall, 48 (60%) patients achieved PASI 75, while 36 (45%) and 59 (73.8%) patients achieved PASI 100 and 50, respectively. On intention to treat analysis, PASI ≥ 75 was achieved in 47.5% (19/40) patients in group 1 compared to 85% (34/40) patients in group 2 (p < 0.001). However, on per protocol analysis, PASI ≥ 75 was achieved in 86% (19/22) patients in group 1 and 92% (34/37) patients in group 2 (p = 0.497). Minor clinical and biochemical adverse effects were noted in both the groups, which were comparable. One (7.7%) patient in group 1 and 4 (17.4%) in group 2 relapsed during follow-up. LIMITATIONS: Limitations of study include small sample size and short follow-up. CONCLUSION: Weekly azathioprine pulse appears to be beneficial in the management of chronic plaque psoriasis. However, it is less effective than weekly methotrexate. It can thus be of use as a therapeutic option in patients with contraindication to methotrexate or other similar agents in this disease.

A retrospective comparative study of outcome with surgical excision and repair versus nonsurgical and ablative treatments for basal cell carcinoma.

BACKGROUND: There are few studies on basal cell carcinoma (BCC) from India. Long-term follow-up is available in only one study and the aesthetic outcome of treatment has not been evaluated in Indian patients. AIMS: In this retrospective study on BCC, we compared treatment failure, recurrence rates and aesthetic outcomes on long-term follow-up between surgical excision and repair, and nonsurgical and ablative treatments. METHODS: Records of patients with BCC treated in the dermatologic surgery clinic over the past 10 years were analyzed. Patients with histopathologically confirmed BCC who could be contacted were evaluated for recurrence, treatment failure, overall satisfaction and aesthetic outcomes by global aesthetic improvement scale. RESULTS: Out of 98 patients, 72 were contactable. Four patients received both nonsurgical and ablative treatments and surgical excision and repair sequentially and were excluded. The mean age of patients was 57.9 ± 15.8 years (24-90 years) and the male: female ratio was 1.6:1. The most common site involved was the face (72.1%) followed by trunk and scalp, and the most common type of BCC was the pigmented superficial type (33.8%), followed by the pigmented noduloulcerative type (16.2%). There was no significant difference between the groups in the number of high-risk cases. The mean follow-up period was 37.1 ± 31.4 (range, 4-120) months. Fifty one patients were treated with surgical excision and repair, and 17 with nonsurgical and ablative treatments (9-imiquimod, 5-cryotherapy, 4-radiotherapy). Treatment failure was seen in 5 (7.4%) patients, all in the nonsurgical and ablative treatments group (P = 0.0006). Recurrence was seen in 2 (2.9%) patients, both in the surgical excision and repair group (P > 0.05). Mean patient satisfaction was significantly higher with surgical excision and repair, though there was no significant difference in the Global Aesthetic Improvement Scale between the groups. LIMITATIONS: The sample size was low. Only telephonic and pictorial assessments were done where the patient could not come for follow-up. CONCLUSIONS: Surgical excision and repair was associated with better outcomes than nonsurgical and ablative treatments. Treatment failures and adverse events were high with nonsurgical and ablative treatments. The recurrence rate was low.

Weekly azathioprine pulse versus daily azathioprine in the treatment of Parthenium dermatitis: A non-inferiority randomized controlled study.

BACKGROUND: Azathioprine in daily doses has been shown to be effective and safe in the treatment of Parthenium dermatitis. Weekly pulses of azathioprine (WAP) are also effective, but there are no reports comparing the effectiveness and safety of these two regimens in this condition. AIMS: To study the efficacy and safety of WAP and daily azathioprine in Parthenium dermatitis. METHODS: Sixty patients with Parthenium dermatitis were randomly assigned to treatment with azathioprine 300 mg weekly pulse or azathioprine 100 mg daily for 6 months. Patients were evaluated every month to assess the response to treatment and side effects. RESULTS: The study included 32 patients in the weekly azathioprine group and 28 in the daily azathioprine group, of whom 25 and 22 patients respectively completed the study. Twenty-three (92%) patients on WAP and 21 (96%) on daily azathioprine had a good or excellent response. The mean pretreatment clinical severity score decreased from 26.4±14.5 to 4.7±5.1 in the WAP group, and from 36.1±18.1 to 5.7±6.0 in the daily azathioprine group, which was statistically significant and comparable (P=0.366). Patients on WAP had a higher incidence of adverse effects (P=0.02). LIMITATIONS: The study had a small sample size and the amount of clobetasol propionate used in each patient was not determined, though it may not have affected the study outcome due to its comparable use in both groups. CONCLUSIONS: Azathioprine 300 mg weekly pulse and 100 mg daily dose are equally effective and safe in the treatment of Parthenium dermatitis.

Azathioprine versus betamethasone for the treatment of parthenium dermatitis: a randomized controlled study.

BACKGROUND: Parthenium hysterophorus is the commonest cause of airborne contact dermatitis in India. Azathioprine has been shown to be effective and safe in parthenium dermatitis, but there are no reports of comparison of steroids and azathioprine in this condition. AIMS: To study the therapeutic efficacy of azathioprine versus betamethasone in patients having contact dermatitis to parthenium and compare the side effects of the drugs. METHODS: Fifty-five patients of airborne contact dermatitis to parthenium were randomly assigned to treatment with azathioprine 100 mg daily (group A) or betamethasone 2 mg daily (group B), for 6 months in a blinded manner. The patients were evaluated every month for 6 months to determine the response to treatment and side effects and then further followed up for another 6 months to determine any relapse. RESULTS: There were 26 patients in group A and 29 in group B, of which 20 patients of group A and 21 of group B completed the study. Nineteen (95%) patients in group A and all 21 (100%) patients in group B had an excellent response (complete remission) to treatment (P=0.0156 vs. 0.0005). The patients in group B, however, had more adverse effects (Fisher exact, P

Role of azathioprine in preventing recurrences in a patient of recurrent erythema nodosum leprosum.

The pathogenesis of erythema nodosum leprosum (ENL) involves both immune complex deposition and dysfunction of cell mediated immunity. Tumour necrosis factor-alpha (TNF-alpha) plays an important role in its pathogenesis. Thalidomide and corticosteroids are the mainstay of treatment for ENL. However, there are often severe limitations to their use. We report a case of recurrent ENL treated successfully with azathioprine. A 15-year-old unmarried girl with lepromatous leprosy had recurrent ENL for 2 years. She was treated with WHO-MB MDT and prednisolone in doses of 40-90 mg a day for 2-12 weeks. Her condition was inadequately controlled. The patient was therefore treated with thalidomide 300 mg and prednisolone 40 mg. The symptoms subsided after 5 days and ENL lesions healed in 2 weeks. Prednisolone was reduced by 10 mg per week and stopped, while thalidomide was reduced to 100 twice daily after 4 weeks. Azathioprine 100 mg (2 mg/kg per day) daily orally was added to prevent recurrences. Thalidomide was further reduced and stopped after another 4 weeks while she continued with azathioprine in the same doses for 8 months. There was no recurrence of ENL lesions and no side effects of the therapy. MB-MDT was stopped 1 year ago, and she is on follow-up without any relapse. Azathioprine, therefore, appears to be an effective and safe drug to prevent recurrences of ENL.

Superficial basal cell carcinoma on face treated with 5% imiquimod cream.

Imiquimod, an immune response modifier, is known to possess both anti-viral and anti-tumor effect. We report our experience of treating a large superficial spreading basal cell carcinoma with 5% imiquimod cream. A 65-year-old male had an asymptomatic, hyperpigmented, slowly progressive, indurated, 3 x 4 cm plaque on the left cheek for two months. Biopsy from the lesion showed features of basal cell carcinoma. The patient was treated with imiquimod 5% cream, topically three times a week for six months with complete resolution of the lesion and without any side-effects. There was no clinical or histological recurrence after three months of stopping the treatment.

Parthenium dermatitis treated with azathioprine weekly pulse doses.

BACKGROUND: Parthenium dermatitis is a serious problem in India. Corticosteroids are the mainstay of treatment but the prolonged use of corticosteroids can cause serious side effects. Azathioprine used in daily doses has been shown to be effective. AIM: We have evaluated the effectiveness of azathioprine weekly pulse doses for the treatment of parthenium dermatitis. METHODS: Twelve patients, ten males and two females, aged between 39 and 65 years (mean +/- SD = 53.5 +/- 8.7) having air-borne contact dermatitis to Parthenium hysterophorus for 3-19 years (mean = 6.33) were included in the study. The diagnosis in each patient was confirmed by patch-testing. The severity of the disease was determined by clinical severity score (CSS) on the basis of erythema, itching, type of lesions, and areas of body involved. RESULTS: The pretreatment CSS in these patients varied from 29.7 to 55.5 (mean +/- SD: 40.40 +/- 7.95). After clinical and laboratory evaluation, the patients were treated with 300-mg azathioprine once-weekly doses for 6 months. Clinical and laboratory evaluations were repeated at weeks 1, 2, and then every 4 weeks until the end of therapy to evaluate the therapeutic response and side effects. The response was excellent (80-100% clearance of disease) in seven (58.33%) patients and good (60% clearance) in five (41.66%) patients. The post-treatment CSS decreased from the mean +/- SD of 40.4 +/- 7.95 to 10.9 +/- 8.43 (P = 0.002). There were no significant side effects of the therapy. CONCLUSIONS: In this preliminary open study, azathioprine in weekly pulse doses has been found to be effective without any serious adverse effects in the treatment of parthenium dermatitis. The cost of therapy with this regimen is reduced by 60%.

Failure of titer of contact hypersensitivity to correlate with clinical severity and therapeutic response in contact dermatitis caused by parthenium.

BACKGROUND: The titer of contact hypersensitivity (TCH) has been used to determine the degree of contact hypersensitivity in patients with contact dermatitis. The values have been found to vary in different individuals and also in the same individual at different times apparently due to the varying severity of the disease. We evaluated the correlation of TCH with disease severity and therapeutic response in patients of contact dermatitis caused by the plant Parthenium hysterophorus. METHODS: Forty-two patients, 30 (71.4%) males and 12 (28.6%) females, aged between 30-75 years, having air-borne contact dermatitis to Parthenium hysterophorus for 0.5-20 years were included in the study. The disease severity and TCH at baseline were recorded in all the patients. They were treated with azathioprine and followed up every month for 4-69 months. The TCH was repeated every 3 months and the last recorded TCH value was taken for analysis in each patient. RESULTS: The baseline clinical severity score (CSS) varied from 10-80 (mean +/- SD: 35.47 +/- 19.41) in these patients. It ranged from 10-30 in 22 (52.4%) patients, from 31-50 in 14 (33.3%) patients, and was more than 50 in 6 (14.3%) patients. The baseline TCH to Parthenium was undiluted (UD) in 2 (4.8%), 1:10 in 15 (35.7%), 1:100 in 20 (47.6%), and 1:1000 in 5 (11.9%) patients respectively. At the end of the study, the clinical severity of the disease decreased in most of the patients. The CSS came down to 0 in 31 patients, to 10-20, and to 50 in 4 patients each, but remained stable in three patients who had baseline CSS from 20-40. The overall mean CSS came down from 35.47 +/- 19.41 to 4.76 +/- 9.43 (p = 0.002). However, there was no significant change in the TCH levels over time (p = 0.153). The last TCH value was negative in 2 (4.8%) patients, undiluted in 5 (11.9%), 1:10 in 10 (23.8%), 1:100 in 18 (42.9%), and 1:1000 in 7 (16.7%) patients. There was no change in the TCH values in 16 (38.1%) patients while it increased or decreased by 1-2 dilutions in 12 (28.6%) patients each. CONCLUSIONS: We therefore conclude that the TCH does not correlate with the clinical severity of contact dermatitis or response to treatment.

Extensive alopecia areata treated with betamethasone oral mini-pulse therapy: an open uncontrolled study.

BACKGROUND: Extensive alopecia areata is known to respond to daily oral corticosteroids. To minimize the side effects of daily corticosteroids, oral mini-pulse therapy with betamethasone has been used in vitiligo and other dermatoses. There are a few studies in alopecia areata also. AIM: To evaluate the efficacy of oral mini-pulse therapy in extensive alopecia areata. METHODS: It is an open study on sixteen adolescents and adults with alopecia areata/ totalis/universalis treated with oral mini-pulse therapy for a minimum period of six months. The patients were evaluated clinically and with serial photographs for response and periodical investigations were undertaken to look for the side effects. All the patients were followed up for 5-8 months to look for any relapse. RESULTS: Seven (43.7%) patients showed an excellent response and five (31.2%) patients had good response. Two patients (12.5%) had unsatisfactory response and another two (12.5%) were non-responders. There were insignificant/minimal side effects. CONCLUSION: Oral mini-pulse therapy with betamethasone is a safe and effective therapeutic modality for extensive alopecia areata.

Epidermal and sebaceous nevi treated with carbon dioxide laser.

Eight patients, 2 males and 6 females, between 10-21 years in age with epidermal (4) and sebaceous nevi (4) were taken up for this study. The lesions in all the patients were vaporized with the indigenously developed carbon dioxide laser. All the patients were evaluated at 1, 2, 4, 8 and 12 weekly visits. The final evaluation was done at the 12 weekly visit to assess the overall response to the treatment and side effects. The patients were then followed up every month for 6 months to look for any recurrence. All the patients responded to the treatment. Three patients each with epidermal and sebaceous nevi had 8090% improvement while I patient each with above disorders had % and 60% improvement respectively. Transient hypopigmentation was seen in all the patients. There were no other significant side effects.

Efficacy of H, antihistamine, corticosteroids and cyclophosphamide in the treatment of chronic dermographic urticaria.

H, antihistamines relieve urticaria by blocking the action of histamine on the target tissue, while demonstration of autoantibodies in the sera of a proportion of the patients having chronic idiopathic urticaria, use of immunosuppressive drugs for the treatment of these patients has acquired the greater rationality. We evaluated the role of corticosteroids and cyclophosphamide in the treatment of chronic dermographic urticaria. Twenty-five patients, 13 males and 12 females, between 18-53 years in age, having chronic dermographic urticaria were taken up for this study. The patients were divided into three groups. Group I patients (n=9) were treated with cetirizine hydrochloride 10 mg per day orally, group II patients (n=7) were treated with betamethasone 2 mg along with cyclophosphamide 50 mg along with cetirizine 10 mg per day for a total period of 4 weeks. The patients were evaluated every week to record the therapeutic response and side effects, and then followed up without treatment for a period of 6 months to look for recurrence of the urticaria, if any. Six patients in group I and all the patients in group II and group III had complete remission while the remaining patients in group I had partial relief. The side effects included drowsiness in 4 patients. All the patients in group II had weight gain, 4 patients had acne and 2 patients developed cushingoid features. Majority of the patients relapsed within 3 days after stopping the treatment. Supplementation of the treatment with oral corticosteroids or cyclophosphamide was more effective in controlling the symptoms as compared to cetirizine alone. But a four weeks supplementation was not adequate for preventing the relapses when the drugs were withdrawn.

Treatment of benign vascular skin lesions with carbon dioxide laser.

Fifteen patients, 10 males and 5 females, between 10-27 years age with different benign vascular skin lesions i.e.haemangioma (3) and lymphangioma circumscriptum (2) were taken up for this study. The lesions in all the patients were vaporized/excised with the indigeneously developed carbon dioxide laser. The patients were evaluated at 1,2,4,8 and 12 weekly visits to assess the overall response to the treatment and the side effects. All the patients responded to the treatment. The patients with granuloma pyogenicum showed excellent response with complete disappearance of the lesions while the patients with haemangiomas, lymphangio-haemangiomas and lymphangioma circumscriptum improved by 70-90%. Transient hypopigmentation and mild scarring were seen in all the patients except in patienls with granuloma pyogenieum. There were no other significant side effects in any of the patients.