Tofacitinib in Pediatric Psoriasis: An Open-Label Trial to Study Its Safety and Efficacy in Children.

INTRODUCTION: Psoriasis is a chronic, multifactorial, inflammatory disorder, with an estimated prevalence of 0.71% in children. The commonly used therapeutic agents target the underlying inflammation. Tofacitinib has demonstrated efficacy in adult psoriasis. AIM: To study the efficacy, safety, and tolerability of tofacitinib in pediatric patients with moderate to severe chronic plaque psoriasis. METHODS: The study included children aged between 8 and 17 years, with moderate to severe psoriasis, given tofacitinib 5 mg orally twice daily for at least 36 weeks. The clinical response was estimated using the Psoriasis Area and Severity Index (PASI) score, Physician's Global Assessment (PGA), and the Children's Dermatology Life Quality Index (CDLQI). The incidence and severity of adverse events (AEs) were meticulously recorded in each case. RESULTS: A total of 47 patients, with a median age of 12.3 years, completed the study. At week 12, 55.32% achieved PASI 75, and 70.21% at week 36. PGA of clear or almost clear responses at week 12 were 59.57 and 65.96%, -respectfully, at week 36. Relatively few and mostly minor -adverse effects were noted. No severe AEs were reported. -Conclusion: The treatment with tofacitinib was safe and well tolerated, and led to significant improvement of their disease and quality of life as reflected in CDLQI scores. However, the results need to be validated in larger multicenter trials.

Janus Kinase Inhibitors for the Treatment of Severe Alopecia Areata: An Open-Label Comparative Study.

BACKGROUND: Alopecia areata (AA) is a common autoimmune disorder characterized by patchy hair loss. There are many treatments available for AA. However, treatments of severe forms of AA are not satisfactory. Recently, oral Janus kinase (JAK) inhibitors were found to be effective for the treatment of severe AA variants. OBJECTIVE: The aim of this work was to evaluate and compare the efficacy, side effects, and durability of two oral JAK inhibitor medications (ruxolitinib and tofacitinib) in the treatment of severe AA. METHODS: This study included 75 patients with AA with more than 30% scalp hair loss, alopecia totalis, and alopecia universalis randomized into 2 groups. The first group (n = 38) received ruxolitinib 20 mg twice daily, and the second group (n = 37) received oral tofacitinib 5 mg twice daily. The treatment continued for 6 months followed by 3 months of follow-up off therapy. Efficacy of treatment was assessed by monitoring the change in the Severity of Alopecia Tool (SALT) score. RESULTS: Both tofacitinib and ruxolitinib induced remarkable hair regrowth, with a mean change in SALT score of 93.8 ± 3.25 in the ruxolitinib group and 95.2 ± 2.69 in the tofacitinib group. However, the ruxolitinib group showed a shorter duration for initial hair regrowth. There was no statistically significant difference between the groups regarding hair regrowth at the end of the 6-month treatment and relapse rate at the end of the 3-month follow-up. Around two thirds of cases experienced relapse. Both drugs were well tolerated, with no reported serious adverse effects. CONCLUSION: Both ruxolitinib and tofacitinib could be considered effective and well-tolerated treatments for extensive AA.

Resistant palmoplantar lesions in patients of psoriasis: evaluation of the causes and comparison of the frequency of delayed-type hypersensitivity in patients without palm and sole lesions.

OBJECTIVE: To examine the reasons for resistance to treatment in cases of palmoplantar psoriasis, and also to compare the frequency of delayed-type hypersensitivity to common sensitizers with those cases of psoriasis without palmoplantar involvement. SUBJECTS AND METHODS: One hundred and three patients with resistant palmoplantar psoriasis were examined for a possible drug reaction, fungal infection or contact allergy. Patch testing was done for another 100 patients with psoriasis vulgaris without palm and sole involvement. χ(2), Fischer's exact test, Mann-Whitney U test and logistical regression analysis were done using SPSS 15.0. RESULTS: Of the 103 patients with resistant palmoplantar lesions, 26 (25.24%) had a positive patch test to at least one of the tested allergens, 6 (5.8%) had psoriasiform spongiotic dermatitis on biopsy, 5 (4.8%) reported exacerbation after starting biologic therapy and 3 (2.9%) were potassium hydroxide positive in the sole lesions. In comparison, of the 100 patients with no palm or sole lesions, 11 (11%) had a positive patch test to at least one of the allergens. There was a direct relationship between the increase in the prevalence of dermatitis and the duration of psoriasis. There was no correlation between the clinical type of psoriasis and patch-test positivity. CONCLUSION: Secondary fungal infection, allergic contact dermatitis to topical agents or common allergens, or at times an unusual reaction to the antipsoriatic therapeutic agents sometimes led to treatment failure in patients with psoriasis vulgaris with palmoplantar lesions. Also, psoriasis patients with palm and sole lesions tended to have higher rates of contact hypersensitivity than patients without lesions on their palms and soles.

The effect of weight reduction on treatment outcomes in obese patients with psoriasis on biologic therapy: a randomized controlled prospective trial.

BACKGROUND: Obesity has long been associated with psoriasis and it is considered to be an independent risk factor for chronic heart diseases in these patients. Recently, some of the biologic drugs used for psoriasis have been reported to cause increase in body weight. It is currently not clear if this increased body weight seen in psoriasis patients on biologics leads to decrease in there efficacy or vice versa. We carried out this study to see if reduction in body weight leads to increased efficacy of biologics in obese psoriasis patients. OBJECTIVE: To evaluate the effect of weight reduction by dietary control on treatment efficacy of biologics in obese patients as indicated by the Psoriasis Area and Severity Index (PASI) score. METHODS: Obese patients with psoriasis receiving biologic therapy, satisfying the inclusion criterion, were randomized in a 1:1 ratio to receive low-calorie diet versus normal diet (control group). We included 262 patients with moderate to severe, stable plaque psoriasis with a PASI score 20:50 on anti TNF-α biologic therapy (infliximab, etanercept, ustekinumab and adalimumab). The patients in the dietary intervention group were given a low calorie diet (≤ 1000 kcal per day) for 8 weeks to induce weight loss. The treatment outcome was assessed using PASI. The PASI scores were assessed at baseline and every 4 weeks up to week 24. RESULTS: There were no significant differences in age, sex distribution, body weight, body mass index, waist circumference, psoriasis duration, or PASI score between the two studied groups at base line. At week 24, the mean (±SD) weight loss was 12.9 ± 1.2 kg in the diet intervention group, and -1.5 ± 0.5 kg in the control group. The average improvement in mean PASI score was 84% for the diet group, and 69% for the control group. PASI 75 was achieved by 85.9% in the diet group, and 59.3% in the control group (p < 0.001). The mean (±SD) body surface area values at week 24 were 3.3 ± 4.4% and 8.1 ± 6.9% in the diet group and control group. CONCLUSIONS: Body weight reduction in obese patients on biologics may increase the efficacy of the drug.

Onychomycosis in patients of nail psoriasis on biologic therapy: a randomized, prospective open label study comparing Etanercept, Infliximab and Adalimumab.

INTRODUCTION AND OBJECTIVE: The association between patients of psoriasis on anti TNF therapy and onychomycosis has not been explored. The aim of this study was to determine the rate of onychomycosis in patients of psoriasis with nail involvement on anti TNF therapy. MATERIALS AND METHODS: All patients of psoriasis with nail involvement seen between February 2007 - July 2012 were examined. All the patients with negative nail scrapings for fungus were enrolled. Patients found fit for biologics after investigations were randomly divided into 3 groups (Group A: Infliximab, Group B: Etanercept and Group C: Adalimumab). The patients were followed up every 4 weeks for 24 weeks. Repeat nail scrapings were done at week 24. The results were compared with controls. RESULT: In total, 315 (178 males and 137 females) patients were enrolled. The mean age was 37.5 ± 11.4 years. The results for scraping for fungus at the end of 24 weeks were as follows: 33% (33/100) in patients on Infliximab followed by 15.45% (17/110), 13.33% (14/105) in patients on treatment with Etanercept and Adalimumab respectively as compared to 13.89% (25/180) among controls. Onychomycosis in association with nail psoriasis was more common in males. CONCLUSION: This study revealed statistically significant association between fungal infections of the nail in patients of psoriasis on treatment with Infliximab.