Efficacy and safety of weekend cyclosporine treatment as maintenance therapy for preventing frequent disease exacerbations in moderate to severe chronic plaque psoriasis patients - A retrospective cohort study.

Background Psoriasis is a chronic, inflammatory, systemic disease with predominant manifestations in the skin and joints impairing patient's quality of life. A proportion of patients have frequent severe disease exacerbations requiring repeated systemic treatments. There is a scarcity of literature evaluating the role of systemic maintenance therapy in psoriasis patients in preventing such frequent disease flares. Objective To evaluate the efficacy and safety of weekend cyclosporine treatment (WCT) as maintenance therapy in moderate to severe chronic plaque psoriasis patients for the prevention of frequent disease exacerbations. Methods In this retrospective cohort study, 22 psoriasis patients with a history of frequent disease exacerbations (≥ 3 in the last 1 year) who were administered WCT (group A) were compared with the same number of matched patients (age and gender) not on WCT or any systemic maintenance therapy (group B). Results Four patients (18.2%) in group A had disease exacerbations which was significantly lower (p = 0.00, Fisher's exact test) as compared to 21 patients (95.5%) in group B during the study period. Also, patients in group A had significantly lower number of overall exacerbations [mean ± SD: 0.23 ± 0.53 vs 2.95 ± 1.43) p = 0.00, Mann-Whitney U test] as compared to group B. Four (9.1%) patients in group A encountered adverse effects (acneiform eruptions - two, mild gingival hyperplasia - one, myalgia - one) as compared to three (acneiform eruptions - two, headache - one) in group B (p = 1.00). Conclusion WCT significantly reduced the number of disease exacerbations and is a safe and effective mode of maintenance therapy in such subset of psoriasis patients.

Assessment of Clinical, Histopathological, and Bacteriological Findings in Treated Leprosy Patients with Persistent Skin Lesions: A Retrospective Cohort Study.

Since the introduction of multidrug therapy (MDT), various disabilities/morbidities due to leprosy have been prevented. However, there is a subset of patients in whom the skin lesions do not resolve completely or remain unchanged despite a full course of MDT, which is a great source of anxiety to the patient and their family members. Hence, we tried to ascertain the putative causes and risk factors of persistent skin lesions (PSLs) by analyzing the clinical, histopathological, bacteriological, and drug resistance patterns. This is a retrospective, cohort study wherein 35 patients who had PSLs after completion of MDT were included. The majority of the patients were 18 to 30 years of age, with males predominating. Borderline tuberculoid leprosy was the most common clinical spectrum observed (71.4%). The majority had PSLs distributed predominantly over photo-exposed sites (upper limbs > trunk > face). Eight patients (22.8%) had a history of contact with leprosy patients in their family, and six patients (17.1%) had associated comorbidities. Improvement in histopathological parameters such as a decrease in granuloma fraction was observed in 22 patients (62.8%) with PSLs after release from treatment in comparison with baseline. Four patients (11.4%) were noted to have drug resistance (three to rifampicin and one to dapsone). Thus, our study emphasizes that leprosy patients with PSLs after completion of MDT should undergo histopathological evaluation and drug resistance studies.

A prospective study to estimate the incidence and pattern of adverse drug reactions to first-line antiretroviral therapy (tenofovir, efavirenz, and lamivudine).

Background: Antiretroviral drugs are efficacious but are associated with long-term toxicities, drug interactions, and emergence of drug resistance. Objective: To study the incidence and pattern of adverse drug reactions in human immunodeficiency virus (HIV) patients receiving first-line antiretroviral therapy (ART) (tenofovir, efavirenz, and lamivudine (TEL) which was introduced by NACO in 2013. Materials and Methods: A prospective, single-center observational study that included 135 treatment-naive HIV patients who were started on fixed drug once-daily regimen (TEL). At baseline, detailed clinical history, body weight, waist-hip ratio, complete blood count, liver and renal function test, CD4 cell count were performed. Clinical monitoring for cutaneous, neuropsychiatric, and gastrointestinal side effects was done every month along with laboratory monitoring and anthropometric measurement for every 6 months. CD4 counts were measured at baseline and end of the study at 12 months. Results: Out of 135 participants, 89 (65.9%) were males and 46 (34%) were females. The mean age and the mean duration of illness at inclusion were 35.10 ± 8.97 years and 1.2 ± 0.6 years, respectively. The mean increase in weight at baseline and at 12 months (57.55 ± 6.56 to 64.04 ± 8.2) was statistically significant (95% confidence interval [CI]: 4.35-8.62, P < 0.001). The mean CD4 counts at baseline were 309.73 ± 118.44 and increased after 12 months of treatment to 421 ± 129.4 which was statistically significant (95% CI: 81.54-140.99, P < 0.001). The mean difference in platelet count was statistically significant between baseline and 12 months (95% CI: 10.32-46.13, P = 0.002). The mean difference in serum urea levels at baseline and at 6 months (95% CI: 0.60-1.61, P < 0.001) as well as 12 months were statistically significant (95% CI: 0.08-1.03, P = 0.02). The mean increase in serum creatinine at baseline (0.75 ± 0.12) and at 12 months (0.97 ± 0.16) was also significant (95% CI: 0.21-0.28, P < 0.001). There was a significant difference between mean creatinine clearance at baseline and at 12 months (109.9 ± 13.75 to 99.33 ± 12.52, P < 0.0001). One patient discontinued treatment due to adverse effects while two patients were shifted to second-line antiretroviral treatment. Limitations: Small sample size, single-center study and short follow-up period, long-term toxicities were not appreciated. Conclusion: Fixed drug combination with TEL as a first-line ART for HIV is a safe regime as we observed minimal side effects with current regimen.

Validation and usability of modified palmoplantar psoriasis area and severity index in patients with palmoplantar psoriasis: A prospective longitudinal cohort study.

Background Palmoplantar psoriasis (PPP), a troublesome variant, does not have any validated scoring system to assess disease severity. Objective To validate modified Palmoplantar Psoriasis Area and Severity Index (m-PPPASI) in patients affected with PPP and to categorise it based on Dermatology Life Quality Index (DLQI). Methods In this prospective study, patients with PPP aged > 18 years visiting the psoriasis clinic at a tertiary care centre were included and requested to complete DLQI during each visit at baseline, 2nd week, 6th and 12th week. m-PPPASI was used by the raters to determine the disease severity. Results Overall, 73 patients were included. m-PPPASI demonstrated high internal consistency (α = 0.99), test-retest reliability of all three raters, that is, Adithya Nagendran (AN) (r = 0.99, p < 0.0001), Tarun Narang (TN) (r = 1.0, p < 0.0001) and Sunil Dogra (SD) (r = 1.0, p < 0.0001) and inter-rater agreement (intra-class correlation coefficient = 0.83). Face and content validity index for items I-CVI = 0.845 were robust, and the instrument was uniformly rated as easy to use (Likert scale 2) by all three raters. It was found to be responsive to change (r = 0.92, p < 0.0001). Minimal clinically important differences (MCID)-1 and MCID-2 calculated by receiver operating characteristic curve using DLQI as anchor were 2 and 35%, respectively. DLQI equivalent cutoff points for m-PPPASI were 0-5 for mild, 6-9 for moderate, 10-19 for severe, and 20-72 for very severe disease. Limitation Small sample size and single-center validation were the major limitations. m-PPPASI doesn't objectively measure all characteristics of PPP such as "fissuring" and "scaling" which could also be taken into consideration. Conclusion m-PPPASI is validated in PPP and can be readily utilized by physicians. However, further large-scale studies are needed.

A randomized, open-label study to compare two different dosing regimens of oral tranexamic acid in treatment of moderate to severe facial melasma.

Oral tranexamic acid (TXA) demonstrates promising results in melasma management. However, no clear consensus on the dosing and duration of maintenance doses of TXA therapy in melasma exists. In this study, we intend to evaluate and compare the efficacy of two different TXA dosing regimens in patients with melasma using the mMASI score. This was a randomized, open-label study wherein 50 patients (age > 18 years) with moderate to severe melasma were randomized into group A (250 mg TXA twice a day) and group B (500 mg TXA twice a day). Treatment was administered for 12 weeks and later followed up 4-weekly for next 12 weeks. The primary outcome measure was proportion of patients achieving 75% reduction in modified Melasma area and severity index (mMASI-75) at 12 weeks from baseline, reduction in mMASI and melasma quality of life (MelasQOL) score at 12 and 24 weeks. To assess the rate of relapse by end of 12 weeks post-treatment. Among 50 patients, proportion of patients achieving mMASI-75 at 12 weeks were 20% and 25% in group A and B, respectively (p-0.71). Both groups showed a significant reduction in mean mMASI (4.8 ± 2.2 in group A and 6.8 ± 3.4 in group B; p-0.02) at 12 weeks of treatment. mMASI remained stable after 12 weeks of follow-up and was 4.9 ± 2.43 and 4.93 ± 2.85 in group A and B, respectively (p-0.97). The mean percentage reduction in MelasQOL in group A and B were 41.8 ± 15.3 and 29.5 ± 21.5, respectively (p-0.03). No adverse effects were observed in both groups. Relapse rates was very less and comparable between both groups. Thus, we conclude that both dosing regimens showed comparable efficacy in terms of mMASI reduction at 12-weeks and the improvement achieved was well maintained even after 12-weeks of discontinuing treatment with very few patients relapsed. Hence, lower doses of TXA are equally effective and safe compared to higher doses and not all patients might require tapering or dosing maintenance.

Comparison of the efficacy and safety of minocycline and clofazimine in chronic and recurrent erythema nodosum leprosum-A randomized clinical trial.

Management of chronic/recurrent erythema nodosum leprosum (ENL) is challenging. The majority of these patients become steroid-dependent and suffer from the adverse effects of long-term corticosteroid use. Minocycline has shown promising results in a small series of chronic/recurrent ENL patients. The aim of this study was to compare the efficacy and safety of minocycline and clofazimine in patients with chronic/recurrent ENL. In this prospective randomized clinical trial, 60 participants with chronic/recurrent ENL were randomized (1:1) to receive either minocycline 100 mg once daily or clofazimine 100 mg thrice daily for 12 weeks along with prednisolone according to WHO protocol and followed up for 6 months. The outcome measures were mean time for initial control of ENL, proportion of patients having a recurrence of ENL, mean time for recurrence after initial control, additional prednisolone requirement, and frequency of adverse events. Initial control of ENL was achieved earlier in the minocycline group as compared to the clofazimine group (2.97 ± 1.9 weeks vs. 4 ± 1.96 weeks, respectively; p-0.048). The number of participants having ENL flares/recurrences during the study period was comparable in both groups (71.4% in clofazimine vs. 55.2% in minocycline group; p-0.2). The participants in the minocycline group remained in remission for a longer duration after initial control of ENL as compared to the clofazimine group (p-0.001). Mean additional prednisolone dose required for control of ENL flares/recurrences was also comparable in both groups (p-0.09). The minocycline group had fewer side effects than the clofazimine group (p-0.047). Minocycline led to a rapid and sustained improvement of ENL episodes with fewer adverse events showing a superior efficacy to clofazimine.