Psoriasis is a chronic, immune-mediated, inflammatory skin disorder characterized by erythematous, scaly plaques that often follow a relapsing and remitting course. It affects approximately 1–3% of the global population and imposes a substantial burden on physical, psychological and social well-being [1]. Although psoriasis can occur at any age, it commonly presents in young and middle-aged adults, thereby exerting a considerable impact on quality of life, productivity and health care costs [2]. Moderate-to-severe psoriasis, in particular, is associated with extensive skin involvement, pruritus, disfigurement and comorbid conditions such as psoriatic arthritis, metabolic syndrome, diabetes mellitus and cardiovascular disease [3]. These factors underscore the importance of effective and safe long-term therapeutic strategies.

Conventional systemic agents, including methotrexate, cyclosporine and retinoids, have long been used to control moderate-to-severe psoriasis [4]. While often effective, these drugs are limited by cumulative toxicity, organ-specific side effects and loss of efficacy over time. Phototherapy, although valuable, may be impractical for many patients due to the need for frequent hospital visits [5]. The limitations of these conventional modalities highlight the need for more targeted treatment approaches that address the underlying immunopathogenesis of the disease.

Advances in molecular immunology have established psoriasis as a T-cell mediated disease driven by pro-inflammatory cytokines, particularly tumor necrosis factor-alpha (TNF-α), interleukin-12, interleukin-23 and interleukin-17 [6, 7]. This understanding has paved the way for the development of biologic therapies, which are recombinant proteins or monoclonal antibodies designed to selectively inhibit specific immune pathways involved in psoriatic inflammation [8]. Biologics such as etanercept, infliximab and adalimumab, which target TNF-α, have demonstrated significant efficacy in reducing disease severity, improving quality of life and achieving higher rates of PASI 75 and PASI 90 responses compared to conventional systemic agents. Importantly, these therapies offer the potential for long-term disease control with a more favorable safety profile when used in carefully selected patients [9].

Despite the growing global use of biologics, their application in low- and middle-income countries, has been limited due to high cost, availability issues and limited local data on their safety and effectiveness [10]. Most of the evidence originates from large randomized controlled trials conducted in Western populations and there is a relative paucity of real-world data from South Asian contexts [11]. Since genetic, environmental and healthcare delivery factors may influence treatment outcomes, it is essential to evaluate the performance of biologic agents within the local clinical setting [12].

The present study was therefore undertaken to assess the efficacy and safety of biologic therapies in patients with moderate-to-severe psoriasis attending the Department of Dermatology and Venereology, BSMMU. By systematically analyzing clinical outcomes, treatment responses and adverse events over a one-year period, this study aims to generate baseline evidence that will help guide clinicians in optimizing management strategies for psoriasis in Bangladesh and contribute to the global understanding of biologic therapy in diverse populations.

This prospective observational study was conducted in the Department of Dermatology and Venereology, Bangabandhu Sheikh Mujib Medical University (BSMMU), Dhaka, over a period of twelve months from July 2007 to June 2008. A total of 120 patients with moderate-to-severe plaque psoriasis, defined by a Psoriasis Area and Severity Index (PASI) score greater than 10 or body surface area involvement more than 10%, were enrolled following informed written consent. Patients were selected consecutively from outpatient and inpatient services and were eligible if they were between 18 and 65 years of age, had an established diagnosis of psoriasis vulgaris confirmed clinically and were suitable candidates for biologic therapy according to departmental protocol. Patients with active infections, prior malignancy, uncontrolled systemic illness, or contraindications to biologic therapy were excluded. Baseline demographic and clinical data including age, sex, duration of disease, family history, comorbidities and initial PASI score were recorded. Patients received biologic therapies including etanercept, infliximab, adalimumab, or other agents as per availability and clinical indication. Treatment responses were assessed at 12 weeks and 24 weeks using PASI 50, PASI 75 and PASI 90 response rates and safety was evaluated by monitoring adverse events and laboratory parameters. All patients were followed at regular intervals and adherence was ensured through direct supervision in the clinic. Data were entered and analyzed using Statistical Package for Social Sciences (SPSS) version 12.0. Categorical variables were expressed as frequencies and percentages, while continuous variables were presented as mean with standard deviation.

Table 1: Baseline Characteristics of Patients (N = 120)

Table 1 summarizes the baseline demographic and clinical characteristics of the study population. A total of 120 patients with moderate-to-severe psoriasis were included. The majority of patients were in the 30–39 year age group (35.0%), followed by those aged below 30 years (28.3%). The mean age of the cohort was 38.6 ± 12.4 years (range: 18–65 years). Males constituted a higher proportion of cases (61.7%) compared to females (38.3%). A positive family history of psoriasis was documented in 15.0% of patients. Co-morbidities were present in 26.7% of cases, with hypertension (11.7%) and diabetes mellitus (8.3%) being the most common, while 6.7% had other associated illnesses. The mean duration of disease was 8.1 ± 5.6 years, indicating a chronic disease course. The average baseline PASI score was 19.8 ± 5.2, reflecting moderate-to-severe disease activity in the enrolled population.

Table 2: Distribution of Biologic Therapies Used

Table 2 shows the distribution of biologic agents used among the study population. Etanercept was the most frequently prescribed biologic, administered to 40.0% of patients, followed by infliximab in 30.0% and adalimumab in 20.0%. A smaller proportion (10.0%) received other biologics such as alefacept.

Table 3: Treatment Response at Week 12 and Week 24

Table 3 presents the treatment response to biologic therapy at 12 and 24 weeks. At week 12, 68.3% of patients achieved PASI 50, while 48.3% and 20.0% achieved PASI 75 and PASI 90, respectively. By week 24, treatment responses improved further, with 86.7% of patients reaching PASI 50, 73.3% attaining PASI 75 and 38.3% achieving PASI 90.

Table 4: Safety Profile and Adverse Events

Table 4 summarizes the safety profile and adverse events observed during biologic therapy. Injection site reactions were the most common adverse event, occurring in 11.7% of patients, followed by upper respiratory tract infections in 8.3% and headache or fatigue in 6.7%. Elevated liver enzymes were noted in 5.0% of patients, while serious infections occurred in 1.7%. No cases of malignancy were reported during the study period. Treatment discontinuation due to adverse events was required in 3.3% of patients.

Table 5: Overall Clinical Outcome

Table 5 illustrates the overall clinical outcomes of patients following biologic therapy. A majority of patients (73.3%) achieved significant improvement, defined as PASI 75 or greater, while 13.3% experienced moderate improvement with PASI scores between 50 and 74. An equal proportion of 13.3% had minimal response, achieving less than PASI 50.

In this study, we evaluated the efficacy and safety of biologic therapies in 120 patients with moderate-to-severe psoriasis over a one-year period at BSMMU. Our findings demonstrate that biologic therapy is highly effective in reducing disease severity, as evidenced by the progressive increase in PASI 50, PASI 75 and PASI 90 response rates from week 12 to week 24. The majority of patients (73.3%) achieved significant improvement (PASI ≥75), with a favorable safety profile, supporting the role of biologics as a cornerstone in the management of moderate-to-severe psoriasis.

The demographic characteristics of our cohort, with a mean age of 38.6 years and male predominance (61.7%), align with previous observations that psoriasis often affects young and middle-aged adults and shows a slightly higher prevalence in males [13, 14]. The mean baseline PASI score of 19.8 ± 5.2 reflects the moderate-to-severe nature of disease in this population, similar to the patient profiles reported in clinical trials of etanercept, infliximab and adalimumab [15, 16]. Co-morbidities, including hypertension and diabetes mellitus, were present in 26.7% of patients, highlighting the need for therapies that are effective while minimizing systemic toxicity.

Etanercept was the most commonly used biologic in our study, followed by infliximab, adalimumab and alefacept. The high frequency of etanercept use reflects both clinical familiarity and availability at our center during the study period. These agents target key immunologic pathways, particularly TNF-α and have been shown to interrupt the inflammatory cascade that drives psoriatic lesions [17]. Our results corroborate earlier reports demonstrating that TNF-α inhibitors produce rapid and sustained improvements in PASI scores, with response rates comparable to those in controlled trials [18, 19, 20].

Treatment responses in our study showed a gradual improvement over time, with PASI 75 achieved by 48.3% of patients at week 12 and 73.3% at week 24, indicating the importance of continued therapy for optimal outcomes. These findings are consistent with previous study demonstrating that biologics induce early clinical responses, which continue to improve with ongoing treatment [21]. Our PASI 90 results, achieved in 38.3% of patients by week 24, further support the potential of biologics to induce near-complete clearance in a substantial subset of patients, as reported by Rich and Bello-Quintero, and Weinberg et al, [13, 22].

Regarding safety, biologic therapies were generally well tolerated. Injection site reactions (11.7%) and upper respiratory tract infections (8.3%) were the most common adverse events, while serious infections were rare (1.7%) and no malignancies were observed. Treatment discontinuation due to adverse events occurred in only 3.3% of patients. These findings align with prior reports indicating that biologics are associated with low rates of serious complications and a favorable safety profile when administered under careful clinical supervision [23, 24]. Our experience also supports the notion that routine monitoring of liver function and clinical status is sufficient to manage minor adverse effects [14, 21].

Overall, the high proportion of patients achieving PASI 75 or greater, combined with a low incidence of serious adverse events, underscores the clinical utility of biologic therapies in the management of moderate-to-severe psoriasis. This is particularly relevant in the context of Bangladesh, where conventional systemic therapies may be limited by toxicity and patient adherence. Our findings are consistent with global evidence highlighting biologics as effective and safe agents capable of improving both disease severity and quality of life [13, 15, 25].

This study was conducted at a single tertiary care center with a relatively small sample size, which may limit the generalizability of the findings. The observational design and lack of a control group preclude direct comparison with conventional therapies. Additionally, the follow-up period of 24 weeks may not capture long-term efficacy and rare adverse events associated with biologic therapy. Despite these limitations, the study provides valuable real-world data on the use of biologics in moderate-to-severe psoriasis in Bangladesh.

In conclusion, biologic therapies provide substantial clinical benefit and are generally well tolerated in patients with moderate-to-severe psoriasis. Our study contributes real-world evidence from a tertiary care setting in Bangladesh, demonstrating outcomes comparable to those reported in international literature. Continued evaluation and long-term follow-up will further define the role of biologics in managing psoriasis and optimizing patient care in this population.

Financial support and sponsorship

No funding sources.

Conflicts of interest

There are no conflicts of interest.

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