Ocena jakości życia w chorobie Leśniowskiego-Crohna w grupie pacjentów leczonych biologicznie

Introduction

Crohn’s disease (CD) is classified as an inflammatory bowel disease (IBD). Its exact etiology remains unknown. However, genetic factors (NOD2 gene mutations), the individual’s intestinal microflora, and the immune response of the gastrointestinal wall play a significant role in the pathogenesis of the CD [1]. Crohn’s disease is characterized by alternating periods of exacerbation and remission, and the disease process can affect any part of the gastrointestinal tract—from the oral cavity to the anus. Additionally, this disease is characterized by segmental inflammatory lesions of the gastrointestinal tract, separated by healthy sections.

The primary goal of CD treatment is to reduce the intestinal inflammation responsible for clinical symptoms. This leads to remission, meaning the disappearance of symptoms and healing of the lesions. Treatment strategy includes non-pharmacological, pharmacological, and surgical interventions.

Non-pharmacological management includes the avoidance of factors that trigger flare-ups, such as infections, non-steroidal anti-inflammatory drugs, and psychological stress. Smoking cessation is crucial for individuals diagnosed with CD, as tobacco use is associated with disease exacerbation and an increased risk of complications requiring surgical intervention [2,3,4].

Pharmacological treatment of CD primarily involves the use of aminosalicylates, immunosuppressive drugs such as glucocorticosteroids, purine analogues, and methotrexate. In recent years, significant progress has been made in the treatment of CD using biologic drugs that are antibodies directed against tumor necrosis factor-α (TNF-α). This group of drugs has provided good responses in moderate to severe disease. However, approximately 20% of patients experienced a lack of response, while around 30% experienced a loss of response during treatment [5].

For the past decades, infliximab and adalimumab have been the mainstays of this group of drugs used in the treatment of inflammatory bowel disease. Numerous published studies have demonstrated their efficacy and safety in the treatment of both moderate and severe CD. A lower rate of exacerbations and a reduced number of serious complications requiring surgical interventions have also been demonstrated during such treatments [6,7].

Objective

The aim of this study was to assess the quality of life of patients with Crohn’s disease (including the risk of malnutrition) and to analyze the frequency of complications during biological treatment.

Materials and methods

The study involved 120 individuals with Crohn’s disease undergoing biological treatment, residents of the Lodz Voivodeship. The study was conducted at the Gastroenterology Clinic and the Gastroenterology Outpatient Clinic of the Central Clinical Hospital of the Medical University of Lodz. Respondents were informed of the voluntary and anonymous nature of their participation. The study began in October, after obtaining approval from the Bioethics Committee of the Medical University of Lodz (RNN/222/24/KE of October 8, 2024), and concluded on April 18, 2025. The study was conducted in accordance with the principles of the Declaration of Helsinki.

The research material was obtained using a diagnostic survey. The research tools included the standardized SF-36v2 questionnaire (The Short Form (36) Health Survey, version 2), the MNA questionnaire, and a custom-designed questionnaire developed specifically for the study.

SF-36v2 Questionnaire: The Polish-language version of the licensed SF-36v2 form (Student License Agreement QUO-02767-R7H5W1) was used to assess quality of life. This questionnaire comprehensively captures patients’ subjective experiences, and the license, professional translation, and standardization further ensure the reliability of the results. The SF-36v2 consists of 11 questions and assesses quality of life in the following domains: physical function (PF), activity limitations due to health (RP), pain (BP), general health perception (GH), vitality (VT), social functioning (SF), sense of mental health (MH), activity limitations due to emotional problems (RE), and changes in health status (HT). The above categories are grouped into two main scales: physical PCS, which includes: PF, RP, BP, GH, and mental MCS, which includes: VT, SF, RE and MH – functioning in the mental dimension, overall mental health [8,9].

MNA Questionnaire: The MNA (Mini Nutritional Assessment) questionnaire was used to assess nutritional status. It consists of six screening questions and a 12-question assessment tool. The MNA test is designed to detect malnutrition or the risk of developing it. A score of 24 to 30 indicates good nutritional status, 17 to 23,5 points indicates a risk of malnutrition, and 17 points or less indicates malnutrition.

Author’s Questionnaire: The author’s questionnaire consisted of 21 questions regarding observed symptoms in the course of CD, treatment (including surgical procedures), and subjective assessment of the quality of life of CD patients (e.g., perception of the impact of CD on respondents’ social relationships and intimate lives). The survey also included metric variables used to analyze correlations.

Statistical analysis: Calculations were performed using the SPSS Statistics 28.0 statistical package. The chi-square test was used to examine the statistical relationship between the analyzed characteristics. A 5% risk of inference error was assumed. A probability value of p<0.05 was considered statistically significant.

Results

The study involved 120 patients, half of whom (n=60) were women. The majority of respondents (71.7%) were over 30 years of age, had higher education (49.2%), and held sedentary jobs (42.5%). Most had no family history of Crohn’s disease (82.5%) or ulcerative colitis (79.1%). One in ten patients surveyed admitted to smoking cigarettes, and one in four occasionally drank alcohol (Table 1).

Perianal fistulas occurred in 21.7% (n=26) of respondents, internal fistulas in 5.8% (n=7) of respondents, and anal fissures in 10.8% (n=13). Abscesses occurred in 13.3% (n=16) of respondents, and intestinal stenosis in 29.2% (n=35). Anemia was diagnosed in 39.2% (n=47) of respondents, and skin lesions occurred in 23.3% (n=28). Less common were arthritis (n=3) and iritis (n=5). Additionally, 1.7% (n=2) of respondents had concurrent perianal fistulas, abscesses, and skin lesions. The majority of respondents (65%) stated that their disease influenced their work.

Additionally, respondents perceived that the disease had a variable impact on their social relationships. The majority of respondents, 35% (n=42), rated this impact as level 3, indicating a moderate impact. Another 17.5% (n=21) rated this impact at levels 2 and 4, while 15% (n=18) each rated it at the lowest (1) and highest (5). Nearly half of the respondents (47.5%) rated the effectiveness of their biological treatment as very good (5). A total of 21.7% of respondents rated the effectiveness at level 4, indicating good effectiveness. Another 20% rated it at level 3, indicating average effectiveness. Additionally, 9.2% rated the effectiveness at level 2, while 1.7% assessed it as poor (1).

85.8% of the respondents participating in the study experienced no complications resulting from the biological treatment they received. Additionally, the majority of the study group (68,3%) were individuals who had not undergone surgical treatment for their inflammatory bowel disease. However, 13,3% of respondents had undergone surgery once, 8.3% twice, and 10% three or more times. The most common surgical procedures included small intestine removal (n=16), colon resection (n=10), fistulas (n=15), inflammatory abdominal masses (n=8), and abscesses (n=5). Statistical analysis was performed to assess the relationship between physical health, mental health, and quality of life indicators of the respondents by gender.

After performing the calculations, significant differences were observed in the assessment of physical health, mental health, and quality of life index between women and men. Statistical analysis of the study also revealed no significant differences in the assessment of physical health, mental health, or quality of life index between smokers and non-smokers.

In the next part of the paper, individual domains included in the SF36v2 questionnaire were statistically analyzed in order to calculate the means and standard deviations of each quality of life scale (Table 2).

Statistical analysis of the respondents’ overall physical health assessment produced a mean score of 62.154, suggesting that, on average, participants attained approximately 62 points out of 100. The standard deviation (SD) was 14.25945, indicating a degree of variability in scores among the respondents.

The overall mental health assessment was also statistically analyzed, revealing a mean of 79.7226, indicating a higher rating of mental health compared to physical health. However, the standard deviation of 27.32828 suggests that scores in this category are more variable than those in the physical assessment. The quality of life index was also statistically analyzed, which averaged 160.731, indicating a relatively high level of quality of life in the study group. However, the standard deviation of 47.11776 indicates significant variability in scores in this category. Details are provided in Table 3.

It was assumed that the total score for a given indicator reflects either its positive or negative value. Accordingly, the scoring configuration can be adjusted depending on whether the analysis focuses on a higher level of positive health assessments or on the degree of negative evaluations.

The principle is that the higher the index, the more positive the respondent’s self-assessment in terms of accepted quality of life concepts. Alternatively, the less negative the respondent’s self-assessment, i.e., the lower the „negativity” index, the better the quality of life.

Risk of malnutrition: Based on the results of the malnutrition rate assessment, the majority of respondents 49.2% (n=59) were classified as being at risk of malnutrition, with almost one in ten (9.2%) already experiencing malnutrition.

Discussion

Crohn’s disease is chronic, and currently, known treatment methods do not provide a complete cure. Patients can strive to alleviate symptoms and maintain remission for as long as possible. Inappropriate treatment can lead to health deterioration, causing limitations in daily life [10].

According to a literature review, „the most common reasons for hospital admission in patients with CD are pain, nausea, vomiting, and gastrointestinal bleeding. In the studied CD patients, the most common sites of disease were the terminal section of the small intestine and the initial section of the large intestine. The disease caused complications such as fistulas, perforations, and gastrointestinal bleeding in a significant proportion of patients. These conditions are among the most difficult clinical problems for both physicians and nurses. Treating patients with CD with complications requires specialist knowledge of this disease and the management of its complications from physicians and nurses” [10]. Analyzing the survey data reveals the diversity of health problems faced by the respondents and the need for further diagnosis and treatment to improve their health. The most common were anemia (47 individuals), intestinal stenosis (35 individuals), and skin lesions (28 individuals).

Studies have shown that gender has no influence on the likelihood of developing CD. Most of these individuals were over 30 years of age, but it’s important to note that this group of respondents includes those who have been struggling with the disease for many years. The survey results clearly show that the largest number of respondents received a diagnosis of CD in 2011. This was the year in which the highest rate of diagnoses was recorded, suggesting increased disease activity during that period. Another significant group consists of individuals diagnosed in 2010, representing 6.7% of respondents. These results suggest that these two consecutive years were crucial for the development and diagnosis of CD among the study participants.

Włocha and Grzymisławski [11] speculate that environmental factors, such as improved living standards, hygiene conditions, and the financial status of developing countries, changing lifestyles, and dynamic economic changes, influence the development of intestinal diseases among society. The study group shows that almost half of them, specifically 49.2%, have higher education. This means that nearly half of the respondents completed bachelor’s, master’s, or academic degrees. An additional factor supporting the abovementioned authors’ assumptions is the higher percentage of people with sedentary jobs (42.5%) compared to those with physically demanding jobs (38.3%). This observation may suggest a predominance of occupations such as office workers, technical workers, and health professionals in regions with higher financial status.

The majority of respondents (over 80%) stated that neither Crohn’s disease nor ulcerative colitis existed in their family. This suggests that genetic factors may have limited significance in the development of these diseases, which may indicate a greater role for environmental or random factors. Różalski disagrees, emphasizing the influence of genetic factors in the etiology of CD. According to Różalski [12], the occurrence of the disease is closely linked to a mutation in the NOD2/CARD15 gene on chromosome 16, increasing the risk of inheriting the mutation by as much as 20-40 times. For example, the increased risk of a child developing the disease can be as much as 40% higher if both parents suffer from Crohn’s disease.

Nearly half of the respondents (47.5%) rated the effectiveness of their biological treatment as very good (5), and 21.7% rated the effectiveness of the treatment as 4. At the same time, the treatment has a low risk of complications. This suggests that biological treatment may be an effective therapeutic option for patients with Crohn’s disease.

The survey revealed that the disease had a varied impact on both their social relationships and intimate life. In terms of social relationships, the majority of respondents (52.5%) rated the impact of the disease as moderate (3). This suggests that the disease had a significant, but not dominant, impact on social interactions. However, a significant percentage (30%) rated this impact as low (1 and 2) and high (4 and 5), indicating a wide range of experiences. In the case of intimate life, differences in perception of the disease’s impact are also evident. The largest group of respondents (28.3%) rated this impact as moderate (2), but an equally large group (24.2%) rated it as 3, also indicating a moderate impact. However, some (28.4%) experienced a very slight (1) or very high (5) impact of the disease on their intimate life.

These conclusions are supported by data collected using the SF-36 quality of life questionnaire. The mean physical health score was 62.154 out of 100 points, indicating a moderate level of physical health among the participants. However, the standard deviation of 14.25945 suggests that there is variability in physical health scores among participants, meaning that some may score higher or lower than the average. It is worth noting that Crohn’s disease can lead to physical impairments and limitations that can impact daily functioning. A mean score of 62.5 indicates the presence of pain in patients with Crohn’s disease. Pain is a common symptom of this disease and can significantly impact patients’ quality of life. The lowest mean score on the SF-36 questionnaire is the global health score of 45.6. Due to its demanding diagnostic procedures, lengthy treatment process, and numerous complications, Crohn’s disease significantly impacts patients’ perception of health from a holistic perspective. An average score of 48.5 indicates a relatively low level of vitality, resulting in fatigue, weakness, and a lack of energy. The final aspect examined is mental health, with an average score of 55.8.

In his publication, Medar [13] emphasizes the importance of providing patients with comprehensive education regarding the disease, its symptoms, treatment options, and potential outcomes. This can help reduce anxiety and worry related to the disease, which can improve their mental health. Analyzing the mental health of patients with Crohn’s disease requires a holistic approach, taking into account both the symptoms of the disease and the psychosocial factors that influence their mental well-being.

In the case of Crohn’s disease, regular monitoring of patients’ nutritional status is crucial. The results of the MNA survey indicate a risk of malnutrition (49.5%). This result is an alarming factor for appropriate nutritional interventions [14,15].

The survey concluded that the disease has a varied impact on patients’ lives, with a predominant moderate impact on both social relationships and intimate life. However, there is a significant percentage of people who experience more extreme experiences, both positive and negative, related to the impact of the disease on their daily lives.

Conclusions