The term “immune-mediated inflammatory diseases” (IMIDs) encompasses a series of chronic, clinically heterogeneous diseases that share pathogenic mechanisms and are affected by both genetic and environmental factors.1 The most prevalent pathologies that constitute this group are inflammatory bowel disease (IBD), psoriasis (Ps), psoriatic arthritis (PsA), rheumatoid arthritis (RA), and spondyloarthropathies (SpAs) (ankylosing spondylitis or undifferentiated). In Spain, the global prevalence of IMIDs in people aged 16 years or older is 6.4%,2 affecting near 3 million people.3

The coexistence of several IMIDs in the same person is quite common, also the family aggregation of multiple IMIDs,1 which in these cases results in a greater impact of the diseases when several members of the same family are affected.1 In addition, people with IMID have an increased risk of developing comorbidities and complications derived from the chronic effects of inflammation, such as cardiovascular diseases, metabolic syndrome, diabetes, depression, fatty liver, or kidney diseases, complicating the management of these pathologies. Therefore, patients with IMID have high morbidity and a high degree of disability, considerably reducing their health-related quality of life (HRQoL).1 People with IMID have an impaired ability to perform daily activities.4 Therefore, their mood and psychological well-being can affect different social and family relationships,5 consequently, many people are unable to work or require reduced working hours.6 Taking into account everything said, these pathologies have a high impact on society, while individuals experience impact on their quality of life.

There are several methods to assess HRQoL. The 5-dimensional and 5-level EuroQol (EQ-5D-5L) is a generic, preference-based instrument to evaluate HRQoL of patients, that has demonstrated high validity and reliability for multiple chronic diseases.7 In addition to the generic instruments, there are specific questionnaires that evaluate HRQoL of each IMID individually. Knowing HRQoL of chronic patients is one of the health strategies that favour the adaptation of care services to the needs of patients. Therefore, the objective of this study was to evaluate the HRQoL in patients with at least 1 of the 5 IMIDs with the highest prevalence in Spain (IBD, Ps, PsA, RA, and SpAs) and to analyse the influence of sociodemographic and clinical characteristics on the HRQoL of these patients. However, the SACVINFA study also had other objectives, such as assessing the satisfaction with the health care received by patients.8

A total of 596 patients were recruited from the 4 participating centres, 18 of whom were excluded (7 for not meeting the inclusion criteria, and 11 for unwillingness to complete the patient diary), for a total of 578 patients included in the final analysis (PsA=17.8%, RA=18.5%, SpAs=18.7%, IBD=25.3%, Ps=19.7%).

The sociodemographic and clinical characteristics of the patients included in the study and the adherence reported by the patients are shown in Supplementary table 1. The mean age and standard deviation (SD) of all patients was 49.8 (12.3) years. A total of 50.7% of the participants were men. The pathology with the greatest difference between the genders was RA, in which 81.3% were women. The mean (SD) on the current biological therapy was 4.2 (3.5) years. A total of 92.0% of patients were administered their treatment subcutaneously. Tumour necrosis factor-α (TNF-α) inhibitors were administered to 60.9% of patients. A total of 42.9% of all patients had their main pathology in remission, 33.4% had mild disease, and 23.7% had moderate/severe disease. In addition, 8.3% of patients also had a second pathology, and 0.3% had 2 additional pathologies. Patients with PsA were most likely to have moderate/severe disease (34.0%) and to present with an additional pathology. In contrast, Ps patients were least likely to present with moderate/severe disease (1.8%). According to the data reported, more than 70% of all patients properly adhered to their therapy, being PsA patients the most adherent group (76.8%), and RA patients (63.1%) the least adherent group.

Fig. 1 shows the general scores of the EQ-5D-5L questionnaire. The average (SD) overall score for all patients was 0.77 (0.22). Significant differences were observed between the pathologies with the highest (mean (SD): Ps, 0.87 (0.17) and IBD, 0.81 (0.20)) and the lowest scores (mean (SD): SpAs, 0.71 (0.21), RA, 0.72 (0.25), and PsA, 0.73 (0.24)). Regarding the VAS, patients with Ps had the highest mean (SD) score, at 76.9 (17.6), and patients with RA had the lowest mean (SD) score, at 67.5 (22.5). The difference between these groups was statistically significant (p=.024).

Fig. 1.

Mean EQ-5D-5L and VAS scores.

IBD: inflammatory bowel disease; Ps: psoriasis; PsA: psoriatic arthritis; RA: rheumatoid arthritis SpAs: ankylosing spondylitis; VAS: visual analogue scale.

EQ-5D-5L: Statistically significant differences were observed in the patient scores for the following pairwise comparisons: IBD vs. PsA (p=.040); IBD vs. RA (p=.011); IBD vs. SpAs (p=.001); Ps vs. PsA (p<.001); Ps vs. RA (p<.001); Ps vs. SpAs (p<.001).

VAS: Significant differences were observed in the scores of patients with Ps vs. RA (p=.024).

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In assessing the relationship of the baseline sociodemographic and clinical characteristics with the average general utility scores of the EQ-5D-5L of all patients, it was observed that gender, disease severity, patient age, number of previous treatments, and duration of the current biological therapy were associated with statistically significant differences in the HRQoL of the patients (Supplementary table 2). Female patients reported a lower score on the EQ-5D-5L than the male participants, and the difference was statistically significant for all pathologies (women: 0.74; men 0.80; p=.002) and for SpAs (women: 0.63; men 0.75; p=.007). In relation to disease severity, among all patients, those with moderate/severe disease reported a worse HRQoL than those in remission or with mild disease (p<.001 for both) (Supplementary table 2).

Regarding the relationship between HRQoL and patient age, age was significantly inversely related to HRQoL in the total sample (p<.001) and in patients with RA (p=.004). Likewise, for all patients, the greater the number of treatments prior to the current therapy, the worse HRQoL was reported (p<.001). This was also observed in all IMIDs except Ps. In contrast, in all patients, a positive correlation was observed between the duration of the current biological therapy and HRQoL: the persistence was, the higher HRQoL (p=.005). This correlation was also observed for patients with IBD and Ps (p=.012 and p=.049, respectively) (Supplementary table 2).

Fig. 2 shows the values of each dimension of the EQ-5D-5L. For the total sample, pain/discomfort (2.177) had the greatest impact, followed by daily activities (1.727) and anxiety/depression (1.724). Patients with Ps reported the best state in each of the dimensions evaluated.

Fig. 2.

Dimensions of the EQ-5D-5L.

IBD: inflammatory bowel disease; Ps: psoriasis; PsA: psoriatic arthritis; RA: rheumatoid arthritis SpAs: ankylosing spondylitis.

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The results reported by the patients for the specific questionnaires for each pathology are shown in Table 1. Patients with RA, IBD, and Ps achieved 70% of the maximum score, while patients with PsA and SpAs did not reach 50% of the maximum possible score.

The SACVINFA study analysed HRQoL of a large multicentric cohort of patients with IMIDs treated in the Pharmacy Services of various hospitals. A set of factors were identified as associated with a better HRQoL: male gender, low disease activity, and persistence to current treatment. In contrast, patient age was negatively associated with HRQoL; the older the patients were, the worse the HRQoL. To the best of our knowledge, few studies have evaluated HRQoL of patients with IMID. Most of the published studies evaluated HRQoL for a single IMID pathology, but the SACVINFA study is the first to evaluate HRQoL of the 5 IMIDs with the highest prevalence in Spain.

The results of the SACVINFA study are in line with published findings on HRQoL both in the general Spanish population and in patients with rheumatological diseases. In a study carried out on non-institutionalised adults from a Spanish population (n=20 587), female gender, age, and a greater number of chronic diseases were negatively associated with HRQoL.19 These results are in concordance with the results observed in studies with patients with RA, SpAs, and rheumatological diseases, in which the scores of EQ-5D-5L questionnaire were significantly lower in female than male patients.20–22 Advanced age and longer disease duration were also significantly associated with a lower HRQoL score.21,22 Disease severity was also associated with a worse HRQoL in patients with RA21 and Ps.23 In the SACVINFA study, a worse HRQoL was observed among patients with moderate/severe disease than those with mild disease (p<.001) or in remission (p<.001) for all IMIDs except IBD.

In relation to the dimensions evaluated in the EQ-5D-5L questionnaire, what affected in the most negative HRQoL was pain/discomfort, followed by the ability to perform daily activities and anxiety/depression. These results are in line with the literature, since IMIDs share some common symptomatic characteristics that may be responsible for functional deterioration, including fatigue and pain, which negatively influence the ability to perform daily activities24 and trigger anxiety or depression disorders,25 which are very common among patients with IMID.26 Comparing the pathologies, it should be noted that patients who presented inflammatory rheumatic diseases (PsA, RA, and SpAs) reported a worse general health status in the EQ-5D questionnaire (with scores of 0.73, 0.72, and 0.71, respectively) than patients diagnosed with IBD or Ps (with scores of 0.81 and 0.87, respectively). The dimensions most affected among patients with a rheumatological component pathologies were pain/discomfort, the ability to perform daily activities and mobility, which could be explained by the joint inflammation that occurs in these pathologies. Similar results were observed in other studies of patients with IMIDs, in which patients with diseases with a rheumatic component had worse self-reported health status than those without an inflammatory component in all. This was especially evident in domains related to mobility, and in relation to limitations in performance and usual activities due to physical function and bodily pain.22

The anxiety/depression achieved similar scores for patients of all IMIDs. It was the third most affected dimension in total population, which is in concordance with published literature, since patients with IMIDs tend to have a high prevalence of anxiety and/or depression compared to the general population.27 In addition, recent studies have demonstrated interaction between inflammation and mood disorders, especially for patients with high levels of inflammatory mediators such as interleukin-6 (IL-6) and TNF-α.3,28 Likewise, both the duration of the disease and the number of treatments that are usually administered over time could result in negative feedback for the mood of the patient.

The specific questionnaires for each IMID are not comparable to each other, but in relation to the best possible score, patients with pathologies with a rheumatological component reported the worst HRQoL results, except for patients with RA, who achieved a score of approximately 7/10 in their specific questionnaire.

Finally, it is worth mentioning that in the SACVINFA study, pharmacological adherence did not significantly influence in HRQoL. This result has also been observed in other studies conducted on patients with IMID (RA and IBD), in which no significant differences were observed among psychological factors or HRQoL and pharmacological adherence.29 However, other studies on patients with IMID (PsA and Ps) did report a positive relationship between adherence and HRQoL; those patients who did adhere to and persisted with the medication showed significant improvements in clinical parameters, functionality, and in their quality of life.30 Likewise, in another study in which RA, PsA, and SpAs patients were evaluated, patients with greater adherence to treatment had a higher score on the VAS.31

One strength of the present study was the involvement of a large patient cohort, the context of real-world evidence, the multicentre setting, and a reasonable balance of involved pathologies. Regarding the limitations, it is worth mentioning that the patients were not randomly selected, which would have provided more solid evidence. The consecutive inclusion of patients was chosen to favour the collection of data due to the different periods of medication collection. On the other hand, other comorbidities with impact on the quality of life were not considered in addition to immune-mediated inflammatory diseases. The patient care model was also not analysed, e.g. the existence of multidisciplinary units.

The results of the SACVINFA study showed that patients with IMIDs have impaired HRQoL, especially those IMIDs with a rheumatological component. Older age, female gender, greater disease severity, and a shorter treatment duration were related to a worse HRQoL in these patients. However, treatment adherence did not affect HRQoL. All these findings are relevant and can help in clinical decision-making and the establishment of priorities for the management of people with these diseases with the goal of improving their HRQoL.

The SACVINFA study evaluated the quality of life related to health by patients with the most prevalent Immune-mediated inflammatory diseases in Spain. The results of the study could help to generate knowledge to establish strategies that help to optimise adherence, achieve therapeutic goals, and prevent complications.

The study was funded by the Instituto Fundación Teófilo Hernando.

Ethical approval was granted by the Clinical Research Ethics Committee of the Hospital General Universitario Gregorio Marañón (code: ESC-INM-2019-01).

All subjects personally gave consent and signed and dated the written informed consent form.

Esther Chamorro-de-Vega: Writing – review & editing, Writing – original draft, Validation, Investigation, Data curation. Alberto Calvo: Writing – review & editing, Validation, Investigation, Data curation. María Fernández-Pacheco: Writing – review & editing, Methodology, Investigation, Conceptualization. Belén Hernández-Muniesa: Writing – review & editing, Validation, Methodology, Investigation. Rosa Romero-Jiménez: Writing – review & editing, Validation, Methodology, Investigation, Formal analysis, Data curation. Araceli Casado-Gómez: Visualization, Formal analysis, Data curation. Esther Ramírez: Writing – review & editing, Writing – original draft, Validation, Investigation, Data curation. Alberto Morell: Writing – review & editing, Validation, Investigation, Data curation. Nuria Herrero: Writing – review & editing, Writing – original draft, Validation, Investigation, Data curation. Bárbara Úbeda: Writing – review & editing, Writing – original draft, Validation, Investigation, Data curation. Arantza Ais-Larisgoitia: Writing – review & editing, Writing – original draft, Validation, Investigation, Data curation. Elena Lobato-Matilla: Writing – review & editing, Writing – original draft, Validation, Investigation, Data curation. Álvaro Muñoz: Writing – review & editing, Writing – original draft, Validation, Investigation, Data curation. Miguel Ángel Casado: Writing – review & editing, Writing – original draft, Validation, Investigation, Data curation. Vicente Escudero-Vilaplana: Writing – review & editing, Writing – original draft, Validation, Investigation, Data curation.