A Pilot Study to Assess the Feasibility of a Web-Based Survey to Examine Patient-Reported Symptoms and Satisfaction in Patients with Ankylosing Spondylitis Receiving Secukinumab

Ankylosing spondylitis (AS) is a chronic, inflammatory rheumatic disease that predominantly affects the axial skeleton, resulting in bony ankylosis and often leading to impairment or loss of physical function [1‐3]. Patients with AS are known to have a higher risk for many co-morbid conditions, including cardiovascular disease and osteoporosis [4‐9]. AS is associated with decreased quality of life (QOL), increased mortality, and substantial healthcare-related costs, therefore imposing a high burden on patients, their caregivers, and society [10].

Based on recommendations from the Assessment of SpondyloArthritis international Society/European League Against Rheumatism [11], American College of Rheumatology, Spondylitis Association of America, and Spondyloarthritis Research and Treatment Network [12], the first-line treatment for AS should include nonsteroidal anti-inflammatory drugs (NSAIDs) for the management of pain and stiffness. For patients with an inadequate response to NSAIDs, or who experience adverse effects, biologics have emerged as a novel anti-inflammatory therapy [13]. Current practice suggests tumor necrosis factor inhibitors as first-line biologic therapy for patients with persistent disease activity despite NSAID treatment [14].

Significant progress has been made in our understanding of AS in the last decade, and interleukin (IL)-17 has been identified as a key cytokine driving inflammation in AS [15‐17]. Several studies suggest that the IL-17 pathway is a promising target in the treatment of AS [18‐20]. Additionally, patients with AS have elevated numbers of IL-17-producing cells [21‐23]. Secukinumab, a fully human monoclonal antibody targeting IL-17A, is the first and only approved non-TNFi biologic approved in the USA for the treatment of AS; it is also indicated for the treatment of psoriasis and psoriatic arthritis (PsA) [24].

In two phase III placebo-controlled trials (MEASURE 1 and MEASURE 2), secukinumab showed efficacy in reducing the signs and symptoms of AS at week 16 following treatment initiation; benefits were sustained through week 52 [25, 26]. Based on MEASURE 1 and MEASURE 2, secukinumab was approved in the USA for the treatment of active AS [27]. Even though secukinumab has demonstrated efficacy in randomized clinical trials, little is known about patient experience with secukinumab for the treatment of AS in real-world settings. Disease activity measures, such as the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) and Assessment of SpondyloArthritis international Society criteria, are routinely used to measure treatment efficacy in clinical trials and are recommended for disease assessment in clinical practice [28]. However, these composite disease activity measures do not fully capture patient perspectives on treatment effectiveness. Additionally, randomized clinical trials often do not account for patient experience and satisfaction with treatment.

In this exploratory study, we sought to determine the feasibility of garnering and understanding real-world patient narratives with regard to their treatment experience and satisfaction. We surveyed patients with active AS who were receiving treatment with secukinumab and collected their accounts of AS symptom improvement and treatment satisfaction in a real-world setting in the USA. Our overarching goal is to develop a practical means of capturing treatment-related experiences from the patient perspective.

We determined the feasibility of collecting measurable patient-reported experiences with regard to symptom improvement and treatment satisfaction by using a cross-sectional study to survey 200 patients with active AS in the USA. This was an exploratory endeavor to determine the practicality of capturing treatment-related experiences using simple questions that resonate with patients. The study design and interview questions will be applied to a large planned prospective study. Here, we evaluated patient experience with improvements in various AS symptoms and satisfaction with secukinumab treatment in a real-world setting. The majority of patients in our study reported overall symptom improvement since secukinumab initiation, and almost half of patients surveyed experienced overall improvement within 4 weeks of initiating secukinumab; > 90% of patients expressed overall satisfaction with their treatment experience.

In AS clinical studies, emphasis is often placed on measuring treatment efficacy, disease activity, and limitations in physical function. Impairment in QOL, as associated with symptoms such as pain and fatigue [31], and treatment satisfaction are not routinely measured during a clinic visit. A survey of 592 patients with rheumatic diseases, including AS and PsA, indicated that 30–50% of patients were seldom or never queried on the impact of their disease on QOL, and that normalization of QOL and symptom relief were the most important treatment attributes for these patients [32]. In this study, we sought to understand treatment outcomes and satisfaction as verbalized by the patients. A large proportion of patients reported alleviation of AS symptoms with secukinumab with regard to pain, soreness, and stiffness, which was more pronounced with longer duration of secukinumab use, and overall satisfaction with the speed of symptom improvement, suggesting quicker resolution of these symptoms.

Improvement in pain and fatigue, in particular, is critical in mitigating the physical, social, and psychological aspects of AS [33]. It is important to note that patients often endure other challenges stemming from their disease in addition to disease-specific symptoms. Data obtained from real-world studies can offer invaluable insight into the efficacy and safety of therapeutic agents among more diverse patient populations that are often unrepresented or under-represented in clinical trials with regard to factors such as age, ethnicity, differences in disease severity, and co-morbidities. Additionally, in our real-world study, approximately 87% of patients surveyed were biologic experienced compared with patients enrolled in clinical trials who are typically biologic naive [34‐36]. Few studies have assessed the efficacy and safety of secukinumab in real-world settings [37‐40]. Our study is the first to highlight patient-reported experiences with AS symptom improvement and treatment experience with secukinumab among patients with active AS in a US real-world setting, and may complement the efficacy data obtained from clinical trials.

As with all survey-based studies, patient perspectives may be subject to the patients’ bias and experience. Physician-confirmed diagnosis and detailed treatment history were not available in this cross-sectional study; in addition, cross-sectional studies are not inherently representative of all patient populations. Furthermore, patient experiences before secukinumab initiation were based on patient recall. No inferences can be made on patient satisfaction and experience with secukinumab compared with specific previous treatments. Because our survey was offered online, only respondents with access to the Internet were able to participate. Our sample size of 200 patients may not be adequately powered for a complete analysis of patient satisfaction, and our patient recruitment method for this study did not allow for the selection of patients who have discontinued treatment with secukinumab. However, our objective was not to evaluate treatment experiences of patients who continued versus those who discontinued treatment; rather, the goal of this survey was to assess the feasibility of collecting patient perspectives on treatment experiences and satisfaction using a self-administered, online survey. A planned future study will examine patients’ symptom improvement and experience with secukinumab compared with other biologic therapies as well as patient perspectives among secukinumab responders and nonresponders. Evaluating patient satisfaction is challenging, as “satisfaction” is a complex dynamic—while generic measures of treatment satisfaction exist [41, 42], no rheumatology-specific evaluations are currently available. We relied on perceived contribution of treatment to perceived health improvement, which may not be a correct inference. This study used patient-reported outcomes, such as symptom control and drug tolerability, as measures of satisfaction, and did not include clinical assessment. Additionally, no validated instrument was used to assess the magnitude of patient satisfaction; rather, satisfaction was measured on a 4-point gradient scale (e.g., very satisfied, mostly satisfied, somewhat satisfied, and not satisfied). The study also included some close-ended questions (i.e., questions with “yes” or “no” as answers), which may not adequately capture the nuances of patient experiences.

Using a web-based survey, the majority of patients with AS in our study who were treated with secukinumab reported improvement in AS symptoms since secukinumab initiation and expressed overall satisfaction with their treatment experience. Additionally, most reported experiencing improvements in their symptoms within a month of secukinumab initiation. Collection of real-world data and patient insights such as these provides perspectives that guide effective and comprehensive clinical decision making. This pilot endeavor indicates that assessment of symptom improvement and treatment satisfaction as conducted in our study is feasible and will be applicable in our future study for evaluation of these elements among responders and nonresponders of AS therapeutic agents.