The Dermatomyositis Disease Symptom Questionnaire (DM-DSQ): A Measure to Assess the Patient Experience of Dermatomyositis Symptoms

Abstract

Objective Dermatomyositis (DM) symptoms negatively affect the quality of life of individuals living with the disease. Disease-specific, patient-reported outcome (PRO) instruments are needed to assess symptoms important to individuals with DM. This study aimed to conceptualize patient DM experience and disease activity definition to refine the development of the Dermatomyositis Disease Symptom Questionnaire (DM-DSQ), a novel PRO instrument capturing patient-reported symptoms.

Methods An observational, qualitative study was conducted with 30 individuals with DM (aged ≥ 18 yrs) in the US. A 1-hour semistructured interview, including concept elicitation and cognitive debriefing, was conducted with each participant. Inductive coding was used to identify concepts; a saturation analysis was conducted to confirm sample size. Concepts from transcripts were used to refine the preliminary conceptual model and DM-DSQ items.

Results Concept elicitation analysis findings included disease symptoms (eg, muscle weakness) and functional impacts (eg, walking). The analysis achieved conceptual saturation; the first 5 interviews uncovered most of the concepts. During cognitive debriefing of the DM-DSQ, participants found the items relevant, comprehensive, and easily understood (except for “skin sensitivity in sunlight”). The revised DM-DSQ content appears preliminarily valid in the patient population surveyed, pending further additions and debriefing based on refinement of the preliminary conceptual disease model and items.

Conclusion The DM-DSQ is being used in a phase II clinical trial and could become a valuable tool for studies evaluating PROs in patients with DM. Preliminary results indicate its content validity; extensive psychometric analysis using clinical trial data will determine its ability to capture symptoms for patients with DM.

Key Indexing Terms:

Dermatomyositis (DM) is a rare, life-altering, chronic, immune-mediated disease.1,2 The overall prevalence of DM varies somewhat based on several factors, including geographical region. The prevalence in the US, after adjustment for age and sex, is estimated to be 13 per 100,000 persons,2 whereas in a nationwide population-based study in Sweden, the estimated prevalence of DM was approximately 4 per 100,000 persons.3 Individuals with DM exhibit skin manifestations, notably rash or ulceration, and muscle manifestations, including proximal skeletal muscle weakness and inflammation.4-6 The European Alliance of Associations for Rheumatology (formerly the European League Against Rheumatism) and the American College of Rheumatology developed classification criteria for idiopathic inflammatory myopathy and its major subgroups, including DM based on cases and their most common and specific manifestations of the disease.7

DM negatively affects the quality of life (QOL) of individuals living with the condition. They can experience limitations in day-to-day functions, such as climbing stairs, standing, and lifting objects; fatigue; and difficulty breathing or swallowing.6,8 Moreover, increased skin disease severity, fatigue, and pruritus associated with DM are correlated with poor QOL.9 Identifying the most relevant symptoms to individuals with DM is important to promote shared decision-making for treatment and to optimize therapies. A study by the Outcome Measures in Rheumatology (OMERACT) myositis special interest group (SIG) surveyed patients, caregivers, and healthcare providers (HCPs) to identify crucial domains to prioritize in clinical and research settings for idiopathic inflammatory myopathies.10 For both HCPs and patients, muscle symptoms, medication side effects, joint and cardiovascular symptoms, and ability to work were initial key domains identified to assess in individuals living with idiopathic inflammatory myopathies.10 Patients also prioritized domains related to symptoms and disease experiences, such as fatigue, pain, cognition, and difficulty sleeping, whereas HCPs selected traditional measures, including skin, lung, and muscle symptoms.10 This study focused on idiopathic inflammatory myopathies as a group and not DM alone; therefore, some items identified may not be relevant for DM. More specific measures may be necessary for DM, such as skin manifestations, which patients surveyed as part of the OMERACT studies did not rank highly.

The gold standard in assessing DM and other myositis disease activity includes a combination of validated assessments known as the Disease Activity Core Set Measures from the International Myositis Assessment and Clinical Studies Group (IMACS), which is used in both clinical and research settings.11-14 The Disease Activity Core Set Measures are blood tests to measure serum levels of muscle enzymes, including creatine kinase levels, manual muscle strength tests, the Health Assessment Questionnaire (HAQ; a patient-reported assessment of functional ability), evaluation of extraskeletal muscle involvement (Myositis Disease Activity Assessment Tool), and global assessment of disease activity by patient and physician.11,12 The Disease Activity Core Set Measures do not contain DM-specific patient-reported outcome (PRO) measures (eg, skin manifestations).10,12,15 Although additional PRO measures have been validated in DM, including Skindex-17 and Skindex-29, which measure the effect of skin disease on patient QOL, and the 36-item Short Form Health Survey to measure health-related QOL,14,16 these were not proactively developed for DM; therefore, they are not able to measure other important DM-specific symptoms.

Thus, an unmet need remains for disease-specific instruments that assess symptoms and functional impacts important to individuals living with DM.12,15 The primary aims of this study were to conceptualize the patient experience of DM and to develop an instrument to capture patient-reported symptoms and outcomes important for individuals with DM, including patient definition of disease activity, for use in clinical trials. This questionnaire is meant to serve as an additional, symptom-specific tool for providers to use in clinical management of DM symptoms. A preliminary conceptual model was developed based on literature, input from individual patients with DM, and patient videos on The Myositis Association (TMA) website and refined using concept elicitation with the purpose of creating a PRO instrument. The Dermatomyositis Disease Symptom Questionnaire (DM-DSQ) was drafted based on the preliminary model to assess the symptoms and severity of DM and refined based on the updated conceptual model and debriefing results. This preliminary DM-DSQ was then used in patient interviews and this manuscript summarizes the findings from those interviews.

METHODS

Study design. This was an observational, mixed-method, qualitative study involving adults with DM. All study documents were approved by a central institutional review board (IRB), and the study was conducted in accordance with the ethical principles outlined in the Declaration of Helsinki. Research practices were guided by Good Clinical Practice and regulatory requirements as applicable. All computer-processed data were identified by patient identification number only, and transcripts were anonymized to ensure that the patients’ identities remained unknown to the sponsor.

Study population. Recruitment occurred in the US in partnership with TMA, which advertised the study through their network using IRB-approved language. Modus Outcomes performed the recruitment and interviews. A recruiter from Modus Outcomes screened individuals interested in the study by phone or email to confirm that they met the inclusion/exclusion criteria. Individuals gave verbal consent to provide their contact details and to participate in the study. Eligible participants completed the consent form electronically, and a copy of the signed consent form was provided to each participant. The interview was scheduled once the consent form was signed.

To be included in the study, individuals had to be adults (aged ≥ 18 years) with a clinician-confirmed DM diagnosis provided using a clinician-completed form or image of their medical records; be able to speak, read, and understand English; and be able and willing to participate in a 60-minute phone interview. To focus on primary symptoms related to DM, individuals with another type of myositis, as well as those with overlapping skin cancer, rheumatoid or psoriatic arthritis, systemic lupus erythematosus, systemic sclerosis, fibromyalgia, or interstitial lung disease, were excluded. Participant selection was intended to reflect the continuum of DM severity based on the participant’s self-reported level (ie, mild, moderate, or severe). The proposed allocation of participants for each level of severity was 25% mild, 50% moderate, and 25% severe. Treatment type was used as another indicator that participants had active DM, with a goal of 50% of the sample to have received either corticosteroids or nonsteroidal immunosuppressive therapy, and the remaining 50% to have received both treatments.

Participant interviews. Participants underwent a single semistructured telephone interview lasting approximately 1 hour conducted in American English by Modus Outcomes researchers. The interviews were audio-recorded with participants’ verbal permission, and transcripts were used for qualitative analysis. At the end of the interview, participants completed a demographic and health information form and received compensation for their participation.

Concept elicitation and cognitive debriefing. The semistructured interview included 2 components: concept elicitation and cognitive debriefing. Concept elicitation documented the participants’ experiences of DM, including disease symptoms and functional impacts. The interview consisted of open-ended questions, allowing participants to describe their experience with DM in their own words. Targeted probes or specific prompts were used to obtain clarification and/or additional information on concepts reported. Cognitive debriefing was conducted to evaluate participant understanding of the DM-DSQ, clarity of the response options related to the concepts, and relevance to the patient population.

Inductive coding. An independent transcription agency (Fantastic Transcripts) and Modus Outcomes personnel reviewed the patient interview transcripts. Transcripts were analyzed thematically17 through line-by-line open and inductive coding18,19 using ATLAS.ti software. The code was developed based on the raw data (transcripts), and a coding framework was created based on all coded transcripts. The lists of codes and associated quotes obtained by the independent coders were compared for overlaps and inconsistencies. The code book was continuously updated to include new concepts as they arose. The coding targeted symptoms and impacts of DM, including the patient definition of disease activity and the most bothersome aspects of the condition, and aspects of QOL associated with DM (eg, emotional impact, role functioning).

Saturation analysis. Saturation analysis was conducted in groups of 5 transcripts ordered chronologically to assess whether most of the important concepts informing the patient experience of DM were identified in initial transcripts, with subsequent groups of transcripts evaluated against these to determine whether any new concepts emerged. If 1 to 2 new concepts emerged in the last group of interviews that were closely related to concepts from previous interviews, saturation was considered achieved.

Refinement of the preliminary conceptual model. A preliminary conceptual model of the patient experience with DM was developed from literature, individual patient input, and patient videos on the TMA website. Emerging concepts identified from analysis of patient transcripts were used to refine the preliminary conceptual model.

Cognitive debriefing analysis. Participant feedback on their understanding of the items, the relevance of the concepts assessed, and the response choices for the DM-DSQ was compiled into summary tables. The feedback included participant interpretation of the disease activity measure taken from the global IMACS Patient Global Activity (PGA) in addition to the global disease activity item on the DM-DSQ. The disease activity question is worded slightly differently on the DM-DSQ and has an ordinal response option, unlike the visual analog scale (VAS) found in the IMACS PGA.

RESULTS

Patient demographics and health information. Thirty participants were enrolled in the study; mean age was 49.3 years and 80% of the participants were female (Table 1). DM diagnosis had occurred within the past 5 years for 14 (47%), 6-10 years for 7 (23%), 11-15 years for 5 (17%), 15-20 years for 1 (3%), and > 20 years for 3 (10%) participants. Twenty percent of participants self-reported their DM severity as severe, 50% as moderate, and 30% as mild. Ongoing or previously reported treatments included 16 (53%) participants treated with corticosteroids and 11 (37%) received immunosuppressive therapies. Treatment types were not mutually exclusive, as some participants may have received > 1 treatment type.

Table 1.

Participant characteristics.

Concept elicitation analysis and refinement of preliminary conceptual model. The preliminary literature-based model of the DM-DSQ was refined and updated based on emerging concepts from transcripts of participant interviews (Supplementary Table S1, available from the authors upon request). The concept elicitation stage collected quotations from the participants related to their DM symptoms and functional impacts (Supplementary Table S1). Concepts that emerged in alignment with the preliminary model included muscular and skin manifestations, fatigue, difficulty sleeping, shortness of breath, and overall slowness of movement (Figure 1A). The overarching domain of functional impacts included impact on the head/neck, core, upper and lower limbs, self-care, and other activities. Other subdomains were cognitive symptoms or “brain fog,” as well as impacts on emotions, roles, and social life.

Figure 1.Figure 1.Figure 1.

Updated conceptual model and DM-DSQ questionnaire. (A) Preliminary conceptual model developed based on the literature and patient input from videos on The Myositis Association website and used as a basis for defining conceptual domains, subdomains, and concepts. This model was updated based on concepts that emerged from the participant interviews. (B) Updated DM-DSQ 19-item diary after cognitive debriefing. DM: dermatomyositis; DM-DSQ: Dermatomyositis Disease Symptom Questionnaire.

Several symptoms of DM were also added to the preliminary model. For muscle-only manifestations, the concept of muscle fatigability associated with muscle weakness was added, given that some participants reported that their muscles were easily tired. Specific locations of muscle weakness/fatigability (ie, legs, arms, wrists, shoulders, core, neck, hand/finger, back, ankles) were also included. Descriptions of muscle/joint manifestations experienced by participants, such as pain, aching, burning, cramping, swelling, tightness, stiffness, and discomfort, were added to the updated model. Skin manifestation symptoms added to the model comprised specific concepts related to rash, skin pain, and “mechanic’s hands.”

Updates to the model relating to the functional impact of DM included the effects of DM on participants’ ability to perform activities (eg, self-care, daily activities) and the associated regions of the body (eg, raising and turning head, lifting arms). Brain fog was added as a cognitive concept based on participant experience and the description that their body was not carrying out the intended task they thought they were doing. Emotional impacts and impacts on roles and social life (including work) were included in the conceptual DM-DSQ model.

Saturation analysis. Participants reported most of the concepts related to DM symptoms (Table 2A) and functional impacts (Table 2B) in the first 5 interviews; weakness, rash, and lower limb functional impacts emerged as overarching concepts. Subsequent interviews only added granularity to the concepts that emerged in the first 5 interviews. These concepts were visually grouped according to the same categories observed in the refined conceptual DM-DSQ model.

Table 2A.

Conceptual saturation analysis of chronologically ordered transcripts for dermatomyositis symptoms.

Table 2B.

Conceptual saturation analysis of chronologically ordered transcripts for dermatomyositis impacts.

Most troublesome symptoms and impacts. Participants reported that the most troublesome DM symptoms were itchiness and weakness. Participants who reported weakness were unable to predict when they would experience the weakness; they also experienced fatigability and difficulty with lower limb function (Table 3). Other troublesome DM symptoms were rash, pain, fatigue, and mechanic’s hands/sore cuticles. The most troublesome impacts of DM reported by participants were difficulty swallowing, self-image, having to avoid the sun, anxiety, and loss of independence during flares.

Table 3.

Most troublesome DM symptoms and impacts.

DM-DSQ cognitive debriefing analysis. Participants understood most items on the DM-DSQ well (Table 4); “skin sensitivity in sunlight” was the only item that was difficult to interpret or that caused confusion. Interpretation issues for this item stemmed from participants answering hypothetically (ie, they would answer that their sensitivity was severe if they knew exposure to the sun would cause problems, but this response did not mean they experienced severe problems in the past 24 hours). In addition, participants reported no difficulty in interpreting the global DM activity item presented as an ordinal response in the DM-DSQ.

Table 4.

DM-DSQ item-level debriefing.

Content validity of the DM-DSQ. The main concepts of the DM-DSQ (Figure 1B) appear to be preliminarily valid based on the updated conceptualization model from the participant population surveyed. Several granular concepts and items identified from patient interviews were added to the updated version of the conceptual model (Table 5), including skin redness and hyperpigmentation/hypopigmentation, muscle spasm, fatigability, soreness, aching, cramping, swelling, and skin pain (aches, sensitivity).

Table 5.

Evaluation of conceptual coverage: updated conceptual model.

DISCUSSION

In this qualitative observational study, a novel PRO preliminary literature-based DM-DSQ model was refined based on findings from interviewing participants who reported their DM to be mild, moderate, or severe. Most of the concepts related to DM symptoms and functional impact in the DM-DSQ had associated items that were relevant and well understood by participants, except for “skin sensitivity in sunlight.” Conceptual saturation was achieved in the study, with the last 5 interviews adding only additional granularity to the concepts identified in the first 5 interviews. The updated conceptual DM-DSQ model captured patient-reported symptoms of DM, such as fatigue, muscle weakness, muscle/joint pain, and skin symptoms, as well as functional, emotional, role functioning (including work), and cognitive impacts. Although brain fog and cognitive issues were confirmed by participants, these experiences were not considered proximal in terms of concepts and symptoms most related to treatment benefit and were not included in the final questionnaire. The DM-DSQ may offer better symptom assessment than current assessments from the IMACS, which are not disease specific and lack symptom assessment.

The mean duration of disease of enrolled participants was approximately 8 years, with almost half of participants enrolled within 5 years of diagnosis. Overall, the proposed self-reported disease severity allocation generally matched the sample’s observed severity. Specifically, the 50% of participants with moderate DM severity matched the proposed allocation. The observed proportion of participants with mild or severe DM varied slightly from the proposed allocation of 25% for each group. It is possible that disease severity, along with duration of disease from diagnosis, affected participants’ overall responses. For instance, the inclusion of more patients with severe DM or greater disease duration may elicit more or different concepts.

The core domains identified in our study are similar to those identified by the OMERACT Myositis SIG, wherein patients, HCPs, and caregivers were surveyed to identify important domains to assess for clinical and research settings.10,20,21 Patients prioritized domains related to symptoms and disease experiences, such as pain, fatigue, cognition, effect on mental health, and difficulty sleeping.10,20 The findings from the OMERACT Myositis SIG surveys further refined these core domains to include pain, fatigue, and physical function, which were evaluated in the instrument selection to validate myositis PROs.21 Specific skin disease measures are not included in the OMERACT-derived PRO and thus this instrument may be synergistic with this proposed DM-DSQ.

During the refinement of the DM-DSQ model, some domains were identified that are not captured in traditional PRO measures, including mechanic’s hands and impacts on functional roles and social life. Domains such as disease activity, similar to those found in the DM-DSQ, are assessed in the IMACS Disease Activity Core Set Measures, but are not disease specific, including the global assessment of disease activity reported by the patient/parent questionnaire.14 Additional PROs validated for DM include domains that assess disease activity, disease damage, and health-related QOL.14 However, PROs for pain (ie, VAS 0-10, short-form McGill Pain Questionnaire) and fatigue (ie, Chalder Fatigue Scale; Multidimensional Assessment of Fatigue; Profile of Mood States, fatigue subscale), as well as the Patient Reported Outcome Measurement Information System (PROMIS), have not been validated for patients with DM.15,22,23 Although some PROs related to skin-specific QOL, such as Skindex-26 or Skindex-16, have limited validity for adults with DM,16 Skindex-29 has been clinically validated in individuals with DM.24 Treatment-related improvements in DM skin symptoms correlated well with improvements in skin-specific QOL as measured by Skindex-29,24 with demonstrated clinical responsiveness of subscales and strong association with patient-reported degrees of improvement.25,26 Active disease has been validated for DM within the IMACS Disease Activity Core Set Measures for extramuscular disease activity through modification of the Myositis Intention-to-Treat Activity Index and the Myositis Disease Activity Assessment VAS tools.27 The DM-DSQ can identify symptoms specific to DM, including muscle pain, joint pain, and skin that is painful to touch. Whereas the conceptual model considers functional impacts, emotional impacts, and impact on roles or social life, this questionnaire was developed with a focus on measuring symptoms and symptom severity. Notably, participants reported no difficulty in interpreting the global DM activity item in the DM-DSQ during cognitive debriefing. The global item in the DM-DSQ has distinct ordinal response options, which may be preferable for interpreting results, unlike the VAS found in the IMACS PGA. Psychometric analysis using phase II clinical trial data and a larger sample size will be conducted to support finalization of DM-DSQ content and scoring algorithm.

Because the study included participants’ self-reported disease severity, participants may have overclassified or underclassified their DM severity compared to how a physician may characterize the disease severity. Although the exclusion criteria attempted to limit the influence of comorbid conditions (eg, interstitial lung disease, skin cancer), this may have prevented the identification of relevant concepts. Additionally, this study focused on general DM, and data on disease subtype and autoantibodies were not collected. Participants were not asked to specify the predominant domain of their DM symptoms; therefore, it is unknown whether they had predominantly skin or muscular disease activity. Patient inclusion was also based on physician diagnosis (ie, broad criteria to account for different features, individual-based evaluation) instead of validated classification criteria used in clinical trial settings (ie, well-defined standardized definitions to select individuals with similar features).28 The sample size in this study for initial development of the DM-DSQ was limited to 30 participants; however, further analyses of the DM-DSQ are underway. Although conceptual saturation was achieved for the participants interviewed, the tool may work better in some populations than others. All participants were American English speakers who were selected by TMA; thus, concepts and findings from this study may not be generalizable to other countries with different languages. Translation into other languages and cultural validation of the DM-DSQ is planned. Moreover, individuals who join TMA may not be representative of all patients with DM in the US and demographic data related to geographic location within the US were not collected. Methods to increase generalizability to the DM patient population can include involvement of patient support groups, such as TMA, to gain further understanding of their experience living with DM and increase study recruitment, evaluation of social determinants of health, and planned follow-up to evaluate patient experience over time. Despite these potential limitations, the patient-centered DM-DSQ may offer better symptom assessment than current assessments, which are not disease specific.

In conclusion, findings from participant interviews support the preliminary content validity of the DM-DSQ in evaluating the symptoms important to individuals with DM within the group surveyed. Additional studies are required to further confirm content validity with correlation to gold standard or well-known instruments known to assess DM symptoms. The items of the DM-DSQ include concepts elicited during participant interviews, and items within the DM-DSQ were understood by and relevant to participants. The DM-DSQ could become a broadly useful tool for studies evaluating DM-specific symptoms and experiences in patients.

ACKNOWLEDGMENT

Patrick Marquis, MD, MBA, participated in the conduct of the study and publication planning. Medical writing support was provided by Sejal Gunness, PhD, from The Curry Rockefeller Group, a Citrus Health Group company, and was funded by Alexion, AstraZeneca Rare Disease.

Footnotes

This study was funded by Alexion, AstraZeneca Rare Disease. HC is supported by the National Institute for Health and Care Research Manchester Biomedical Research Centre Funding Scheme (NIHR203308). The views expressed in this publication are those of the authors and not necessarily those of the National Health Service, the National Institute for Health and Care Research, or the Department of Health.

LCS has been on advisory boards and/or served as a consultant for Alexion, AstraZeneca Rare Disease; Allogene; Argenx; Boehringer Ingelheim; EMD Serono; Horizon Therapeutics; Galapagos; Janssen; Mallinckrodt; Octapharma; Pfizer; Priovant; PTC: Immunovant; and UCB; and has received research support as a principal investigator or site investigator from Argenx, Corbus, EMD Serono, Janssen, Kezar, Pfizer, and Priovant. AC and GV are employees of Modus Outcomes. HC has received personal compensation as a speaker, advisory board member, and/or consultancy activities for Alexion, AstraZeneca Rare Disease; Biogen; Eli Lilly; Kezar Life Sciences; Novartis; Orphazyme; Pfizer; and UCB; received research grants from MedImmune, Novartis, and UCB; and received travel support from AbbVie and Janssen. NAG has received research support as a site principal investigator from Alexion, AstraZeneca Rare Disease; Annelixis; Annexon; Amylyx; Brainstorm Cell Therapeutics; Calico; Cytokinetics; Fulcrum; Healey; Kezar; Medicinova; MT Pharma; Octapharma; Orphazyme; PTC; and Transposon; served on advisory boards for Abcuro; Alexion, AstraZeneca Rare Disease; Amylyx; Annexon; Argenx; AstraZeneca; CSL Behring; Fulcrum; Kezar; MT Pharma; Sanofi Genzyme; Sarepta; and UCB; and served on speaker bureaus for Argenx and CSL. KG is a patient with dermatomyositis; a member of the Alexion, AstraZeneca Rare Disease advisory board; and serves on patient-focus panels with Argenx and EMD Serono. DI has consulted for AstraZeneca, Eli Lilly, GSK, Merck Serono, Pfizer, and Servier; the honoraria offered are passed onto a local arthritis charity. AK and SR are employees and stockholders of Alexion, AstraZeneca Rare Disease. IEL has received consulting fees from Corbus and research grants from AstraZeneca; served on advisory boards for Argenx, Corbus, EMD Serono Research & Development Institute, Kezar, Janssen, Octapharma, Orphazyme, and Pfizer; and has stock shares in Roche and Novartis. TM has served in an advisory capacity and/or as a consultant for Alexion, AstraZeneca Rare Disease; Amicus; Argenx; Arvinas; Audentes; AvroBio; Horizon Therapeutics; Immunovant; Janssen; Maze Therapeutics; Modis/Zogenix; Sanofi Genzyme; Sarepta; Spark Therapeutics; and UCB; serves on speaker bureaus for Argenx and Sanofi Genzyme; serves on medical advisory boards for The Myositis Association, Myasthenia Gravis Foundation of California, Myasthenia Gravis Foundation of America, and Neuromuscular Disease Foundation; has received research funding from The Myositis Association, the Muscular Dystrophy Association, and the National Institutes for Health, and from the following sponsors: Alexion, AstraZeneca Rare Disease; Amicus; Argenx; Arvinas; Audentes/Astellas Gene Therapy; BMS; Cartesian Therapeutics; Grifols; Momenta; Ra Pharma; Sanofi Genzyme; Spark Therapeutics; UCB; and Valerion; and has served on the data safety monitoring board for Acceleron, Avexis, Sarepta, and the NIH. RA has received research grants from Boehringer Ingelheim, BMS, EMD Serono, Janssen, Mallinckrodt, Pfizer, and Q32; and has consulted for AbbVie; Actigraph; Alexion, AstraZeneca Rare Disease; ANI Pharmaceuticals; Argenx; Beigene; Biogen; Boehringer Ingelheim; BMS; CabalettaBio; Capella Bioscience; Corbus; CSL Behring; EMD Serono; Galapagos; Horizon Therapeutics; Janssen; Kezar; Kyverna; Mallinckrodt; Merck; Nuvig; Octapharma; Pfizer; Roivant; Scipher; and Teva.

Accepted for publication July 8, 2024.Copyright © 2024 by the Journal of Rheumatology

This is an Open Access article, which permits use, distribution, and reproduction, without modification, provided the original article is correctly cited and is not used for commercial purposes.

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