Abstract
Objectives
Janus kinase inhibition (JAKi) has been proposed as a treatment for idiopathic inflammatory myopathies to target increased interferon signalling. Predominantly retrospective reports have demonstrated effectiveness of JAKi in refractory JDM. However, JAKi remains an off-label treatment for JDM and there may be variation in use worldwide. An international survey was conducted to investigate approaches to JAKi for JDM.
Methods
The Childhood Arthritis and Rheumatology Research Alliance (CARRA) JDM Therapeutics workgroup and core members of the Paediatric Rheumatology European Society (PReS) JDM working party devised an electronic survey to assess the use of JAKi in JDM. CARRA and PReS members were invited by e-mail to complete the survey.
Results
There were 229 respondents (18%), with 50% from the USA and 29% from Europe. One hundred and fifty had used JAKi for over 450 patients with JDM; among them, 77% noted clinical improvement in most or all patients and 17% reported side effects. The highest ranked perceived barriers to JAKi use were lack of clinical data and inability to obtain insurance approval. The highest ranked clinical indications for starting JAKi were refractory skin disease, refractory muscle disease, inability to wean steroids and intolerance to other steroid-sparing agents.
Conclusion
Paediatric rheumatologists use JAKi off-label for refractory JDM. Most providers noted clinical improvement in their patients. Barriers to JAKi use include lack of clinical data and insurance coverage. Clinical trials are needed to provide better data on the efficacy and safety of JAKi.
Keywords: Janus kinase inhibitors, juvenile dermatomyositis, pediatric rheumatology
Rheumatology key messages.
Janus kinase inhibition (JAKi) is widely used by paediatric rheumatologists as an off-label treatment for refractory JDM, with apparent therapeutic effect and an acceptable safety profile.
Lack of high-quality clinical data and insurance coverage remain barriers to JAKi use in JDM.
Clinical trials are needed to provide better data on the efficacy and safety of JAKi in JDM.
Introduction
JDM is an autoimmune connective tissue disease characterized by vasculopathy and inflammation predominantly affecting skeletal muscle and skin, though manifestations commonly include other organ systems. Patients with JDM may experience significant impairments in daily functioning, severe morbidity related to complications such as calcinosis, and even mortality [1]. High-quality data guiding treatment decisions, including for refractory disease, are limited. Consequently, treatment recommendations are largely based on expert opinion [2–5].
Janus kinase inhibition (JAKi) has been proposed as a mechanism-based treatment for JDM, targeting increased interferon expression via inhibition of JAK-STAT signalling [6–9]. Predominantly retrospective reports have demonstrated effectiveness of JAKi in refractory JDM, including for skin, muscle and lung disease, as well as even for some cases of calcinosis [10]. However, JAKi remains an off-label treatment for JDM and there may be significant variation in use worldwide. An international survey of paediatric rheumatology providers was therefore conducted to investigate approaches to JAKi in JDM.
Methods
The Childhood Arthritis and Rheumatology Research Alliance (CARRA) JDM Therapeutics workgroup and core members of the Paediatric Rheumatology European Society (PReS) JDM working party developed a survey using REDCap to assess the use of JAKi in JDM (Supplementary Data S1, available at Rheumatology online). Survey questions focused on provider experience, prescribing patterns, clinical indications, barriers to use, side effects and effectiveness. CARRA and PReS members were invited by e-mail to complete the survey, which was distributed to 453 CARRA members between 26 March and 7 May 2024, and to 817 PReS members between 4 April to 16 May 2024. Participants indicated that they wished to participate; formal consent was not required given the anonymous nature of this survey.
Figures were prepared using R Statistical Software (version 4.3.0; R Core Team 2023), including the following packages: ggplot2, ggpubr and gtsummary [11–14]. This project was approved by the Indiana University Institutional Review Board (#21799).
Results
There were 229 respondents from 36 countries across five continents (Fig. 1A). The response rate overall was 18%, 29% (130 of 453) from the CARRA distribution and 12% (99 of 817) from the PReS distribution (Table 1). Most respondents resided in the USA (50%) or Europe (29%) and were paediatric rheumatologists (84%). Most respondents saw 1–5 (44%) or 6–15 (37%) patients with JDM per year, and 10% reported seeing >25 per year. Excluding trainees, 74% of respondents had at least 9 years of experience with JDM.
Figure 1.
Location of respondents and respondent preferences for systemic JAKi indications and medications. (A) Map indicating location of respondents and number of responses per country. (B) Respondents ranked the most important clinical indications for initiating systemic JAKi. (C) Systemic JAKi that respondents would consider using. (D) Concomitant medications that respondents would consider using with systemic JAKi. For (B), respondents selected and ranked their top five indications. For (C) and (D), respondents could select all applicable. GI: gastrointestinal; JAKi: Janus kinase inhibitor
Table 1.
Survey respondent characteristics and experience with JAKi
| N = 229a | |
|---|---|
| Respondent characteristics | |
| Professional organization | |
| CARRA | 112 (48.9%) |
| PReS | 96 (41.9%) |
| Both | 21 (9.2%) |
| Location of practice | |
| USA | 114 (49.8%) |
| Europe | 67 (29.3%) |
| Otherb | 48 (21.0%) |
| Professional title | |
| Paediatric rheumatology attending | 193 (84.3%) |
| Paediatric rheumatology trainee | 27 (11.8%) |
| Medicine/paediatrics rheumatology attending | 4 (1.7%) |
| Medicine/paediatrics trainee | 3 (1.3%) |
| Otherc | 2 (0.9%) |
| Patients with JDM seen per year | |
| 1–5 | 101 (44.1%) |
| 6–15 | 85 (37.1%) |
| 16–25 | 19 (8.3%) |
| 26+ | 24 (10.5%) |
| Years of experience with JDM (excludes trainees) | |
| 4–8 years | 51 (25.6%) |
| 9–15 years | 66 (33.2%) |
| 16+ years | 82 (41.2%) |
| Experience with JAKi | |
| JAKi use | 150 (65.5%) |
| JAKi type | |
| Systemic | 124/150 (82.7%) |
| Topical | 1/150 (0.7%) |
| Systemic and topical | 25/150 (16.7%) |
| Patients treated with systemic JAKi | 3 (3, 1–20) |
| Patients treated with topical JAKi | 6 (8, 1–35) |
| Patients with improvement on JAKi | |
| None | 12/150 (8.0%) |
| Few | 23/150 (15.3%) |
| Most | 58/150 (38.7%) |
| All | 57/150 (38.0%) |
| Side effect occurred | 25/150 (16.7%) |
| Severe infection requiring hospitalization | 0/150 (0.0%) |
| Opportunistic infection | 6/150 (4.0%) |
| Herpes virus reactivation | 8/150 (5.3%) |
| Clinically significant BK viraemia | 1/150 (0.7%) |
| Weight gain | 3/150 (2.0%) |
| Increased liver function tests | 7/150 (4.7%) |
| Altered lipid profile | 5/150 (3.3%) |
| Venous thromboembolism | 2/150 (1.3%) |
| Cancer | 0/150 (0.0%) |
| Reason for discontinuation | |
| Remission | 15/150 (10.0%) |
| Inefficacy | 33/150 (22.0%) |
| Side effects | 14/150 (9.3%) |
| Not applicable | 98/150 (65%) |
n (%), mean (s.d., min–max).
See map in Fig. 1.
Paediatric dermatologist, paediatrician with special interest in paediatric rheumatology. CARRA: Childhood Arthritis and Rheumatology Research Alliance; JAKi: Janus kinase inhibitor; PReS: Paediatric Rheumatology European Society.
JAKi use was reported by 150 (66%) respondents, representing 457 patients treated with systemic JAKi and 146 with topical JAKi; it is not clear how many distinct patients this may represent as 25 respondents reported using both systemic and topical JAKi. The most common reasons provided for not having used JAKi were satisfactory response to other treatments, difficulty obtaining or unavailability of JAKi, and lack of evidence. Respondents who saw more patients per year had a higher frequency of JAKi use (1–5, 48% vs 6–15, 74% vs 16–25, 84% vs 26+, 96%). Among respondents who have used JAKi, 83% had used systemic JAKi only (Table 1). The majority (77%) reported improvement in most or all patients they treated with JAKi, in particular by respondents who had seen at least 16 compared with 1–5 patients per year (87% vs 67%). Side effects were reported by 17%, including opportunistic infection (4%), herpesvirus reactivation (5%), increased liver function tests (5%) and venous thromboembolism (VTE) (1%). No cancers were reported. Fewer respondents from the USA compared with Europe reported that a side effect occurred (14% vs 29%), and side effects were reported more frequently among respondents who saw more patients per year (1–5, 8% vs 6–15, 14% vs 16–25, 25% vs 26+, 35%). Systemic and topical JAKi use was reported more frequently by respondents seeing 26+ compared with 1–5 patients per year (43% vs 13%). The mean number of patients treated with systemic JAKi (7 vs 2) and topical JAKi (10 vs 2) was greater among respondents seeing 26+ compared with 1–5 patients per year. Of respondents who had discontinued JAKi, 22% did so due to inefficacy, 10% due to remission and 9% due to side effects.
Respondents identified availability of evidence and route of administration as important considerations in the decision to start systemic JAKi (Supplementary Table S1, Supplementary Fig. S1, available at Rheumatology online). More respondents from the USA compared with Europe selected patient preference (70% vs 43%) and route of administration (78% vs 54%). Provider preference was selected as a consideration by more respondents who see 26+ compared with 1–5 patients per year (71% vs 44%), and insurance was identified as a consideration by more respondents who see 1–5 compared with 26+ patients per year (50% vs 25%). Key barriers to starting systemic JAKi included lack of clinical data and inability to obtain insurance approval. Insurance approval was identified as a barrier by more respondents in the USA than Europe (75% vs 33%). History of and/or risk factors for VTE and clinically significant BK viraemia were the most commonly selected patient risk factors that would decrease the likelihood of using systemic JAKi.
In terms of clinical indications for JAKi use, refractory skin disease, refractory muscle disease, inability to wean steroids and intolerance of other steroid sparing agents were the most frequently selected (Supplementary Table S2, available at Rheumatology online, Fig. 1B). More respondents from the USA compared with Europe selected inability to wean steroids (78% vs 54%) and intolerance of other steroid-sparing agents (81% vs 63%) as clinical indications. Respondents with 4–8 years of experience compared with 16+ years also more frequently considered inability to wean steroids (78% vs 61%) and intolerance of other steroid sparing agents (82% vs 61%) to be indications for systemic JAKi. Forty-one percent of respondents indicated that myositis-specific autoantibody results would inform their decision to start systemic JAKi, in particular positivity for anti-MDA5 (Supplementary Table S2, available at Rheumatology online).
Tofacitinib followed by baricitinib and ruxolitinib were the systemic JAKi most frequently considered for JDM (Fig. 1C). Key reasons for these selections included availability and prior experience with these medications (Supplementary Table S3, available at Rheumatology online). Ninety-three percent of those who selected tofacitinib would use JIA dosing; 50% and 53% of those who selected baricitinib would use JIA or interferonopathy dosing, respectively; and 49% of those who selected ruxolitinib would use graft-vs-host disease (GVHD) dosing.
Approximately 90% of respondents would consider using a conventional DMARD or IVIG in combination with systemic JAKi (Fig. 1D). Forty-five percent would consider using a biologic in combination. Of the respondents who specified why they would not use a particular medication type with JAKi, lack of evidence regarding concurrent conventional and biologic DMARD use, hesitation regarding VTE risk with concurrent IVIG and concern for infection, were reported. Among those who would use a conventional DMARD, MTX, HCQ and mycophenolate were the DMARDs most considered for use in combination with systemic JAKi (Supplementary Fig. S2B, available at Rheumatology online). More respondents from the USA compared with Europe (91% vs 58%) would consider using HCQ in combination. Among those who would use a biologic, anti-B cell agents followed by abatacept were the biologics most considered.
Discussion
This survey investigated the approaches and experiences of paediatric rheumatology providers worldwide regarding JAKi in JDM. Most respondents were paediatric rheumatologists with extensive experience treating patients with JDM, with two-thirds reporting experience with JAKi, primarily systemic JAKi. Respondents who reported seeing >25 patients per year and having over 15 years of experience reported treating more patients with JAKi, suggesting that specialists and referral centres, which may serve a higher proportion of patients with more severe disease, use JAKi more frequently. Consistent with published cases and reviews, the majority reported improvement in most or all patients treated with JAKi [10].
The safety profile emerging from this survey accounting for over 450 patients treated with JAKi appears reassuring, with only 17% of respondents with prior JAKi use reporting side effects and fewer than 10% reporting that JAKi was discontinued due to side effects. The most common side effects were infection, though none required hospitalization, and laboratory changes such as elevated liver enzymes and altered lipid profiles. This is generally consistent with what has been reported in a recent review of JAKi for JDM, but it should be noted that the published data are a combination of retrospective and prospective studies and that side effects or adverse events were not consistently collected [10]. In 2021, the United States Food and Drug Administration mandated warnings regarding the risk of several events including cancer and blood clots based on signals in other immune-mediated inflammatory diseases. Respondents to this survey who have used JAKi for JDM did not report any instances of cancer, but two did report VTE. It is not known whether these patients may have had additional risk factors for thrombosis, such as treatment with IVIG. Thrombosis does not appear previously to have been reported with JAKi use for JDM. In a meta-analysis of randomized controlled trials including predominantly adults, the risk of thromboembolism was not substantiated [15]. Nonetheless, the present survey findings suggest that careful evaluation of potential thrombotic risk factors should be considered in patients with JDM starting JAKi.
It is notable and encouraging that the most common reason that respondents here had not used JAKi was satisfactory response to current existing treatments. Given that JAKi is currently used primarily for refractory JDM, it is not surprising that respondents ranked signs of refractory disease such as ongoing cutaneous involvement, muscle involvement or steroid dependence as the main reasons for starting JAKi [10]. Relatedly, ∼90% of respondents indicated that they would use a systemic JAKi in combination with DMARDs or with IVIG. There was a comparative relative reluctance, however, to combine systemic JAKi with biologics. Whether this is due to lack of evidence, concern for increased risk of infection or other factors is not clear. It does reinforce that safe and effective combination treatment for JDM beyond first-line management remains unknown.
Among available systemic medications for JAKi, respondents most preferred tofacitinib, baricitinib and ruxolitinib. This may be due to their relative availability, country-related restrictions and approval in other autoimmune and inflammatory indications like JIA, IBD, atopic dermatitis and GVHD. Over 90% of respondents who selected tofacitinib would use JIA dosing. However, there was variability for baricitinib, with ∼50% each selecting JIA or interferonopathy dosing, and ruxolitinib, with ∼50% selecting GVHD dosing. It remains unclear whether any of these JAKi dosing regimens is optimal for JDM. Indeed, insufficient evidence was a key theme identified through the survey and was both the top ranked consideration about and barrier to starting systemic JAKi.
This study has several limitations. Though there were over 200 responses, this constituted only 18% of those invited to participate. Despite including respondents from across the globe, most were based in North America and Europe, and the results therefore may not be widely generalizable. Furthermore, there are likely important regional differences in practice patterns and healthcare systems; the number of respondents per country, aside from the USA, was too small to address this. Data related to outcomes were qualitative rather than based on validated outcome measures. As with other surveys, recall bias cannot be excluded and may perhaps be a factor in the relatively low rate of adverse events reported. Nonetheless, strengths of this survey include the unprecedentedly large number of respondents for this topic and inclusion of paediatric rheumatology providers spanning a range of experience, practice size and location.
These real-world data from paediatric rheumatology providers demonstrate that JAKi is widely used for JDM with apparent therapeutic effect and an acceptable safety profile, supplementing the growing literature supporting this treatment strategy. Important barriers remain, including lack of access and high-quality safety and efficacy data. While a phase II single-arm trial (MYOCIT, NCT05524311) is underway and an open-label randomized controlled trial is under development (BARJDM), both evaluating baricitinib in combination with glucocorticoids in patients with new-onset JDM, the present study emphasizes the imperative for large randomized controlled clinical trials to more rigorously evaluate and optimize the use of JAKi for JDM [16].
Supplementary Material
Acknowledgements
This work was accepted as a poster, ‘Approach to Janus Kinase Inhibition for Juvenile Dermatomyositis among Childhood Arthritis and Rheumatology Research Alliance (CARRA) and Paediatric Rheumatology European Society (PReS) Providers’, at the 2024 ACR Convergence. The authors wish to acknowledge CARRA and the ongoing Arthritis Foundation financial support of CARRA. The authors acknowledge PReS for their support. The authors also thank Dr Massimo Gadina for critical review of this manuscript.
Contributor Information
Matthew A Sherman, Division of Allergy, Immunology, and Transplantation, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD, USA.
Rebecca Nicolai, Division of Rheumatology, Bambino Gesù Children’s Hospital, IRCCS, Rome, Italy.
Emily K Datyner, Department of Pediatric Rheumatology, Vanderbilt University Medical Center, Nashville, TN, USA.
Silvia Rosina, UOC Reumatologia E Malattie Autoinfiammatorie, IRCCS Istituto Giannina Gaslini, Genoa, Italy.
Angela Hamilton, Department of Pediatrics, Indiana University School of Medicine, Indianapolis, IN, USA.
Kaveh Ardalan, Department of Pediatrics, Duke University School of Medicine, Durham, NC, USA.
Brigitte Bader-Meunier, Department of Pediatric Immunology and Rheumatology, Necker Hospital, Assistance Publique-Hôpitaux de Paris, Paris, France.
Amanda G Brown, Department of Rheumatology, Children’s Hospital of Arkansas, University of Arkansas for Medical Sciences, Little Rock, AR, USA.
Marc H A Jansen, Department of Paediatric Immunology & Rheumatology, Wilhelmina Children’s Hospital, University Medical Center Utrecht, Utrecht, The Netherlands; RITA, European Reference Networks, Brussels, Belgium.
Susan Kim, Department of Pediatrics, University of California, San Francisco, CA, USA.
Bianca Lang, Department of Pediatrics, Dalhousie University and IWK Health, Halifax, NS, Canada.
Raquel Campanilho-Marques, Department of Rheumatology, Unidade Local de Saúde de Santa Maria, Lisbon, Portugal; Instituto de Medicina Molecular João Lobo Antunes, Lisbon Academic Medical Centre, Lisbon, Portugal.
Liza J McCann, Department of Paediatric Rheumatology, Alder Hey Children’s NHS Foundation Trust, Liverpool, UK.
Helga Sanner, Department of Rheumatology, Oslo University Hospital, Oslo, Norway; Department of Health Sciences, Oslo New University College, Oslo, Norway.
Saskia R Veldkamp, Center for Translational Immunology, University Medical Center Utrecht, Utrecht, The Netherlands.
Meredyth G Ll Wilkinson, Infection, Immunity and Inflammation Research and Teaching Department, UCL Great Ormond Street Institute of Child Health, London, UK; Centre for Adolescent Rheumatology Versus Arthritis at UCL UCLH and GOSH, London, UK; Rare Diseases Theme NIHR Biomedical Research Centre, Great Ormond Street Hospital, London, UK.
Belina Y Yi, Department of Pediatrics, Johns Hopkins University School of Medicine, Baltimore, MD, USA.
Hanna Kim, Juvenile Myositis Pathogenesis and Therapeutics Unit, National Institute of Arthritis and Musculoskeletal and Skin Diseases, National Institutes of Health, Bethesda, MD, USA.
Stacey E Tarvin, Department of Pediatrics, Indiana University School of Medicine, Indianapolis, IN, USA.
Charalampia Papadopoulou, Rare Diseases Theme NIHR Biomedical Research Centre, Great Ormond Street Hospital, London, UK; Department Paediatric Rheumatology, Great Ormond Street Hospital for Children, NHS Foundation Trust, London, UK.
CARRA JDM Therapeutics Workgroup and the PReS JDM Working Party:
Matthew A Sherman, Rebecca Nicolai, Emily K Datyner, Silvia Rosina, Angela Hamilton, Kaveh Ardalan, Brigitte Bader-Meunier, Amanda G Brown, Marc H A Jansen, Susan Kim, Bianca Lang, Raquel Campanilho-Marques, Liza J McCann, Helga Sanner, Saskia R Veldkamp, Meredyth G Ll Wilkinson, Belina Y Yi, Hanna Kim, Stacey E Tarvin, and Charalampia Papadopoulou
Supplementary material
Supplementary material is available at Rheumatology online.
Data availability
The data underlying this article will be shared on reasonable request to the corresponding author.
Funding
This work was supported by the Intramural Research Program of the National Institute of Arthritis and Musculoskeletal and Skin Diseases of the National Institutes of Health(AR041215 to H.K.).
Disclosure statement: K.A. reports the following conflicts: Cabaletta Bio (advisory board, consultant); Childhood Arthritis and Rheumatology Research Alliance (consultant, Juvenile Dermatomyositis Committee Vice Chair); ReveraGen BioPharma/Cure JM Foundation (received funding from Cure JM to consult on clinical trial design with ReveraGen BioPharma, but did not receive any funding directly from ReveraGen BioPharma); Rheumatology Research Foundation Pediatric Visiting Professorship (honorarium, travel reimbursement); University of Chicago (honorarium); New York University-Brooklyn (honorarium). H.K. reports the following conflicts: CRADA with Eli Lilly and Company for study support and provision of drug; CRADA with Bristol Meyers Squibb for provision of drug. The other authors have no conflicts of interest to declare.
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Associated Data
This section collects any data citations, data availability statements, or supplementary materials included in this article.
Supplementary Materials
Data Availability Statement
The data underlying this article will be shared on reasonable request to the corresponding author.