Implementation of regulatory guidance for JAK inhibitors use in patients with immune-mediated inflammatory diseases: An international appropriateness study

Solitano, Virginia; Facheris, Paola; Petersen, Magnus; D'Amico, Ferdinando; Ortoncelli, Michela; Aletaha, Daniel; Olivera, Pablo A.; Bieber, Thomas; Ramiro, Sofia; Ghosh, Subrata; D'Agostino, Maria Antonietta; Siegmund, Britta; Chary-Valckenaere, Isabelle; Hart, Ailsa; Dagna, Lorenzo; Magro, Fernando; Felten, Renaud; Kotze, Paulo Gustavo; Jairath, Vipul; Costanzo, Antonio; Kristensen, Lars Erik; Biroulet, Laurent Peyrin; Danese, Silvio

doi:10.1016/j.autrev.2023.103504

Cited by 5 publications

(1 citation statement)

References 35 publications

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“…Nevertheless, new guidelines evaluating the safety of JAKi and certain BD are needed. Recently, the Pharmacovigilance Risk Assessment Committee proposed measures to address severe side effects linked to JAKi in immune-mediated inflammatory diseases [ 131 ]. These and other measures may provide a more comprehensive understanding of JAKi and other BD.…”

Section: Discussionmentioning

confidence: 99%

Biologics Versus JAK Inhibitors. Part I: Cancer Risk. A Narrative Review

Mansilla-Polo,

Morgado-Carrasco

2024

Dermatol Ther (Heidelb)

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Introduction Biological drugs (BD) and Janus kinase inhibitors (JAKi) have revolutionized the treatment of diverse dermatoses. However, there are concerns regarding their safety, especially the risk of cancer and opportunistic infections. Here, we discuss the risk of cancer associated with the BD and JAKi used in dermatology. Methods A narrative review was carried out. All relevant articles evaluating the risk of cancer associated with BD or JAKi and published between January 2010 and February 2024 were selected. Results Multiple large studies have evaluated the association between BD, JAKi and cancer risk. However, there is a lack of prospective, comparative studies. Overall, patients undergoing BD and JAKi present a cutaneous cancer incidence similar to that in the general population. The drugs more strongly associated with non-skin cancer risk were anti-tumor necrosis factor (anti-TNFs) agents and JAKi (especially tofacitinib and oral ruxolitinib). This risk appears to increase with age, the presence of other factors (such as chronic immunosuppression from previous drugs or other comorbidities), and specific diseases such as rheumatoid arthritis (RA) and myelodysplastic syndrome. Conversely, BD such as interleukin (IL)-17 and IL-23 inhibitors may even reduce the risk of some visceral and hematological malignancies. In patients with dermatological conditions such as psoriasis and atopic dermatitis, the risk of malignancies may be lower than in other subgroups, and probably comparable to the general population. Conclusions The incidence of cancer in patients undergoing BD or JAKi is generally low. This incidence can be higher in elderly patients with RA or myelodysplastic syndrome, and in those undergoing prolonged therapy with tofacitinib or ruxolitinib (oral), or anti-TNF agents.

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Section: Discussionmentioning

confidence: 99%

Biologics Versus JAK Inhibitors. Part I: Cancer Risk. A Narrative Review

Mansilla-Polo,

Morgado-Carrasco

2024

Dermatol Ther (Heidelb)

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Therapeutic inhibition of the JAK-STAT pathway in the treatment of inflammatory bowel disease

Chen,

Jiang,

et al. 2024

Cytokine & Growth Factor Reviews

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Pharmacologic Anticoagulation Is Associated With a Lower Risk of Recurrent Venous Thromboembolic Events During Janus Kinase Inhibitor Use for Patients With a Prior Thrombosis

Lowell,

Sharma,

Swaminath

et al. 2024

Inflammatory Bowel Diseases

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Background Janus kinase (JAK) inhibitors tofacitinib and upadacitinib are effective therapies for inflammatory bowel disease and rheumatologic disorders but currently possess a warning for increased venous thromboembolism (VTE) risk. Some patients with a history of VTE may benefit from a JAK inhibitor, but the risk of recurrent VTE with JAK inhibitor use is unclear. Our goal was to observe rates of new VTE events after starting JAK inhibitor therapy in patients with a prior VTE, and observe whether concurrent anticoagulation (AC) reduces this risk. Methods We conducted a review of adults prescribed tofacitinib or upadacitinib between January 1, 2000, and June 30, 2023, with a prior history of VTE. Patient charts were reviewed for demographic data, disease type, and VTE date(s), and to verify duration of JAK inhibitor use along with any concurrent AC. VTEs following JAK inhibitor initiation were identified by International Classification of Diseases–Tenth Revision code and verified by physician documentation and imaging. Results We identified 79 patients with a documented VTE history before initiating JAK inhibitors, 47 of whom began a JAK inhibitor with concurrent AC. Of these, 15 patients discontinued AC while receiving JAK inhibitors. In total, 5 new VTE events were observed during 55.42 patient-years of JAK inhibitor treatment without concurrent AC (9.0 events per 100 patient-years), while no new VTE events occurred during 65.2 patient-years of JAK inhibitor treatment with concurrent AC, demonstrating a lower risk of recurrent VTE (P = .020). Conclusions These results suggest that for patients with a prior VTE history there is a high risk for recurrent VTE while receiving JAK inhibitors. Concurrent use of AC with JAK inhibitors appears to be protective against recurrent VTEs in this population.

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Implementation of regulatory guidance for JAK inhibitors use in patients with immune-mediated inflammatory diseases: An international appropriateness study

Cited by 5 publications

References 35 publications

Biologics Versus JAK Inhibitors. Part I: Cancer Risk. A Narrative Review

Biologics Versus JAK Inhibitors. Part I: Cancer Risk. A Narrative Review

Therapeutic inhibition of the JAK-STAT pathway in the treatment of inflammatory bowel disease

Pharmacologic Anticoagulation Is Associated With a Lower Risk of Recurrent Venous Thromboembolic Events During Janus Kinase Inhibitor Use for Patients With a Prior Thrombosis

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