Assessing the safety and efficacy of ruxolitinib in a multicenter, open-label study in Japanese patients with myelofibrosis

Komatsu, Norio; Kirito, Keita; Shimoda, Kazuya; Ishikawa, Takayuki; Ohishi, Kohshi; Ohyashiki, Kazuma; Takahashi, Naoto; Okada, Hikaru; Amagasaki, Taro; Yonezu, Toshio; Akashi, Koichi

doi:10.1007/s12185-016-2130-z

Cited by 12 publications

(15 citation statements)

References 31 publications

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“…Only one case of herpes zoster reactivation has been described, whereas no cases of tuberculosis were reported. In a study of ruxolitinib in Japanese patients with MF, herpes zoster infections were reported in 2 patients (3.9%), pneumonia in 4 (8%), urinary tract infection in 1 (2%) and sepsis in 1 (2%) . Finally, in a very small study of 10 patients in Taiwan, one hepatitis B reactivation was reported …”

Section: Resultsmentioning

confidence: 97%

“…Eight papers were excluded for the following reasons: pooled analysis ( n = 1), follow‐up of phase I or II trial ( n = 1), sub‐analyses ( n = 2), data on extension phase study with a shorter follow‐up ( n = 2), redundant publications ( n = 2). Five phase III RCTs (3 phase IIIa with their most recently published extended phase (750 patients) and 2 phase IIIb RCTs (283 patients)), 6 phase IV studies (1524 patients) and 28 case report publications (31 patients, of whom 4 were included also in phase III studies and 1 in phase IV study) were included in this systematic review.…”

Section: Resultsmentioning

confidence: 99%

“…Six phase IV post‐marketing studies were analysed: their main characteristics are reported in Table . All studies included patients with MF, who received oral ruxolitinib at doses ranging between 5 mg and 50 mg daily.…”

Section: Resultsmentioning

confidence: 99%

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Ruxolitinib‐associated infections: A systematic review and meta‐analysis

et al. 2017

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Ruxolitinib exerts immunosuppressive activity that may increase the risk of infectious complications. We performed a systematic review of the literature with the aim of estimating the risk of infections in patients treated with ruxolitinib. Studies were identified by electronic search of MEDLINE and EMBASE database. Differences in the incidence of infectious events between ruxolitinib and comparison groups were expressed as odds ratios (ORs) and 95% confidence intervals (95% CI). Five phase III randomized clinical trials (RCTs) (3 phase IIIa with their extended phase and 2 phase IIIb), 6 phase IV studies and 28 case reports were included in this systematic review. Ruxolitinib was associated with a statistically significant increased risk of herpes zoster infection compared to control group in 3 RCTs including patients with polycythemia vera (OR 7.39 [1.33, 41.07]) and in a pooled analysis of the extended phase IIIa RCTs (OR 5.20 [95%CI 1.27, 21.18]). In the larger phase IV post-marketing study, the incidence of the most frequent infections was 8% for herpes zoster, 6.1% for bronchitis and 6% for urinary tract infections. In the published case reports, the most frequent infections were tuberculosis (N = 10), hepatitis B reactivation (N = 5) and pneumocystis jeroveci infection (N = 2). Evidence is not solid enough to accurately estimate the risk of infection in ruxolitinib-treated patients. However, published data clearly suggest that the infection risk may be clinically relevant. Well-designed studies are warranted to evaluate the risk of ruxolitinib-associated infection, in order to identify the most appropriate antimicrobial prophylactic strategy.

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Section: Resultsmentioning

confidence: 97%

Section: Resultsmentioning

confidence: 99%

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Ruxolitinib‐associated infections: A systematic review and meta‐analysis

et al. 2017

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“…14 The change in infectious rate is not always obvious. 15,16 We note that the incidence of herpes zoster infection is significantly increased in the rux group, while other infections are not. 2 Revealing the same outcome, a systematic review suggested a clinical relevance to the risk.…”

Section: Dovepressmentioning

confidence: 77%

<p>Tuberculosis in Patients with Primary Myelofibrosis During Ruxolitinib Therapy: Case Series and Literature Review</p>

Peng

et al. 2020

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Background: The selective Janus-activated kinase inhibitor ruxolitinib (rux) is now widely used to treat myelofibrosis and polycythemia vera due to its remarkable effect of reducing splenomegaly and improving constitutional symptoms. With opportunistic infections secondary to rux constantly reported; however, an increasing number of studies have begun to investigate the mechanism and underlying immunosuppressive effect of rux. Case Presentation: We report two cases of tuberculosis (TB) in primary myelofibrosis patients during rux therapy. The first patient received rux soon after diagnosis, and tracheobronchial TB (TBTB) and bronchoesophageal fistula were found after 4 months. After discontinuation of rux, antituberculosis therapy (ATT) was introduced. The second patient initiated rux due to progressive splenomegaly after 7.5 years of interferon therapy and was diagnosed with disseminated TB after 2 months. He received ATT as well. His rux was maintained due to the high burden of systematic symptoms and splenomegaly. Both myelofibrosis and TB were well controlled in these patients. Conclusion: This is the first case report that describes rux-related TBTB accompanied by a bronchoesophageal fistula. Through a review of the literature, we provide supporting evidence to the finding that intrinsic disorders of myeloproliferative neoplasms and rux-induced immunologic deregulation together lead to TB. We highlight the importance of screening for latent TB infection and timely chemoprophylaxis before rux therapy. Once TB is diagnosed during treatment, rux is recommended to be stopped and active ATT should begin quickly.

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“…Based on these findings, the patient was diagnosed with post-PV myelofibrosis. She was enrolled in an AJP-01 study ( 8 ), and treatment with ruxolitinib (10 mg, b.i.d.) was initiated according to the protocol.…”

Section: Case Reportmentioning

confidence: 99%

Tumor Lysis Syndrome after the Administration of Ruxolitinib in a Patient with Post-polycythemia Vera Myelofibrosis

et al. 2017

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The development of tumor lysis syndrome (TLS) in association with treatment for myeloproliferative neoplasms (MPNs) is relatively rare. We herein present the case of a post-polycythemia vera (PV) myelofibrosis patient with massive splenomegaly who developed laboratory TLS after treatment with ruxolitinib, a potent JAK1/JAK2 inhibitor. She also exhibited a rapid reduction of spleen volume. Our present case suggests the potential risk of TLS development after ruxolitinib treatment, particularly in patients with massive splenomegaly.

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Assessing the safety and efficacy of ruxolitinib in a multicenter, open-label study in Japanese patients with myelofibrosis

Cited by 12 publications

References 31 publications

Ruxolitinib‐associated infections: A systematic review and meta‐analysis

Ruxolitinib‐associated infections: A systematic review and meta‐analysis

<p>Tuberculosis in Patients with Primary Myelofibrosis During Ruxolitinib Therapy: Case Series and Literature Review</p>

Tumor Lysis Syndrome after the Administration of Ruxolitinib in a Patient with Post-polycythemia Vera Myelofibrosis

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