Safety and effectiveness of peficitinib (ASP015K) in patients with rheumatoid arthritis: interim data (22.7 months mean peficitinib treatment) from a long-term, open-label extension study in Japan, Korea, and Taiwan
Identifieur interne : 000168 ( 2020/Analysis ); précédent : 000167; suivant : 000169Safety and effectiveness of peficitinib (ASP015K) in patients with rheumatoid arthritis: interim data (22.7 months mean peficitinib treatment) from a long-term, open-label extension study in Japan, Korea, and Taiwan
Auteurs : Tsutomu Takeuchi [Japon] ; Yoshiya Tanaka [Japon] ; Sakae Tanaka [Japon] ; Atsushi Kawakami [Japon] ; Yeong-Wook Song [Corée du Sud] ; Yi-Hsing Chen [Taïwan] ; Mitsuhiro Rokuda [Japon] ; Hiroyuki Izutsu [Japon] ; Satoshi Ushijima [Japon] ; Yuichiro Kaneko [Japon] ; Yoshihiro Nakashima [Japon] ; Teruaki Shiomi [Japon] ; Emi Yamada [Japon]Source :
- Arthritis Research & Therapy [ 1478-6354 ] ; 2020.
Abstract
Peficitinib (ASP015K), a novel oral Janus kinase inhibitor, has demonstrated efficacy and safety for the treatment of rheumatoid arthritis (RA) in randomized, controlled trials of up to 52 weeks’ duration. However, safety and effectiveness after long-term treatment have not been assessed.
This was an interim analysis of an ongoing open-label, multicenter extension study in RA patients who completed phase 2b (RAJ1; 12 weeks) and phase 3 (RAJ3 and RAJ4; 52 weeks) peficitinib studies in Asia (mainly Japan). Eligible patients (
Results up to May 2018 are summarized. Mean peficitinib duration of exposure was 22.7 months and the maximum dose was 100 mg in most (66.5%) patients. ACR responses were maintained during the extension study, with ACR20/50/70 response rates of 71.6%, 52.1%, and 34.7% at week 0 and 78.9%, 61.4%, and 42.7% at end of treatment, respectively. ACR components and DAS28-CRP showed improvements from baselines of the preceding studies and continued to show improvements during the extension study. Treatment-emergent adverse events (TEAEs) were reported in 757/843 (89.8%) patients, the most common being nasopharyngitis (39.7%) and herpes zoster (11.7%). The majority of TEAEs were severity grade 1/2. Drug-related TEAEs leading to permanent study drug discontinuation occurred in 55/843 (6.5%) patients. Regarding AEs of special interest, the incidence per 100 patient-years of serious infections was 2.3 (95% CI 1.6 – 3.1), herpes zoster-related disease 6.8 (95% CI, 5.6 – 8.3), and malignancies 1.1 (95% CI, 0.7 – 1.8). One death from diffuse large B cell lymphoma during the study and one death from uterine sarcoma after the study were considered probably and possibly related to study drug, respectively.
The effectiveness of peficitinib was maintained or improved during long-term administration and treatment up to 6 years was well tolerated in Asian patients with RA.
ClinicalTrials.gov,
Url:
DOI: 10.1186/s13075-020-2125-2
PubMed: 32164762
PubMed Central: 7068874
Affiliations:
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institution-id-type="GRID">grid.26091.3c</institution-id><institution-id institution-id-type="ISNI">0000 0004 1936 9959</institution-id><institution>Keio University School of Medicine,</institution></institution-wrap>Tokyo, Japan</nlm:aff><country xml:lang="fr">Japon</country><wicri:regionArea>Tokyo</wicri:regionArea></affiliation></author><author><name sortKey="Tanaka, Yoshiya" sort="Tanaka, Yoshiya" uniqKey="Tanaka Y" first="Yoshiya" last="Tanaka">Yoshiya Tanaka</name><affiliation wicri:level="1"><nlm:aff id="Aff2"><institution-wrap><institution-id institution-id-type="GRID">grid.271052.3</institution-id><institution-id institution-id-type="ISNI">0000 0004 0374 5913</institution-id><institution>University of Occupational and Environmental Health, Japan,</institution></institution-wrap>Kitakyushu, Japan</nlm:aff><country xml:lang="fr">Japon</country><wicri:regionArea>Kitakyushu</wicri:regionArea></affiliation></author><author><name sortKey="Tanaka, Sakae" sort="Tanaka, Sakae" uniqKey="Tanaka S" first="Sakae" last="Tanaka">Sakae Tanaka</name><affiliation wicri:level="1"><nlm:aff id="Aff3"><institution-wrap><institution-id institution-id-type="GRID">grid.26999.3d</institution-id><institution-id institution-id-type="ISNI">0000 0001 2151 536X</institution-id><institution>University of Tokyo,</institution></institution-wrap>Tokyo, Japan</nlm:aff><country xml:lang="fr">Japon</country><wicri:regionArea>Tokyo</wicri:regionArea></affiliation></author><author><name sortKey="Kawakami, Atsushi" sort="Kawakami, Atsushi" uniqKey="Kawakami A" first="Atsushi" last="Kawakami">Atsushi Kawakami</name><affiliation wicri:level="1"><nlm:aff id="Aff4"><institution-wrap><institution-id institution-id-type="GRID">grid.174567.6</institution-id><institution-id institution-id-type="ISNI">0000 0000 8902 2273</institution-id><institution>Nagasaki University Graduate School of Biomedical Sciences,</institution></institution-wrap>Nagasaki, Japan</nlm:aff><country xml:lang="fr">Japon</country><wicri:regionArea>Nagasaki</wicri:regionArea></affiliation></author><author><name sortKey="Song, Yeong Wook" sort="Song, Yeong Wook" uniqKey="Song Y" first="Yeong-Wook" last="Song">Yeong-Wook Song</name><affiliation wicri:level="4"><nlm:aff id="Aff5">Seoul National University, Seoul National University Hospital, Seoul, South Korea</nlm:aff><country xml:lang="fr">Corée du Sud</country><wicri:regionArea>Seoul National University, Seoul National University Hospital, Seoul</wicri:regionArea><placeName><settlement type="city">Séoul</settlement><region type="capital">Région capitale de Séoul</region></placeName><orgName type="university">Université nationale de Séoul</orgName></affiliation></author><author><name sortKey="Chen, Yi Hsing" sort="Chen, Yi Hsing" uniqKey="Chen Y" first="Yi-Hsing" last="Chen">Yi-Hsing Chen</name><affiliation wicri:level="1"><nlm:aff id="Aff6"><institution-wrap><institution-id institution-id-type="GRID">grid.410764.0</institution-id><institution-id institution-id-type="ISNI">0000 0004 0573 0731</institution-id><institution>Taichung Veterans General Hospital,</institution></institution-wrap>Taichung, Taiwan</nlm:aff><country xml:lang="fr">Taïwan</country><wicri:regionArea>Taichung</wicri:regionArea></affiliation></author><author><name sortKey="Rokuda, Mitsuhiro" sort="Rokuda, Mitsuhiro" uniqKey="Rokuda M" first="Mitsuhiro" last="Rokuda">Mitsuhiro Rokuda</name><affiliation wicri:level="1"><nlm:aff id="Aff7"><institution-wrap><institution-id institution-id-type="GRID">grid.418042.b</institution-id><institution>Astellas Pharma, Inc.,</institution></institution-wrap>Tokyo, Japan</nlm:aff><country xml:lang="fr">Japon</country><wicri:regionArea>Tokyo</wicri:regionArea></affiliation></author><author><name sortKey="Izutsu, Hiroyuki" sort="Izutsu, Hiroyuki" uniqKey="Izutsu H" first="Hiroyuki" last="Izutsu">Hiroyuki Izutsu</name><affiliation wicri:level="1"><nlm:aff id="Aff7"><institution-wrap><institution-id institution-id-type="GRID">grid.418042.b</institution-id><institution>Astellas Pharma, Inc.,</institution></institution-wrap>Tokyo, Japan</nlm:aff><country xml:lang="fr">Japon</country><wicri:regionArea>Tokyo</wicri:regionArea></affiliation></author><author><name sortKey="Ushijima, Satoshi" sort="Ushijima, Satoshi" uniqKey="Ushijima S" first="Satoshi" last="Ushijima">Satoshi Ushijima</name><affiliation wicri:level="1"><nlm:aff id="Aff7"><institution-wrap><institution-id institution-id-type="GRID">grid.418042.b</institution-id><institution>Astellas Pharma, Inc.,</institution></institution-wrap>Tokyo, Japan</nlm:aff><country xml:lang="fr">Japon</country><wicri:regionArea>Tokyo</wicri:regionArea></affiliation></author><author><name sortKey="Kaneko, Yuichiro" sort="Kaneko, Yuichiro" uniqKey="Kaneko Y" first="Yuichiro" last="Kaneko">Yuichiro Kaneko</name><affiliation wicri:level="1"><nlm:aff id="Aff7"><institution-wrap><institution-id institution-id-type="GRID">grid.418042.b</institution-id><institution>Astellas Pharma, Inc.,</institution></institution-wrap>Tokyo, Japan</nlm:aff><country xml:lang="fr">Japon</country><wicri:regionArea>Tokyo</wicri:regionArea></affiliation></author><author><name sortKey="Nakashima, Yoshihiro" sort="Nakashima, Yoshihiro" uniqKey="Nakashima Y" first="Yoshihiro" last="Nakashima">Yoshihiro Nakashima</name><affiliation wicri:level="1"><nlm:aff id="Aff7"><institution-wrap><institution-id institution-id-type="GRID">grid.418042.b</institution-id><institution>Astellas Pharma, Inc.,</institution></institution-wrap>Tokyo, Japan</nlm:aff><country xml:lang="fr">Japon</country><wicri:regionArea>Tokyo</wicri:regionArea></affiliation></author><author><name sortKey="Shiomi, Teruaki" sort="Shiomi, Teruaki" uniqKey="Shiomi T" first="Teruaki" last="Shiomi">Teruaki Shiomi</name><affiliation wicri:level="1"><nlm:aff id="Aff7"><institution-wrap><institution-id institution-id-type="GRID">grid.418042.b</institution-id><institution>Astellas Pharma, Inc.,</institution></institution-wrap>Tokyo, Japan</nlm:aff><country xml:lang="fr">Japon</country><wicri:regionArea>Tokyo</wicri:regionArea></affiliation></author><author><name sortKey="Yamada, Emi" sort="Yamada, Emi" uniqKey="Yamada E" first="Emi" last="Yamada">Emi Yamada</name><affiliation wicri:level="1"><nlm:aff id="Aff7"><institution-wrap><institution-id institution-id-type="GRID">grid.418042.b</institution-id><institution>Astellas Pharma, Inc.,</institution></institution-wrap>Tokyo, Japan</nlm:aff><country xml:lang="fr">Japon</country><wicri:regionArea>Tokyo</wicri:regionArea></affiliation></author></analytic><series><title level="j">Arthritis Research & Therapy</title><idno type="ISSN">1478-6354</idno><idno type="eISSN">1478-6362</idno><imprint><date when="2020">2020</date></imprint></series></biblStruct></sourceDesc></fileDesc><profileDesc><textClass></textClass></profileDesc></teiHeader><front><div type="abstract" xml:lang="en"><sec><title>Background</title><p id="Par1">Peficitinib (ASP015K), a novel oral Janus kinase inhibitor, has demonstrated efficacy and safety for the treatment of rheumatoid arthritis (RA) in randomized, controlled trials of up to 52 weeks’ duration. However, safety and effectiveness after long-term treatment have not been assessed.</p></sec><sec><title>Methods</title><p id="Par2">This was an interim analysis of an ongoing open-label, multicenter extension study in RA patients who completed phase 2b (RAJ1; 12 weeks) and phase 3 (RAJ3 and RAJ4; 52 weeks) peficitinib studies in Asia (mainly Japan). Eligible patients (<italic>n</italic> = 843) received oral peficitinib once daily (100 mg, or 50 mg for patients transferring from RAJ1). The peficitinib dose could be increased (up to 150 mg) or reduced (to 50 mg) at the discretion of the investigator. Efficacy variables assessed included American College of Rheumatology (ACR) response rates, ACR components, and disease activity score in 28 joints based on C-reactive protein (DAS28-CRP).</p></sec><sec><title>Results</title><p id="Par3">Results up to May 2018 are summarized. Mean peficitinib duration of exposure was 22.7 months and the maximum dose was 100 mg in most (66.5%) patients. ACR responses were maintained during the extension study, with ACR20/50/70 response rates of 71.6%, 52.1%, and 34.7% at week 0 and 78.9%, 61.4%, and 42.7% at end of treatment, respectively. ACR components and DAS28-CRP showed improvements from baselines of the preceding studies and continued to show improvements during the extension study. Treatment-emergent adverse events (TEAEs) were reported in 757/843 (89.8%) patients, the most common being nasopharyngitis (39.7%) and herpes zoster (11.7%). The majority of TEAEs were severity grade 1/2. Drug-related TEAEs leading to permanent study drug discontinuation occurred in 55/843 (6.5%) patients. Regarding AEs of special interest, the incidence per 100 patient-years of serious infections was 2.3 (95% CI 1.6 – 3.1), herpes zoster-related disease 6.8 (95% CI, 5.6 – 8.3), and malignancies 1.1 (95% CI, 0.7 – 1.8). One death from diffuse large B cell lymphoma during the study and one death from uterine sarcoma after the study were considered probably and possibly related to study drug, respectively.</p></sec><sec><title>Conclusions</title><p id="Par4">The effectiveness of peficitinib was maintained or improved during long-term administration and treatment up to 6 years was well tolerated in Asian patients with RA.</p></sec><sec><title>Trial registration</title><p id="Par5">ClinicalTrials.gov, <ext-link ext-link-type="uri" xlink:href="https://clinicaltrials.gov/ct2/show/NCT01638013">NCT01638013</ext-link>, registered retrospectively 11 July 2012.</p></sec></div></front><back><div1 type="bibliography"><listBibl><biblStruct><analytic><author><name sortKey="Cheung, Tt" uniqKey="Cheung T">TT Cheung</name></author><author><name sortKey="Mcinnes, Ib" uniqKey="Mcinnes I">IB McInnes</name></author></analytic></biblStruct><biblStruct><analytic><author><name sortKey="Rubbert Roth, A" uniqKey="Rubbert Roth A">A Rubbert-Roth</name></author><author><name sortKey="Finckh, A" uniqKey="Finckh A">A Finckh</name></author></analytic></biblStruct><biblStruct><analytic><author><name sortKey="O Ell, Jr" uniqKey="O Ell J">JR O’Dell</name></author></analytic></biblStruct><biblStruct><analytic><author><name sortKey="Hamaguchi, H" uniqKey="Hamaguchi H">H Hamaguchi</name></author><author><name sortKey="Amano, Y" uniqKey="Amano Y">Y Amano</name></author><author><name sortKey="Moritomo, A" uniqKey="Moritomo A">A Moritomo</name></author><author><name sortKey="Shirakami, S" uniqKey="Shirakami S">S Shirakami</name></author><author><name sortKey="Nakajima, Y" uniqKey="Nakajima Y">Y Nakajima</name></author><author><name sortKey="Nakai, K" uniqKey="Nakai K">K 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Morita</name></author><author><name sortKey="Okuma, K" uniqKey="Okuma K">K Okuma</name></author></analytic></biblStruct><biblStruct><analytic><author><name sortKey="Takeuchi, T" uniqKey="Takeuchi T">T Takeuchi</name></author><author><name sortKey="Tanaka, Y" uniqKey="Tanaka Y">Y Tanaka</name></author><author><name sortKey="Iwasaki, M" uniqKey="Iwasaki M">M Iwasaki</name></author><author><name sortKey="Ishikura, H" uniqKey="Ishikura H">H Ishikura</name></author><author><name sortKey="Saeki, S" uniqKey="Saeki S">S Saeki</name></author><author><name sortKey="Kaneko, Y" uniqKey="Kaneko Y">Y Kaneko</name></author></analytic></biblStruct><biblStruct><analytic><author><name sortKey="Kivitz, Aj" uniqKey="Kivitz A">AJ Kivitz</name></author><author><name sortKey="Gutierrez Urena, Sr" uniqKey="Gutierrez Urena S">SR Gutierrez-Urena</name></author><author><name sortKey="Poiley, J" uniqKey="Poiley J">J Poiley</name></author><author><name sortKey="Genovese, Mc" uniqKey="Genovese M">MC Genovese</name></author><author><name sortKey="Kristy, R" uniqKey="Kristy R">R Kristy</name></author><author><name sortKey="Shay, K" uniqKey="Shay K">K Shay</name></author></analytic></biblStruct><biblStruct></biblStruct><biblStruct></biblStruct><biblStruct><analytic><author><name sortKey="Smolen, Js" uniqKey="Smolen J">JS Smolen</name></author><author><name sortKey="Genovese, Mc" uniqKey="Genovese M">MC Genovese</name></author><author><name sortKey="Takeuchi, T" uniqKey="Takeuchi T">T Takeuchi</name></author><author><name sortKey="Hyslop, Dl" uniqKey="Hyslop D">DL Hyslop</name></author><author><name sortKey="Macias, Wl" uniqKey="Macias W">WL Macias</name></author><author><name sortKey="Rooney, T" uniqKey="Rooney T">T Rooney</name></author></analytic></biblStruct><biblStruct></biblStruct><biblStruct><analytic><author><name sortKey="Winthrop, Kl" uniqKey="Winthrop K">KL Winthrop</name></author><author><name sortKey="Yamanaka, H" uniqKey="Yamanaka H">H Yamanaka</name></author><author><name sortKey="Valdez, H" uniqKey="Valdez H">H Valdez</name></author><author><name sortKey="Mortensen, E" uniqKey="Mortensen E">E Mortensen</name></author><author><name sortKey="Chew, R" uniqKey="Chew R">R Chew</name></author><author><name sortKey="Krishnaswami, S" uniqKey="Krishnaswami S">S Krishnaswami</name></author></analytic></biblStruct><biblStruct></biblStruct><biblStruct></biblStruct><biblStruct><analytic><author><name sortKey="Fleischmann, R" uniqKey="Fleischmann R">R Fleischmann</name></author><author><name sortKey="Wollenhaupt, J" uniqKey="Wollenhaupt J">J Wollenhaupt</name></author><author><name sortKey="Takiya, L" uniqKey="Takiya L">L Takiya</name></author><author><name sortKey="Maniccia, A" uniqKey="Maniccia A">A Maniccia</name></author><author><name sortKey="Kwok, K" uniqKey="Kwok K">K Kwok</name></author><author><name sortKey="Wang, L" uniqKey="Wang L">L Wang</name></author></analytic></biblStruct><biblStruct><analytic><author><name sortKey="Keystone, Ec" uniqKey="Keystone E">EC Keystone</name></author><author><name sortKey="Genovese, Mc" uniqKey="Genovese M">MC Genovese</name></author><author><name sortKey="Schlichting, De" uniqKey="Schlichting D">DE Schlichting</name></author><author><name sortKey="De La Torre, I" uniqKey="De La Torre I">I De La Torre</name></author><author><name sortKey="Beattie, Sd" uniqKey="Beattie S">SD Beattie</name></author><author><name sortKey="Rooney, Tp" uniqKey="Rooney T">TP Rooney</name></author></analytic></biblStruct><biblStruct><analytic><author><name sortKey="Takeuchi, T" uniqKey="Takeuchi T">T Takeuchi</name></author><author><name sortKey="Kameda, H" uniqKey="Kameda H">H Kameda</name></author></analytic></biblStruct></listBibl></div1></back></TEI><affiliations><list><country><li>Corée du Sud</li><li>Japon</li><li>Taïwan</li></country><region><li>Région capitale de Séoul</li></region><settlement><li>Séoul</li></settlement><orgName><li>Université nationale de Séoul</li></orgName></list><tree><country name="Japon"><noRegion><name sortKey="Takeuchi, Tsutomu" sort="Takeuchi, Tsutomu" uniqKey="Takeuchi T" first="Tsutomu" last="Takeuchi">Tsutomu Takeuchi</name></noRegion><name sortKey="Izutsu, Hiroyuki" sort="Izutsu, Hiroyuki" uniqKey="Izutsu H" first="Hiroyuki" last="Izutsu">Hiroyuki Izutsu</name><name sortKey="Kaneko, Yuichiro" sort="Kaneko, Yuichiro" uniqKey="Kaneko Y" first="Yuichiro" last="Kaneko">Yuichiro Kaneko</name><name sortKey="Kawakami, Atsushi" sort="Kawakami, Atsushi" uniqKey="Kawakami A" first="Atsushi" last="Kawakami">Atsushi Kawakami</name><name sortKey="Nakashima, Yoshihiro" sort="Nakashima, Yoshihiro" uniqKey="Nakashima Y" first="Yoshihiro" last="Nakashima">Yoshihiro Nakashima</name><name sortKey="Rokuda, Mitsuhiro" sort="Rokuda, Mitsuhiro" uniqKey="Rokuda M" first="Mitsuhiro" last="Rokuda">Mitsuhiro Rokuda</name><name sortKey="Shiomi, Teruaki" sort="Shiomi, Teruaki" uniqKey="Shiomi T" first="Teruaki" last="Shiomi">Teruaki Shiomi</name><name sortKey="Tanaka, Sakae" sort="Tanaka, Sakae" uniqKey="Tanaka S" first="Sakae" last="Tanaka">Sakae Tanaka</name><name sortKey="Tanaka, Yoshiya" sort="Tanaka, Yoshiya" uniqKey="Tanaka Y" first="Yoshiya" last="Tanaka">Yoshiya Tanaka</name><name sortKey="Ushijima, Satoshi" sort="Ushijima, Satoshi" uniqKey="Ushijima S" first="Satoshi" last="Ushijima">Satoshi Ushijima</name><name sortKey="Yamada, Emi" sort="Yamada, Emi" uniqKey="Yamada E" first="Emi" last="Yamada">Emi Yamada</name></country><country name="Corée du Sud"><region name="Région capitale de Séoul"><name sortKey="Song, Yeong Wook" sort="Song, Yeong Wook" uniqKey="Song Y" first="Yeong-Wook" last="Song">Yeong-Wook Song</name></region></country><country name="Taïwan"><noRegion><name sortKey="Chen, Yi Hsing" sort="Chen, Yi Hsing" uniqKey="Chen Y" first="Yi-Hsing" last="Chen">Yi-Hsing Chen</name></noRegion></country></tree></affiliations></record>Pour manipuler ce document sous Unix (Dilib)
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