Sarilumab monotherapy or in combination with non-methotrexate disease-modifying antirheumatic drugs in active rheumatoid arthritis : A Japan phase 3 trial (HARUKA)
Objectives: To determine long-term safety and efficacy of sarilumab as monotherapy or with non-methotrexate (MTX) conventional synthetic disease-modifying antirheumatic drugs (csDMARDs) in Japanese patients with active rheumatoid arthritis (RA).Methods: In this double-blind, randomized study (NCT02373202), patients received subcutaneous sarilumab 150 mg q2w (S150) or 200 mg q2w (S200) as monotherapy or with non-MTX csDMARDs for 52 weeks. The primary endpoint was safety.Results: Sixty-one patients received monotherapy (S150, n = 30; S200, n = 31) and 30 received combination therapy (S150 + csDMARDs, n = 15; S200 + csDMARDs, n = 15). Rates of treatment-emergent adverse events (TEAEs) were 83.3%/90.3%/93.3%/86.7% for S150/S200/S150 + csDMARDs/S200 + csDMARDs, respectively. Nasopharyngitis and neutropenia were the most frequently reported TEAEs. One serious infection was reported in each monotherapy group and in the S200 + csDMARDs group. There were no cases of grade 4 neutropenia; no patients with grade 3 neutropenia experienced associated serious infection. Improvements in ACR20/50/70 response rates were generally similar between the two monotherapy groups and between the two combination groups; improvements in physical function (Health Assessment Questionnaire-Disability Index, HAQ-DI) and DAS28-CRP were observed at weeks 24 and 52 (all groups).Conclusion: The safety profile of sarilumab was consistent with known class effects of interleukin-6 signaling blockade therapeutics. Sarilumab as mono- or combination therapy improved clinical signs/symptoms and physical function in Japanese RA patients.
| Medienart: |
E-Artikel |
|---|
| Erscheinungsjahr: |
2020 |
|---|---|
| Erschienen: |
2020 |
| Enthalten in: |
Zur Gesamtaufnahme - volume:30 |
|---|---|
| Enthalten in: |
Modern rheumatology - 30(2020), 2 vom: 01. März, Seite 239-248 |
| Sprache: |
Englisch |
|---|
| Beteiligte Personen: |
Kameda, Hideto [VerfasserIn] |
|---|
| Links: |
|---|
| Anmerkungen: |
Date Completed 10.08.2020 Date Revised 10.08.2020 published: Print-Electronic Citation Status MEDLINE |
|---|
| doi: |
10.1080/14397595.2019.1639939 |
|---|
| funding: |
|
|---|---|
| Förderinstitution / Projekttitel: |
|
| PPN (Katalog-ID): |
NLM298820072 |
|---|
| LEADER | 01000naa a22002652 4500 | ||
|---|---|---|---|
| 001 | NLM298820072 | ||
| 003 | DE-627 | ||
| 005 | 20231225095012.0 | ||
| 007 | cr uuu---uuuuu | ||
| 008 | 231225s2020 xx |||||o 00| ||eng c | ||
| 024 | 7 | |a 10.1080/14397595.2019.1639939 |2 doi | |
| 028 | 5 | 2 | |a pubmed24n0996.xml |
| 035 | |a (DE-627)NLM298820072 | ||
| 035 | |a (NLM)31268376 | ||
| 040 | |a DE-627 |b ger |c DE-627 |e rakwb | ||
| 041 | |a eng | ||
| 100 | 1 | |a Kameda, Hideto |e verfasserin |4 aut | |
| 245 | 1 | 0 | |a Sarilumab monotherapy or in combination with non-methotrexate disease-modifying antirheumatic drugs in active rheumatoid arthritis |b A Japan phase 3 trial (HARUKA) |
| 264 | 1 | |c 2020 | |
| 336 | |a Text |b txt |2 rdacontent | ||
| 337 | |a ƒaComputermedien |b c |2 rdamedia | ||
| 338 | |a ƒa Online-Ressource |b cr |2 rdacarrier | ||
| 500 | |a Date Completed 10.08.2020 | ||
| 500 | |a Date Revised 10.08.2020 | ||
| 500 | |a published: Print-Electronic | ||
| 500 | |a Citation Status MEDLINE | ||
| 520 | |a Objectives: To determine long-term safety and efficacy of sarilumab as monotherapy or with non-methotrexate (MTX) conventional synthetic disease-modifying antirheumatic drugs (csDMARDs) in Japanese patients with active rheumatoid arthritis (RA).Methods: In this double-blind, randomized study (NCT02373202), patients received subcutaneous sarilumab 150 mg q2w (S150) or 200 mg q2w (S200) as monotherapy or with non-MTX csDMARDs for 52 weeks. The primary endpoint was safety.Results: Sixty-one patients received monotherapy (S150, n = 30; S200, n = 31) and 30 received combination therapy (S150 + csDMARDs, n = 15; S200 + csDMARDs, n = 15). Rates of treatment-emergent adverse events (TEAEs) were 83.3%/90.3%/93.3%/86.7% for S150/S200/S150 + csDMARDs/S200 + csDMARDs, respectively. Nasopharyngitis and neutropenia were the most frequently reported TEAEs. One serious infection was reported in each monotherapy group and in the S200 + csDMARDs group. There were no cases of grade 4 neutropenia; no patients with grade 3 neutropenia experienced associated serious infection. Improvements in ACR20/50/70 response rates were generally similar between the two monotherapy groups and between the two combination groups; improvements in physical function (Health Assessment Questionnaire-Disability Index, HAQ-DI) and DAS28-CRP were observed at weeks 24 and 52 (all groups).Conclusion: The safety profile of sarilumab was consistent with known class effects of interleukin-6 signaling blockade therapeutics. Sarilumab as mono- or combination therapy improved clinical signs/symptoms and physical function in Japanese RA patients | ||
| 650 | 4 | |a Clinical Trial, Phase III | |
| 650 | 4 | |a Journal Article | |
| 650 | 4 | |a Randomized Controlled Trial | |
| 650 | 4 | |a Japan | |
| 650 | 4 | |a Rheumatoid arthritis | |
| 650 | 4 | |a anti-IL-6 receptor | |
| 650 | 4 | |a phase III | |
| 650 | 4 | |a sarilumab | |
| 650 | 7 | |a Antibodies, Monoclonal, Humanized |2 NLM | |
| 650 | 7 | |a Antirheumatic Agents |2 NLM | |
| 650 | 7 | |a Drug Combinations |2 NLM | |
| 650 | 7 | |a sarilumab |2 NLM | |
| 650 | 7 | |a NU90V55F8I |2 NLM | |
| 700 | 1 | |a Wada, Kazuteru |e verfasserin |4 aut | |
| 700 | 1 | |a Takahashi, Yoshinori |e verfasserin |4 aut | |
| 700 | 1 | |a Hagino, Owen |e verfasserin |4 aut | |
| 700 | 1 | |a van Hoogstraten, Hubert |e verfasserin |4 aut | |
| 700 | 1 | |a Graham, Neil |e verfasserin |4 aut | |
| 700 | 1 | |a Tanaka, Yoshiya |e verfasserin |4 aut | |
| 773 | 0 | 8 | |i Enthalten in |t Modern rheumatology |d 2000 |g 30(2020), 2 vom: 01. März, Seite 239-248 |w (DE-627)NLM162086628 |x 1439-7609 |7 nnns |
| 773 | 1 | 8 | |g volume:30 |g year:2020 |g number:2 |g day:01 |g month:03 |g pages:239-248 |
| 856 | 4 | 0 | |u http://dx.doi.org/10.1080/14397595.2019.1639939 |3 Volltext |
| 912 | |a GBV_USEFLAG_A | ||
| 912 | |a GBV_NLM | ||
| 951 | |a AR | ||
| 952 | |d 30 |j 2020 |e 2 |b 01 |c 03 |h 239-248 | ||