Evidence map›Paper›PMID 33407801›Full record

Trial reportArthritis research & therapy2021

Efficacy and safety of upadacitinib over 84 weeks in Japanese patients with rheumatoid arthritis (SELECT-SUNRISE).

Hideto Kameda, Tsutomu Takeuchi, Kunihiro Yamaoka, Motohiro Oribe, Mitsuhiro Kawano, Masayuki Yokoyama, Aileen L Pangan, Yuko Konishi, Sebastian Meerwein, Yoshiya Tanaka

Registry-linked trialOpen access · goldAbstract readRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Arthritis research & therapy, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02720523 (A Phase 2b/3, Randomized, Double-Blind Study Comparing Upadacitinib), which is not on this map. Cited by 18 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
18citing papers in PubMed, 2 pooled it
3.6field-weighted citation impact, top 7% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT02720523 phase2 / phase3completednot on this map

A Phase 2b/3, Randomized, Double-Blind Study Comparing Upadacitinib (ABT-494) to Placebo in Japanese Subjects With Moderately to Severely Active Rheumatoid Arthritis Who Are on a Stable Dose of Conventional Synthetic Disease-Modifying Anti-Rheumatic Drugs (csDMARDs) and Have an Inadequate Response to csDMARDs

TypeinterventionalSponsorAbbVieRan2016 to 2022Enrolled197ConditionsRheumatoid ArthritisArmsPlacebo, Upadacitinib
3 · Its place in the literature

Who cites it

18 citing papers in PubMed, 2 syntheses or guidelines pooled it, 26 citations in OpenAlex.

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  14. The infection risks of JAK inhibition.Expert review of clinical immunology · 2022
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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

10 authors at 7 institutions in 3 countries.

Hideto KamedaDivision of Rheumatology, Department of Internal Medicine, Faculty of Medicine, Toho University, 2-22-36, Ohashi, Meguro-ku, Tokyo, 153-8515, Japan. hideto.kameda@med.toho-u.ac.jp.ORCID 0000-0002-4330-5782
Tsutomu TakeuchiKeio University School of Medicine, 2 Chome-15-45 Mita, Minato City, Tokyo, 108-8345, Japan.
Kunihiro YamaokaKitasato University School of Medicine, 1 Chome-15-1 Kitazato, Minami Ward, Sagamihara, Kanagawa, 252-0374, Japan.
Motohiro OribeDepartment of Internal Medicine, Oribe Clinic of Rheumatism and Medicine, Oita Oita-shi Otemachi 2-1-15, Oita, Japan.
Mitsuhiro KawanoRheumatology, Honjo Rheumatism Clinic, Takaoka, Toyama, 933-0874, Japan.
Masayuki YokoyamaImmunology, AbbVie GK, 16F, 3 Chome-1-14F Shibaura, Minato City, Tokyo, 105-0023, Japan.
Aileen L PanganImmunology, AbbVie, 1400 Sheridan Rd, North Chicago, IL, 60064, USA.
Yuko KonishiImmunology, AbbVie GK, 16F, 3 Chome-1-14F Shibaura, Minato City, Tokyo, 105-0023, Japan.
Sebastian MeerweinPharmaceutical Development, AbbVie Deutschland GmbH & Co KG, Knollstraße 50, 67061, Ludwigshafen am Rhein, Germany.
Yoshiya TanakaThe First Department of Internal Medicine, University of Occupational and Environmental Health, 1-1 Iseigaoka, Yahatanishi Ward, Kitakyushu, Fukuoka, 807-8555, Japan.
ABB (Japan) · JPAbbVie (Germany) · DEAbbVie (United States) · USKeio University · JPKitasato University · JPToho University · JPUniversity of Occupational and Environmental Health Japan · JP

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundThe objective of the study was to evaluate the efficacy and safety of upadacitinib over 84 weeks in Japanese patients with active rheumatoid arthritis (RA) and an inadequate response to conventional synthetic disease-modifying anti-rheumatic drugs.

methodsAll patients completing a 12-week, randomized, double-blind treatment period entered a blinded extension and continued upadacitinib 7.5, 15, or 30 mg once daily (QD), or were switched from placebo to upadacitinib 7.5, 15, or 30 mg QD. Efficacy and safety were assessed over 84 weeks.

resultsOf 197 randomized patients, 187 (94.9%) completed the 12-week period and entered the blinded extension; 152 (77.2%) patients were ongoing at week 84. At week 84, the proportions of patients achieving a 20% improvement in American College of Rheumatology criteria (ACR20) were 85.7%, 77.6%, and 58.0% with continued upadacitinib 7.5, 15, and 30 mg, respectively (nonresponder imputation), and were similar in patients who had switched from placebo. Favorable response rates were also observed for more stringent measures of response (ACR50/70) and remission (defined by the Disease Activity Score of 28 joints with C-reactive protein, Clinical Disease Activity Index, or Simplified Disease Activity Index). The 15 mg and 30 mg doses of upadacitinib were associated with more rapid and numerically higher initial responses for some measures of disease activity and remission compared with the 7.5 mg dose. Rates of adverse events, infection, opportunistic infection, serious infection, and herpes zoster were lower with upadacitinib 7.5 and 15 mg versus 30 mg.

conclusionsUpadacitinib demonstrated sustained efficacy and was well tolerated over 84 weeks in Japanese patients with RA, with upadacitinib 15 mg offering the most favorable benefit-risk profile.

trial registrationClinicalTrials.gov NCT02720523 . Registered on March 22, 2016.

Indexed as

Antirheumatic AgentsArthritis, RheumatoidJanus Kinase InhibitorsDouble-Blind MethodDrug Therapy, CombinationHeterocyclic Compounds, 3-RingHumansJapanMethotrexateTreatment OutcomeAntirheumatic AgentsHeterocyclic Compounds, 3-RingJanus Kinase InhibitorsMethotrexateupadacitinibJanus kinase inhibitorJapaneseRheumatoid arthritisUpadacitinib

Identifiers

PMID33407801
PMCPMC7789301
OpenAlexW3118431063

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.