Evidence map›Paper›PMID 26056119›Full record

Trial reportAnnals of the rheumatic diseases2016

Efficacy and safety of subcutaneous tocilizumab versus intravenous tocilizumab in combination with traditional DMARDs in patients with RA at week 97 (SUMMACTA).

Gerd R Burmester, Andrea Rubbert-Roth, Alain Cantagrel, Stephen Hall, Piotr Leszczynski, Daniel Feldman, Madura J Rangaraj, Georgia Roane, Charles Ludivico, Min Bao and 3 more

Registry-linked trialOpen access · hybridAbstract readClinical Trial, Phase IIIComparative StudyMulticenter Study
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Annals of the rheumatic diseases, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01194414 (A Randomized, Double-blind, Parallel Group Study of the Safety and Effect on Clinical Outcome of Tocilizumab SC Versus Tocilizumab IV, in Combination With Traditional Disease Modifying Anti-rheumatic Drugs), which is not on this map. Cited by 60 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
60citing papers in PubMed, 3 pooled it
10.7field-weighted citation impact, top 1% 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.

NCT01194414 phase3completednot on this map

A Randomized, Double-blind, Parallel Group Study of the Safety and Effect on Clinical Outcome of Tocilizumab SC Versus Tocilizumab IV, in Combination With Traditional Disease Modifying Anti-rheumatic Drugs (DMARDs), in Patients With Moderate to Severe Active Rheumatoid Arthritis

TypeinterventionalSponsorHoffmann-La RocheRan2010 to 2013Enrolled1,262ConditionsRheumatoid ArthritisArmstocilizumab SC, tocilizumab IV, placebo to tocilizumab SC, placebo to tocilizumab IV, Disease-modifying antirheumatic drugs (DMARDs)
3 · Its place in the literature

Who cites it

60 citing papers in PubMed, 3 syntheses or guidelines pooled it, 123 citations in OpenAlex.

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  16. Advancing Subcutaneous Dosing Regimens for Biotherapeutics: Clinical Strategies for Expedited Market Access.BioDrugs : clinical immunotherapeutics, biopharmaceuticals and gene therapy · 2024
    Review
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  20. Observational
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

13 authors at 9 institutions in 8 countries.

Gerd R BurmesterFree University and Humboldt University of Berlin, Berlin, Germany.
Andrea Rubbert-RothKlinikum der Universität zu Köln, Köln, Germany.
Alain CantagrelCentre Hospitalier Universitaire de Toulouse, Toulouse, France.
Stephen HallCabrini Medical Centre, Malvern, Australia.
Piotr LeszczynskiPoznan Medical University, Poznan, Poland.
Daniel FeldmanUniversidade Federal de São Paulo, São Paulo, Brazil.
Madura J RangarajArthritis & Diabetes Clinic, Inc, Monroe, Louisiana, USA.
Georgia RoaneRheumatology Associates of South Carolina, Charleston, South Carolina, USA.
Charles LudivicoEast Penn Rheumatology Associates, Bethlehem, Pennsylvania, USA.
Min BaoGenentech Inc, South San Francisco, California, USA.
Lucy RowellRoche Products Limited, Welwyn Garden City, UK.
Claire DaviesRoche Products Limited, Welwyn Garden City, UK.
Eduardo F MyslerOrganizacion Medica de Investigación, Buenos Aires, Argentina.
Roche (United Kingdom) · GBCabrini Medical Center · USCentre Hospitalier Universitaire de Toulouse · FRCharleston Hematology Oncology Associates · USDiabetes Australia · AUHumboldt-Universität zu Berlin · DEPoznan University of Medical Sciences · PLUniversidade Federal de São Paulo · BRUniversity of Cologne · DE

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectivesTo evaluate the long-term efficacy and safety of subcutaneous (SC) tocilizumab (TCZ) versus intravenous (IV) TCZ, including switching formulations, in patients with rheumatoid arthritis (RA) and inadequate response to disease-modifying antirheumatic drugs (DMARDs).

methodsPatients (n=1262) were randomised 1:1 to receive TCZ-SC 162 mg weekly (qw)+placebo-IV every four weeks (q4w) or TCZ-IV 8 mg/kg q4w+placebo-SC qw in combination with DMARD(s). After a 24-week double-blind period, patients receiving TCZ-SC were re-randomised 11:1 to TCZ-SC (n=521) or TCZ-IV (TCZ-SC-IV, n=48), and patients receiving TCZ-IV were re-randomised 2:1 to TCZ-IV (n=372) or TCZ-SC (TCZ-IV-SC; n=186). Maintenance of clinical responses and safety through week 97 were assessed.

resultsThe proportions of patients who achieved American College of Rheumatology (ACR)20/50/70 responses, Disease Activity Score in 28 joints remission and improvement from baseline in Health Assessment Questionnaire Disability Index ≥0.3 were sustained through week 97 and comparable across arms. TCZ-SC had a comparable safety profile to TCZ-IV through week 97, except that injection site reactions (ISRs) were more common with TCZ-SC. Safety profiles in patients who switched were similar to those in patients who received continuous TCZ-SC or TCZ-IV treatment. The proportion of patients who developed anti-TCZ antibodies remained low across treatment arms. No association between anti-TCZ antibody development and clinical response or adverse events was observed.

conclusionsThe long-term efficacy and safety of TCZ-SC was maintained and comparable to that of TCZ-IV, except for ISRs. Profiles in patients who switched formulations were comparable to those in patients who received TCZ-IV or TCZ-SC. TCZ-SC provides additional treatment options for patients with RA. TRIAL REGISTRATION NUMBER: NCT01194414.

Indexed as

Antibodies, Monoclonal, HumanizedAntirheumatic AgentsArthritis, RheumatoidDouble-Blind MethodDrug Administration RoutesDrug Therapy, CombinationHumansInjections, IntravenousInjections, SubcutaneousSeverity of Illness IndexTime FactorsTreatment OutcomeAntibodies, Monoclonal, HumanizedAntirheumatic AgentstocilizumabDMARDs (biologic)Rheumatoid ArthritisTreatment

Identifiers

PMID26056119
PMCPMC4717437
OpenAlexW2163480494

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
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.