Trial reportArthritis research & therapy2019
Health-related quality of life in patients with giant cell arteritis treated with tocilizumab in a phase 3 randomised controlled trial.
Trial report in Arthritis research & therapy, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01791153 (A Phase III, Multicenter, Randomized, Double-Blind Placebo-Controlled Study to Assess the Efficacy and Safety of Tocilizumab in Subjects With Giant Cell Arteritis), which is not on this map. Cited by 19 papers, 4 of them syntheses that pooled 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.
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.
A Phase III, Multicenter, Randomized, Double-Blind Placebo-Controlled Study to Assess the Efficacy and Safety of Tocilizumab in Subjects With Giant Cell Arteritis
Who cites it
19 citing papers in PubMed, 4 syntheses or guidelines pooled it, 45 citations in OpenAlex.
- Evidence on treat to target strategies in polymyalgia rheumatica and giant cell arteritis: a systematic literature review.Rheumatology (Oxford, England) · 2024Pooled it
- Pooled it
- Pooled it
- Tocilizumab for giant cell arteritis.The Cochrane database of systematic reviews · 2021Pooled it
- Treatment failure in giant cell arteritis.Annals of the rheumatic diseases · 2021Trial
- Long-term efficacy and safety of tocilizumab in refractory Takayasu arteritis: final results of the randomized controlled phase 3 TAKT study.Rheumatology (Oxford, England) · 2020Trial
- Treatment strategies in giant cell arteritis and polymyalgia rheumatica: beyond glucocorticoids.Nature reviews. Rheumatology · 2026Review
- Patient-reported outcomes and disease activity in giant cell arteritis: a longitudinal registry-based study.Rheumatology (Oxford, England) · 2026Article
- Measurement of the impact of giant cell arteritis and treatment with glucocorticoids on health-related quality of life.Therapeutic advances in musculoskeletal disease · 2026Review
- Efficacy and Safety of Biological Agents in Giant Cell Arteritis: An Updated Meta-Analysis.Avicenna journal of medicine · 2025Review
- Illness Burden and Unmet Patient Needs in Giant Cell Arteritis: Current State and Future Prospects.Open access rheumatology : research and reviews · 2025Review
- Blocking GM-CSF receptor α with mavrilimumab reduces infiltrating cells, pro-inflammatory markers and neoangiogenesis in ex vivo cultured arteries from patients with giant cell arteritis.Annals of the rheumatic diseases · 2022Article
- Treatment of Giant Cell Arteritis (GCA).Journal of clinical medicine · 2022Review
- Large-vessel vasculitis.Nature reviews. Disease primers · 2022Review
- Patient perceptions of health-related quality of life in giant cell arteritis: international development of a disease-specific patient-reported outcome measure.Rheumatology (Oxford, England) · 2021Article
- Patient Reported Outcomes in Large Vessel Vasculitides.Current rheumatology reports · 2021Review
- Will biological agents supplant systemic glucocorticoids as the first-line treatment for thyroid-associated ophthalmopathy?European journal of endocrinology · 2019Review
- Tocilizumab improves quality of life in GCA.Nature reviews. Rheumatology · 2019Article
- Systemic vasculitis and patient-reported outcomes: how the assessment of patient preferences and perspectives could improve outcomes.Patient related outcome measures · 2019Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
6 authors at 3 institutions in 2 countries.
Funding
Abstract
backgroundPatients with giant cell arteritis (GCA) treated with tocilizumab (TCZ) every week or every other week and prednisone tapering achieved superior rates of sustained remission to patients treated with placebo and prednisone tapering in a randomised controlled trial. Health-related quality of life (HRQOL) in patients from this trial is now reported.
methodsExploratory analyses of SF-36 PCS and MCS and domain scores, PtGA and FACIT-Fatigue were performed in patients treated with weekly subcutaneous TCZ 162 mg plus 26-week prednisone taper (TCZ-QW + Pred-26) or placebo plus 26-week or 52-week prednisone tapers (PBO + Pred-26 or PBO + Pred-52). These analyses were performed on responder and non-responder patients, including those who achieved the primary outcome and those who experienced flare and received escape prednisone doses.
resultsBaseline SF-36 PCS, MCS and domain scores were low, indicating impaired HRQOL related to GCA. At week 52, least squares mean (LSM) changes in PCS scores improved with TCZ-QW + Pred-26 but worsened in both PBO + Pred groups (p < 0.001). LSM changes in MCS scores increased with TCZ-QW + Pred-26 versus PBO + Pred-52 (p < 0.001). Treatment with TCZ-QW + Pred-26 resulted in significantly greater improvement in four of eight SF-36 domains compared with PBO + Pred-26 and six of eight domains compared with PBO + Pred-52 (p < 0.01). Improvement with TCZ-QW + Pred-26 met or exceeded minimum clinically important differences (MCID) in all eight domains compared with five domains with PBO + Pred-26 and none with PBO + Pred-52. Domain scores in the TCZ-QW + Pred-26 group at week 52 met or exceeded age- and gender-matched normative values (A/G norms). LSM changes from baseline in FACIT-Fatigue scores increased significantly with TCZ-QW + Pred-26, exceeding MCID and A/G norms (p < 0.001).
conclusionsPatients with GCA receiving TCZ-QW + Pred-26 reported statistically significant and clinically meaningful improvement in SF-36 and FACIT-Fatigue scores compared with those receiving prednisone only. Improvements in the TCZ-QW + Pred-26 group led to recovery of HRQOL to levels at least comparable to those of A/G-matched normative values at week 52 and exceeded normative values in five of eight domains.
trial registrationClinicalTrials.gov, NCT01791153. Date of registration: February 13, 2013.
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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.