Health-related quality of life in patients with giant cell arteritis treated with tocilizumab in a phase 3 randomised controlled trial
Abstract Background Patients 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...
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| Format: | Article |
| Language: | English |
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BMC
2019-02-01
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| Series: | Arthritis Research & Therapy |
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| Online Access: | http://link.springer.com/article/10.1186/s13075-019-1837-7 |
| _version_ | 1828473913444663296 |
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| author | Vibeke Strand Sophie Dimonaco Katie Tuckwell Micki Klearman Neil Collinson John H. Stone |
| author_facet | Vibeke Strand Sophie Dimonaco Katie Tuckwell Micki Klearman Neil Collinson John H. Stone |
| author_sort | Vibeke Strand |
| collection | DOAJ |
| description | Abstract Background Patients 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. Methods Exploratory 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. Results Baseline 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). Conclusions Patients 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 registration ClinicalTrials.gov, NCT01791153. Date of registration: February 13, 2013. |
| first_indexed | 2024-12-11T05:52:30Z |
| format | Article |
| id | doaj.art-d5182778a4e444d1860a3d83240a805d |
| institution | Directory Open Access Journal |
| issn | 1478-6362 |
| language | English |
| last_indexed | 2024-12-11T05:52:30Z |
| publishDate | 2019-02-01 |
| publisher | BMC |
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| series | Arthritis Research & Therapy |
| spelling | doaj.art-d5182778a4e444d1860a3d83240a805d2022-12-22T01:18:47ZengBMCArthritis Research & Therapy1478-63622019-02-012111910.1186/s13075-019-1837-7Health-related quality of life in patients with giant cell arteritis treated with tocilizumab in a phase 3 randomised controlled trialVibeke Strand0Sophie Dimonaco1Katie Tuckwell2Micki Klearman3Neil Collinson4John H. Stone5Division of Immunology/Rheumatology, Stanford UniversityRoche Products Ltd.GenentechGenentechRoche Products Ltd.Massachusetts General Hospital Rheumatology Unit, Harvard Medical SchoolAbstract Background Patients 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. Methods Exploratory 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. Results Baseline 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). Conclusions Patients 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 registration ClinicalTrials.gov, NCT01791153. Date of registration: February 13, 2013.http://link.springer.com/article/10.1186/s13075-019-1837-7DMARDs (biologic)InflammationGiant cell arteritisPatient-reported outcomesQuality of lifeTocilizumab |
| spellingShingle | Vibeke Strand Sophie Dimonaco Katie Tuckwell Micki Klearman Neil Collinson John H. Stone Health-related quality of life in patients with giant cell arteritis treated with tocilizumab in a phase 3 randomised controlled trial Arthritis Research & Therapy DMARDs (biologic) Inflammation Giant cell arteritis Patient-reported outcomes Quality of life Tocilizumab |
| title | Health-related quality of life in patients with giant cell arteritis treated with tocilizumab in a phase 3 randomised controlled trial |
| title_full | Health-related quality of life in patients with giant cell arteritis treated with tocilizumab in a phase 3 randomised controlled trial |
| title_fullStr | Health-related quality of life in patients with giant cell arteritis treated with tocilizumab in a phase 3 randomised controlled trial |
| title_full_unstemmed | Health-related quality of life in patients with giant cell arteritis treated with tocilizumab in a phase 3 randomised controlled trial |
| title_short | Health-related quality of life in patients with giant cell arteritis treated with tocilizumab in a phase 3 randomised controlled trial |
| title_sort | health related quality of life in patients with giant cell arteritis treated with tocilizumab in a phase 3 randomised controlled trial |
| topic | DMARDs (biologic) Inflammation Giant cell arteritis Patient-reported outcomes Quality of life Tocilizumab |
| url | http://link.springer.com/article/10.1186/s13075-019-1837-7 |
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