PMID- 30786937 OWN - NLM STAT- MEDLINE DCOM- 20200406 LR - 20200408 IS - 1478-6362 (Electronic) IS - 1478-6354 (Print) IS - 1478-6354 (Linking) VI - 21 IP - 1 DP - 2019 Feb 20 TI - Health-related quality of life in patients with giant cell arteritis treated with tocilizumab in a phase 3 randomised controlled trial. PG - 64 LID - 10.1186/s13075-019-1837-7 [doi] LID - 64 AB - 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. FAU - Strand, Vibeke AU - Strand V AD - Division of Immunology/Rheumatology, Stanford University, Palo Alto, CA, USA. FAU - Dimonaco, Sophie AU - Dimonaco S AD - Roche Products Ltd., Welwyn Garden City, UK. FAU - Tuckwell, Katie AU - Tuckwell K AD - Genentech, South San Francisco, CA, USA. FAU - Klearman, Micki AU - Klearman M AD - Genentech, South San Francisco, CA, USA. FAU - Collinson, Neil AU - Collinson N AD - Roche Products Ltd., Welwyn Garden City, UK. FAU - Stone, John H AU - Stone JH AD - Massachusetts General Hospital Rheumatology Unit, Harvard Medical School, Yawkey 2, 55 Fruit Street, Boston, MA, 02114, USA. jhstone@mgh.harvard.edu. LA - eng SI - ClinicalTrials.gov/NCT01791153 GR - N/A/Roche/International PT - Clinical Trial, Phase III PT - Journal Article PT - Randomized Controlled Trial PT - Research Support, Non-U.S. Gov't DEP - 20190220 PL - England TA - Arthritis Res Ther JT - Arthritis research & therapy JID - 101154438 RN - 0 (Anti-Inflammatory Agents) RN - 0 (Antibodies, Monoclonal, Humanized) RN - I031V2H011 (tocilizumab) RN - VB0R961HZT (Prednisone) SB - IM MH - Aged MH - Anti-Inflammatory Agents/therapeutic use MH - Antibodies, Monoclonal, Humanized/administration & dosage/*therapeutic use MH - Double-Blind Method MH - Drug Therapy, Combination MH - Fatigue/drug therapy/physiopathology/psychology MH - Female MH - Giant Cell Arteritis/*drug therapy/physiopathology/psychology MH - *Health Status MH - Humans MH - Male MH - Middle Aged MH - Prednisone/administration & dosage/*therapeutic use MH - *Quality of Life MH - *Surveys and Questionnaires MH - Treatment Outcome PMC - PMC6381622 OTO - NOTNLM OT - DMARDs (biologic) OT - Giant cell arteritis OT - Inflammation OT - Patient-reported outcomes OT - Quality of life OT - Tocilizumab COIS- ETHICS APPROVAL AND CONSENT TO PARTICIPATE: The trial was conducted in accordance with Good Clinical Practice guidelines and the Declaration of Helsinki. All patients provided written informed consent as approved by the institutional review board or ethics committee. CONSENT FOR PUBLICATION: All patients provided written informed consent for publication of information resulting from the trial without any personally identifying information. COMPETING INTERESTS: VS has received consulting fees from AbbVie, Amgen, AstraZeneca, Bristol-Myers Squibb, Boehringer Ingelheim, Celgene, Celltrion, CORRONA, Crescendo, EMD Serono, Genentech/Roche, GlaxoSmithKline, Janssen, Lilly, Merck, Novartis, Pfizer, Protagen, Regeneron, Samsung, Sandoz, Sanofi and UCB. SD and NC are employees of Roche Products Ltd. KT is an employee of Genentech and owns shares in Roche. MK was an employee of Genentech at the time of the study. JHS has received grants and consulting fees from Roche and Genentech. PUBLISHER'S NOTE: Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations. EDAT- 2019/02/23 06:00 MHDA- 2020/04/09 06:00 PMCR- 2019/02/20 CRDT- 2019/02/22 06:00 PHST- 2018/09/25 00:00 [received] PHST- 2019/01/30 00:00 [accepted] PHST- 2019/02/22 06:00 [entrez] PHST- 2019/02/23 06:00 [pubmed] PHST- 2020/04/09 06:00 [medline] PHST- 2019/02/20 00:00 [pmc-release] AID - 10.1186/s13075-019-1837-7 [pii] AID - 1837 [pii] AID - 10.1186/s13075-019-1837-7 [doi] PST - epublish SO - Arthritis Res Ther. 2019 Feb 20;21(1):64. doi: 10.1186/s13075-019-1837-7.