Background: Patients with giant cell arteritis (GCA) treated with tocilizumab (TCZ) every week or every other week\nand prednisone tapering achieved superior rates of sustained remission to patients treated with placebo and\nprednisone tapering in a randomised controlled trial. Health-related quality of life (HRQOL) in patients from this trial\nis now reported.\nMethods: Exploratory analyses of SF-36 PCS and MCS and domain scores, PtGA and FACIT-Fatigue were performed\nin patients treated with weekly subcutaneous TCZ 162 mg plus 26-week prednisone taper (TCZ-QW + Pred-26) or\nplacebo plus 26-week or 52-week prednisone tapers (PBO + Pred-26 or PBO + Pred-52). These analyses were\nperformed on responder and non-responder patients, including those who achieved the primary outcome and\nthose who experienced flare and received escape prednisone doses.\nResults: Baseline SF-36 PCS, MCS and domain scores were low, indicating impaired HRQOL related to GCA. At week\n52, least squares mean (LSM) changes in PCS scores improved with TCZ-QW + Pred-26 but worsened in both PBO\n+ Pred groups (p < 0.001). LSM changes in MCS scores increased with TCZ-QW+ Pred-26 versus PBO + Pred-52\n(p < 0.001). Treatment with TCZ-QW + Pred-26 resulted in significantly greater improvement in four of eight SF-36\ndomains compared with PBO + Pred-26 and six of eight domains compared with PBO + Pred-52 (p < 0.01).\nImprovement with TCZ-QW+ Pred-26 met or exceeded minimum clinically important differences (MCID) in all eight\ndomains compared with five domains with PBO + Pred-26 and none with PBO + Pred-52. Domain scores in the\nTCZ-QW + Pred-26 group at week 52 met or exceeded age- and gender-matched normative values (A/G norms).\nLSM changes from baseline in FACIT-Fatigue scores increased significantly with TCZ-QW + Pred-26, exceeding MCID\nand A/G norms (p < 0.001).\nConclusions: Patients with GCA receiving TCZ-QW + Pred-26 reported statistically significant and clinically\nmeaningful improvement in SF-36 and FACIT-Fatigue scores compared with those receiving prednisone only.\nImprovements in the TCZ-QW + Pred-26 group led to recovery of HRQOL to levels at least comparable to those of\nA/G-matched normative values at week 52 and exceeded normative values in five of eight domains.
Loading....