Impact of tocilizumab monotherapy on patient-reported outcomes in patients with rheumatoid arthritis from two randomised controlled trials

Strand, Vibeke; Michalska, Margaret; Birchwood, Christine; Pei, Jinglan; Tuckwell, Katie; Finch, Rebecca; Gabay, Cem; Kavanaugh, Arthur; Jones, Graeme

doi:10.1136/rmdopen-2017-000496

Cited by 19 publications

(15 citation statements)

References 23 publications

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“…Tocilizumab therapy results in superior improvements in disease activity compared with antitumor necrosis factor (TNF) agents [12,13]. In addition to improving objective clinical outcomes, tocilizumab results in significant improvements in PROs, including pain, fatigue, and function, compared with anti-TNF drugs [14].…”

Section: Introductionmentioning

confidence: 99%

Individual therapeutic DAS28-dcrit responses differentiate between effectiveness of rheumatoid arthritis therapies and reflect patient-reported outcomes: retrospective analysis of DAS28 responses in comparative tocilizumab studies

Koehm

McIntosh²,

Hofmann³

et al. 2020

Rheumatol Int

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Assessment of individual therapeutic responses provides valuable information concerning treatment benefits in individual patients. We evaluated individual therapeutic responses as determined by the Disease Activity Score-28 joints critical difference for improvement (DAS28-d crit ) in rheumatoid arthritis (RA) patients treated with intravenous tocilizumab or comparator anti-tumor necrosis factor (TNF) agents. The previously published DAS28-d crit value [DAS28 decrease (improvement) ≥ 1.8] was retrospectively applied to data from two studies of tocilizumab in RA, the 52-week ACT-iON observational study and the 24-week ADACTA randomized study. Data were compared within (not between) studies. DAS28 was calculated with erythrocyte sedimentation rate as the inflammatory marker. Stability of DAS28-d crit responses and European League Against Rheumatism (EULAR) good responses was determined by evaluating repeated responses at subsequent timepoints. A logistic regression model was used to calculate p values for differences in response rates between active agents. Patient-reported outcomes (PROs; pain, global health, function, and fatigue) in DAS28-d crit responder versus non-responder groups were compared with an ANCOVA model. DAS28-d crit individual response rates were 78.2% in tocilizumab-treated patients and 58.2% in anti-TNF-treated patients at week 52 in the ACT-ion study (p = 0.0001) and 90.1% versus 59.1% at week 24 in the ADACTA study (p < 0.0001). DAS28-d crit responses showed greater stability over time (up to 52 weeks) than EULAR good responses. For both active treatments, DAS28-d crit responses were associated with statistically significant improvements in mean PRO values compared with non-responders. The DAS28-d crit response criterion provides robust assessments of individual responses to RA therapy and may be useful for discriminating between active agents in clinical studies and guiding treat-to-target decisions in daily practice.

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Section: Introductionmentioning

confidence: 99%

Individual therapeutic DAS28-dcrit responses differentiate between effectiveness of rheumatoid arthritis therapies and reflect patient-reported outcomes: retrospective analysis of DAS28 responses in comparative tocilizumab studies

Koehm

McIntosh²,

Hofmann³

et al. 2020

Rheumatol Int

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“…Patients with JIA often experience diminished health-related quality of life (HRQOL) with respect to both physical functioning and emotional state due to the pain, stiffness, fatigue and disability that can result from this inflammation. (12) Early and sensitive markers are needed to evaluate the activation of the immune system and relate it to its pathogenesis as well as selecting the most suitable therapy for each patient (13) .…”

Section: Discussionmentioning

confidence: 99%

“…Table (12) and figure (9) showed a highly significant difference between neopterin levels within the two groups (Group AI and Group AII) in the activity and remission states (P < 0.001).…”

Section: Figure (9)mentioning

confidence: 93%

Serum Neopterin Level in Children with Juvenile Idiopathic Arthritis

Dower

Abdelhameed²,

Maksoud³

et al. 2018

Egyptian Journal of Hospital Medicine

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Background: Juvenile idiopathic arthritis (JIA) is generally considered a clinical syndrome involving several disease subsets, with a number of inflammatory flows, leading to an eventual common pathway in which persistent synovial inflammation and associated damage to articular cartilage and underlying bone are present. Neoptrin is a reliable marker in the assessment of the rate of IFN-γ production. Levels of neoptrin increase in direct proportion with the level of interferon. Measurement of neopterin level is useful because of its relative stability also it is a prognostic indicator for cell-mediated immunity. Aims: This study aims to assess serum level of neopterin in patients with Juvenile Idiopathic Arthritis (JIA) in relation to the disease activity, severity and response to conventional and biological therapy. Methodology: The study was conducted on 30 patients (Group A) previously diagnosed as SoJIA, they were divided into two subgroups according to their therapy into Group AI on biological therapy (15 patients) and Group AII on conventional therapy (15 patients). These in addition to 20 healthy controls (Group B). Results: Basic clinical evaluation and laboratory investigations were done. We found that JIA patients had significantly higher levels of serum neopterin than healthy controls. We also found a highly significant difference between neopterin levels in the activity and remission states among all patients (Group AI and Group AII). Conclusion: We concluded that serum neopterin is a useful marker for cellular immune activation and also indicative of the activity of JIA. Our findings are supported by positive correlations between serum neopterin levels and other markers of activity as TLC, PLT counts, ESR, and CRP. We also concluded that serum neopterin is a sensitive and accurate predictor of disease activity where sensitivity of that test was 93.3% and accuracy was 72.5%. Recommendations: Investigating the serum neopterin measurement in other autoimmune collagen diseases. Assessment the influence of biological therapy on neopterin levels in relation to disease progression.

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“…HRQOL was evaluated at baseline in each study and at 16 weeks in OPTION, 12 weeks in BREVACTA and 24 weeks in SUMMACTA. PROs were assessed as previously described, 19 and included patient global assessment of disease activity (PtGA; visual analogue scale 0–100 mm), pain (visual analogue scale 0–100 mm), Health Assessment Questionnaire-Disability Index (HAQ-DI; 0–3), Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue score (0–52; OPTION and BREVACTA only), Short Form-36 (SF-36) physical component score (PCS) and mental component score (MCS) (0–50), and SF-36 individual domain scores (physical functioning, role-physical, bodily pain, general health, vitality, social functioning, role-emotional and mental health; 0–100). Outcomes included mean changes from baseline in PRO scores, the proportion of patients reporting improvements from baseline ≥ minimum clinically important differences (MCID) for each PRO, 20 21 and the proportion of patients who reported scores ≥ to age and gender-matched normative values ( table 1 ).…”

Section: Methodsmentioning

confidence: 99%

“… 16–18 Additionally, post hoc analyses of RCT populations have shown that TCZ administered as monotherapy improves HRQOL in patients with RA. 19 …”

Section: Introductionmentioning

confidence: 99%

Impact of tocilizumab administered intravenously or subcutaneously on patient-reported quality-of-life outcomes in patients with rheumatoid arthritis

Strand

Michalska²,

Birchwood³

et al. 2018

RMD Open

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ObjectiveRandomised controlled trials (RCTs) have shown tocilizumab (TCZ) administered intravenously or subcutaneously with conventional synthetic disease-modifying antirheumatic drugs (csDMARDs) to be superior to csDMARDs alone for improving rheumatoid arthritis (RA) disease activity. This study evaluated the effect of TCZ-intravenous and TCZ-subcutaneous on patient-reported outcomes (PROs) in three RCT populations.MethodsOPTION (NCT00106548), BREVACTA (NCT01232569) and SUMMACTA (NCT01194414) were independent RCTs evaluating the efficacy and safety of TCZ-intravenous and/or TCZ-subcutaneous with csDMARDs in patients with RA. PROs included patient global assessment, pain, Health Assessment Questionnaire-Disability Index, Functional Assessment of Chronic Illness Therapy-Fatigue and Short Form-36. Study outcomes included the proportions of patients reporting changes from baseline in PRO scores ≥ minimum clinically important differences (MCID) and scores ≥ age and gender-matched normative values.ResultsIn OPTION, more patients who received TCZ-intravenous reported improvements in PROs ≥MCID (50%–82% vs 31%–57%) and scores ≥ normative values (16%–44% vs 5%–28%) at week 16 compared with placebo. Similarly, a greater proportion of patients in BREVACTA who received TCZ-subcutaneous reported improvements ≥ MCID (54%–73% vs 42%–55%) and scores ≥ normative values (8%–34% vs 4%–25%) at week 12 compared with placebo. In SUMMACTA, 61%–84% of patients who received TCZ-subcutaneous and 64%–84% of those who received TCZ-intravenous reported improvements ≥ MCID and 14%–41% and 15%–24%, respectively, scores ≥ normative values at week 24.ConclusionsTCZ-intravenous or TCZ-subcutaneous with csDMARDs resulted in more patients reporting clinically meaningful improvements and PRO scores ≥ normative values compared with placebo. These improvements were similar with TCZ-intravenous and TCZ-subcutaneous.

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Impact of tocilizumab monotherapy on patient-reported outcomes in patients with rheumatoid arthritis from two randomised controlled trials

Cited by 19 publications

References 23 publications

Individual therapeutic DAS28-dcrit responses differentiate between effectiveness of rheumatoid arthritis therapies and reflect patient-reported outcomes: retrospective analysis of DAS28 responses in comparative tocilizumab studies

Individual therapeutic DAS28-dcrit responses differentiate between effectiveness of rheumatoid arthritis therapies and reflect patient-reported outcomes: retrospective analysis of DAS28 responses in comparative tocilizumab studies

Serum Neopterin Level in Children with Juvenile Idiopathic Arthritis

Impact of tocilizumab administered intravenously or subcutaneously on patient-reported quality-of-life outcomes in patients with rheumatoid arthritis

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