title: Effectiveness and survival-on-drug of certolizumab pegol in rheumatoid arthritis in clinical practice: results from the national Swedish register.
abstract: OBJECTIVE
  Evidence regarding the efficacy and effectiveness of certolizumab pegol (CZP) in rheumatoid arthritis (RA) patients who have failed to respond to treatment with a tumour necrosis factor inhibitor (TNFi) is limited. The aim of this study was to describe the effectiveness and survival-on-drug of CZP in a real-life setting, both in TNFi-naïve patients and in patients who had previously failed TNFis, and in relation to disease activity at baseline.
  
  
  METHODS
  The national Swedish Rheumatology Quality Register (SRQ) was used to identify patients with RA starting treatment with CZP between 2009 and 2013. The effectiveness of treatment was assessed using the 28-joint Disease Activity Score (DAS28), the Health Assessment Questionnaire (HAQ), measures of remission, the European League Against Rheumatism (EULAR) response during 0-6 months from start of treatment, and survival-on-drug during the first 30 months.
  
  
  RESULTS
  A total of 945 RA patients started treatment with CZP. Of these, 540 (57.1%) received CZP as the first biological treatment, 215 (23%) had failed one previous TNFi, and 190 (20%) had failed at least two TNFis. Overall, 71% achieved at least a EULAR moderate response and 38% had a EULAR good response at 6 months from baseline. TNFi-naïve patients achieved significantly better results and had better survival-on-drug compared to patients who had failed previous TNFis. Around 20% of patients who had not responded to two or more prior TNFis achieved EULAR good response to therapy and a similar percentage achieved remission. Patients who had high baseline disease activity had a higher risk of discontinuing treatment compared to those without high disease activity.
  
  
  CONCLUSIONS
  In this real-life RA cohort, CZP was associated with significant clinical improvement. The effectiveness and survival-on-drug vary markedly depending on the line of treatment.
authors.affiliation: a Unit for Clinical Research Therapy , Inflammatory Diseases (ClinTRID), Karolinska Institutet , Stockholm , Sweden.
authors.forename: K
authors.initials: K
authors.lastname: Chatzidionysiou
authors.affiliation: b Department of Rheumatology , Skåne University Hospital , Lund , Sweden.
authors.forename: L-E
authors.initials: LE
authors.lastname: Kristensen
authors.affiliation: c Clinical Epidemiology Unit, Karolinska Institutet , Stockholm , Sweden.
authors.forename: J
authors.initials: J
authors.lastname: Eriksson
authors.affiliation: c Clinical Epidemiology Unit, Karolinska Institutet , Stockholm , Sweden.
authors.forename: J
authors.initials: J
authors.lastname: Askling
authors.affiliation: a Unit for Clinical Research Therapy , Inflammatory Diseases (ClinTRID), Karolinska Institutet , Stockholm , Sweden.
authors.forename: R
authors.initials: R
authors.lastname: van Vollenhoven
mesh_terms: D000328:Adult; D000368:Aged; D018501:Antirheumatic Agents / Q000627:therapeutic use*; D001172:Arthritis, Rheumatoid / Q000188:drug therapy* / Q000453:epidemiology / Q000401:mortality*; D001688:Biological Products / Q000627:therapeutic use; D000068582:Certolizumab Pegol / Q000627:therapeutic use*; D015331:Cohort Studies; D004185:Disability Evaluation; D005060:Europe; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D008297:Male; D008875:Middle Aged; D012042:Registries; D012189:Retrospective Studies; D012720:Severity of Illness Index; D011795:Surveys and Questionnaires; D015996:Survival Rate; D013548:Sweden / Q000453:epidemiology; D016896:Treatment Outcome; D014409:Tumor Necrosis Factor-alpha / Q000037:antagonists & inhibitors
chemical_list: D018501:Antirheumatic Agents; D001688:Biological Products; D014409:Tumor Necrosis Factor-alpha; D000068582:Certolizumab Pegol