NE Rheumatology Issue - July 2009

Baseline characteristics of patients receiving biologic and traditional DMARD therapy in Ontario: results from the Ontario Biologics Research Initiative

Background

The Ontario Biologics Research Initiative (OBRI) is a collaboration of rheumatologists, patients, and researchers who aim to improve the quality of care and clinical outcomes of rheumatoid arthritis (RA) patients. OBRI gathers long-term information on the therapies used in a wide cross-section of RA patients. At EULAR 2009, Bombardier and colleagues presented data describing the baseline characteristics and preliminary clinical and patient-reported efficacy outcomes for the first 366 patients enrolled in the OBRI Safety and Effectiveness Research Study.1

Study desgin

  • Patients were enrolled in the OBRI study after being prescribed a disease-modifying anti-rheumatic drug (DMARD) or biologic therapy and prospectively followed to assess their response and to gather information about current and latent adverse events.
  • At the time of the analysis, standardized baseline data were available for 323 (88%) of patients enrolled.
  • All enrolled patients (366; 100%) completed baseline telephone questionnaires.
  • Physician-reported data at baseline included RA diagnostic data and disease duration, data on components of the 28-joint Disease Activity Score (DAS28), co-morbidities, concurrent medications, and serious adverse events (SAEs). These data were collected every 6 months.
  • Patient-reported data at baseline included informed consent, demographics, arthritis history, co-morbidities, concurrent medications, Health Assessment Questionnaire (HAQ), Rheumatoid Arthritis Disease Activity Index (RADAI), patient global scores, fatigue, work productivity, hospitalizations, and infections. Patient-reported data were collected at 3 months and every 6 months.
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Key findings

  • Patients were divided into three cohorts:
    • DMARD cohort (n = 62): 56% female, mean age 58.7 ± 14.5 years, >65 years 32%, mean RA duration 1.3 ± 4.3 years, early RA (<2 years) 88%, concomitant methotrexate 65%, concomitant glucocorticosteroid 39%, biologic naïve 100%;
    • DMARD change cohort (n = 185): 72% female, mean age 56.0 ± 13.5 years, >65 years 28%, mean RA duration 8.7 ± 9.9 years, early RA (<2 years) 34%, concomitant methotrexate 83%, concomitant glucocorticosteroid 21%, biologic naïve 92%;
    • Biologic cohort (n = 76): 84% female, mean age 55.5 ± 13.3 years, >65 years 26%, mean RA duration 11.7 ± 10.7 years, early RA (<2 years) 11%, concomitant methotrexate 93%, concomitant glucocorticosteroid 16%, biologic naïve 68%.
  • DMARDs at baseline included methotrexate, leflunomide, sulfasalazine, hydroxychlorquine, and azathioprine; biologics at baseline included etanercept, adalimumab, infliximab, abatacept, and rituximab.
  • Physician-reported co-morbidities for the DMARD cohorts included heart disease (15%), hypertension (24%), lung disease (9%), diabetes (8%), stomach disease (4%), kidney disease (4%), blood disease (6%), cancer (3%), depression (7%), degenerative arthritis (19%), back pain (5%), and liver disease (2%).
  • Physician-reported co-morbidities for the biologics cohort included heart disease (14%), hypertension (13%), lung disease (13%), diabetes (4%), stomach disease (5%), kidney disease (0%), blood disease (14%), cancer (5%), depression (12%), degenerative arthritis (29%), back pain (5%), and liver disease (1%).
  • Patient-reported co-morbidities for the DMARD cohorts included heart disease (13%), hypertension (33%), lung disease (12%), diabetes (9%), stomach disease (10%), kidney disease (2%), blood disease (7%), cancer (6%), depression (24%), degenerative arthritis (23%), psoriasis (5%), back pain (47%), and liver disease (1%).
  • Patient-reported co-morbidities for the biologics cohort included heart disease (14%), hypertension (32%), lung disease (11%), diabetes (6%), stomach disease (7%), kidney disease (3%), blood disease (12%), cancer (8%), depression (25%), degenerative arthritis (33%), psoriasis (1%), back pain (49%), and liver disease (0%).
  • Overall disease activity reported included:
    • physician-reported DAS28: mild 9% (≥2.6, ≤3.2), moderate 40% (>3.2, ≤5.1), severe 51% (>5.1);
    • patient-reported RADAI: mild 11% (<2.2), moderate 37% (≥2.2, ≤4.9), severe 53% (>4.9).
  • Physician-reported and patient-reported mean disease activity data are shown in Figures 1 and 2.

Efficacy

  • Preliminary efficacy outcomes for both the DMARD and biologics cohorts were physician-reported for:
    • 28 tender joint count (TJC) score (DMARD cohort: baseline 7.51, at 6 months 3.68; Biologics cohort: baseline 10.87, at 6 months 4.96);
    • 28 swollen joint count (SJC) score (DMARD cohort: baseline 6.38, at 6 months 3.14; Biologics cohort: baseline 8.27, at 6 months 3.63);
    • Clinical Disease Activity Index (CDAI) score (DMARD cohort: baseline 24.1, at 6 months 13.13; Biologics cohort: baseline 30.86, at 6 months 15.16).
  • Physican-reported preliminary efficacy outcomes for Patient Global and DAS28 scores are shown in Figures 3 and 4.
  • Preliminary efficacy outcomes for both the DMARD and biologics cohorts were patient reported for:
    • Global (DMARD cohort: baseline 5.75, at 3 months 4.61, at 6 months 4.07; Biologics cohort: baseline 7.31, at 3 months 5.24, at 6 months 4.93);
    • Fatigue (DMARD cohort: baseline 5.22, at 3 months 4.83, at 6 months 4.22; Biologics cohort: baseline 6.98, at 3 months 5.62, at 6 months 5.02);
    • RADAI scores (DMARD cohort: baseline 4.6, at 3 months 3.74, at 6 months 3.35; Biologics cohort: baseline 5.73, at 3 months 4.66, at 6 months 4.02).
  • Patient-reported preliminary efficacy outcomes for HAQ-Pain and HAQ-DI scores are shown in Figures 5 and 6.

Key conclusions

  • This cohort of patients show that in routine practice, biologics are being prescribed to patients with longer mean disease duration who have more severe disease activity and disability compared with those receiving traditional DMARDs.
  • Existence of co-morbidities such as hypertension, depression, and blood disease compared to clinical trial patients highlight the importance of actual practice data to inform clinical decision-making.
  • OBRI’s ongoing data collection and its expansion to a larger number of recruiting rheumatologists and provincial administrative data linkage (for physician billing, prescriptions, hospitalizations, and vital statistics) will provide a unique source of information on anti-rheumatic drug usage, safety, and effectiveness.

Reference: 1. Bombardier C, Bernatsky S, Cividino A, et al. Baseline characteristics of patients receiving biologic and traditional disease modifiying anti-rheumatic drug (DMARD) therapy in Ontario: results from the Ontario Biologics Research Initiative. Program and abstracts of the 2009 European League Against Rheumatism (EULAR) Scientific Meeting, June 10–13, 2009, Copenhagen, Denmark: Abstract THU0187.