Background/Purpose:

Data on clinical status of biologic-naïve Rheumatoid Arthritis (RA) patients who are considered suitable for biologic therapy (by their physicians) is lacking. We assessed clinical characteristics of RA patients who are considered suitable for biologic therapy (by their physicians) in comparison to those currently treated with 1^stline biologics in the United States (US).

Methods:

A retrospective chart review study of RA patients was conducted among physicians (primarily rheumatologists) in hospitals/private practices to collect de-identified data on patients who were either recently treated with a biologic as part of usual care or considered suitable for biologic treatment. Physicians from the US were screened for duration of practice (3-30 yrs) and patient volume (incl. >2RA biologic patients/week) and recruited from a large panel to be geographically representative. Eligible patient charts (>6 biologic patients, > 2 biologic-suitable (and yet biologic-naïve) patients per physician judgment) were randomly selected from a sample of prospective patients visiting each center/practice during the screening period. Physicians abstracted patient diagnosis, treatment patterns/dynamics and patient symptomatology/disease status. This retrospective de-identified data collection method met the criteria for IRB exemption under federal regulation 45 CFR 46.101(b)(4).

Results:

Seven hundred and twenty six eligible RA patient charts were abstracted; 378 (52%) patients were on their first biologic and 175 (24%) patients have never experienced biologic but were considered suitable for one. Mean age was: 1^st line-52.8yrs, biologic-suitable-51.5yrs; Female: 1^st line-73%, biologic-suitable-76%. Disease severity at diagnosis and current disease severity (both per physician judgment) (mild:moderate:severe) were: 1^st line – 6%:74%:14% and 67%:29%:3%, biologic-suitable – 11%,74%, 10% and 25%:66%:9% respectively. Current drug class usage differed between the two groups (1^st line/biologic-suitable): non-biological DMARD (57%/88%), steroids (19%/36%), NSAIDs-COX2 inhibitors (6%/10%), NSAIDs- non-COX2 inhibitors (14%/22%), and analgesics (11%/12%). Key lab measures documented were (1^st line/biologic suitable): ESR (24.2/40.0 mm/h) and CRP (2.5mg/5.6 dl). Current ACR scores were (1^st line/biologic-suitable):  no response (2%/19%), ACR20 (12%/36%), ACR50 (18%/15%), ACR70 (20%/5%), ACR90 (26%/1%). Among patients with available data, current HAQ (1^st line – 0.7, biologic-suitable – 1.1), DAS28 (1^st line – 2.5, biologic-suitable – 4.1), 100mmVAS (1^st line – 2.3, biologic-suitable – 4.6), Swollen Joint Count (1^st line – 2.0, biologic-suitable – 5.9) and Tender Joint Count (1^st line – 2.8, biologic-suitable – 7.0) differed between the patient groups.

Conclusion:

Compared to the patients currently treated with 1^st line biologic, RA biologic-naïve but suitable patients (per physician judgment) had relatively higher disease burden. Reasons for non-initiation of biologic treatment among ‘biologic-suitable’ patients warrant further investigation to alleviate disease burden.

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ACR Meeting Abstracts - https://acrabstracts.org/abstract/comparison-of-clinical-characteristics-of-patients-with-rheumatoid-arthritis-receiving-their-first-biologic-and-biologic-naive-patients-considered-biologic-suitable-in-the-united-states/