Background/Purpose:

Long-term prospective observational studies are complementary to controlled clinical trials in exploring the effectiveness and safety of biological therapies in rheumatoid arthritis (RA). We sought to study abatacept survival, reasons of discontinuation and clinical responses in everyday clinical practice.

Methods:

Prospective, observational, single-center study at the Rheumatology Clinic, University Hospital of Heraklion, Greece. Patient demographics, co-morbidities and disease characteristics were recorded at baseline, while drug discontinuations, disease activity and adverse events were monitored during follow-up, All patients who received abatacept intravenously between 29/6/2017 till 31/8/2014 were analyzed.

Results:

243 RA patients (84% women, 44% with destructive arthritis) with median (IQR) age 61 (15) years (37% aged >65 years), disease duration 7.9 (11) years and DAS28 5.9 (1.6) at baseline were included. Total follow-up time was 407 patient-years [median (IQR): 1.4 (1.3) years per patient]. Abatacept was used as first, 2^nd or 3^rdbiologic agent in 28%, 34%, and 38% of the patients, respectively.

Forty percent of the patients discontinued therapy after median (IQR) 1.0 (1.1) years. Reasons for discontinuation were treatment failure in 88 patients, adverse events in 8, other reasons in 3. In multivariable regression analysis controlling for potential possible confounding factors (demographic, disease characteristics, treatments), independent predictors of abatacept survival were male sex, older age, abatacept used as 1^st or 2^nd (as compared to ≥3^rd) biologic agent, lower CRP and higher DAS28 and HAQ at baseline.

Regarding responses at 6 (12) months of therapy, 5.7% (13.2%) of patients had good and another 46.3% (47.6%) had moderate EULAR response, while 10.8% (16.5%) and 5.9% (7.8%) of the patients had DAS28 ≤3.2 or remission, respectively. The response rate at 12 months was higher in patients who received abatacept as 1^st or 2^nd as compared to ≥3^rdbiologic agent (p= 0.021).

257 adverse events were registered, 43 being serious adverse events (SAE). The rate of total or serious infections was 37 and 2.7 per 100 patients/year respectively, while the median (IQR) time to first serious infection was 1.3 (1.8) years. SAE (including 5 cancers and 11 infections, mainly of the respiratory tract) occurred more frequently in geriatric RA patients (p=0.05). 

Conclusion:

In this large, single-center observational study with abatacept-treated RA patients, nearly 60% of the patients remained on therapy and only 9% of drug discontinuations were due to adverse events. The majority of patients discontinued therapy due to inadequate response, mainly when abatacept was the third or more biologic agent administered. Abatacept when used as 1^st or 2nd line biologic agent has better survival and efficacy profile.

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ACR Meeting Abstracts - https://acrabstracts.org/abstract/abatacept-treated-rheumatoid-arthritis-patients-have-better-drug-survival-rate-when-abatacept-is-the-first-or-second-line-biologic-agent-with-an-excellent-overall-safety-profile-a-single-center-exper/