Session Information
Date: Tuesday, November 15, 2016
Title: Rheumatoid Arthritis – Small Molecules, Biologics and Gene Therapy - Poster III
Session Type: ACR Poster Session C
Session Time: 9:00AM-11:00AM
Background/Purpose: South Africa is a tuberculosis (TB) endemic country having one of the highest TB infection rates in the world with close to 1000 cases per 100 000 population per year1. Screening for latent TB infection (LTBI) and treatment of any positive patient has reduced reactivation however the chance of TB infection remains high. Use of a biologic therapy with a lower risk of TB infection is a high priority. Bristol- Myers Squibb introduced a compassionate use programme (CUP) for RA patients who had completed long-term extension phases of clinical trials using subcutaneous (SC) abatacept 125 mg
Methods: Demographic, safety and clinical data were retrospectively collected from patient records of 50 patients receiving regular follow up during the CUP (June 2013 to December 2015)
Results: Data were received for 50 patients who completed the CUP. Eighty-six percent of patients (n=43) were still on SC abatacept at the end of 30 months. Discontinuation was due to adverse events 4% (n=2), lost to follow up 4% (n=2) and joint replacement 2% (n=1). Only 4% (n=2) discontinued due to lack of efficacy. Ten percent of all patients (n=5) experienced an adverse event after commencement of the CUP. In total, 7 adverse events were reported; 5 were classified as moderate and 2 as severe. The adverse events were as follows: bunionectomy (n=1; moderate); elbow replacement (n=1; moderate); pneumonia (n=1; moderate); right shoulder acromioplasty (n=1; moderate); right wrist replacement (n=1; severe); spastic colon (n=1; severe) and upper respiratory tract infection (n=1; moderate). No TB cases were recorded and general infections were recorded in 4% (n=2) which is similar to data published from other countries (3.1%) 2, 3. Seventy percent (n=35) of patients had one or more co-morbidity; of these 43% (n=15/35) were reported to have a co-morbidity that is cardiovascular in nature.
Conclusion: The evidence from the CUP programme provides insight into the retention of SC abatacept treatment as well as the safety of SC abatacept use in a TB endemic country. The results demonstrate that SC abatacept is a well-tolerated and safe treatment option with a good retention rate in South Africa.
- WHO Global tuberculosis report 2014
- Ruppert-Roth A. Rheumatology 2012; 51 (Suppl 5): v38-v47
- Alten R et al. Arthritis and Rheumatology 2014; 66 (8): 1987-1997
Table 1. Demographic and Disease Characteristics of Patients on the CUP
| Demographics | n/N (%) |
| Gender | |
| Male | 8/50 (16%) |
| Female | 42/50 (84%) |
| Age (in years) | |
| Mean | 60 |
| Population group | |
| Black African | 5/50 (10%) |
| Caucasian | 39/50 (78%) |
| Coloured | 5/50 (10%) |
| Indian | 1/50 (2%) |
| Disease duration (years from date of diagnosis) | |
| Mean | 15 |
| Minimum | 7 |
| Maximum | 47 |
| Sero-positivity | |
| Positive | 27/42 (64%) |
| Negative | 15/42 (36%) |
To cite this abstract in AMA style:
Louw I, Ally M, Janse van Rensburg D, Van Duuren E, Nel D, Miller-Janson H, de Necker M, de Beer J, Duvenhage H. Retention of Use and Safety of Subcutaneous Abatacept in Rheumatoid Arthritis: A Patient Record Assessment in a Compassionate Use Programme in South Africa, a Tuberculosis Endemic Country [abstract]. Arthritis Rheumatol. 2016; 68 (suppl 10). https://acrabstracts.org/abstract/retention-of-use-and-safety-of-subcutaneous-abatacept-in-rheumatoid-arthritis-a-patient-record-assessment-in-a-compassionate-use-programme-in-south-africa-a-tuberculosis-endemic-country/. Accessed .« Back to 2016 ACR/ARHP Annual Meeting
ACR Meeting Abstracts - https://acrabstracts.org/abstract/retention-of-use-and-safety-of-subcutaneous-abatacept-in-rheumatoid-arthritis-a-patient-record-assessment-in-a-compassionate-use-programme-in-south-africa-a-tuberculosis-endemic-country/