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Abstract
Background With the advent of biological therapy a range of new drugs have become available for patients with rheumatoid arthritis (RA). Adalimumab was one of the first biologicals to become widely available, and as many patients use biologicals indefinitely, data on very long-term efficacy and safety in daily clinical practice is important as results obtained in short-term clinical registration trials might differ from those observed in long-term daily clinical practice, especially after many years of continuous use.
Objectives To ascertain the efficacy and safety of very long- term adalimumab treatment for RA.
Methods From December 2004 to October 2013, 587 consecutive patients have been included in the adalimumab for RA (AdRA) cohort at the Jan van Breemen research center at Reade in Amsterdam, the Netherlands.
Results The mean age was 54 years (SD:13), and 469 (80%) were female. At baseline, the median disease duration was 7 (3–15) years, and 399 (70%) were Rheumatoid factor positive. At baseline, 373 (64%) used methotrexate, 183 (31%) used prednisolone, and 144 (25%) a DMARD other than MTX and 176 (39%) had used at least one other biological prior to start. On average patients had used 3.2 (SD:2.1) DMARDs. A total of 237 (40%) patients are currently on drug, and 350 (60%) patients have dropped out. The median follow-up duration was 4.0 (IQR:1.0–7.2) years for patients currently still on adalimumab treatment, and 0.7 (0.3–2.2) years for drop-outs. The maximum follow-up duration was 9.2 years, the total was 1507 patients years. The main reason for discontinuing adalimumab treatment were failure (121, 35%), followed by adverse events (69, 20%). Eight (2%) patients discontinued because of remission and 3 (1%) patients died while on drug (one of sepsis, one of lung cancer, and one at age 84 of unknown causes). In total 1892 adverse events were reported by patients, who deemed 137 to be severe, 51 times patients required hospitalization, and 317 times antibiotics were given.
The mean DAS-28 drops significantly from 4.9 (SD: 1.3) at baseline to 3.3 (1.4) at 16 weeks. This improvement was sustained, and steadily improved further over the whole 9 years with a DAS-28 of 2.8 (1.3), 2.6 (1.2), 2.6 (1.2) and 2.2 (0.6) at 1, 2, 5 and 9 years, respectively (see Figure 1). The patient reported outcome of patient global assessment (PGA) was also good, the mean PGA drops from 60 (23) to 35 (25) at 16 weeks of treatment, and remains stable after that with a mean PGA of 29 (23), 26 (22), 27 (22) and 29 (28) at 1, 2, 5 and 9 years, respectively (see Figure 1).
Conclusions The initial good response on adalimumab persists for the 9 years of follow-up, with the decrease in DAS28 continuing for the entire 9 years. Over time, a satisfactory response in DAS28 and PGA is sustained during further follow-up for 9 years.
Disclosure of Interest I. Visman: None declared, G.-J. Wolbink: None declared, M. Nurmohamed Grant/research support from: AbbVie, BMS, Pfizer, UCB, Roche; (Ad Hoc), Consultant for: Abbott, BMS, Pfizer, Roche, Biogen, Speakers bureau: AbbVie, Pfizer, Roche