ADALIMUMAB (HUMIRA®) THERAPY IS EFFECTIVE AND WELL–TOLERATED IN ANKYLOSING SPONDYLITIS (AS), RHEUMATOID ARTHRITIS (RA), OR PSORIATIC ARTHRITIS (PSA) PATIENTS WITH A HISTORY OF ANTI–TNF THERAPY

Background: Patients (pts) with active AS, RA, or PsA may not respond optimally to or may be intolerant of treatment with etanercept (ETN) or infliximab (IFX).Objectives: To investigate the effectiveness and safety of adalimumab (ADA) treatment in pts with AS, RA, or PsA who had prior ETN and/or IFX therapy. To stratify effectiveness analyses by type of prior TNF antagonists and reason for prior discontinuation in pts with AS or RA (not done for PsA because of the relatively small number of pts).Methods: Pts with active disease were enrolled in large, open-label studies (AS:RHAPSODY, RA:ReAct, PsA: STEREO) in which ADA 40 mg subcutaneously every other week (wk) was added to their current antirheumatic treatment regimens for 12 wks. Pts with prior TNF experience (pTNF) could enroll only if IFX had been discontinued ≥2 months before baseline (BL); and/or if ETN had been discontinued ≥3 wks before BL of RHAPSODY and STEREO or ≥2 months before entry in ReAct. For AS and RA, analyses were conducted by the type of prior TNF (PsA analyses were not conducted because of small patient samples). Investigators could report 3 reasons for discontinuation: no response, loss of initial response, or intolerance.Results: At BL, mean (mn) age (yrs) of pts with/without pTNF was 44/44 (AS), 53/54 (RA), and 47/48 (PsA), respectively. The mns of disease duration ranged from 9–12 yrs across the 3 subgroups. BL DAS28 scores were 5.1/4.9 for 66/376 PsA pts with/without pTNF. For PsA pts with/without pTNF, Week 12 mn changes in DAS28 were –2.1/–2.3, and 42/52% pts achieved ACR50, respectively. BL disease characteristics and effectiveness data of pts with RA or AS are shown in the table below. Mn changes in BASDAI in pts with AS previously treated with ETN/IFX were –2.4/–2.9. Mn change in DAS28 in pts with RA previously treated with ETN and IFX was –2.0/–2.0. ADA safety data were comparable for pts with/without pTNF: % pts with a serious infection was reported for AS (0.3/0.3%); RA, (1.3/2.0%); and PsA (0.0/1.5%), respectively. There were no differences in safety between the 3 subgroups. Effectiveness of ADA by Indication, Prior Anti-TNF, and Reason for Discontinuation AS, n=1,250 (RHAPSODY) Baseline Week 12 BASDAI BASFI ASAS 20% ASAS40% ΔBASDAI ΔBASFI [0-10] [0-10] No prior TNF (n=924) 6.2 5.2 76 59 –3.5 –2.4 ≥1 pTNF (n=326) 6.5 5.7 54 38 –2.6 –1.6 No response n=84 6.9 6.1 41 27 –1.9 –0.9 Lost response n=136 6.7 5.8 61 42 –3.0 –1.9 Intolerance n=62 6.0 5.5 54 37 –2.6 –1.6 RA, n=6,610 (ReAct) DAS28 HAQ DI [0–3] ACR20% ACR50% ΔDAS28 ΔHAQ DI No pTNF n=5,711 6.0 1.60 70 41 –2.2 –0.55 ≥1 pTNF n= 899 6.3 1.85 60 33 –1.9 –0.48 No response n=195 6.5 2.01 51 26 –1.8 –0.42 Lost response n=327 6.2 1.84 66 36 –1.9 –0.50 Intolerance n=188 6.4 1.82 67 39 –2.2 –0.55 Conclusion: Adalimumab is effective and well–tolerated in patients with a history of prior ETN and/or IFX therapy for AS, RA, or PsA. There is a somewhat higher response rate in patients who had lost the initial response to or had been intolerant of the prior TNF antagonist compared to patients who had no response to their prior TNF therapy.Citation: Ann Rheum Dis, volume 67, supplement II, year 2008, page 177Session: RA – Anti-TNF therapy