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Backround: Even after pre-treatment with up to three biologics adalimumab shows effectiveness in active psoriatic arthritis patients Tuesday 2217 Frank Behrens 1 , Michaela Koehm 1 , Diamant Thaci 2 , Brigitte Krummel-Lorenz 3 , Gerd Greger 4 , Bianca Wittig 4 and Harald Burkhardt 1 1 CIRI/Rheumatology, J.W. Goethe University, Frankfurt/Main, 2 Dermatology, J.W. Goethe University, Frankfurt/Main, 3 CIRI/Endokrinologikum, Frankfurt/Main, 4 Abbott GmbH & Co KG, Germany For the treatment of patients with psoriatic arthritis (PsA), only anti- tumour necrosis factor (TNF) biologics are licensed. Therefore, anti- TNF treatment failures are often switched to another anti-TNF agent, despite the fact that only minimal evidence of effectiveness is available for anti-TNF switch in PsA. Background: A multicentre, prospective observational study included patients (n=3320) with moderate to severe PsA treated with adalimumab (ADA) according indication. Treatment response to ADA when used as first-, second- or third/fourth-line anti-TNF-therapy in patients with active PsA in clinical routine care in Germany was measured. In addition to documentation of demographic data, disease activity assessments such as number of swollen (SJC) and tender joints (TJC), disease activity score in 28 joints (DAS28), enthesitis, dactylitis as well as target lesion score (TLS) and body surface area (BSA) for skin involvement were calculated at baseline and every 3 months during the first year of treatment, followed by every 6 months until the end of the 2-year treatment period. Differences of treatment effects were tested of significances by stepwise regression analyses. Methods: Conclusion: ADA treatment is effective in patients with active PsA on all facets of the disease (arthritis, enthesitis, dactylitis, nail involvement, and skin involvement). A switch from another anti-TNF results in a meaningful reduction in disease activity. In contrast to rheumatoid arthritis, in which previous anti-TNF use leads to a significant decrease in response, in PsA the reduction in SJC is independent of pre-treatment with anti-TNF agents. Nevertheless, the mean DAS after two years of treatment was lower in anti-TNF naïve patients than in those previously treated with anti-TNFs. Table 1: Demographic data and disease characteristics at baseline* A greater significant reduction in DAS28 was observed in the group of anti-TNF-naïve patients (-2.22) than in those pre-treated with at least one TNF (-1.79) (Figure 1). 58% of patients who were naive to anti-TNF agents fulfilled remission criteria (DAS28 <2.6) at month 24, while the proportion of pre-treated patients who achieved remission was lower (51.2% for 1 previous anti-TNF and 44.4% for ≥2 previous anti-TNF agents). Disclosure: Abbott GmbH & Co. KG sponsored the observational study and funded data analyses and medical writing services (provided by Sharon Cross, Mission Viejo, CA). Frank Behrens, Diamant Thaci, Brigitte Krummel-Lorenz and Harald Burkhardt have received honoraria, speaker’s fees, or compensation for consultancies, board memberships, or study documentation from Abbott GmbH & Co. KG. Bianca Wittig and Gerd Greger are employees of Abbott. Michaela Koehm has no conflicts of interest to report. Baseline demographic and disease characteristics are shown in Table 1. All patient demographics were well balanced across the different groups. In PsA patients treated with ADA, the reduction in disease activity was clinically meaningful regardless of the number of previously used anti-TNF agents (0, 1, or ≥ 2). SJC was reduced from 8.7 at baseline to 1.4 after 24 months (anti-TNF-naïve patients). A comparable reduction was seen in patients pre-treated with one (7.7 to 2.8) or two or more (8.5 to 1.9) anti-TNF agents. Results: Figure 1: DAS28 course during ADA-treatment Course of DAS28 over the ADA treatment period of 24 months in the three observed groups: anti-TNF naïve, one previous anti-TNF, and 2 or more previous anti-TNFs Figure 2: Proportion of patients with non- arthritic manifestations Baseline characteristics and disease activity were comparable in anti-TNF naïve and pre-treated patients, with a trend for earlier onset of psoriasis and PsA in patients who had failed prior anti-TNF therapy 2,0 2,5 3,0 3,5 4,0 4,5 5,0 0 3 6 9 12 15 18 21 24 DAS28 Month an TNF naïve one previous an TNF two or more previous an TNF A comparable reduction in the percentages of patients with dactylitis was seen in all groups during ADA treatment, while enthesitis and affected nail responses were better in TNF-na ve patients versus those who failed one or more anti-TNF agents (Figure 2). Additionally, skin response was comparable in all groups illustrated by an improvement in TLS of 77% in the TNF naïve group, and 71% in the pre-treated group with two or more anti-TNFs. Comparison of the proportion of patients with dactylitis, enthesitis, or affected nails (no involvement [none], mild involvement, or moderate to severe involvement) at baseline, month 12 and month 24 of ADA treatment. Anti-TNF naïve One previous anti-TNF Two or more previous anti-TNFs No. of previous anti-TNF agents 0 n=2588 1 n=624 ≥2 n=109 Age (years) 49.3 49.5 48.7 Gender (% female:% male) 48:52 51:49 47:53 Duration of PsA (years) 9.0 10.2 10.9 Onset of PsA (years) 40.3 39.2 37.8 Duration of psoriasis (years) 17.6 18.7 20.5 Onset of psoriasis (years) 31.7 30.9 28.3 No. of previous anti-TNF agents 0 n=2588 1 n=624 ≥2 n=109 BSA >20% (% of patients) 15.5 21.1 26.3 Arthritis (% poly:% oligo) 61:28 59:29 62:29 SJC 8.7 7.7 8.5 TJC 15.3 12.8 13.7 DAS28 4.71 4.45 4.74 0% 20% 40% 60% 80% 100% 0 12 24 Month 0 12 24 Month 0 12 24 Month 0% 20% 40% 60% 80% 100% 0 12 24 Month 0 12 24 Month 0 12 24 Month 0% 20% 40% 60% 80% 100% 0 12 24 Month 0 12 24 Month % % % % % % 0 12 24 Month Dactylitis Enthesitis Affected Nails none mild moderate to severe *Data are presented as mean values unless otherwise indicated
