Post on 22-Aug-2019
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Even after pre-treatment with up to three biologics adalimumab shows effectiveness in active psoriatic arthritis patients Tuesday 2217
Frank Behrens1, Michaela Koehm1, Diamant Thaci2, Brigitte Krummel-Lorenz3, Gerd Greger4, Bianca Wittig4 and Harald Burkhardt1
1CIRI/Rheumatology, J.W. Goethe University, Frankfurt/Main, 2Dermatology, J.W. Goethe University, Frankfurt/Main, 3CIRI/Endokrinologikum, Frankfurt/Main, 4Abbott 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 TNFnaïve
onepreviousan TNF
twoormorepreviousan 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-naive 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
an TNFnaïve
non
mild
moderatetosevere
0%
20%
40%
60%
80%
100%
0 12 24
Month
onepreviousan TNF
non
mild
moderatetosevere
0%
20%
40%
60%
80%
100%
0 12 24
Month
twoandmorepreviousan TNF
non
mild
moderatetosevere
0%
20%
40%
60%
80%
100%
0 12 24
Month
an TNFnaïve
non
mild
moderatetosevere
0%
20%
40%
60%
80%
100%
0 12 24
Month
onepreviousan TNF
non
mild
moderatetosevere
0%
20%
40%
60%
80%
100%
0 12 24
Month
twoormorean TNF
non
mild
moderatetosevere
0%
20%
40%
60%
80%
100%
0 12 24
Month
an TNFnaïve
non
mild
moderatetosevere
0%
20%
40%
60%
80%
100%
0 12 24
Month
onepreviousan TNF
non
mild
moderatetosevere
0%
20%
40%
60%
80%
100%
0 12 24
Month
twoormorepreviousan TNF
non
mild
moderatetosevere
Dactylitis
Enthesitis
Affected Nails
0%
20%
40%
60%
80%
100%
0 12 24
Month
twoormorepreviousan TNF
none
mild
moderatetosevere
*Data are presented as mean values unless otherwise indicated