Poster abstracts
initial and long-term treatment of moderate-to-severe psoriasis.
In Germany, FAEs have been licensed for > 20 years and are
commonly used as 1 st -line therapy. In the rest of Europe, there
is growing acceptance of FAEs as a systemic therapy option in
moderate-to-severe disease. Guidelines continue to evolve as ex-
perience grows outside Germany, and will need to be updated to
guide the use of the newly approved DMF monotherapy in future.
References:
1. NICE 2017. https://www.nice.org.uk/guidance/TA475
2. Nast A, et al. JEADV 2015;29:2277-94
3. Nast A, et al. 2017 https://bit.ly/2ESJhv3
4. Zweegers J, et al. 2014 https://bit.ly/2GtvwA2
5. Kolios AG, et al. Dermatol 2016. 232:385-406
6. Krogstad A. Psoriasis 2017 https://bit.ly/2F05vbh
7. Dauden E, et al. JEADV 2016;30 Suppl 2:1-18
8. Gisondi P, et al. JEADV 2017;31(5):774-790
P039
SECUKINUMAB PROVIDES RAPID AND SUSTAINED
RESOLUTION OF ENTHESITIS IN PSORIATIC
ARTHRITIS PATIENTS: POOLED ANALYSIS OF TWO
PHASE 3 STUDIES, FUTURE 2 AND FUTURE 3
Laura C Coates 1 , Dennis McGonagle 2 , Georg Schett 3 , Philip J
Mease 4 , Erhard Quebe-Fehling 5 , Darren L Asquith 6 , Lawrence Ra-
souliyan 7 , Shephard Mpofu 5 , Corine Gaillez 5
1
University of Oxford, Oxford, UK, 2 University of Leeds, Leeds, UK, 3 Uni-
versity of Erlangen-Nuremberg, Erlangen, Germany, 4 Swedish Medical
Centre and University of Washington, Seattle, USA, 5 Novartis Pharma AG,
Basel, Switzerland, 6 Novartis Pharmaceuticals UK Ltd., Camberley, UK,
7
RTI Health Solutions, Barcelona, Spain
Introduction: Enthesitis, one of the key features of psoriatic
arthritis (PsA), shows chronicity in 50–70% of affected patients
(pts).1 Secukinumab (SEC), a fully human monoclonal antibody
that selectively neutralises IL-17A, provided significant and sus-
tained improvement in the signs and symptoms of active PsA, with
sustained resolution of enthesitis in Phase 3 studies.2,3
Objectives: To evaluate the effect of SEC on resolution of enthesi-
tis count (EC; defined by Leeds Enthesitis Index) in PsA pts using
pooled data from two Phase 3 studies, FUTURE 2 (NCT01752634)
and FUTURE 3 (NCT01989468).
Methods: SEC and placebo (PBO) were administered weekly
during the first 4 weeks (wks) followed by subcutaneous mainte-
nance dosing every 4 weeks thereafter (PBO until Wk 16/24). The
re sults are reported only for SEC 300 and 150 mg (approved do-
ses). Pts with baseline (BL) enthesitis (BLE) or without BLE (No
BLE) were included. Evaluation through Wk 104 included: time
to first resolution of enthesitis (i.e. EC = 0); shift analysis of BL
EC (1, 2 or 3–6) to full resolution (FR) and partial resolution (PR;
reduction of EC) at Wks 24 and 104; and number of new enthesitis
sites developed in No BLE pts. Data are as observed in the overall
population; time to first resolution of enthesitis was analysed in
the overall population and by prior use of tumour necrosis factor
inhibitor (TNFi-naïve and -inadequate responders [IR]).
Results: A total of 466 pts had BLE with a mean EC of 3.1 ± 1.6,
and 246 pts had no BLE. Median days to resolution of EC in BLE
pts for SEC 300, 150 mg and PBO groups were 57, 85 and 167 in
overall population; 57, 85 and 120 in TNFi-naïve pts; and 92, 82
and 169 in TNFi-IR pts, respectively. In pts with BL EC = 1/2,
72%/61% (SEC 300 mg), 71%/66% (SEC 150 mg) and 45%/44%
(PBO), respectively, achieved FR at Wk 24, with FR in SEC groups
sustained or increased to 77%/81% (SEC 300 mg) and 75%/88%
(SEC 150 mg) at Wk 104. In BL EC = 3–6, 81% (SEC 300 mg),
73% (SEC 150 mg) and 71% (PBO) of pts achieved FR and PR
at Wk 24, with an increase of FR and PR to 88% (in both SEC
300 and 150 mg) at Wk 104. A total of 89% of pts with No BLE
did not develop enthesitis by Wk 104.
Conclusions: Time to resolution of enthesitis was earlier with SEC
than PBO in the overall population, with faster resolution observed
19
in TNFi-naïve than TNFi-IR pts. Majority of SEC-treated pts with
BL EC = 1/2 had FR by Wk 24, with further an improvement
by Wk 104. In pts with BL EC = 3–6, greater improvement was
observed with SEC 300 mg vs PBO in the proportion of pts with
FR and PR of enthesitis at Wk 24; further improvements were
observed in both SEC groups at Wk 104.
References:
1. Schett G, et al. Nat Rev Rheumatol. 2017;13:731–41.
2. Mease PJ, et al. N Engl J Med. 2015;373:1329–39.
3. McInnes IB, et al. Lancet 2015;386:1137–46.
P041
LONG-TERM SAFETY OF ADALIMUMAB (HUMIRA) IN
ADULT PATIENTS FROM GLOBAL CLINICAL TRIALS
ACROSS MULTIPLE INDICATIONS: AN UPDATED
ANALYSIS IN 29,987 PATIENTS REPRESENTING 56,951
PATIENT-YEARS
Gerd R. Burmester 1 , Remo Panaccione 2 , Kenneth B. Gordon 3 , Ja-
mes Rosenbaum 4 , Dilek Arikan 5 , Winnie L. Lau 5 , Rita Tarzynski-
Potempa 2
1
Charité - University Medicine Berlin, Berlin, Germany, 2 University of Cal-
gary, Calgary, AB, Canada, 3 Medical College of Wisconsin, Milwaukee,
WI, USA, 4 Oregon Health & Science University and Legacy Devers Eye
Institute, Portland, OR, USA, 5 AbbVie Inc., North Chicago, IL, USA
Introduction: Adalimumab is an anti–tumor necrosis factor-α
(TNF-α) agent indicated for the treatment of immune-mediated
diseases. The long-term safety of adalimumab was previously
reported in 23,458 patients representing up to 12 years of clinical
trial exposure in rheumatoid arthritis (RA), juvenile idiopathic
arthritis, ankylosing spondylitis (AS), psoriatic arthritis (PsA),
plaque psoriasis (Ps), and Crohn’s disease (CD).
Objectives: Here we report an updated analysis examining the
long-term safety of adalimumab in adult patients with RA, AS,
non-radiographic axial spondyloarthritis (nr-axSpA), peripheral
SpA (pSpA), PsA, Ps, hidradenitis suppurativa (HS), CD, ulcera-
tive colitis (UC), and non-infectious uveitis (UV).
Methods: Safety data from 78 clinical trials of adalimumab (RA,
33; AS, 5; nr-axSpA, 2; pSpA, 1; PsA, 3; Ps, 13; HS, 3; CD, 11;
UC, 4; UV, 2; other, 1) were included in these analyses, including
randomized controlled, open-label, and long-term extension stu-
dies conducted in Europe, North America, South America, Asia,
Australia, New Zealand, and South Africa through December
31, 2016. Adalimumab postmarketing surveillance data were not
included in this analysis. Safety assessments included all adverse
events (AEs) and serious AEs (SAEs) that occurred after the first
adalimumab study dose and up to 70 days (5 half-lives) after the
last study dose.
Results: This analysis included 29,987 patients, representing 56,951
patient-years of exposure. The majority of adalimumab exposure
was in RA studies (37,106 PYs). The most frequently reported SAE
of interest was infection (highest incidences in CD: 6.9, UV: 4.1,
RA: 3.9, and UC: 3.5). The overall standardized mortality ratio was
0.65, 95% CI [0.5, 0.74]. For most of the adalimumab populations
(AS, PsA, Ps, UC, CD, and RA), the observed number of deaths
was below what would be expected in an age- and sexadjusted po-
pulation. For HS, nr-axSpA, pSpA, and UV studies, the small size
of these trials precluded accurate assessment of the standardized
mortality ratio, and the 95% CIs all included 1.0.
Conclusion: This analysis of data from clinical trials of adali-
mumab demonstrated an overall safety profile consistent with
previous findings and with the TNF inhibitor class. No new safety
signals or tolerability issues with adalimumab treatment were
identified and, for most indications, the mortality rate was below
what would be expected in an age- and sexadjusted population.
Efficacy and safety data continue to support the well-established
benefits of adalimumab for the approved indications.
Previously Published Arthritis Rheumatol. 2017; 69 (suppl 10).
Acta Derm Venereol 2018