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Abstract Number: 3009

Safety and Effectiveness of Adalimumab±Methotrexate for the Treatment of Polyarticular Juvenile Idiopathic Arthritis

Daniel J Lovell1, Nicola Ruperto2, Carol Wallace1, Mary Toth1, Ivan Foeldvari2, John Bohnsack1, Diana Milojevic1, C. Egla Rabinovich1, Daniel Kingsbury1, Katherine Marzan1, Pierre Quartier3, Kirsten Minden2, Elizabeth Chalom1, Gerd Horneff2, Rolf M. Kuester2, Jason Dare1, Miriam Heinrich4, Hartmut Kupper4, Jasmina Kalabic4, Hermine I. Brunner1, Alberto Martini2 and on behalf of PRINTO and PRCSG, 1PRCSG, Cincinnati, OH, 2PRINTO-IRCCS, Genova, Italy, 3Hopital Necker-Enfants Malades, Paris, France, 4AbbVie Deutschland GmbH & Co. KG, Ludwigshafen, Germany

Meeting: 2016 ACR/ARHP Annual Meeting

Date of first publication: September 28, 2016

Keywords: Adalimumab, juvenile idiopathic arthritis (JIA) and methotrexate (MTX)

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Session Information

Date: Tuesday, November 15, 2016

Title: Pediatric Rheumatology – Clinical and Therapeutic Aspects II: Juvenile Arthritis

Session Type: ACR Concurrent Abstract Session

Session Time: 2:30PM-4:00PM

Background/Purpose:  Juvenile Idiopathic Arthritis (JIA) is the most common chronic inflammatory rheumatic diseases of childhood. Due to their long-term safety and efficacy, biologic disease modifying antirheumatic drugs (DMARD) are commonly necessary for control of polyarticular JIA (pJIA) patients (pts). The objective of this study is to evaluate 6-year (y) safety and 2 y effectiveness profile of Adalimumab with or without methotrexate (ADA±MTX) when used in current clinical practice for the treatment of moderately to severely active pJIA.

Methods:  This is a 6 y interim analysis of an ongoing, multicenter, non-interventional, observational registry of pts with moderately to severely active pJIA with up to10 y safety follow-up. Included pts are treated with either ADA±MTX or MTX alone as part of their routine clinical care enrolled in the US, EU, and Australia. MedDRA observational adverse events (AEs) were recorded from the first day in the registry through last contact, irrespective of the duration of registry treatment. Effectiveness was assessed by 27-joint juvenile arthritis disease activity score (JADAS27), based on CRP.

Results:  As of January 2014, enrollment was complete. As of June 1, 2015 cut-off date, 846 pts (543 in ADA±MTX and 303 in MTX groups) were treated in the registry. There were 39 pts who rolled over from the MTX to the ADA±MTX arm. At registry entry mean pJIA disease duration was 1.4 y and 3.7 y for MTX and ADA±MTX arms, respectively. At baseline (BL), mean AJC71 was 5.8 and 5.3 for MTX and ADA±MTX arms, respectively, and Childhood Health Assessment Questionnaire Disability Index (CHAQ-DI) was 0.6 for both arms. At data cutoff, the mean duration of study exposure was 1.81 y and 2.15 y for MTX and ADA±MTX arms, respectively. Overall, 206 pts (68%) in the MTX and 216 pts (39.8%) in the ADA±MTX arms discontinued registry drug through 6 y. The main reasons for registry drug discontinuation for the MTX arm: pts required additional therapy (32.3%), other (11.9%), lack of efficacy (10.9%), AEs (8.3%), or pts achieved JIA remission (7.6%), and for ADA±MTX arm: lack of efficacy (16%), lost to follow-up (7.2%), other (5.9%), and AEs (5.3%). Frequencies and rates of treatment-emergent AEs were similar to those reported for observational AEs (Table). There were no reports of deaths, malignancies, opportunistic infections, active TB, oral candidiasis, or CHF. Mean JADAS27(CRP) improved from 12.2 at BL to 9.7, 5.2, 4.4, 3.5, 2.2 at months 1, 6, and 12, 18, 24 for pts in the MTX and from 11.8 at BL to 7.0, 4.-2, 4.2, 3.6, 3.9 in the ADA±MTX arms, respectively (observed data).

Conclusion:  Overall, ADA±MTX was well-tolerated in these pts with pJIA with no new safety signals. Discontinuations from the registry drug were relatively high through 6 y, but greater in the MTX only arm.

Table: Overview of Observational Adverse Events (AEs)

MTX

ADA±MTX

N=303 n (%)

PYs=1014.6 E (E/100 PYs)

N=543 n (%)

PYs=1562.7 E (E/100 PYs)

Any AE

156 (51.5)

470 (46.3)

229 (42.2)

683 (43.7)

At least “possibly drug related” per the investigator

83 (27.4)

171 (16.9)

110 (20.3)

222 (14.2)

Severe AE

14 (4.6)

18 (1.8)

34 (6.3)

55 (3.5)

Serious AE

29 (9.6)

45 (4.4)

66 (12.2)

117 (7.5)

AE leading to discontinuation of study drug or study

25 (8.3)

33 (3.3)

35 (6.4)

56 (3.6)

Infectious AE

85 (28.1)

164 (16.2)

134 (24.7)

226 (14.5)

Serious infectious AE

12 (4.0)

15 (1.5)

26 (4.8)

36 (2.3)

Injection site-related AE

6 (2.0)*

8 (0.8)

28 (5.2)

37 (2.4)

*3 pts experienced injection site-related AEs with etanercept injections. During the registry, 47 (15.5%) pts in MTX arm and 38 (7.0%) pts in ADA arm started with biologic DMARD other than ADA. All except one pt in MTX arm had been documented as permanently discontinued registry drug or registry, at time of cut-off date for this analysis.


Disclosure: D. J. Lovell, AbbVie Inc., AstraZeneca, Centocor, Bristol-Myers Squibb, Boehringer-Ingelheim, Pfizer, Regeneron, Hoffman La-Roche, Novartis, UCB, and Genentech., 5,Genentech Pharmaceuticals., 8; N. Ruperto, AbbVie Inc., AstraZeneca, Bristol-Myers Squibb, Janssen Biologics B.V., Eli Lilly and Co., "Francesco Angelini", GlaxoSmithKline, Italfarmaco, Novartis, Pfizer, Roche, Sanofi Aventis, Schwarz Biosciences GmbH, Xoma, and Wyeth Pharmaceuticals., 9,Astellas, AstraZeneca, Bristol-Myers Squibb, Italfarmaco, Janssen Biologics B.V., MedImmune, Roche, and Wyeth/Pfizer., 8; C. Wallace, Pfizer and Amgen, 2,Amgen and Novartis., 5; M. Toth, None; I. Foeldvari, AbbVie and Novartis., 9; J. Bohnsack, Novartis., 5; D. Milojevic, Genentech and Novartis, 5; C. E. Rabinovich, UCB Pharma, Janssen Research & Development, LLC, Hoffmann-La Roche Inc., and AbbVie, 9; D. Kingsbury, AbbVie, 9; K. Marzan, AbbVie, 2; P. Quartier, AbbVie, Novartis, Pfizer, BMS, Chugai-Roche, Medimmune, Servier, and Swedish Orphan Biovitrum., 2,AbbVie, Novartis, Pfizer, BMS, Chugai-Roche, Medimmune, Servier, and Swedish Orphan Biovitrum., 5,Sanofi, 9; K. Minden, Pfizer, Abbvie, Roche/Chugai, Novartis, Medac and Pharma-Allergan., 5,Pfizer and Abbvie., 9; E. Chalom, AbbVie, 8; G. Horneff, AbbVie, Pfizer, and Roche, 2,AbbVie, Novartis, Pfizer, and Roche, 8; R. M. Kuester, AbbVie Inc. and Wyeth/Pfizer, 9; J. Dare, AbbVie, AstraZeneca, Bristol-Myers Squibb, Horizon Pharma, Medac, Pfizer, Roche and UCB, 9; M. Heinrich, AbbVie, 3; H. Kupper, AbbVie, 3; J. Kalabic, AbbVie, 3; H. I. Brunner, AbbVie Inc., AstraZeneca, Centocor, Bristol-Myers Squibb, Boehringer-Ingelheim, Pfizer, Regeneron, Hoffman La-Roche, Novartis, UCB, and Genentech, 5,Genentech Pharmaceuticals, 8; A. Martini, AbbVie Inc., AstraZeneca, Bristol-Myers Squibb, Janssen Biologics B.V., Eli Lilly and Co., "Francesco Angelini", GlaxoSmithKline, Italfarmaco, Novartis, Pfizer, Roche, Sanofi Aventis, Schwarz Biosciences GmbH, Xoma, and Wyeth Pharmaceuticals, 9,Astellas, AstraZeneca, Bristol-Myers Squibb, Italfarmaco, and MedImmune., 8.

To cite this abstract in AMA style:

Lovell DJ, Ruperto N, Wallace C, Toth M, Foeldvari I, Bohnsack J, Milojevic D, Rabinovich CE, Kingsbury D, Marzan K, Quartier P, Minden K, Chalom E, Horneff G, Kuester RM, Dare J, Heinrich M, Kupper H, Kalabic J, Brunner HI, Martini A. Safety and Effectiveness of Adalimumab±Methotrexate for the Treatment of Polyarticular Juvenile Idiopathic Arthritis [abstract]. Arthritis Rheumatol. 2016; 68 (suppl 10). https://acrabstracts.org/abstract/safety-and-effectiveness-of-adalimumab%c2%b1methotrexate-for-the-treatment-of-polyarticular-juvenile-idiopathic-arthritis/. Accessed .
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