ARTHRITIS & RHEUMATOLOGYVol. 66, No. S3, March 2014, pp S77–S78DOI 10.1002/art.38468© 2014, American College of Rheumatology

A52: The Impact of Adalimumab on Growth inPatients With Juvenile Idiopathic Arthritis

Daniel J. Lovell,1 Nicola Ruperto,2 Katerina Jarosova,3 Dana Nemcova,4

Veronika Vargova,3 Hartmut Michels,3 Elizabeth Chalom,5 Norman Ilowite,5

Carine Wouters,6 Hermine Brunner,7 Hartmut Kupper,8 Edward Giannini,5

and Alberto Martini6

Background/Purpose: Children with juvenile id-iopathic arthritis (JIA) often exhibit growth impair-ments. Treatment with adalimumab (ADA) has beenshown to be safe and effective in JIA patients (pts) whendosed every other week (eow) for up to 3 years, but theeffect of ADA on growth is not known. The purpose ofthis post hoc analysis is to describe growth parameters inpts with JIA treated with ADA in a clinical trial setting.

Methods: Pts aged 4–17 with polyarticular courseJIA were enrolled in a phase 3, randomized-withdrawal,double-blind (DB), stratified, parallel-group study,which consisted of a 16-wk open-label (OL) lead-inphase, a 32-wk DB phase, and an OL extension (OLE)phase. In the OLE phase, pts were dosed based on bodysurface area (24 mg/m2, max 40 mg dose), followed by aswitch to 20 or 40 mg eow based on a body weight of �30kg or �30 kg, respectively. To enter the DB phase, ptshad to achieve an American College of RheumatologyPediatric score �30% (ACR Pedi 30) during the OLlead-in. Pts could enter the OLE after 32 wks in the DBphase or at time of first flare (whichever came sooner).For this analysis, all pts who received �1 dose ofADA � methotrexate (MTX) were included and ptswere grouped by baseline height into 4 categories: �5th,�5th–�25th, �25th–�50th, and �50th percentile basedon the US Centers for Disease Control and Prevention(CDC) growth charts. Mean CDC percentile changes inheight, weight, and body mass index (BMI) percentiles

were calculated through 250 weeks. Growth and efficacydata were analyzed as observed.

Results: Among the 171 pts enrolled in this study,79% were female with a mean age of 11.1 years. 28(16%) were in the �5th percentile, and these pts had asignificantly different baseline height (130.5 cm) andweight (33.0 kg) compared with those pts who were �5th

percentile (147.0 cm and 43.9 kg, respectively). Addi-tionally, pts in the �5th percentile had a significantlyincreased disease duration of 5.7 years compared to 3.4years for �5th percentile. In the �5th and �5th–�25th

percentile, pts had a larger change in mean heightpercentile through 250 weeks of ADA treatment (10.5,13.5, 5.4, 4.0% change for �5th, �5th–�25th, �25th–�50th, and �50th percentile, respectively). Similar pat-terns were observed for BMI percentiles in these groups.ACR Pedi70 response rates improved over time in allgroups, reaching 80% for �5th, 94% for �5th–�25th,88% for �25th–�50th, and 96% for �50th percentilewith ADA treatment. From baseline to the final visit,there was a decrease in the number of pts that remainedin the �5th percentile category (Table).

Table. Distribution of Height and Weight by CDC Percentile at Baseline andFinal Visit

n (%)CDC Percentile

<5%CDC Percentile

>5–<25%CDC Percentile

>25–<50%CDC Percentile

>50%

Height, N�171Baseline 28 (16.4) 35 (20.5) 42 (24.6) 66 (38.6)Final Visit 20 (11.7) 39 (22.8) 32 (18.7) 80 (46.8)

Weight, N�171Baseline 22 (12.9) 39 (22.8) 36 (21.1) 74 (43.3)Final Visit 15 (8.8) 35 (20.5) 35 (20.5) 86 (50.3)

Conclusion: Long-term adalimumab treatmentwas associated with improvement and maintenance ofgrowth in children with JIA who were among the lowestCDC height percentiles at baseline. ADA treatment

1Cincinnati Children’s Hospital Medical Center, Cin-cinnati, OH, 2PRINTO, Gaslini Institute, Genoa, Italy, 3PRINTO,Gaslini Institute, Genova, Italy, 4General University Hospital inPrague, Prague, Czech Republic, 5PRCSG, Cincinnati Children’sHospital Medical Center, Cincinnati, OH, 6PRINTO, Genoa, Italy,7PRCSG, Cincinnati Children’s Hospital Medical Center, Genova,Italy, 8AbbVie Deutschland GmBH & Co. KG, Ludwigshafen, Ger-many.

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improved JIA signs and symptoms, regardless of base-line growth status.

Disclosure: D. J. Lovell, AbbVie Inc., AstraZeneca, Centocor, Bristol-MyersSquibb, Pfizer, Regeneron, Hoffman La-Roche, Novartis, UBC, Xoma, and Genen-tech, 5, Wyeth Pharmaceuticals, 8, Amgen and Forest Research, 9; N. Ruperto,AbbVie Inc., AstraZeneca, Bristol-Myers Squibb, Janssen Biologics B.V., Eli Lillyand Co., “Francesco Angelini”, GlaxoSmithKline, Italfarmaco, Novartis, Pfizer,Roche, Sanofi Aventis, Schwarz Biosciences GmbH, Xoma, and Wyeth Pharma-ceuticals, 9, Astellas, AstraZeneca, Bristol-Myers Squibb, Italfarmaco, Janssen

Biologics B.V., MedImmune, Roche, and Wyeth/Pfizer, 8; K. Jarosova, None; D.Nemcova, None; V. Vargova, None; H. Michels, AbbVie Inc, 5; E. Chalom,None; N. Ilowite, None; C. Wouters, None; H. Brunner, AbbVie Inc.,AstraZeneca, Centocor, Bristol-Myers Squibb, Pfizer, Regeneron, Hoffman La-Roche, Novartis, UCB, and Genentech, 5, Genentech Pharmaceuticals, 8; H.Kupper, AbbVie, 1, AbbVie, 3; E. Giannini, AbbVie Inc, 5; A. Martini,AbbVie Inc., AstraZeneca, Bristol-Myers Squibb, Janssen Biologics B.V., Eli Lillyand Co., “Francesco Angelini”, GlaxoSmithKline, Italfarmaco, Novartis, Pfizer,Roche, Sanofi Aventis, Schwarz Biosciences GmbH, Xoma, and Wyeth Pharma-ceuticals, 9, Astellas, AstraZeneca, Bristol-Myers Squibb, Italfarmaco, and Med-Immune, 8.

S78 THURSDAY, APRIL 3, 2014; 8:30 AM–6:00 PM