HUMIRA (adalimumab) Pasienten i fokus Pediatrisk Crohns Sykdom & Neglepsoriasis Tobias Heatta-Speicher, PhD Medical Affairs Manager LIS anbudsseminar 26. januar 2016 1
HUMIRA (adalimumab) rekombinant fullhumant monoklonalt antistoff til behandling av autoimmune lidelser og immunmedierte inflammatoriske sykdommer markedsføringstillatelse i Norge siden 2003 13 godkjente indikasjoner som inkluderer 4 pediatriske indikasjoner veletablert sikkerhetsprofil Humira SPC, avsnitt 4.1, sist oppdatert 12.12.2016 Burmester GR et al. Ann Rheum Dis. 2013;72(4):517-524.
Nytt om HUMIRA ved behandling av pediatrisk Crohns sykdom Indikasjonen ble utvidet til moderat aktiv pediatrisk Crohns sykdom i 2016 «Humira er indisert til behandling av moderat til alvorlig aktiv Crohns sykdom hos pediatriske pasienter (fra alderen 6 år), som har respondert utilstrekkelig på konvensjonell terapi inkludert primær ernæringsterapi og et kortikosteroid og/eller et immunmodulerende legemiddel, eller som ikke tolererer eller har kontraindikasjoner mot slike behandlinger» Oppdatert produktbeskrivelsen med data fra en langtids forlengelsesstudie i pasienter med pedcd Humira SPC, avsnitt 4.1, sist oppdatert 12.12.2016.
Nytt om HUMIRA ved behandling av pediatrisk Crohns sykdom: Stabil respons og remisjon over 5 år med Humira IMAgINE 1 (4-52 uker) IMAgINE 2 (inntil 5 år) IMAgINE 2: n = 100 ved oppstart n = 50 etter 5 år Prosentandel pasienter i respons/remisjon etter 5 år 100 80 60 40 20 46/50 37/50 92 % av gjenværende pasienter fortsatte å ha klinisk respons etter 5 år 74 % av gjenværende pasienter var i klinisk remisjon etter 5 år 0 Respons Remisjon Remisjon: PCDAI 10 Respons: Nedgang PCDAI 15 poeng TNF-α-hemmere som har indikasjon pediatrisk Crohns sykdom: Humira SPC, avsnitt 4.1, sist oppdatert 12.12.2016. Remicade, Remsima, Inflectra SPC, avsnitt 4.1, gjeldende per 18.01.2016.
Biologisk behandling (anti-tnf) av pediatrisk Crohns sykdom Nationwide observational cohort study Retrospective pt chart review 15 Dutch centres 53 pt with CD, IFX ADA (2005-2013) wpcdai or PGA Response: wpcdai 17.5 pts Response PGA: severe/moderate mild Remisjon: wpcdai <12.5 pts / PGA=0 Conclusions: In clinical practice, adalimumab induces remission in two-thirds of children with IFX refractory CD. Population-based registry study Retrospective pt chart review EPIMAD registry (Fr) 27 pt with CD, IFX ADA (2001-2010) PGA (1-4) Response PGA 2pt Remisjon: PGA=1 Conclusions: In the present populationbased cohort of pediatric-onset CD with IFX failure, treatment with ADA was safe and effective in two-thirds of patients. Cozijnsen M et al. JPGN 2015;60 205 210 Fumery M et al. JPGN 2015;60: 744 748
Nytt om HUMIRA og neglepsoriasis Nail psoriasis is a painful, chronic nail disease affecting patients with psoriasis, with or without psoriatic arthritis. Nail psoriasis may cause pain (at least half of patients) and restrict daily activities. In patients with plaque psoriasis, nail psoriasis has an estimated prevalence of over 50 %. Manhart R & Rich P. Clin Exp Rheumatol. 2015;33(Suppl 93):S7 S13.; de Jong EM et al. Dermatology. 1996;193(4):300-303. Klaassen KMG et al. Br J Dermatol. 2013;169:314 9. Pasch MC. Nail psoriasis. Drugs. 2016;76(6):675-705.
A Phase 3, Multicenter, Double-Blind, Randomized, Parallel-Arm, placebocontrolled Study to Evaluate the Safety and Efficacy of Adalimumab for Treatment of Nail Psoriasis in Subjects with Chronic Plaque Psoriasis Objective: To evaluate the safety and efficacy of adalimumab for the treatment of nail psoriasis in patients with moderate to severe chronic plaque psoriasis Primary endpoint: Proportion of subjects who achieved mnapsi75 response relative to baseline at Week 26 Key inclusion criteria: 18 years Chronic plaque psoriasis ( 6 months duration) and nail psoriasis (any duration) BSA 10 % or BSA 5 % and a total mnapsiscore 20 PGA-F and PGA-S at least moderate Target fingernail mnapsi 8 Placebo Adalimumab N=108 N=109 Elewski et al., P131, Presented at the 5th Congress of the Psoriasis International Network (Psoriasis 2016) Paris, France July 7 9, 2016
A Phase 3, Multicenter, Double-Blind, Randomized, Parallel-Arm, placebocontrolled Study to Evaluate the Safety and Efficacy of Adalimumab for Treatment of Nail Psoriasis in Subjects with Chronic Plaque Psoriasis % mnapsi 75 (%) Adalimumab (N=109) Placebo (N=108) Safety results: The safety results were comparable to those observed in other adalimumab trials for plaque psoriasis. No new safety risks associated with adalimumab were observed. Elewski et al., P131, Presented at the 5th Congress of the Psoriasis International Network (Psoriasis 2016) Paris, France July 7 9, 2016
A Phase 3, Multicenter, Double-Blind, Randomized, Parallel-Arm, placebocontrolled Study to Evaluate the Safety and Efficacy of Adalimumab for Treatment of Nail Psoriasis in Subjects with Chronic Plaque Psoriasis Summary This study demonstrated the effectiveness of the currently approved adalimumab psoriasis dose for the treatment of fingernail psoriasis. All primary and ranked secondary endpoints demonstrated clinically meaningful and statistically significant results vs. placebo. This study did not identify any new safety findings/risks associated with adalimumab treatment. Elewski et al., P131, Presented at the 5th Congress of the Psoriasis International Network (Psoriasis 2016) Paris, France July 7 9, 2016