natgillin/translations-raw huggingface dataset:
The rate of pregnancies ending with at least one live born infant with a major birth defect was 6/69 (8.7 %) in the adalimumab-treated women with RA and 5/74 (6.8 %) in the untreated women with RA (unadjusted OR 1.31, 95 % CI 0.38-4.52) and 16/152 (10.5 %) in the adalimumab-treated women with CD and 3/32 (9.4 %) in the untreated women with CD (unadjusted OR 1.14, 95 % CI 0.31-4.16).
Razmerje nosečnosti, ki so se končale vsaj z enim živorojenim otrokom z večjim defektom ob rojstvu je bilo 6/69 (8,7 %) pri nosečnicah, zdravljenih z adalimumabom z RA, in 5/74 (6,8 %) pri nezdravljenih nosečnicah z RA (neprilagojeno razmerje obetov 1.31, 95 % interval zaupanja 0.38-4.52), ter 16/152 (10,5 %) pri nosečnicah, zdravljenih z adalimumabom s CB, in 3/32 (9,4 %) pri nezdravljenih nosečnicah s CB (neprilagojeno razmerje obetov 1.14, 95 % interval zaupanja 0.31-4.16).
The conduct and results of these tests should be recorded on your child's Patient Reminder Card.
Izvedbo in rezultate teh preiskav je treba zabeležiti na otrokovi Opozorilni kartici za bolnika.
Prescribers should exercise caution in considering the use of Imraldi in patients with pre-existing or recent-onset central or peripheral nervous system demyelinating disorders; discontinuation of Imraldi should be considered if any of these disorders develop.
Pri odločanju za uporabo zdravila Imraldi pri bolnikih z že prej obstoječimi ali nedavno nastalimi demielinizirajočimi boleznimi osrednjega ali perifernega živčevja je potrebna previdnost; če se razvije katera od teh bolezni, je treba razmisliti o prenehanju zdravljenja z zdravilom Imraldi.
79 (73.1)a, b a p<0.001 adalimumab vs. placebo b p<0.001 adalimumab vs. methotrexate c p<0.01 adalimumab vs. placebo d p<0.05 adalimumab vs. methotrexate
79 (73,1)a, b a p < 0,001 adalimumab v primerjavi s placebom b p < 0,001 adalimumab v primerjavi z metotreksatom c p < 0,01 adalimumab v primerjavi s placebom d p < 0,05 adalimumab v primerjavi z metotreksatom
Women of childbearing potential should consider the use of adequate contraception to prevent pregnancy and continue its use for at least five months after the last Imraldi treatment.
Ženske v rodni dobi morajo premisliti o uporabi ustrezne kontracepcijske zaščite za preprečitev nosečnosti in z njo nadaljevati vsaj še pet mesecev po zadnjem zdravljenju z zdravilom Imraldi.
673 patients with active nr-axSpA (mean baseline disease activity [BASDAI] was 7.0) who had an inadequate response to ≥ 2 NSAIDs, or an intolerance to or a contraindication for NSAIDs enrolled into the open-label period of study nr-axSpA II during which they received adalimumab 40 mg eow for 28 weeks.
673 bolnikov z aktivnim nr-axSpA (srednja vrednost aktivnosti bolezni [BASDAI] je bila 7,0), ki so nezadostno reagirali na vsaj dva NSAID ali niso prenašali NSAID ali s kontraindikacijo za NSAID, je bilo vključenih v odprto fazo študije nr-axSpA II, v kateri so prejemali zdravilo adalimumab 40 mg vsak drugi teden 28 tednov.
• Use your other hand to flip the pink needle cover down toward the syringe.
• Z drugo roko obrnite rožnati pokrovček igle dol proti brizgi.
How to use Imraldi
Kako uporabljati zdravilo Imraldi
• Gently flip the pink needle cover up, over the needle and snap into place and set the syringe with needle on the work surface.
• Previdno obrnite rožnati pokrovček igle gor, čez iglo, da se zaskoči na mesto, in položite brizgo z iglo na delovno površino.
RA study II evaluated 544 patients with moderately to severely active rheumatoid arthritis who were ≥18 years old and had failed therapy with at least one disease-modifying, anti-rheumatic drugs.
V študiji revmatoidnega artritisa II je bilo ocenjeno 544 bolnikov z zmerno do hudo aktivnim revmatoidnim artritisom, starih ≥ 18 let, pri katerih zdravljenje z vsaj enim imunomodulirajočim antirevmatičnim zdravilom ni bilo uspešno.
Of the patients who lost adequate response after re-randomisation to placebo who then enrolled into the open-label extension trial, 38 % (25/66) and 55 % (36/66) regained PASI 75 response after 12 and 24 weeks of re-treatment, respectively.
Med bolniki, ki so izgubili ustrezen odziv ob ponovni randomizaciji na placebo med podaljšanim odprtim preskušanjem, je po 12 tednih ponovne terapije PASI 75 znova doseglo 38 % (25/66), po 24 tednih pa 55 % (36/66) bolnikov.
Rates of discontinuation of corticosteroids or immunomodulators are presented in Table 21.
Stopnja prenehanja zdravljenja s kortikosteroidi ali imunomodulatorji je predstavljena v preglednici 21.
- Your doctor will also give you a Patient Reminder Card, which contains important safety information that you need to be aware of before your child is given Imraldi and during treatment with Imraldi.
- Zdravnik vam bo dal tudi Opozorilno kartico za bolnika, ki vsebuje pomembne varnostne informacije, s katerimi morate biti seznanjeni, preden vaš otrok prejme zdravilo Imraldi in med zdravljenjem z njim.
solution for injection 1 vial
raztopina za injiciranje 1 viala
Imraldi works by reducing this inflammation.
Zdravilo Imraldi deluje tako, da zmanjša tako vnetje.
No ALT elevations ≥3 × ULN occurred in the Phase 3 trial of adalimumab in paediatric patients with plaque psoriasis.
Do nobenih zvišanj ALT ≥ 3 × ULN ni prišlo v preskušanju faze 3 z adalimumabom pri pediatričnih bolnikih s psoriazo v plakih.
Neurologic evaluation should be performed in patients with non-infectious intermediate uveitis prior to the initiation of Imraldi therapy and regularly during treatment to assess for pre-existing or developing central demyelinating disorders.
Pri bolnikih z neinfekcijskim intermediarnim uveitisom je treba pred začetkom zdravljenja z zdravilom Imraldi in redno med zdravljenjem opravljati nevrološko oceno, da se oceni že obstoječe ali razvijajoče se demielinizirajoče bolezni osrednjega živčevja.
Imraldi is used to treat children from 2 years of age with chronic non-infectious uveitis with inflammation affecting the front of the eye.
Zdravilo Imraldi se uporablja za zdravljenje otrok, starejših od 2 let, s kroničnim neinfekcijskim uveitisom, kjer vnetje prizadene sprednji del očesa.
Week 52 Open-label
52. teden Odprta
- Your doctor will also give you a Patient Reminder Card, which contains important safety information that you need to be aware of before you are given Imraldi and during treatment with Imraldi.
- Zdravnik vam bo dal tudi Opozorilno kartico za bolnika, ki vsebuje pomembne varnostne informacije, s katerimi morate biti seznanjeni, preden prejmete zdravilo Imraldi in med zdravljenjem z njim.
If you use more Imraldi than you should
Če ste uporabili večji odmerek zdravila Imraldi, kot bi smeli
At week 12, a significantly higher proportion of patients in study HS-II experienced a clinically relevant decrease in HS-related skin pain (see Table 21).
V 12. tednu je statistično pomembno večji delež bolnikov v študiji HS-II občutil klinično pomembno zmanjšanje bolečine na koži, povezane s HS (glejte preglednico 21).
At week 12, a significantly higher proportion of patients in study HS-II experienced a clinically relevant decrease in HS-related skin pain (see Table 17).
V 12. tednu je statistično pomembno večji delež bolnikov v študiji HS-II občutil klinično pomembno zmanjšanje bolečine na koži, povezane s HS (glejte preglednico 17).
Among patients who were at least partial responders at week 12, and who received continuous weekly adalimumab therapy, the HiSCR rate at week 48 was 68.3% and at Week 96 was 65.1%.
Pri bolnikih z vsaj delnim odzivom na adalimumab v odmerku 40 mg v 12. tednu, in ki so prejemali neprekinjeno tedensko terapijo adalimumaba vsak teden, je bila stopnja kliničnega odziva (HiSCR) v 48. tednu 68,3 %, v 96. tednu pa 65,1 %.
Place your pre-filled pen and alcohol pads on a clean, dry surface.
Napolnjen injekcijski peresnik in alkoholne zložence položite na čisto, suho površino.
A total of 347 stable responders participated in a withdrawal and retreatment evaluation in an open-label extension study.
V odprti podaljšani študiji je v oceni prenehanja uporabe in ponovnega zdravljenja sodelovalo skupno 347 stabilnih odzivnih bolnikov.
Your doctor will decide if your child should receive Imraldi.
On se bo odločil, ali lahko vaš otrok dobiva zdravilo Imraldi.
Of 542 patients who were randomised to adalimumab 40 mg every other week, 170 patients continued on adalimumab 40 mg every other week for 10 years.
Od 542 bolnikov, ki so bili randomizirani na 40 mg adalimumaba vsak drugi teden, jih je 170 nadaljevalo zdravljenje s 40 mg adalimumaba vsak drugi teden še 10 let.
If your doctor considers that methotrexate is inappropriate, Imraldi can be given alone.
Če zdravnik meni, da metotreksat ni primeren, lahko zdravilo Imraldi dobivate samo.
It is important that you tell your baby's doctors and other health care professionals about your Imraldi use during your pregnancy before the baby receives any vaccine (for more information on vaccines see the “Warnings and precautions” section).
Pomembno je, da obvestite zdravnika vašega dojenčka in druge zdravstvene delavce, da ste med nosečnostjo prejemali zdravilo Imraldi, preden bo vaš dojenček prejel katerokoli cepivo (za več informacij o cepljenju glejte poglavje "Opozorila in previdnostni ukrepi").
1 sterile injection syringe 1 sterile needle 1 sterile vial adapter 2 alcohol pads
1 sterilno injekcijsko brizgo 1 sterilno iglo 1 sterilen adapter za vialo
Tell your doctor if your child is taking azathioprine or mercaptopurine with Imraldi.
Povejte zdravniku, če vaš otrok prejema azatioprin ali merkaptopurin sočasno z zdravilom Imraldi.
The safety and efficacy of adalimumab were assessed in randomised, double-blind, placebo-controlled studies and an open-label extension study in adult patients with moderate to severe hidradenitis suppurativa (HS) who were intolerant, had a contraindication or an inadequate response to at least a 3month trial of systemic antibiotic therapy.
Varnost in učinkovitost adalimumaba so raziskali v randomiziranih, dvojno slepih študijah, kontroliranih s placebom, in v odprti podaljšani študiji pri odraslih bolnikih z zmerno do hudo obliko hidradenitis suppurativa (HS), ki imajo intoleranco, kontraindikacijo ali se ne odzovejo zadovoljivo pri vsaj 3-mesečnem preskušanju sistemske antibiotične terapije.
In the open-label lead in phase (OL LI) patients were stratified into two groups, MTX (methotrexate)-treated or non-MTX- treated.
V odprti uvajalni fazi so bolnike stratificirali v dve skupini: zdravljene z metotreksatom in zdravljene brez metotreksata.
In rheumatoid arthritis, methotrexate is continued while using Imraldi.
Pri revmatoidnem artritisu se uporaba metotreksata med uporabo zdravila Imraldi nadaljuje.
Adalimumab 40 mg every other week was assessed in 393 patients in two randomised, 24 week double blind, placebo − controlled studies in patients with active ankylosing spondylitis (mean baseline score of disease activity [Bath Ankylosing Spondylitis Disease Activity Index (BASDAI)] was 6.3 in all groups) who have had an inadequate response to conventional therapy.
40 mg adalimumaba vsak drugi teden so ocenili v dveh randomiziranih 24-tedenskih dvojno slepih, s placebom kontroliranih študijah pri 393 bolnikih z aktivnim ankilozirajočim spondilitisom (povprečna izhodiščna ocena aktivnosti bolezni [indeks BASDAI (Bathov indeks bolezenske aktivnosti ankilozirajočega spondilitisa - Bath Ankylosing Spondylitis Disease Activity Index)] je bil v vseh skupinah 6,3), ki se niso odzvali ustrezno na konvencionalno terapijo.
The decision to stop using Imraldi should be discussed with your doctor.
O odločitvi, da bi prenehali uporabljati zdravilo Imraldi, se morate posvetovati z zdravnikom.
Upon completion of the first 52 weeks, 457 patients enrolled in an open-label extension phase in which 40 mg of adalimumab/MTX was administered every other week up to 10 years.
Po zaključenih prvih 52 tednih so 457 bolnikov vključili v odprto nadaljevalno fazo, med katero so dobivali 40 mg adalimumaba/MTX vsak drugi teden v obdobju do 10 let.
If you accidentally inject a larger amount of Imraldi liquid, or if you inject Imraldi more frequently than you should, call your child's doctor or pharmacist and explain that your child has taken more.
Če pomotoma injicirate več tekočine z zdravilom Imraldi ali pa zdravilo Imraldi injicirate pogosteje, kot bi smeli, se morate posvetovati z zdravnikom svojega otroka ali farmacevtom in razložiti, da je vaš otrok dobil večji odmerek.
If your doctor determines that methotrexate is inappropriate, Imraldi can be given alone.
Če zdravnik ugotovi, da metotreksat ni primeren, lahko zdravilo Imraldi dobivate samo.
Among patients whose adalimumab treatment was withdrawn at week 12 in studies HS-I and HS-II, the HiSCR rate 12 weeks after re-introduction of adalimumab 40 mg weekly returned to levels similar to that observed before withdrawal (56.0 %).
Med bolniki, pri katerih je bilo zdravljenje z adalimumabom ukinjeno v 12. tednu v študijah HS-I in HS-II, se je po ponovni uvedbi 40 mg adalimumaba enkrat na teden raven kliničnega odziva (HiSCR) vrnila na podobno raven, kot so jo opazili pred ukinitvijo (56,0 %).
• Tell your doctor if you reside or travel in regions where fungal infections such as histoplasmosis, coccidioidomycosis or blastomycosis are endemic.
• Zdravniku morate povedati, če živite na območju ali potujete v predele, kjer so endemične glivične okužbe, npr. histoplazmoza, kokcidioidomikoza ali blastomikoza.
After two further weeks, continue with a dose of 40 mg every week or 80 mg every other week, as prescribed by your doctor.
Čez nadaljnja dva tedna nadaljujte z odmerkom 40 mg vsak teden ali 80 mg vsak drugi teden, kot vam je predpisal zdravnik.
The Imraldi vial is a glass vial containing a solution of adalimumab.
Viala z zdravilom Imraldi je steklena viala, ki vsebuje raztopino adalimumaba.
Vial disposal
Odstranjevanje viale
After treatment with adalimumab, a rapid decrease in levels of acute phase reactants of inflammation (Creactive protein (CRP) and erythrocyte sedimentation rate (ESR)) and serum cytokines (IL-6) was observed, compared to baseline in patients with rheumatoid arthritis.
Po zdravljenju z adalimumabom so pri bolnikih z revmatoidnim artritisom opažali hitro znižanje reaktantov akutne faze vnetja (C-reaktivnega proteina (CRP) in hitrosti sedimentacije eritrocitov (SR)) in serumskih citokinov (IL-6) v primerjavi z izhodiščem.
The serum levels of free adalimumab (not bound to anti-adalimumab antibodies, AAA) were observed to be lower in patients with measurable AAA.
Ugotovljeno je bilo, da so koncentracije prostega adalimumaba (tistega, ki ni vezan na protitelesa proti adalimumabu) v serumu manjše pri bolnikih, ki imajo merljivo raven teh protiteles.
Patients who had been randomised to placebo in Period A were assigned to receive adalimumab 40 mg every week in Period B.
Bolniki, ki so jih randomizirali na placebo v obdobju A, so v obdobju B prejemali 40 mg adalimumaba vsak teden.
Polyarticular juvenile idiopathic arthritis from 2 years of age
Poliartikularni juvenilni idiopatski artritis od 2. leta starosti
• Peel the clear package just far enough to expose the white plunger rod, but do not take the syringe out of the package.
• Odlepite ovojnino ravno toliko, da odkrijete beli nosilec bata, vendar brizge ne vzemite iz ovojnine.
• There have been very rare cases of certain kinds of cancer in children and adults taking Imraldi or other TNFα blockers.
• Med otroci in odraslimi, ki so jemali zdravilo Imraldi ali druge zaviralce TNFα, so se pojavili zelo redki primeri določenih vrst raka.
The safety and efficacy of adalimumab was assessed in an open-label, multicentre study in 32 children (2<4 years old or aged 4 and above weighing <15 kg) with moderately to severely active polyarticular JIA.
Varnost in učinkovitost adalimumaba so ocenili v odprti, multicentrični študiji pri 32 otrocih (starih od 2 do < 4 leta ali starih 4 leta ali več in s telesno maso < 15 kg) z zmernim do zelo aktivnim poliartikularnim JIA.
A total of 76.5% (218/285) of patients who entered the retreatment period had a response of PGA “clear” or “minimal” after 16 weeks of retreatment, irrespective of whether they relapsed during withdrawal (69.1 %[123/178] and 88.8 % [95/107] for patients who relapsed and who did not relapse during the withdrawal period, respectively).
Od bolnikov, deležnih ponovnega zdravljenja, jih je skupno 76,5 % (218/285) po 16 tednih ponovnega zdravljenja imelo odziv PGA "čisto" ali "minimalno", ne glede na to, ali je med prenehanjem uporabe prišlo do relapsa (69,1 % [123/178] bolnikov, pri katerih je med prenehanjem uporabe prišlo do relapsa, in 88,8 % [95/107]
The combination of Imraldi and anakinra is not recommended (see section 4.4 “Concurrent administration of biologic DMARDS or TNF-antagonists”).
Kombinacija zdravila Imraldi in anakinre ni priporočljiva (glejte poglavje 4.4 “Sočasna uporaba bioloških DMARDS ali antagonistov TNF”).
• Tell your doctor if your child resides or travels in regions where fungal infections such as histoplasmosis, coccidioidomycosis or blastomycosis are endemic.
• Zdravniku morate povedati, če vaš otrok živi na območju ali potuje v predele, kjer so endemične glivične okužbe, npr. histoplazmoza, kokcidioidomikoza ali blastomikoza.
• low blood measurements for white blood cells, red blood cells and platelet count.
• nizke krvne vrednosti za bele krvne celice, rdeče krvne celice in trombocite.
Clinical remission Clinical response
Klinična remisija Klinični odziv
Adalimumab significantly delayed the time to treatment failure, as compared to placebo (See Figure 3, P < 0.0001 from log rank test).
Adalimumab je značilno podaljšal čas do neuspeha zdravljenja v primerjavi s placebom (glejte sliko 3, p < 0,0001 iz testa log-rank).
The incidence of serious infections was 0.04 per patient year in adalimumab treated patients and 0.03 per patient year in placebo and active control-treated patients.
Incidenca resnih okužb je bila 0,04 na bolnikov-let med bolniki, ki so dobivali adalimumab, in 0,03 na bolnikov-let med bolniki, ki so dobivali placebo oziroma kontrolno učinkovino.
Disease flare criteria were defined as a worsening of ≥30% from baseline in ≥3 of 6 Paediatric ACR core criteria, ≥2 active joints,
Merila zagona bolezni so bila opredeljena kot poslabšanje ≥ 3 od 6 osnovnih meril Paediatric ACR za ≥ 30 % v primerjavi z izhodiščem, ≥ 2 aktivna sklepa in izboljšanje ne več kot 1 od 6 meril za > 30 %.
• DO NOT use the white plunger rod to remove the syringe from the package.
• NE UPORABITE belega nosilca bata, da bi brizgo potegnili iz ovojnine.
In the pivotal controlled trials in adults and children, the rate of infection was 1.51 per patient year in the adalimumab treated patients and 1.46 per patient year in the placebo and active control-treated patients.
V kontroliranih preskušanjih, ki podpirajo vlogo za pridobitev dovoljenja za promet, pri odraslih in otrocih je bil delež okužb 1,51 na bolnikov-let med bolniki, ki so dobivali adalimumab, in 1,46 na bolnikov-let med bolniki, ki so dobivali placebo oziroma kontrolno učinkovino.
Your doctor may recommend temporary discontinuation.
Zdravnik bo morda priporočil začasno prenehanje uporabe zdravila.
Imraldi may have a minor influence on the ability to drive, cycle or use machines.
Zdravilo Imraldi ima lahko blag vpliv na sposobnost vožnje, kolesarjenja ali upravljanja strojev.
Adalimumab significantly delayed the time to treatment failure, as compared to placebo (See Figure 1, P < 0.0001 from log rank test).
Adalimumab je značilno podaljšal čas do neuspeha zdravljenja v primerjavi s placebom (glejte sliko 1, p < 0,0001 iz testa log-rank).
PsA study I with 24 week duration, treated 313 adult patients who had an inadequate response to non-steroidal anti-inflammatory drug therapy and of these, approximately 50 % were taking methotrexate.
V njej so zdravili 313 odraslih, ki se niso ustrezno odzvali na terapijo z nesteroidnimi protivnetnimi zdravili; približno 50 % od teh je jemalo metotreksat.
Coagulation and bleeding disorders (including activated partial thromboplastin time prolonged), autoantibody test positive (including double stranded DNA antibody), blood lactate dehydrogenase increased
pogosti koagulacija in motnje krvavenja (vključno s podaljšanim aktiviranim parcialnim tromboplastinskim časom), prisotnost avtoprotiteles (vključno s protitelesi proti dvovijačni DNA),
• If your child has or develops a demyelinating disease (a disease that affects the insulating layer around the nerves, such as multiple sclerosis), your doctor will decide if he/she should receive or continue to receive Imraldi.
• Če vaš otrok ima ali se pri njem razvija demielinizirajoča bolezen (bolezen, ki prizadene izolativno plast okoli živcev, kot je multipla skleroza), bo zdravnik presodil, ali lahko dobiva oziroma še nadalje dobiva zdravilo Imraldi.
If you have rheumatoid arthritis and you do not receive methotrexate with your Imraldi therapy, your doctor may decide to give 40 mg adalimumab every week or 80 mg every other week.
Če imate revmatoidni artritis in hkrati z zdravilom Imraldi ne dobivate metotreksata, vam bo zdravnik morda predpisal 40 mg adalimumaba vsak teden ali 80 mg vsak drugi teden.
Imraldi can slow down the damage to the cartilage and bone of the joints caused by the disease and improve physical function.
Zdravilo Imraldi lahko upočasni napredovanje prizadetosti sklepnih hrustancev in kosti, ki jo povzroči bolezen, in izboljša telesno delovanje.
What you need to know before you use Imraldi Do not use Imraldi
Kaj morate vedeti, preden boste uporabili zdravilo Imraldi Ne uporabljajte zdravila Imraldi
Figure 1: Kaplan-Meier Curves Summarizing Time to Flare in Study nr-axSpA II
Slika 1: Kaplan-Meierjeve krivulje povzemajo čas do ponovnega zagona bolezni v študiji nr-axSpA II
Imraldi is indicated for the treatment of non-infectious intermediate, posterior and panuveitis in adult patients who have had an inadequate response to corticosteroids, in patients in need of corticosteroidsparing, or in whom corticosteroid treatment is inappropriate.
Zdravilo Imraldi je indicirano za zdravljenje neinfekcijskega intermediarnega, posteriornega uveitisa in panuveitisa pri odraslih bolnikih, ki se niso zadostno odzvali na zdravljenje s kortikosteroidi, pri bolnikih s potrebo po zmanjšani uporabi kortikosteroidov ali pri bolnikih, pri katerih je zdravljenje s kortikosteroidi neprimerno.
For patients who dose escalated from eow to weekly regimen, the mean (±SD) serum concentrations of adalimumab at week 52 were 15.3±11.4 μg/ml (40/20 mg, weekly) and 6.7±3.5 μg/ml (20/10 mg, weekly).
Pri bolnikih, ki so prešli z režima vsak drugi teden na režim vsak teden, so bile povprečne (±SD) serumske koncentracije adalimumaba v 52. tednu 15,3 ± 11,4 μg/ml (40/20 mg, tedensko) in 6,7 ± 3,5 μg/ml (20/10 mg, tedensko).
Table 24 Time to Treatment Failure in Studies UV I and UV II
Čas do neuspeha zdravljenja v študijah UV I in UV II
• Adults with non-infectious uveitis with inflammation affecting the back of the eye
• odraslih z neinfekcijskim uveitisom, kjer vnetje prizadene zadnji del očesa,
117/276 patients from CD study I and 272/777 patients from CD studies II and III were followed through at least 3 years of open-label adalimumab therapy.
Med odprtim obdobjem zdravljenja z adalimumabom so vsaj 3 leta spremljali 117/276 bolnikov iz študije I Crohnove bolezni ter 272/777 bolnikov iz študij II in III Crohnove bolezni.
In an analysis in which all patients who dropped out of the study for adverse events or lack of efficacy, or who dose-escalated, were considered non-responders, PASI 75 and PGA of clear or minimal response rates in these patients were 69.6 % and 55.7 %, respectively, after an additional 108 weeks of open-label therapy (total of 160 weeks).
Opravljena je bila analiza, v kateri so vse bolnike, ki so izpadli iz študije zaradi neželenih učinkov ali nezadostne učinkovitosti ali jim je bil povečan odmerek, obravnavali kot neodzivne; pri teh bolnikih sta bila po dodatnih 108 tednih odprtega zdravljenja (skupaj 160 tednov) delež odziva PASI 75 69,6 % in delež odziva PGA "čisto" ali "minimalno" 55,7 %.