natgillin/translations-raw huggingface dataset:
Forsøgspersoner (n=215, 54, 7%), som ikke opnåede ASAS 20 ved uge 12, eller 16 eller 20 fik tidligere adgang til åben adalimumab 40 mg subkutant hver anden uge og blev efterfølgende behandlet som non- respondere i de dobbeltblindede statistiske analyser.
Subjects (n = 215, 54.7%) who failed to achieve ASAS 20 at Weeks 12, or 16 or 20 received early escape open-label adalimumab 40 mg every other week subcutaneously and were subsequently treated as non-responders in the double-blind statistical analyses.
I det største AS- forsøg I med 315 patienter, viste resultaterne statistisk signifikant forbedring af tegn og symptomer på ankyloserende spondylitis hos patienter behandlet med Humira sammenlignet med placebo.
In the larger AS study I with 315 patients, results showed statistically significant improvement of the signs and symptoms of ankylosing spondylitis in patients treated with Humira compared to placebo.
Tabel 10 - Effekt respons i placebo- kontrolleret AS forsøg – forsøg I Reduktion af tegn og symptomer
21 Table 10– Efficacy Responses in Placebo-Controlled AS Study – Study I Reduction of Signs and Symptoms
Respons ASASa 20
Response ASASa 20
Uge 2 Uge 12 Uge 24 ASAS 50
Week 2 Week 12 Week 24 ASAS 50
Uge 2 Uge 12 Uge 24 ASAS 70
Week 2 Week 12 Week 24 ASAS 70
***, ** Statistisk signifikant på < 0, 001, < 0, 01 for alle sammenligning mellem Humira og placebo ved uge 2, 12 og 24 a Assessment in Ankylosing Spondylitis b Bath Ankylosing Spondylitis Disease Activity Index
***, ** Statistically significant at p < 0.001, < 0.01 for all comparisons between Humira and placebo at Weeks 2, 12 and 24 a ASsessments in Ankylosing Spondylitis b Bath Ankylosing Spondylitis Disease Activity Index
Lignende tendenser (ikke alle statistisk signifikante) blev set i det mindre, randomiserede, dobbelt - blindede, placebokontrollerede AS- forsøg II på 82 voksne patienter med aktiv ankyloserende spondylitis.
Similar trends (not all statistically significant) were seen in the smaller randomised, double − blind, placebo controlled AS study II of 82 adult patients with active ankylosing spondylitis.
22 Crohns sygdom
Crohn’ s disease
Sikkerhed og effekt af Humira er undersøgt i randomiserede, dobbelt- blinde, placebo- kontrollerede forsøg i over 1400 patienter med moderat til svær aktiv Crohns sygdom (Crohns sygdoms - aktivitetsindeks (CDAI) ≥ 220 og ≤ 450).
The safety and efficacy of Humira were assessed in over 1400 patients with moderately to severely active Crohn’ s disease (Crohn’ s Disease Activity Index (CDAI) ≥ 220 and ≤ 450) in randomised, double-blind, placebo-controlled studies.
4. 1).
478 of the enrolled patients (32%) were defined as having a severe disease (CDAI score > 300 and concomitant corticosteroid and/ or immunosuppressants) corresponding to the population defined in the indication (see section 4.1).
Samtidige faste doser af aminosalicylater, kortikosteroider, og/ eller immunmodulerende- midler var tilladt, og 79% af patienterne fortsatte med at modtage mindst et af disse lægemidler.
Concomitant stable doses of aminosalicylates, corticosteroids, and/ or immunomodulatory agents were permitted and 79% of patients continued to receive at least one of these medications.
Induktion af klinisk remission (defineret som CDAI < 150) blev undersøgt i to forsøg, CD- forsøg I (CLASSIC I) og CD- forsøg II (GAIN).
Induction of clinical remission (defined as CDAI < 150) was evaluated in two studies, CD Study I (CLASSIC I) and CD Study II (GAIN).
In CD- forsøg I, blev 299 TNF- antagonist- naive patienter randomiseret til en af fire behandlingsgrupper; placebo i uge 0 og 2, 160 mg Humira i uge 0 og 80 mg i uge 2, 80 mg i uge 0 og 40 mg i uge 2, og 40 mg i uge 0 og 20 mg i uge 2.
In CD Study I, 299 TNF-antagonist naive patients were randomised to one of four treatment groups; placebo at Weeks 0 and 2, 160 mg Humira at Week 0 and 80 mg at week 2, 80 mg at Week 0 and 40 mg at Week 2, and 40 mg at Week 0 and 20 mg at Week 2.
I CD- forsøg II, blev 325 patienter, der ikke længere responderede eller var intolerante over for infliximab, randomiseret til at modtage enten 160 mg Humira i uge 0 og 80 mg i uge 2 eller placebo i uge 0 og 2.
In CD Study II, 325 patients who had lost response or were intolerant to infliximab were randomised to receive either 160 mg Humira at Week 0 and 80 mg at Week 2 or placebo at weeks 0 and 2.
De oprindelige non- responders blev ekskluderet fra forsøgene, og derfor blev disse patienter ikke yderligere undersøgt.
The primary non-responders were excluded from the studies and therefore these patients were not further evaluated.
Vedligeholdelse af klinisk remission blev undersøgt i CD- forsøg III (CHARM).
Maintenance of clinical remission was evaluated in CD Study III (CHARM).
I CD- forsøg III modtog 854 patienter open- label 80 mg i uge 0 og 40 mg i uge 2.
In CD Study III, 854 patients received open-label 80 mg at Week 0 and 40 mg at Week 2.
Ved uge 4 blev patienterne randomiseret til 40 mg hver anden uge, 40 mg hver uge, eller placebo gennem hele forsøgsforløbet på 56 uger.
22 randomised to 40 mg every other week, 40 mg every week, or placebo with a total study duration of 56 weeks.
Patienter i klinisk respons (nedgang i CDAI ≥ 70) i uge 4 blev stratificeret og analyseret adskilt fra dem, som ikke havde klinisk respons ved uge 4.
Patients in clinical response (decrease in CDAI ≥ 70) at Week 4 were stratified and analysed separately from those not in clinical response at week 4.
Tabel 11 viser rater for induktion af remission og respons i CD- forsøg I og CD- forsøg II.
CD Study I and CD Study II induction of remission and response rates are presented in Table 11.
Table 11 Induktion af klinisk remission og respons (Procent af patienterne) Uge 4
Table 11 Induction of Clinical Remission and Response (Percent of Patients) Week 4
CD- forsøg I:
CD Study I:
Infliximab naive patienter Placebo Humira Humira N=74 80/ 40 mg 160/ 80 m N = 75 g N=76
Infliximab Naive Patients Placebo Humira Humira N=74 80/ 40 mg 160/ 80 m N = 75 g N=76
CD- forsøg II:
CD Study II:
Infliximab erfarne patienter Placebo Humira N=166 160/ 80 mg N=159
Infliximab Experienced Patients Placebo Humira N=166 160/ 80 mg N=159
12% 24% 36% * **
12% 24% 36%* **
7% 21% *
7% 21%*
Klinisk respons (CR - 100)
Clinical response (CR- 100)
24% 37% 49%
24% 37% 49%
25% 38% **
25% 38%**
Alle p- værdier er parvise sammenligninger af forholdet for Humira vs. placebo * p < 0, 001 ** p < 0, 01
All p-values are pairwise comparisons of proportions for Humira versus placebo * p < 0.001 ** p < 0.01
Lignende remissions- rater sås for 160/ 80 mg og 80/ 40 mg induktionsregimerne ved uge 8, mens bivirkninger oftere sås i gruppen med 160/ 80 mg.
Similar remission rates were observed for the 160/ 80 mg and 80/ 40 mg induction regimens by Week 8 and adverse events were more frequently noted in the 160/ 80 mg group.
I CD- forsøg III var 58% (499/ 854) af patienterne i klinisk respons i uge 4 og blev vurderet i den primære analyse.
In CD Study III, at Week 4, 58% (499/ 854) of patients were in clinical response and were assessed in the primary analysis.
Blandt patienter med klinisk respons i uge 4 havde 48% tidligere været eksponeret for anden anti- TNF- behandling.
Of those in clinical response at Week 4, 48% had been previously exposed to other anti-TNF therapy.
Vedligeholdelse af remission - og respons- raterne er vist i Tabel 12.
Maintenance of remission and response rates are presented in Table 12.
Raterne for klinisk remission forblev forholdvis konstante uanset tidligere TNF- antagonist - eksposition.
Clinical remission results remained relatively constant irrespective of previous TNF antagonist exposure.
23 Tabel 12 Vedligeholdelse af klinisk remission og respons (Procent af patienterne)
23 Table 12 Maintenance of Clinical Remission and Response (Percent of Patients)
40 mg Humira
40 mg Humira
anden uge
every other week
hver uge
every week
Uge 26 Klinisk remission Klinisk respons (CR- 100)
Week 26 Clinical remission Clinical response (CR-100)
Patienter i steroid- fri remission i ≥90 dagea
Patients in steroid-free remission for > =90 daysa
19%
19% (11/ 58)**
(11/ 74) **
15% (11/ 74)**
56
Week 56 Clinical remission Clinical response (CR-100)
N=170
N=170 12% 17%
N=172
N=172 36%* 41%*
N=157
N=157 41%* 48%*
Patienter i steroidfri remission i ≥90 dagea
Patients in steroid-free remission for > =90 daysa
* p < 0, 001 for Humira vs. placebo parvise sammenligninger af forholdet ** p < 0, 02 for Humira vs. placebo parvise sammenligninger af forholdet a Af dem som modtog kortikosteroider ved baseline
* p < 0.001 for Humira versus placebo pairwise comparisons of proportions ** p < 0.02 for Humira versus placebo pairwise comparisons of proportions a Of those receiving corticosteroids at baseline
Blandt de patienter, som ikke havde respons i uge 4, responderede 43% af patienterne i Humira vedligeholdelsesbehandling ved uge 12 sammenlignet med 30% af patienter i placebogruppen.
Among patients who were not in response at Week 4, 43% of Humira maintenance patients responded by Week 12 compared to 30% of placebo maintenance patients.
4. 2).
Therapy continued beyond 12 weeks did not result in significantly more responses (see section 4.2).
I CD- forsøg I og CD- forsøg II, blev der opnået statistisk signifikante forbedringer i total score i det sygdoms- specifikke tarm- sygdoms- spørgeskema (IBDQ) ved uge 4 for patienter randomiseret til Humira 80/ 40 mg og 160/ 80 mg sammenlignet med placebo, og i CD- forsøg III blev det set ved uge 26 og 56, såvel som blandt den adalimumab- behandlede- grupper sammenlignet med placebo- gruppen.
In CD Study I and CD Study II, statistically significant improvement in the disease-specific inflammatory bowel disease questionnaire (IBDQ) total score was achieved at Week 4 in patients randomised to Humira 80/ 40 mg and 160/ 80 mg compared to placebo and was seen at Weeks 26 and 56 in CD Study III as well among the adalimumab treatment groups compared to the placebo group.
Psoriasis Humiras sikkerhed og effekt blev undersøgt hos voksne patienter med kronisk plaque- psoriasis (≥ 10% BSA- involveret og Psoriasis- Area - og Severity- Index (PASI) ≥ 12 eller ≥ 10), som var kandidater til systemisk behandling eller lysbehandling i randomiserede, dobbelt- blinde forsøg.
Psoriasis The safety and efficacy of Humira were studied in adult patients with chronic plaque psoriasis (≥ 10% BSA involvement and Psoriasis Area and Severity Index (PASI) ≥ 12 or ≥ 10) who were candidates for systemic therapy or phototherapy in randomised, double-blind studies.
73% af patienterne i Psoriasis Forsøg I og II havde tidligere modtaget systemisk behandling eller lysbehandling.
73% of patients enrolled in Psoriasis Studies I and II had received prior systemic therapy or phototherapy.
I Psoriasis Forsøg (REVEAL) blev 1212 patienter evalueret i tre behandlingsperioder.
Psoriasis Study I (REVEAL) evaluated 1,212 patients within three treatment periods.
I periode A, modtog patienterne placebo eller Humira i en startdosis på 80 mg efterfulgt af 40 mg hver anden uge med start en uge efter den første dosis.
In period A, patients received placebo or Humira at an initial dose of 80 mg followed by 40 mg every other week starting one week after the initial dose.
Efter 16 ugers behandling, indgik patienterne, der havde opnået mindst et PASI- 75- respons (PASI- score forbedring på mindst 75% i forhold til baseline), over i periode B og modtog åben 40 mg Humira hver anden uge.
After 16 weeks of therapy, patients who achieved at least a PASI 75 response (PASI score improvement of at least 75% relative to baseline), entered period B and received open-label 40 mg Humira every other week.
Patienter, der vedligeholdt ≥PASI- 75 - respons ved uge 33, og som oprindeligt var randomiseret til aktiv behandling i periode A, blev randomiseret igen i periode C til at modtage 40 mg Humira hver anden uge eller placebo i yderligere 19 uger.
Patients who maintained ≥ PASI 75 response at Week 33 and were originally randomised to active therapy in Period A, were re-randomised in period C to receive 40 mg Humira every other week or placebo for an additional 19 weeks.
På tværs af alle behandlingsgrupper, var den gennemsnitlige baseline PASI- score 18, 9 og baseline Physician’ s Global Assessment (PGA) score fordelt fra “ moderat ” (53% af de inkluderede patienter) til “ alvorlig ” (41%) til “ meget alvorlig ” (6%).
Across all treatment groups, the mean baseline PASI score was 18.9 and the baseline Physician’ s Global Assessment (PGA) score ranged from “ moderate” (53% of subjects included) to “ severe” (41%) to “ very severe” (6%).
I Psoriasis Forsøg II (CHAMPION) blev Humiras effekt og sikkerhed sammenlignet med methotrexat og placebo hos 271 patienter.
Psoriasis Study II (CHAMPION) compared the efficacy and safety of Humira versus methotrexate and placebo in 271 patients.
Der er ingen
Patients received placebo, an initial dose of MTX 7.5 mg and thereafter dose increases up to Week 12, with a maximum dose of 25 mg or an initial dose of 80 mg Humira followed
24 tilgængelig dokumentation, som sammenligner Humira og methotrexat i mere end 16 ugers behandling.
There are no data available comparing Humira and MTX beyond 16 weeks of therapy.
Patienter, som modtog methotrexat, som opnåede en ≥PASI- 50- respons ved uge 8 og/ eller 12, fik ikke yderligere forøget dosis.
Patients receiving MTX who achieved a ≥ PASI 50 response at Week 8 and/ or 12 did not receive further dose increases.
På tværs af alle behandlingsgrupper, var den gennemsnitlige baseline PASI- score 19, 7 og baseline PGA- score fordelte sig fra “ mild ” (< 1%) til “ moderat ” (48%) til “ alvorlig ” (46%) til “ meget alvorlig ” (6%).
Across all treatment groups, the mean baseline PASI score was 19.7 and the baseline PGA score ranged from “ mild” (< 1%) to “ moderate” (48%) to “ severe” (46%) to “ very severe” (6%).
I Psoriasis Forsøg I og II, var det primære endpoint den del af patienterne, som opnåede en PASI- 75 - respons fra baseline ved uge 16 (se Tabel 13 og 14).
In Psoriasis Studies I and II, a primary endpoint was the proportion of patients who achieved a PASI 75 response from baseline at Week 16 (see Tables 13 and 14).
Tabel 13 Ps Forsøg I (REVEAL) Resultater af effekt ved uge 16 Humira 40 mg hver Placebo anden uge N=398 N=814 N (%) n (%)
Table 13 Ps Study I (REVEAL) Efficacy - Results at 16 Weeks
≥PASI 75a PASI 100 PGA:
PASI 100 PGA:
Klar/ minimal
Clear/ minimal a
26 (6, 5) 3 (0, 8) 17 (4, 3)
3 (0.8) 17 (4.3)
578 (70, 9) b 163 (20, 0) b 506 (62, 2) b
163 (20.0)b 506 (62.2)b
Procent af patienterne, som opnåede PASI75 respons beregnet med center- tilnærmet hyppighed b p < 0. 001, Humira vs. placebo
Percent of patients achieving PASI75 response was calculated as center- adjusted rate b p < 0.001, Humira vs. placebo
Tabel 14 Ps Forsøg II (CHAMPION) Resultater af effekt ved uge 16 Humira 40 mg hver
Table 14 Ps Study II (CHAMPION) Efficacy Results at 16 Weeks
anden uge
Humira 40 mg eow
N=53
N=53 n (%)
N=110
N=110 n (%)
N=108
N=108 n (%)
≥PASI 75 PASI 100 PGA:
≥ PASI 75 PASI 100 PGA:
10 (18, 9) 1 (1, 9) 6 (11, 3)
10 (18.9) 1 (1.9) 6 (11.3)
39 (35, 5) 8 (7, 3) 33 (30, 0)
39 (35.5) 8 (7.3) 33 (30.0)
86 (79, 6) a, b 18 (16, 7) c, d 79 (73, 1) a, b
86 (79.6) a, b 18 (16.7) c, d 79 (73.1) a, b
Klar/ minimal a p < 0. 001 Humira vs. placebo b p < 0. 001 Humira vs. methotrexat c p < 0. 01 Humira vs. placebo d p < 0. 05 Humira vs. methotrexat
p < 0.01 Humira vs. placebo d p < 0.05 Humira vs. methotrexate
Patienterne blev genrandomiseret til placebo ved uge 33 sammenlignet med 5%, som fortsatte på Humira, p < 0, 001.
In Psoriasis Study I, 28% of patients who were PASI 75 responders and were re-randomised to placebo at Week 33 compared to 5% continuing on Humira, p < 0.001, experienced “ loss of adequate response” (PASI score after Week 33 and on or before Week 52 that resulted in a < PASI 50 response relative to baseline with a minimum of a 6-point increase in PASI score relative to Week 33).
38% (25/ 66) og 55% (36/ 66) af patienterne, som mistede tilstrækkeligt respons efter genrandomisering til placebo, som derefter blev optaget i det åbne forlængelsesforsøg, genvandt PASI- 75- respons efter henholdsvis 12 og 24 ugers genbehandling.
Of the patients who lost adequate response after re-randomization 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.
Der blev vist signifikante forbedringer i DLQI (Dermatology Life Quality Index) ved uge 16 fra baseline sammenlignet med placebo (Forsøg I og II) og MTX (Forsøg II).
Significant improvements at Week 16 from baseline compared to placebo (Studies I and II) and MTX (Study II) were demonstrated in the DLQI (Dermatology Life Quality Index).
I Forsøg I, var der også signifikante forbedringer i den fysiske og mentale komponent i den sammenfattede SF- 36- score sammenlignet med placebo.
In Study I, improvements in the physical and mental component summary scores of the SF-36 were also significant compared to placebo.
I et åbent forlængelsesforsøg, med patienter, hvis dosis blev trappet op fra 40 mg hver anden uge til 40 mg ugentligt på grund af PASI- respons under 50, og som blev evalueret 12 uger efter dosis- stigning, genvandt 59/ 243 (24, 3%) af patienterne PASI- 75- respons.
In an open-label extension study, for patients who dose escalated from 40 mg every other week to 40 mg weekly due to a PASI response below 50 and were evaluated at 12 weeks after dose escalation, 59/ 243 (24.3%) of patients regained PASI 75 response.
25 Immunogenicitet
25 Immunogenicity
Dannelse af adalimumab- antistoffer er forbundet med øget clearence og reduceret effekt af adalimumab.
Formation of anti-adalimumab antibodies is associated with increased clearance and reduced efficacy of adalimumab.
Patienterne i RA forsøg I, II og III blev testet på forskellige tidspunkter for anti- adalimumab antistoffer fra 6. til 12. måned.
Patients in RA Studies I, II and III were tested at multiple timepoints for anti-adalimumab antibodies during the 6 to 12 month period.
I de pivotale forsøg blev der identificeret anti- adalimumab- antistoffer hos 58/ 1. 053 (5, 5%) af de patienter, der blev behandlet med adalimumab, sammenlignet med 2/ 370 (0, 5%) af de patienter, der fik placebo.
In the pivotal trials, anti-adalimumab antibodies were identified in 58/ 1053 (5.5%) patients treated with adalimumab, compared to 2/ 370 (0.5%) on placebo.
Hos patienter, som ikke fik methotrexat samtidig, var incidensen 12, 4% sammenlignet med 0, 6%, når adalimumab blev givet i kombination med methotrexat.
In patients not given concomitant methotrexate, the incidence was 12.4%, compared to 0.6% when adalimumab was used as add-on to methotrexate.
Hos patienter med polyartikulær juvenil idiopatisk arthritis, blev der påvist antistoffer mod adalimumab hos 27/ 171 deltagere (15, 8%), der blev behandlet med adalimumab.
In patients with polyarticular juvenile idiopathic arthritis, adalimumab antibodies were identified in 27/ 171 subjects (15.8%) treated with adalimumab.
Hos patienter, der ikke fik samtidig methotrexat, var forekomsten 22/ 86 (25, 6%) sammenlignet med 5/ 85 (5, 9%), når adalimumab blev anvendt i tillæg til methotrexat.
In patients not given concomitant methotrexate, the incidence was 22/ 86 (25.6%), compared to 5/ 85 (5.9%) when adalimumab was used as add-on to methotrexate.
Hos patienter med psoriasis artrit blev der påvist anti- adalimumab antistoffer hos 38/ 376 patienter (10%) behandlet med adalimumab.
In patients with psoriatic arthritis, anti-adalimumab antibodies were identified in 38/ 376 subjects (10%) treated with adalimumab.
Hos patienter, der ikke samtidig fik methotrexat, var forekomsten 13, 5% (24/ 178 patienter), sammenlignet med 7% (14 ud af 198 patienter), når adalimumab blev anvendt som tillæg til methotrexat.
In patients not given concomitant methotrexate, the incidence was 13.5% (24/ 178 subjects), compared to 7% (14 of 198 subjects) when adalimumab was used as add-on to methotrexate.
Hos patienter med ankyloserende spondylitis blev der påvist anti- adalimumab antistoffer hos 17/ 204 patienter (8, 3%) behandlet med adalimumab.
In patients with ankylosing spondylitis anti-adalimumab antibodies were identified in 17/ 204 subjects (8.3%) treated with adalimumab.
Hos patienter, der ikke samtidig fik methotrexat, var forekomsten 16/ 185 (8, 6%), sammnelignet med 1/ 19 (5, 3%), når adalimumab blev anvendt som tillæg til methotrexat.
In patients not given concomitant methotrexate, the incidence was 16/ 185 (8.6%), compared to 1/ 19 (5.3%) when adalimumab was used as add-on to methotrexate.
Hos patienter med Crohns sygdom, blev der identificeret anti- adalimumab- antistoffer hos 7/ 269 individer (2, 6%) behandlet med adalimumab.
In patients with Crohn’ s disease, anti-adalimumab antibodies were identified in 7/ 269 subjects (2.6%) treated with adalimumab.
Der blev identificeret antistoffer mod adalimumab antistoffer hos 77/ 920 forsøgspersoner (8, 4%) hos patienter med psoriasis, som blev behandlet med adalimumab i monoterapi.
In patients with psoriasis, anti-adalimumab antibodies were identified in 77/ 920 subjects (8.4%) treated with adalimumab monotherapy.
Efter enkeltvise intravenøse doser på mellem 0, 25 og 10 mg/ kg var koncentrationerne dosisrelaterede.
After single intravenous doses ranging from 0.25 to 10 mg/ kg, concentrations were dose proportional.
Efter doser på 0, 5 mg/ kg (~ 40 mg) var clearance 11- 15 ml/ time, fordelingsvolumen (Vss) var mellem 5 og 6 liter, og den gennemsnitlige terminale halveringstid var cirka to uger.
After doses of 0.5 mg/ kg (~40 mg), clearances ranged from 11 to 15 ml/ hour, the distribution volume (Vss) ranged from 5 to 6 litres and the mean terminal phase half- life was approximately two weeks.
Koncentrationen af adalimumab i synovialvæsken fra adskillige reumatoid artrit - patienter målt i serum var 31– 96%.
Adalimumab concentrations in the synovial fluid from several rheumatoid arthritis patients ranged from 31-96% of those in serum.
Efter subkutan administration af 40 mg Humira hver anden uge hos voksne patienter med rheumatoid artrit (RA) var middel steady- state- koncentrationerne på henholdsvis cirka 5 µg/ ml (uden kombination med methotrexat) og 8- 9 µg/ ml (i kombination med methotrexat).
Following subcutaneous administration of 40 mg of Humira every other week in adult rheumatoid arthritis (RA) patients the mean steady-state trough concentrations were approximately 5 µg/ ml (without concomitant methotrexate) and 8 to 9 µg/ ml (with concomitant methotrexate), respectively.
Adalimumab- niveauet i serum ved steady- state- lavpunktet blev forøget omtrent proportionalt med doser på 20, 40 og 80 mg ved subkutan dosering hver anden uge og hver uge.
The serum adalimumab trough levels at steady-state increased roughly proportionally with dose following 20, 40 and 80 mg subcutaneous dosing every other week and every week.
Hos patienter med Crohns sygdom, blev der i induktionsperioden med induktionsregime på 80 mg Humira i uge 0 fulgt af 40 mg Humira i uge 2, opnået laveste serum- adalimumab koncentrationer på
Following the administration of 24 mg/ m2 (up to a maximum of 40 mg) subcutaneously every other week to patients with polyarticular juvenile idiopathic arthritis (JIA) the mean trough steady-state (values measured from Week 20 to 48) serum adalimumab concentration was 5.6 ± 5.6 µg/ mL (102 %CV) Humira monotherapy and 10.9 ± 5.2 µg/ mL (47.7% CV) with concomitant methotrexate.
12 µg/ ml i induktions- perioden.
26 In patients with Crohn’ s disease, the loading dose of 80 mg Humira on Week 0 followed by 40 mg Humira on Week 2 achieves serum adalimumab trough concentrations of approximately 5.5 µg/ ml during the induction period.
Gennemsnitlige steady- state laveste niveauer på omtrent 7 µg/ ml blev set hos patienter med Crohns sygdom, som modtog vedligeholdelsesdosis på 40 mg Humira hver anden uge.
A loading dose of 160 mg Humira on Week 0 followed by 80 mg Humira on Week 2 achieves serum adalimumab trough concentrations of approximately 12 µg/ ml during the induction period.