qanastek/EMEA-V3 huggingface dataset:
In addition, in a double-blind placebo-controlled trial in adult patients receiving background methotrexate, patients treated with Enbrel and anakinra were observed to have a higher rate of serious infections (7%) and neutropenia than patients treated with Enbrel (see sections 4.4 and 4.8).
Flimkien ma ’ dan, fi studju double- blind u kkontrollat bil- plaċebo f’ pazjenti adulti li kienu qed jieħdu methotrexate ukoll, kien osservat li pazjenti kkurati b’ Enbrel u b’ anakinra kellhom rata ogħla ta ’ infezzjonijiet serji (7%) u ta ’ newtropenja milli minn pazjenti kkurati b’ Enbrel biss (ara sezzjonijiet 4. 4 u 4. 8).
The combination Enbrel and anakinra has not demonstrated increased clinical benefit and is therefore not recommended.
Ma ntweriex li l- użu ta ’ Enbrel flimkien ma ’ anakinra jżid il- benefiċċju kliniku, u għalhekk mhuwiex irrakkomandat.
This combination has not demonstrated increased clinical benefit; such use is not recommended (see section 4.4).
Din it- taħlita ma wrietx żieda fil- benefiċċju kliniku; użu bħal dan mhuwiex rakkomandat (ara sezzjoni 4. 4).
Concurrent Enbrel and sulfasalazine treatment
Il- kura b’ Enbrel flimkien ma ’ sulfasalazine
In a clinical study of adult patients who were receiving established doses of sulfasalazine, to which Enbrel was added, patients in the combination group experienced a statistically significant decrease in mean white blood cell counts in comparison to groups treated with Enbrel or sulfasalazine alone.
Fi studju kliniku fuq pazjenti adulti li kienu qed jirċievu dożi stabbiliti ta ’ sulfasalazine, li miegħu kien miżjud Enbrel, pazjenti fil- grupp tat- taħlita kellhom tnaqqis statistikament sinifikanti fil- medja ta ’ l - għadd taċ- ċelluli tad- demm bojod meta mqabbla ma ’ gruppi kkurati b’ Enbrel jew b’ sulfasalazine waħidhom.
The clinical significance of this interaction is unknown.
Ir- rilevanza klinika ta ’ din l- interazzjoni mhijiex magħrufa.
8 Non-interactions
Non- interazzjonijiet
In clinical trials, no interactions have been observed when Enbrel was administered with glucocorticoids, salicylates (except sulfasalazine), nonsteroidal anti-inflammatory drugs (NSAIDs), analgesics, or methotrexate.
Fl- istudji kliniċi, ma ġewx osservati interazzjonijiet meta Enbrel jingħata flimkien ma ’ glucocorticojds, salicylates (ħlief sulfasalazine), mediċini kontra l- infjammazzjoni li mhumiex stirojdi (NSAIDs), analġesiċi, jew methotrexate.
See section 4.4 for vaccination advice.
Ara sezzjoni 4. 4 dwar pariri fuq it- tilqim.
No clinically significant pharmacokinetic drug-drug interactions were observed in studies with digoxin or warfarin.
Ma kienu osservati l- ebda interazzjonijiet farmakokinetiċi sinifikanti bejn mediċina u oħra fi studji b’ digoxin jew warfarin.
There are no studies of Enbrel in pregnant women.
M’ hemm l- ebda studju ta ’ Enbrel f’ nisa tqal.
Developmental toxicity studies performed in rats and rabbits have revealed no evidence of harm to the foetus or neonatal rat due to etanercept.
Studji fuq it- tossiċità ta ’ l- iżvilupp tossiku li saru fil - ġrieden u fil- fniek ma taw l- ebda evidenza ta ’ xi ħsara fil- fetu jew f’ far tat- twelid ikkawżata minn etanercept.
Preclinical data about peri- and postnatal toxicity of etanercept and of effects of etanercept on fertility and general reproductive performance are not available.
M’ hemm l- ebda tagħrif prekliniku dwar tossiċità ta ’ etanercept qabel jew wara l- wild, u l - effetti ta ’ etanercept fuq il- fertilità u l- abiltà ġenerali riproduttiva.
Thus, the use of Enbrel in pregnant women is not recommended, and women of child-bearing potential should be advised not to get pregnant during Enbrel therapy.
Għalhekk l- użu ta ’ Enbrel f’ nisa tqal mhux rakkomandat, u dawk in- nisa li jistgħu jkunu ommijiet għandu jingħatalhom il- parir biex ma joħorġux tqal waqt it- terapija b’ Enbrel.
Use during lactation
L- użu ta ’ Enbrel meta l- omm tredda
It is not known whether etanercept is excreted in human milk.
Mhux magħruf jekk etanercept jitnixxix fil- ħalib ta ’ l- omm.
Following subcutaneous administration to lactacting rats, etanercept was excreted in the milk and detected in the serum of pups.
Wara l- għoti taħt il- ġilda lil firien li jkunu qegħdin ireddgħu, etanercept kien eliminat fil- ħalib u misjub fis- serum tal- ġriewi.
Because immunoglobulins, in common with many medicinal products, can be excreted in human milk, a decision should be made whether to discontinue breast-feeding or to discontinue Enbrel while breast-feeding.
Minħabba li l - immunoglobulini, l- istess bħal ħafna prodotti mediċinali oħra, jistgħu jitnixxu fil- ħalib ta ’ l- omm, deċiżjoni għandha tittieħed sabiex jew jitwaqqaf it- treddigħ jew jitwaqqaf Enbrel waqt it- treddigħ.
4.8 Undesirable effects
8 4. 8 Effetti mhux mixtieqa
Enbrel has been studied in 2,680 patients with rheumatoid arthritis in double-blind and open-label trials.
Reazzjonijiet mhux mixtieqa fl- adulti Enbrel ġie studjat f’ 2, 680 pazjent bl- artrite rewmatojde fi studji double- blind u open- label.
This experience includes 2 placebo-controlled studies (349 Enbrel patients and 152 placebo patients) and 2 active-controlled trials, one active-controlled trial comparing Enbrel to methotrexate (415 Enbrel patients and 217 methotrexate patients) and another active-controlled trial comparing Enbrel (223 patients), methotrexate (228 patients) and Enbrel in combination with methotrexate (231 patients).
Din l - esperjenza tinkludi żewġ studji kkontrollati bi plaċebo (349 pazjenti li ħadu Enbrel u 152 pazjent li ħadu l- plaċebo), u żewġ studji kkontrollati attivament, studju wieħed ikkontrollat attivament li jqabbel Enbrel ma ’ methotrexate (415 pazjent fuq Enbrel u 217- il pazjent fuq methotrexate) u studju ieħor ikkontrollat attivament li qabbel Enbrel (223 pazjent), methotrexate (228 pazjent) u Enbrel flimkien ma ’ methotrexate (231 pazjent).
The proportion of patients who discontinued treatment due to adverse events was the same in both the Enbrel and placebo treatment groups; in the first active-controlled trial, the dropout rate was significantly higher for methotrexate (10%) than for Enbrel (5%).
Il- proporzjon tal- pazjenti li ma komplewx il- kura minħabba avvenimenti avversi kienu l- istess kemm fil- grupp ta ’ Enbrel kif ukoll fil- grupp tal- plaċebo; fl- ewwel studju kkontrollat attivament, in- numru ta ’ pazjenti li waqqfu mit- terapija kien sinjifikament aktar għoli għal methotrexate (10%) minn dak għal Enbrel (5%).
In the second active-controlled trial, the rate of discontinuation for adverse events after 2 years of treatment was similar among all three treatment groups, Enbrel (16%), methotrexate (21%) and Enbrel in combination with methotrexate (17%).
Fit- tieni studju kkontrollat attivament, ir - rata ta ’ pazjenti li waqqfu t- terapija wara sentejn ta ’ trattament minħabba avvenimenti avversi kienet simili għat- tliet gruppi ta ’ kura, Enbrel (16%), methotrexate (21%) u Enbrel flimkien ma ’ methotrexate (17%).
Additionally, Enbrel has been studied in240 psoriatic arthritis patients who participated in 2 double-blind placebo- controlled studies and an open-label extension study.
Barra minn hekk, Enbrel kien studjat f’ 240 pazjent bl- artrite psorjatika li ħadu sehem f’ 2 studji double- blind u kkontrollati bi plaċebo u fi studju ieħor ta ’ estensjoni open- label.
Five hundred and eight (508) ankylosing spondylitis patients were treated with Enbrel in 4 double-blind placebo-controlled studies.
Ħames mija u tmien pazjenti (508) b’ immobilità tal- vertebre kawża ta ’ infjammazzjoni ħadu kura b’ Enbrel f’ 4 studji double- blind u kkontrollati bi plaċebo.
Enbrel has also been studied in 1,180 patients with plaque psoriasis for up to 6 months in 4 double-blind placebo- controlled studies.
Enbrel ġie mistħarreġ ukoll f’ 1, 180 bi psorjasi tal- plakka sa żmien 6 xhur f’ 4 studji double- blind ikkontrollati bi plaċebo.
Among patients with rheumatoid arthritis treated in
Fi studji kliniċi double- blind fejn Enbrel ġie mqabbel ma ’ plaċebo, reazzjonijiet fis- sit ta ’ l- injezzjoni kienu l- avvenimenti avversi l- aktar frekwenti f’ pazjenti li ħadu Enbrel.
9 placebo-controlled trials, serious adverse events occurred at a frequency of 4% in 349 patients treated with Enbrel compared with 5% of 152 placebo-treated patients.
Fi studji kkontrollati bi plaċebo, fost il- pazjenti bl- artrite rewmatojde kkurati, avvenimenti avversi serji seħħew bi frekwenza ta ’ 4% f’ 349 pazjent ikkurati b’ Enbrel, imqabbla ma ’ 5% f’ 152 pazjent ikkurati bil- plaċebo.
In the first active-controlled trial, serious adverse events occurred at a frequency of 6% in 415 patients treated with Enbrel compared with 8% of 217 methotrexate-treated patients.
Fl- ewwel studju kkontrollat attivament avvenimenti avversi serji kellhom frekwenza ta ’ 6% f’ 415 pazjent ikkurati b’ Enbrel, imqabbla ma ’ 8% f’ 217 pazjent ikkurati b’ methotrexate.
In the second active-controlled trial the rate of serious adverse events after 2 years treatment was similar among the three treatment groups (Enbrel 16%, methotrexate 15% and Enbrel in combination with methotrexate 17%).
Fit- tieni studju kkontrollat attivament wara sentejn ta ’ trattament, ir- rata ta ’ avvenimenti avversi kienet simili għat- tliet gruppi ta ’ kura (Enbrel 16%, methotrexate 15% u Enbrel flimkien ma ’ methotrexate 17%).
Among patients with plaque psoriasis treated in placebo- controlled trials, the frequency of serious adverse events was about 1.2% of 1,029 patients treated with Enbrel compared with 1.5% of 460 placebo-treated patients.
Fost pazjenti bi psorjasi tal- plakka trattati fi provi ikkontrollati bi plaċebo, il- frekwenza ta ’ reazzjonijiet avversi serji kienet madwar 1% minn 933 pazjent ittrattati b’ Enbrel meta mqabbla ma ’ 1. 2% minn 1, 029 pazjenti ttrattati b’ Enbrel meta mqabbla ma ’ 1. 5% ta ’ 460 pazjent ittratti bil- plaċebo.
The following list of adverse reactions is based on experience from clinical trials in adults and on postmarketing experience.
Il- lista li ġejja ta ’ avvenimenti avversi hi bbażata fuq esperjenza minn studji kliniċi f’ adulti u minn informazzjoni miġbura wara li l- prodott ħareġ fis- suq.
Within the organ system classes, adverse reactions are listed under headings of frequency (number of patients expected to experience the reaction), using the following categories: very common (> 1/ 10); common (> 1/ 100 ,< 1/10); uncommon (> 1/1000 ,< 1/100); rare (> 1/10,000, < 1/ 1000); very rare (< 1/10 ,000); not known (could not be accurately estimated through clinical studies).
Fost il- klassijiet tas- sistema ta ’ l- organi, ir- reazzjonijiet avversi huma elenkati skond il- frekwenza (numru ta ’ pazjenti mistennija li jesperjenzaw ir- reazzjoni) skond dawn il- kategoriji: komuni ħafna (> 1/ 10); komuni (> 1/ 100, < 1/ 10); mhux komuni (> 1/ 1000, < 1/ 100); rari (> 1/ 10, 000, < 1/ 1000); rari ħafna (< 1/ 10, 000); mhux magħrufa (ma jisgħux ikunu stmati bi preċiżjoni minn studji kliniċi).
Infections and infestations:
Infezzjonijiet u impestazzjonijiet
Very common:
Komuni Ħafna:
Infections (including upper respiratory tract infections, bronchitis, cystitis, skin infections)* Uncommon:
Infezzjonijiet (inklużi infezzjonijiet fis- sistema respiratorja ta ’ fuq, bronkite, ċistite, infezzjonijiet tal- ġilda) *
Serious infections (including pneumonia, cellulitis, septic arthritis, sepsis)* Tuberculosis, opportunistic infections (including invasive fungal, protozoal, bacterial and atypical mycobacterial infections)*
Infezzjonijiet serji (inklużi pnewmonja, ċellulite, l- artrite settika, sepsis) * Tuberkulożi, infezzjonijiet opportunistiċi (li jinkludu infezzjonijiet fungali invażivi, protożoali, batterjali u mikobatterjali atipiċi) *
Uncommon:
Tromboċitopenja Mhux Komuni:
Very rare:
Anemija, lewkopenja, newtropenja, panċitopenja * Rari ħafna:
Thrombocytopenia Anaemia, leukopenia, neutropenia, pancytopenia* Aplastic anaemia*
Anemija aplastika *
Immune system disorders:
9 Disturbi fis- sistema immunitarja:
Allergic reactions (see Skin and subcutaneous tissue disorders), autoantibody formation* Serious allergic/ anaphylactic reactions (including angioedema, bronchospasm) Macrophage activation syndrome*, anti-neutrophilic cytoplasmic antibody positive vasculitis
Reazzjonijiet allerġiċi/ anafilattiċi serji (inklużi anġjoedema, bronkospażmu) Sindrome ta ’ l- attivazzjoni tal- makrofagu *, vaskulite pożittiva ta ’ l- antikorpi ċitoplażmatika anti- newtrofilika
Seizures CNS demyelinating events suggestive of multiple sclerosis or localised demyelinating conditions such as optic neuritis and transverse myelitis (see section 4.4)
Konvulżjonijiet Avvenimenti demajelinanti tas- CNS li jissuġġerixxu sklerożi multipla jew kundizzjonijiet demajelinanti lokalizzati bħal newrite ottika u mijelite transversa (ara sezzjoni 4. 4)
Interstitial lung disease (including pneumonitis and pulmonary fibrosis)*
Mard interstizjali tal- pulmun (li jinkludi pnewmonite u fibrożi pulmonari) *
Elevated liver enzymes
Enżimi tal- fwied għoljin
10 Skin and subcutaneous tissue disorders:
Disturbi fil- ġilda u fit- tessuti ta ’ taħt il- ġilda:
Pruritus Angioedema, urticaria, rash, psoriasiform rash, psoriasis (including new onset and pustular, primarily palms & soles)
Ħakk, Anġjoedema, urtikarja, raxx, raxx psorjasiformi, psorjasi (li tinkludi bidu ġdid u bil- ponot, primarjament fil- keffa ta ’ l- id u fil- qiegħ tas- saqajn)
Toxic epidermal necrolysis
Vaskulite kutanea (li jinkludi vaskulite lewkoċitoklastika), Sindrome ta ’ Stevens- Johnson, eritema multiforme Nekrolisi epidermali tossika
Musculoskeletal, connective tissue and bone disorders:
Disturbi muskolu- skeltrali, tal- connective tissue u ta ’
Subacute cutaneous lupus erythematosus, discoid lupus erythematosus, lupus-like syndrome
Lupus erythematosus sotto akuta tal- ġilda, discoid lupus erythematosus, sindrome simili għall- lupus
Injection site reactions (including bleeding, bruising, erythema, itching, pain, swelling)* Common:
Reazzjoni fis- sit fejn tingħata l- injezzjoni (inkluż fsada, tbenġil, eritema, ħakk, uġigħ, nefħa) *
There have been reports of worsening of congestive heart failure (see section 4.4).
Kien hemm rapporti ta ’ pazjenti b’ insuffiċjenza tal- qalb konġestiva li marru għall- agħar (ara sezzjoni 4. 4).
*see Additional information, below.
* ara aktar informazzjoni t’ hawn taħt
Additional information
Informazzjoni addizzjonali
Serious adverse events reported in clinical trials
Avvenimenti avversi serji rrappurtati fi studji kliniċi
Among rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis and plaque psoriasis patients in placebo-controlled, active-controlled, and open-label trials of Enbrel, serious adverse events reported included malignancies (see below), asthma, infections (see below), heart failure, myocardial infarction, myocardial ischaemia, chest pain, syncope, cerebral ischaemia, hypertension, hypotension, cholecystitis, pancreatitis, gastrointestinal haemorrhage, bursitis, confusion, depression, dyspnoea, abnormal healing, renal insufficiency, kidney calculus, deep vein thrombosis, pulmonary embolism, membranous glomerulonephropathy, polymyositis, thrombophlebitis, liver damage, leucopenia, paresis, paresthesia, vertigo, allergic alveolitis, angioedema, scleritis, bone fracture, lymphadenopathy, ulcerative colitis, intestinal obstruction, eosinophilia, haematuria, and sarcoidosis.
Fost il- pazjenti bl- artrite rewmatojde, bl- artrite psorjatika, u bl- immobilità tal- vertebra kawża ta ’ infjammazzjoni u psorjasi tal- plakka fi studji kkontrollati bi plaċebo, ikkontrollati attivament u open - 10 label b’ Enbrel, ġew rrappurtati reazzjonijiet avversi serji inklużi tumuri malinni (ara taħt), ażma, infezzjonijiet, (ara taħt) insuffiċjenza tal- qalb, infart mijokardijaku, iskemja mijokardijaka, uġigħ fis - sider, sinkope, iskemja ċerebrali, pressjoni għolja, pressjoni baxxa, koleċistite, pankreatite, ħemoraġija gastrointestinali, burżite, konfużjoni, dipressjoni, dispneja, fejqan annormali, insuffiċjenza renali, ġebla fil- kliewi, trombożi fil- vini fondi, emboliżmu pulmonari, nefropatija glomerulari fir- riti, polimijosite, tromboflebite, ħsara fil- fwied, lewkopenja, pareżi, paresteżja, sturdament, alveolite allerġika, anġjoedema, sklerite, ksur fl- għadam, limfadenopatija, kolite ulċerativa u ostruzzjoni fl - imsaren, eosinofilja, ematurja, u sarkojdożi.
Malignancies
Tumuri malinni
One hundred and twenty-nine new malignancies of various types were observed in 4,114 rheumatoid arthritis patients treated in clinical trials with Enbrel for up to approximately 6 years, including 231 patients treated with Enbrel in combination with methotrexate in the 2-year active-controlled study.
Mija u disgħa u għoxrin tumuri malinni ġodda ta ’ diversi tipi kienu osservati f’ 4114- il pazjent b’ artrite rewmatojde ttrattati b’ Enbrel fi provi kliniċi għal madwar bejn wieħed u ieħor 6 snin, li kienu jinkludu 231 pazjent ittrattati b’ Enbrel flimkien ma ’ methotrexate fl- istudju b’ kontroll attiv ta ’ sentejn.
The observed rates and incidences in these clinical trials were similar to those expected for the population studied.
Ir- rati osservati u inċidenzi f’ dawn il- provi kliniċi kienu simili għal dawk mistennija fil- popolazzjoni studjata.
A total of 2 malignancies were reported in clinical studies of approximately 2 years duration involving 240 Enbrel-treated psoriatic arthritis patients.
Total ta ’ 2 tumuri malinni kienu rrappurtati fi studji kliniċi ta ’ bejn wieħed u ieħor sentejn żmien li involvew 240 pazjenti b’ artrite psorjatika ttrattati b’ Enbrel.
In clinical studies conducted for more than 2 years with 351 ankylosing spondylitis patients, 6 malignancies were reported in Enbrel-treated patients.
Fi studji kliniċi magħmula għal aktar minn sentejn b’ 351 pazjent b’ ankylosing spondylitis, 6 tumuri malinni kienu rrappurtati f’ pazjenti trattati b’ Enbrel.
Twenty-three malignancies were reported in plaque psoriasis patients treated with Enbrel in double-blind and open-label studies of up to 15 months involving 1,261 Enbrel-treated patients.
Tlieta u għoxrin tumur malinn kienu rrappurtati f’ pazjenti bi psorjasi tal - plakka ittrattati b’ Enbrel fi stħarriġ double- blind u open- label sa żmien 15- il xahar li involva 1, 261 pazjent ittrattati b’ Enbrel.
11 There were a total of 15 lymphomas reported in 5,966 patients treated with Enbrel in rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis and psoriasis clinical trials.
Kien hemm total ta ’ 15- il limfoma rrappurtati f’ 5966 pazjent ittrattati b’ Enbrel fi provi kliniċi f’ artrite rewmatojde, artrite psorjatika, ankylosing spondylitis u psorjasi.
Reports of various malignancies (including breast and lung carcinoma and lymphoma) have also been received in the postmarketing period (see section 4.4).
Saru wkoll rapporti ta ’ diversi tumuri malinni (inklużi karċinomi tas- sider u tal- pulmun u limfoma) fil - perijodu ta ’ wara t- tqegħid fis- suq (ara sezzjoni 4. 4).
Injection site reactions
Reazzjonijiet fis- sit tat- tiqiba
Compared to placebo, patients with rheumatic diseases treated with Enbrel had a significantly higher incidence of injection site reactions (36% vs.
Imqabbla mal- plaċebo, pazjenti b’ mard rewmatiku kkurati b’ Enbrel kellhom inċidenza sinjifikament aktar għolja ta ’ reazzjonijiet fis- siti ta ’ l- injezzjoni (36% vs 9%).
Injection site reactions usually occurred in the first month.
Reazzjonijiet fis- siti ta ’ l- injezzjoni ġeneralment tfaċċaw fl- ewwel xahar.
Mean duration was approximately 3 to 5 days.
Iż- żmien medju ta ’ kemm damet ir- reazzjoni kien ta ’ bejn wieħed u ieħor minn 3 għal 5 ijiem.
No treatment was given for the majority of injection site reactions in the Enbrel treatment groups, and the majority of patients who were given treatment received topical preparations such as corticosteroids, or oral antihistamines.
L- ebda kura ma ngħatat għall- maġġoranza tar- reazzjonijiet fis- sit ta ’ l- injezzjoni, fil- gruppi ta ’ kura b’ Enbrel, u l- maġġoranza tal- pazjenti li ngħataw il- kura użaw preperazzjonijiet topiċi bħal kortikosterojdi jew antiħistaminiċi meħuda mill- ħalq.
Additionally, some patients developed recall injection site reactions characterised by a skin reaction at the most recent site of injection along with the simultaneous appearance of injection site reactions at previous injection sites.
Addizzjonalment, xi ftit pazjenti żviluppaw mill- ġdid reazzjonijiet fis- sit ta ’ l- injezzjoni kkaratterizzati b’ reazzjoni tal- ġilda fis- sit ta ’ l- injezzjoni l- aktar riċenti flimkien mad- dehra simultanja ta ’ reazzjonijiet fis- sit ta ’ l - injezzjonijiet f’ sit ta ’ injezzjoni li ngħataw qabel.
These reactions were generally transient and did not recur with treatment.
Dawn ir- reazzjonijiet ġeneralment kienu għal żmien qasir, u bil- kura ma reġgħux dehru.
In controlled trials in patients with plaque psoriasis, approximately 14.5% of patients treated with Enbrel developed injection site reactions compared with 5.2% of placebo-treated patients during the first 12 weeks of treatment.
Fi provi kontrollati f’ pazjenti bi psorjasi tal- plakka, bejn wieħed u ieħor 14. 5% tal- pazjenti ttrattati b’ Enbrel żviluppaw reazzjonijiet fis- siti tat- titqiba meta mqabbla ma ’ 5. 2% tal- pazjenti ttrattati bi plaċebo waqt l- ewwel 12- il ġimgħa tat- trattament.
Serious infections
Infezzjonijiet serji
In placebo-controlled trials, no increase in the incidence of serious infections (fatal, life threatening, or requiring hospitalisation or intravenous antibiotics) was observed.
Fi studji kkontrollati bil- plaċebo, l- ebda żieda ta ’ inċidenza ta ’ infezzjonijiet serji (fatali, ta ’ theddid għall- ħajja, jew li kien hemm il- bżonn li jiddaħħlu l- isptar jew jingħataw injezzjoniet ta ’ antibijotiċi ġol- vini għalihom) ma ġew osservati.
Serious infections occurred in 6.3% of rheumatoid arthritis patients treated with Enbrel for up to 48 months.
Infezzjonijiet serji seħħew f’ 6. 3% tal- pazjenti bl- artrite rewmatojde kkurati b’ Enbrel sa 48 xhur.
These included abscess (at various sites), bacteraemia, bronchitis, bursitis, cellulitis, cholecystitis, diarrhoea, diverticulitis, endocarditis (suspected), gastroenteritis, hepatitis B, herpes zoster, leg ulcer, mouth infection, osteomyelitis, otitis, peritonitis, pneumonia, pyelonephritis, sepsis, septic arthritis, sinusitis, skin infection, skin ulcer, urinary tract infection, vasculitis, and wound infection.
Dawn kienu jinkludu qrada (f’ partijiet differenti), bakteremja, bronkite, burżite, ċellulite, koleċistite, dijarrea, divertikulite, endokardite (suspettata), gastroenterite, epatite B, herpes zoster, ulċera fis- sieq, infezzjoni fil- ħalq, osteomijelite, otitis, peritonite, pnewmonja, pajelonefrite, sepsis, artrite settika, sinużite, infezzjoni tal- ġilda, ulċera tal - ġilda, infezzjoni fil- pajpijiet ta ’ l- awrina, vaskulite, u infezzjoni fil- feriti.
In the 2-year active-controlled study where patients were treated with either Enbrel alone, methotrexate alone or Enbrel in combination with methotrexate, the rates of serious infections were similar among the treatment groups.
Fi studju ta ’ sentejn kkontrollat attivament fejn il- pazjenti kienu kkurati jew b’ Enbrel waħdu, jew b’ methotrexate waħdu 11 jew b’ Enbrel flimkien ma ’ methotrexate, ir- rata ta ’ infezzjonijiet serji kienet simili fost il- gruppi li ġew ikkurati.
However, it cannot be excluded that the combination of Enbrel with methotrexate could be associated with an increase in the rate of infections.
Madankollu ma jistax jiġi eskluż li l- għoti ta ’ Enbrel flimkien ma ’ methotrexate jista ’ jżid ir- rata ta ’ infezzjonijiet.
There were no differences in rates of infection among patients treated with Enbrel and those treated with placebo for plaque psoriasis in placebo controlled trials of up to 24 weeks duration.
Ma kien hemm ebda differenza fir- rata ta ’ infezzjoni fost il- pazjenti ikkurati b’ Enbrel u dawk ikkurati bil- plaċebo għal psorjasi tal- plakka fi provi kkontrolli bil- plaċebo li damu sa 24 ġimgħa.
Serious infections experienced by Enbrel-treated patients included cellulitis, gastroenteritis, pneumonia, cholecystitis, osteomyelitis, gastritis, appendicitis, Streptococcal fasciitis, myositis, septic shock, diverticulitis and abscess.
Infezzjonijiet serji li kellhom pazjenti kkurati b’ Enbrel, kienu jinkludu ċellulite, gastroenterite, pnewmonja, koleċistite, osteomajelite, gastrite, appendiċite, faxxite Streptokokkali, mijosite, xokk settiku, divertikulite u axxess.
In the double-blind and open-label psoriatic arthritis trials, 1 patient reported a serious infection (pneumonia).
Fil- provi double- blind u open- label fuq pazjenti b’ artrite psorjatika, pazjent wieħed irrapporta infezzjoni serja (pnewmonja).
Serious and fatal infections have been reported during use of Enbrel; reported pathogens include bacteria, mycobacteria (including tuberculosis), viruses and fungi.
Infezzjonijiet serji u fatali kienu rrappurtati wara li Enbrel ħareġ fuq is- suq; patoġeni rrappurtati jinkludu batterji, mikobatterji (inkuż it- tuberkolożi), virusijiet u fungi.
Some have occurred within a few weeks after initiating treatment with Enbrel in patients who have underlying conditions (e. g. diabetes, congestive heart failure, history of active or chronic infections) in addition to their rheumatoid arthritis (see section 4.4).
Xi uħud ġraw fi ftit ġimgħat wara li bdiet il- kura b’ Enbrel f’ pazjenti li kellhom ukoll mard ieħor (eż. dijabete, insuffiċjenza tal- qalb konġestiva, passat t’ infezzjonijiet attivi jew kroniċi) flimkien ma ’ l- artite rewmatojde tagħhom (ara sezzjoni 4. 4).
Enbrel treatment may increase mortality in patients with established sepsis.
Il- kura b’ Enbrel tista ’ żżid il- mortalità f’ pazjenti li ġa għandhom is- sepsis.
Opportunistic infections have been reported in association with Enbrel including invasive fungal, protozoal, bacterial (including Listeria and Legionella), and atypical mycobacterial infections.
Infezzjonijiet opportunistiċi kienu rrappurtati b’ rabta ma ’ Enbrel, li jinkludu infezzjonijiet fungali invażivi, protożoali, batterjali (li jinkludu Listeria u Legionella), u infezzjonijiet mikobatterjali atipiċi.
In a pooled data set of clinical trials, the overall incidence of opportunistic infections was 0.09% for the 15,402 subjects who received Enbrel.
F’ sett ta ’ dejta miġbura ta ’ provi kliniċi, l- inċidenza totali ta ’ infezzjonijiet opportunistiċi kienet ta ’ 0. 09% għal 15, 402 persuna li rċivew Enbrel.
In
Ir- rata aġġustata għall- espożizzjoni kienet ta ’ 0. 06 avvenimenti kull 100 sena ta ’ ħajja tal- pazjenti.
12 postmarketing experience, approximately half of all of the case reports of opportunistic infections worldwide were invasive fungal infections.
Fl- esperjenza ta ’ wara l- bejgħ, madwar nofs ir - rapporti kollha ta ’ każijiet ta ’ infezzjonijiet opportunistiċi madwar id- dinja kienu infezzjonijiet fungali invażivi.
The most commonly reported invasive fungal infections were Pneumocystis and Aspergillus.
L- iktar infezzjonijiet fungali invażivi li kienu rrappurtati b’ mod komuni kienu Pneumocystis u Aspergillus.
Invasive fungal infections accounted for more than half of the fatalities amongst patient who developed opportunistic infections.
Infezzjonijiet fungali invażivi ammontaw għal aktar min- nofs tal- fatalitajiet fost pazjenti li żviluppaw infezzjonijiet opportunistiċi.
The majority of the reports with a fatal outcome were in patients with Pneumocystis pneumonia, unspecified systemic fungal infections, and aspergillosis (see section 4.4).
Il- maġġoranza tar- rapporti b’ riżultat fatali kienu f’ pazjenti bi pnewmonja Pneumocystis, infezzjonijiet fungali sistemiċi mhux speċifiċi, u aspergillosi (ara sezzjoni 4. 4).
Autoantibodies
Awtoantikorpi
Adult patients had serum samples tested for autoantibodies at multiple timepoints.
Minn żmien għall- ieħor, pazjenti adulti tteħdilhom kampjun tas- serum għal testijiet.
Of the rheumatoid arthritis patients evaluated for antinuclear antibodies (ANA), the percentage of patients who developed new positive ANA ( 1:40) was higher in patients treated with Enbrel (11%) than in placebo-treated patients (5%).
Mill- pazjenti bl - artrite rewmatojde, evalwati għal antikorpi kontra n- nukleju (ANA), il- perċentwal ta ’ pazjenti li żviluppaw ANA (≥1: 40) ġdid u pożittiv, kien ogħla f’ pazjenti kkurati b’ Enbrel (11%) minn pazjenti li kienu kkurati bil- plaċebo (5%).
The percentage of patients who developed new positive anti-double-stranded DNA antibodies was also higher by radioimmunoassay (15% of patients treated with Enbrel compared to 4% of placebo-treated patients) and by Crithidia luciliae assay (3% of patients treated with Enbrel compared to none of placebo-treated patients).
Il- perċentwal ta ’ pazjenti li żviluppaw antikorpi ġodda u pożittivi tat - tip anti- DNA b’ fili doppji kien ukoll aktar għoli b’ analiżi radjo- immunoloġika (15% tal- pazjenti kkurati b’ Enbrel imqabbel ma ’ 4% tal- pazjenti kkurati bil- plaċebo) u minn analiżi bi Crithidia luciliae (3% tal- pazjenti kkurati b’ Enbrel imqabbel ma ’ ebda pazjent ikkurat bil- plaċebo).
The proportion of patients treated with Enbrel who developed anticardiolipin antibodies was similarly increased compared to placebo-treated patients.
Il- proporzjon tal - pazjenti kkurati b’ Enbrel li żviluppaw antikorpi tat- tip anti- kardjolipin kellhom l- istess żjieda meta mqabbel ma ’ pazjenti kkurati bil- plaċebo.
The impact of long-term treatment with Enbrel on the development of autoimmune diseases is unknown.
L- impatt ta ’ kura fit- tul b’ Enbrel fuq l- iżvilupp ta ’ mard awtoimmunitarju mhux magħruf.
There have been rare reports of patients, including rheumatoid factor positive patients, who have developed other autoantibodies in conjunction with a lupus-like syndrome or rashes that are compatible with subacute cutaneous lupus or discoid lupus by clinical presentation and biopsy.
Kien hemm rapporti ta ’ każijiet rari ta ’ pazjenti, inkużi ukoll ta ’ pazjenti b’ fattur pożittiv rewmatojdu, li żviluppaw awtoantikorpi oħra flimkien ma ’ sindrome bħal tal- lupus jew raxx li huma kompatibbli ma ’ lupus tal- ġilda sottoakut jew discoid lupus bi preżentazzjoni klinika u bijopsija.
There have been postmarketing reports of pancytopenia and aplastic anaemia, some of which had fatal outcomes (see section 4.4).
Panċitopenja u anemija aplastika Wara li Enbrel ħareġ fuq is- suq, kien hemm rapporti ta ’ panċitopenja u anemija aplastika, li x’ uħud minnhom spiċċaw biex kienu fatali (ara sezzjoni 4. 4).
Interstitial lung disease
Mard interstizjali tal- pulmun
There have been postmarketing reports of interstitial lung disease (including pneumonitis and pulmonary fibrosis), some of which had fatal outcomes.
Kien hemm rapporti ta ’ wara l- bejgħ ta ’ mard interstizjali tal- pulmun (li jinkludi pnewmonite u fibrożi pulmonari), li x’ uħud minnu kellu riżultati fatali.
Based on the results of clinical studies, normally no special laboratory evaluations are necessary in addition to careful medical management and supervision of patients.
12 Evalwazzjoni fil- Laboratorju Skond riżultati ta ’ studji kliniċi, is- soltu m’ hemmx bżonn li jsiru evalwazzjonijiet fil- laboratorju ma ’ l - imaniġġar mediku b’ attenzjoni u s- superviżjoni tal- pazjenti.
In studies when adult patients received concurrent treatment with Enbrel plus anakinra, a higher rate of serious infections compared to Enbrel alone was observed and 2% of patients (3/ 139) developed neutropenia (absolute neutrophil count  1000 / mm3).
Il- kura ta ’ Enbrel flimkien ma ’ anakinra Fi studji fejn il- pazjenti adulti kkurati b’ Enbrel fl- istess waqt li kienet għaddejja l- kura b’ anakinra, ġie osservat li kien hemm riskju ogħla ta ’ infezzjonijiet serji meta mqabbla ma ’ l- użu ta ’ Enbrel waħdu, u 2% tal- pazjenti (3/ 139) żviluppaw newtropenja (għadd assolut tan- newtrofils < 1000 / mm3).
While neutropenic, one patient developed cellulitis that resolved after hospitalisation (see sections 4.4 and 4.5).
Waqt li pazjent wieħed kien newtropeniku, dan żviluppa ċellulite li ġiet megħluba wara kura fi sptar (ara sezzjonijiet 4. 4 u 4. 5).
Undesirable effects in paediatric patients with polyarticular juvenile idiopathic arthritis
Effetti mhux mixtieqa f’ pazjenti pedjatriċi bl- artrite idjopatika poliartikolari tal- minorenni
In general, the adverse events in paediatric patients with juvenile idiopathic arthritis were similar in frequency and type to those seen in adult patients.
Ġeneralment, l- avvenimenti avversi f’ pazjenti pedjatriċi b’ artrite idjopatika ġuvenili kienu ta ’ frekwenza u tip simili għal dawk li dehru f’ pazjenti adulti.
Differences from adults and other special considerations are discussed in the following paragraphs.
Id- differenza minn dawk ta ’ adulti u l - konsiderazzjonijiet speċjali huma diskussi fil- paragrafi li ġejjin.
13 The types of infections seen in clinical trials in juvenile idiopathic arthritis patients aged 2 to 18 years were generally mild to moderate and consistent with those commonly seen in outpatient paediatric populations.
It- tipi ta ’ infezzjonijiet murija fi provi kliniċi f’ pazjenti b’ artrite idjopatika tal- minorenni ta ’ etajiet bejn 2 sa 18- il sena kienu ġeneralment ħfief għal moderati u konsistenti ma ’ dawk li komunament jidhru fil- popolazzjonijiet pedjatriċi outpatient.
Severe adverse events reported included varicella with signs and symptoms of aseptic meningitis, which resolved without sequelae (see also section 4.4), appendicitis, gastroenteritis, depression/ personality disorder, cutaneous ulcer, oesophagitis/ gastritis, group A streptococcal septic shock, type I diabetes mellitus, and soft tissue and post-operative wound infection.
Kienu rrappurtati diversi avvenimenti avversi inkużi l - ġidri r- riħ b’ sinjali u sintomi ta ’ meningite asettika li kienu imfejqa mingħajr sintomi morbużi wara l - marda (ara wkoll sezzjoni 4. 4.), appendiċite, gastroenterite, dipressjoni/ diżordni tal- personalità, ulċera fil- ġilda, esofaġite/ gastrite, xokk settiku minn streptokokku tat- tip A, diabetes mellitus tip I, u tessut artab u infezzjoni fil- ġerħa wara l- operazzjoni.
In one study in children with juvenile idiopathic arthritis aged 4 to 17 years, 43 of 69 (62%) children experienced an infection while receiving Enbrel during 3 months of the study (part 1 open-label), and the frequency and severity of infections was similar in 58 patients completing 12 months of open-label extension therapy.
Fi studju fi tfal b’ artrite idjopatika tal- minorenni ta ’ etajiet minn 4 sa 17- il sena, tlieta u erbgħin mid - 69 (62%) tfal bl- artrite kronika ġuvenili li kienu fuq il- kura b’ Enbrel ħadu infezzjoni matul it- tliet xhur ta ’ studju (l- ewwel parti open- label), u l- frekwenza u s- severità ta ’ l- infezzjoni kienet simili f’ 58 pazjent li spiċċaw it- 12- il xahar ta ’ terapija open- label li kompliet.
The types and proportion of adverse events in juvenile idiopathic arthritis patients were similar to those seen in trials of Enbrel in adult patients with rheumatoid arthritis, and the majority were mild.
It- tipi u l- proporzzjoni ta ’ avvenimenti avversi f’ pazjenti bl- artrite idjopatika ġuvenili hi simili għal dawk li nstabu fi studju b’ Enbrel f’ adulti bl- artrite rewmatojde, u li l- maġġoranza tagħhom kienu ħfief.
Several adverse events were reported more commonly in 69 juvenile idiopathic arthritis patients receiving 3 months of Enbrel compared to the 349 adult rheumatoid arthritis patients.
Hemm avvenimenti avversi li kienu rrappurtati aktar ta ’ spiss fil- każ ta’ 69 pazjent bl- artrite idjopatika ġuvenili li ħadu Enbrel għal 3 xhur, imqabbla mat- 349 pazjent adulti b’ artite rewmatojde.
These included headache (19% of patients, 1.7 events per patient year), nausea (9%, 1.0 event per patient year), abdominal pain (19%, 0.74 events per patient year), and vomiting (13%, 0.74 events per patient year).
Dawn jinkludu uġigħ ta ’ ras (19% tal- pazjenti, 1. 7 każ kull pazjent kull sena), dardir (9%, 1. 0 każ kull pazjent kull sena), uġigħ addominali (19%, 0. 74 każ kull pazjent kull sena), u remettar (13%, 0. 74 każ kull pazjent kull sena).
There were 4 reports of macrophage activation syndrome in juvenile idiopathic arthritis clinical trials.
Kien hemm 4 rapporti tas- sindrome ta ’ l- attivazzjoni tal- makrofagu fi provi kliniċi dwar l- artrite idjopatika ġuvenili.
Undesirable effects in paediatric patients with plaque psoriasis
Effetti mhux mixtieqa f’ pazjenti pedjatriċi bi psorjasi tal- plakka
In a 48-week study in 211 children aged 4 to 17 years with paediatric plaque psoriasis, the adverse events reported were similar to those seen in previous studies in adults with plaque psoriasis.
Fi studju li dam 48 ġimgħa li sar fuq 211- il tifel u tifla ta ’ bejn l- 4 u s- 17- il sena li kellhom psorjasi pedjatrika tal- plakka, l- avvenimenti avversi rrappurtati kienu simili għal dawk li kienu osservati fi studji li saru fil- passat fuq adulti bi psorjasi tal- plakka.
No dose-limiting toxicities were observed during clinical trials of rheumatoid arthritis patients.
L- ebda tossiċità li tillimita d- doża ma kienet osservata waqt studji kliniċi ta ’ pazjenti bl- artrite rewmatojde.
The highest dose level evaluated has been an intravenous loading dose of 32 mg/ m2 followed by subcutaneous doses of 16 mg/ m2 administered twice weekly.
L- ogħla livell ta ’ doża evalwata kienet id- doża tal- bidu mogħtija fil- vina ta ’ 32 mg/ m2, li warajha ngħataw id- dożi taħt il- ġilda ta ’ 16 mg/ m2 darbtejn f’ ġimgħa.
One rheumatoid arthritis patient mistakenly self- administered 62 mg Enbrel subcutaneously twice weekly for 3 weeks without experiencing undesirable effects.
Pazjent wieħed bl- artrite rewmatojde li bi żball ta doża lilu nniffsu taħt il- ġilda ta ’ 62 mg Enbrel darbtejn f’ ġimgħa għal tliet ġimgħat, ma kellu ebda effetti mhux mixtieqa.
There is no known antidote to Enbrel.
Ma nafu bl- ebda antidotu għal Enbrel.
Pharmacotherapeutic group:
Grupp Farmakoterapewtiku:
Tumor Necrosis Factor alpha (TNF- α) inhibitors.
Inibituri tal- Fattur tan- Nekrosi tat- Tumur (TNF- α).
Tumour necrosis factor (TNF) is a dominant cytokine in the inflammatory process of rheumatoid arthritis.
Il- fattur nekrotiku għat- tumuri (TNF) huwa cytokine dominanti fil- proċess infjammatorju ta ’ l- artrite rewmatojde.
Elevated levels of TNF are also found in the synovium and psoriatic plaques of patients with psoriatic arthritis and in serum and synovial tissue of patients with ankylosing spondylitis.
Livelli ogħla ta ’ TNF jinstabu wkoll fis- sinovjum u qxur psorjatiku ta ’ pazjenti bl- artrite psorjatika u fis- serum u tessut sinovjali ta ’ pazjenti b’ immobilità tal- vertebra kawża ta ’ infjammazzjoni.
In plaque psoriasis, infiltration by inflammatory cells including T-cells leads to increased TNF levels in psoriatic lesions compared with levels in uninvolved skin.
Fi psorjasi tal- plakka, infiltrazzjoni minn ċelloli infjammatorji inklużi ċelloli- T twassal għal żieda fil- livelli TNF f’ leżjonijiet psorjatiċi meta mqabblin mal- livelli fil- ġilda mhux involuta.
Etanercept is a competitive inhibitor of TNF-binding to its cell surface receptors and thereby inhibits the biological activity of TNF.
Etanercept huwa impeditur kompetittiv ta ’ TNF li jeħel mar- riċetturi fuq is- superfiċje taċ - ċelluli u b’ hekk jimpedixxi l- attività bijoloġika ta ’ TNF.
TNF and lymphotoxin are pro- inflammatory cytokines that bind to two distinct cell surface receptors: the 55-kilodalton (p55) and 75-kilodalton (p75) tumour necrosis factor receptors (TNFRs).
TNF u lymphotoxin huma cytokines pro - infjammatorji li jeħlu ma ’ żewġ tipi differenti ta ’ riċetturi fuq is- superfiċje taċ- ċelluli: ir- riċetturi tal - fattur nekrotiku għat- tumuri (TNFRs) ta ’ 55- kilodalton (p55) u 75- kilodalton (p75).
Both TNFRs exist naturally in membrane- bound and soluble forms.
Iż- żewġ TNFRs jinstabu naturalment f’ forma li teħel ma ’ rita u f’ forma li tinħall.
Soluble TNFRs are thought to regulate TNF biological activity.
Huwa maħsub li TNFRs li jinħallu jirregolaw l- attività bijoloġika ta ’ TNF.
14 TNF and lymphotoxin exist predominantly as homotrimers, with their biological activity dependent on cross-linking of cell surface TNFRs.
TNF u lymphotoxin jinstabu l- aktar bħala homotrimers, li l- attività bijoloġika tagħhom hija dipendenti fuq “ cross- linking ” ma ’ TNFRs fuq is- superfiċje taċ- ċelluli.
Dimeric soluble receptors such as etanercept possess a higher affinity for TNF than monomeric receptors and are considerably more potent competitive inhibitors of TNF binding to its cellular receptors.
Riċetturi dimeriċi li jinħallu bħal etanercept għandhom affinità ogħla għal TNF minn riċetturi monomeriċi u huma impedituri kompetittivi ta ’ TNF li jeħel mar- riċetturi taċ- ċelluli aktar qawwijin.
In addition, use of an immunoglobulin Fc region as a fusion element in the construction of a dimeric receptor imparts a longer serum half-life.
Barra minn hekk, l- użu ta ’ immunoglobina tar- reġjun Fc bħala element li jgħaqqad fil- konstruzzjoni tar- riċetturi dimeriċi jirriżulta b’ half- life fis- serum itwal.
Mechanism of action
Mekkaniżmu ta ’ l- azzjoni
Much of the joint pathology in rheumatoid arthritis and ankylosing spondylitis and skin pathology in plaque psoriasis is mediated by pro-inflammatory molecules that are linked in a network controlled by TNF.
Ħafna mill- patoloġija tal- ġogi fl- artite rewmatojde u fl- immobilità tal- vertebra kawża ta ’ infjammazzjoni u patologija tal- ġilda fi psorjasi tal- plakka hi medjata minn molekuli pro - infjammatorji li huma mqabbda flimkien ġo network ikkontrollat minn TNF.
The mechanism of action of etanercept is thought to be its competitive inhibition of TNF binding to cell surface TNFR, preventing TNF-mediated cellular responses by rendering TNF biologically inactive.
Il- mekkaniżmu ta ’ l - azzjoni ta ’ etanercept hu maħsub li hu ta ’ impedizzjoni kompetittiva ta ’ TNF li jeħel mas- superfiċje taċ- ċelluli TNFR, u jipprevjeni r- risponsi ċellulari medjati ta ’ TNF billi jġib it- TNF bijoloġikalment inattiv.
Etanercept may also modulate biologic responses controlled by additional downstream molecules (e. g., cytokines, adhesion molecules, or proteinases) that are induced or regulated by TNF.
Etanercept jista ’ wkoll jimmodula r- risponsi bijoloġiċi kkontrollati b’ żjieda ta ’ molekuli “ downstream ” (eż. cytokines, molekuli ta ’ l- adeżjoni jew proteinases) li huma nduċati jew regulati mit- TNF.
Clinical trials
Studji Kliniċi
This section presents data from four randomised controlled trials in adults with rheumatoid arthritis, one study in polyarticular juvenile idiopathic arthritis, one study in adults with psoriatic arthritis, one study in adults with ankylosing spondylitis, one study in paediatric patients with plaque psoriasis, and four studies in adults with plaque psoriasis.
Din is- sezzjoni fiha tagħrif meħud minn erba ’ studji b’ għażla każwali u kkontrollati f’ adulti b’ artrite rewmatojde; studju wieħed ta ’ pazjenti b’ artrite idjopatika tal- minorenni tat- tip poliartikulari, studju wieħed ta ’ adulti b’ artrite psorjatika, u studju wieħed ta ’ adulti b’ immobilità tal- vertebra kawża ta ’ infjammazzjoni, studju wieħed fuq pazjenti pedjatriċi bi psorjasi tal- plakka, u erba ’ studji ta ’ adulti bi psorjasi tal- plakka.
Adult patients with rheumatoid arthritis
Pazjenti adulti b’ artrite rewmatojde
The efficacy of Enbrel was assessed in a randomised, double-blind, placebo-controlled study.
L- effikaċja ta ’ Enbrel ġiet imkejla fi studju b’ għażla każwali, double- blind u kkontrollat bi plaċebo.
The study evaluated 234 adult patients with active rheumatoid arthritis who had failed therapy with at least one but no more than four disease-modifying antirheumatic drugs (DMARDs).
L - istudju evalwa 234 pazjent adult li kellhom l- artrite rewmatojde attiva, u fihom minn ta ’ l- inqas ma ħadmitx mediċina waħda, iżda mhux aktar minn erbgħa mediċini anti- rewmatiċi li jimmodifikaw il - marda (DMARDs).
Doses of 10 mg or 25 mg Enbrel or placebo were administered subcutaneously twice a week for 6 consecutive months.
Dożi ta ’ 10 mg jew 25 mg ta ’ Enbrel jew l- plaċebo ngħataw taħt il- ġilda darbtejn f’ ġimgħa għal sitt xhur konsekuttivi.
The results of this controlled trial were expressed in percentage improvement in rheumatoid arthritis using American College of Rheumatology (ACR) response criteria.
Ir- riżultat ta ’ dan l- istudju kkontrollat wera titjib perċentwali fl - artite rewmatojde meta ntużaw il- kriterji tar- rispons tal- Kulleġġ Amerikan tar- Rewmatoloġija (ACR).
ACR 20 and 50 responses were higher in patients treated with Enbrel at 3 and 6 months than in patients treated with placebo (ACR 20:
Ir- rispons ta ’ l- ACR 20 u 50 kien ogħla f’ pazjenti li ġew ikkurati b’ Enbrel għal 3 xhur u 6 xhur minn pazjenti kkurati bil- plaċebo (ACR 20:
ACR 50:
Enbrel 62% u 59%, plaċebo 23% u 11% f ’ 3 u f’ 6 xhur 14 rispettivament; ACR 50:
Enbrel 41% and 40%, placebo 8% and 5% at months 3 and 6 respectively; p < 0.01 Enbrel vs placebo at all time points for both ACR 20 and ACR 50 responses).
Enbrel 41% u 40%, placebo 8% u 5% f ’ 3 u f’ 6 xhur rispettivament; p < 0. 01 Enbrel vs plaċebo f’ kull punt taż- żmien għar- rispons ta ’ ACR 20 kif ukoll ACR 50.
Approximately 15% of subjects who received Enbrel achieved an ACR 70 response at month 3 and month 6 compared to fewer than 5% of subjects in the placebo arm.
Bejn wieħed u ieħor 15% minn dawk li ħadu Enbrel laħħqu rispons ta ’ ACR 70 fit- tielet xahar u fis - sitt xahar meta mqabbla ma ’ inqas minn 5% ta ’ dawk li ngħataw il- plaċebo.
Among patients receiving Enbrel, the clinical responses generally appeared within 1 to 2 weeks after initiation of therapy and nearly always occurred by 3 months.
Fost il- pazjenti li ħadu Enbrel, ir- risponsi kliniċi ġeneralment dehru wara ġimgħa jew tnejn li kienet bdiet it- terapija u kważi dejjem seħħet sa 3 xhur.
A dose response was seen; results with 10 mg were intermediate between placebo and 25 mg.
Deher rispons għad- doża; riżultati b’ 10 mg kienu fin- nofs bejn il- plaċebo u 25mg.
Enbrel was significantly better than placebo in all components of the ACR criteria as well as other measures of rheumatoid arthritis disease activity not included in the ACR response criteria, such as morning stiffness.
Enbrel kien sinjifikament aħjar mill- plaċebo fil- komponenti kollha tal- kriterji ACR kif ukoll ta ’ miżuri oħra ta ’ l- attività fil- marda ta ’ l- artrite rewmatojde, li m’ humiex inklużi fil- krierji tar- rispons ta ’ l- ACR, bħalma hi ebbusija ta ’ fil- għodu.
A Health Assessment Questionnaire (HAQ), which included disability, vitality, mental health, general health status, and arthritis-associated health status subdomains, was administered every 3 months during the trial.
Waqt l- istudju ngħata kwestjonarju jismu “ Kwestjonarju għall- Assessjar tas- Saħħa (HAQ) ”, li nkluda diżabilità, vitalità, saħħa mentali, kundizzjoni tas- saħħa ġenerali, u sotto dominji ta ’ saħħa relatati ma ’ l- artrite.
All subdomains of the HAQ were improved in patients treated with Enbrel compared to controls at 3 and 6 months.
Is- sotto dominji tal- HAQ f’ pazjenti kkurati b’ Enbrel kienu mtejba meta mqabbla ma ’ kontrolli ta ’ 3 jew 6 xhur.
After discontinuation of Enbrel, symptoms of arthritis generally returned within a month.
Wara li ma tkomplietx il- kura b’ Enbrel, is- sintomi ta ’ l- artrite ġeneralment reġgħu tfaċċaw fiż- żmien xahar.
Re-introduction of treatment with Enbrel after discontinuation of up to 24 months resulted in the same magnitudes of responses as patients who received Enbrel without interruption of therapy based on results of open-label studies.
Meta reġgħet inbdiet il- kura b’ Enbrel wara li ma tkomplietx sa 24 xahar irriżulta fl- istess qawwa ta ’ risponsi bħal dawk tal- pazjenti li komplew jieħdu Enbrel mingħajr interruzzjoni tat- terapija li kienet ibbażata fuq ir- riżultati ta ’ studji open- label.
Continued durable responses have been seen for up to 48 months in open-label extension
Baqgħu jidhru risponsi fit- tul sa 48 xahar fl - istudji open- label ta ’ kura li kompliet meta l- pazjenti ħadu Enbrel mingħajr interruzzjoni; m’ hemmx esperjenza fuq tul ta ’ żmien itwal.
The efficacy of Enbrel was compared to methotrexate in a randomised, active-controlled study with blinded radiographic evaluations as a primary endpoint in 632 adult patients with active rheumatoid arthritis (< 3 years duration) who had never received treatment with methotrexate.
L- effikaċja ta ’ Enbrel kien imqabbel ma ’ methotrexate fi studju b’ għażla każwali, ikkontrollat attivament b’ evalwazzjonijiet radjografiċi blinded bħala endpoint primarju fi 632 pazjent adult bl - artrite rewmatojde attiva (għal < 3 snin) u li qatt ma kienu ħadu kura b’ methotrexate.