FrancophonIA/ELRC3.0 huggingface dataset:
English: Population pharmacokinetic analyses indicated that risankizumab exposure was not impacted by concomitant medications (metformin, atorvastatin, lisinopril, amlodipine, ibuprofen, acetylsalicylate and levothyroxine) used by some subjects with plaque psoriasis during the clinical studies.
Maltese: Analiżijiet tal-farmakokineta tal-popolazzjoni indikaw li l-esponiment ta' risankizumab ma kellux impatt minn medikazzjonijiet konkomitanti (metformin, atorvastatin, lisinopril, amlodipine, ibuprofen, acetylsalicylate u levothyroxine) li intużaw minn xi individwi bil-psorjażi bil-qoxra waqt l-istudji kliniċi.
English: Nail Psoriasis Severity Index (NAPSI), Palmoplantar Psoriasis Severity Index (PPASI), Psoriasis Scalp Severity Index (PSSI), and Standard Error (SE) ** P < 0.01 comparing to risankizumab *** P < 0.001 comparing to risankizumab
Maltese: Indiċi tas-Severità tal-Psorjażi tad-Difer (NAPSI, Nail Psoriasis Severity Index), Indiċi tas-Severità tal-Psorjażi tal-pala tal-id u tal-qiegħ tas-sieq (PPASI, Palmoplantar Psoriasis Severity Index), Indiċi tas-Severità tal-Psorjażi tal-Qorriegħa (PSSI, Psoriasis Scalp Severity Index), u Żball Standard (SE, Standard Error) ** P < 0.01 meta mqabbel ma' risankizumab *** P < 0.001 meta mqabbel ma' risankizumab
English: Placebo (N=98) n (%)
Maltese: Plaċebo (N=98) n (%)
English: Tinea infections
Maltese: Infezzjonijiet u infestazzjonijiet
English: STEP 2
Maltese: PASS 2
English: For more information and support on Skyrizi go to www.skyrizi.eu or scan this code.
Maltese: Għal aktar informazzjoni u appoġġ dwar Skyrizi mur fuq www.skyrizi.eu jew skennja dan il-kodiċi.
English: Table 3: Mean changes from baseline in NAPSI, PPASI, and PSSI ULTIMMA-1
Maltese: Tabella 3: Tibdil medju mil-linja bażi f'NAPSI, PPASI, u PSSI
English: Gender or race
Maltese: Sess jew razza
English: For PASI 90 responders at week 16, 88.4% (398/450) of subjects maintained the response at week 52.
Maltese: Għal rispondenti b'PASI 90 f'ġimgħa 16, 88.4% (398/450) talindividwi żammew ir-rispons f'ġimgħa 52.
English: Risankizumab exhibited linear pharmacokinetics with dose-proportional increase in exposure across dose ranges of 18 to 300 mg and 0.25 to 1 mg/kg administered subcutaneously, and 200 to 1,200 mg and 0.01 to 5 mg/kg administered intravenously.
Maltese: Risankizumab wera farmakokinetika lineari b'żieda proporzjonali għad-doża f'esponiment fil-meded tad-doża ta' 18 sa 300 mg u 0.25 sa 1 mg/kg mogħtija taħt il-ġilda, u 200 sa 1,200 mg u 0.01 sa 5 mg/kg mogħtija ġol-vini.
English: Placebo (N=102) n (%)
Maltese: Plaċebo (N=102) n (%)
English: Table 1: List of adverse reactions in clinical studies
Maltese: Tabella 1: Lista tar-reazzjonijiet avversi fl-istudji kliniċi
English: STEP 4
Maltese: PASS 4
English: Examination of age, gender, race, body weight ≤130 kg, baseline PASI score, concurrent psoriatic arthritis, previous non-biologic systemic treatment, previous biologic treatment, and previous failure of a biologic did not identify differences in response to risankizumab among these subgroups.
Maltese: Eżaminazzjoni ta' età, sess, razza, piż tal-ġisem ≤130 kg, punteġġ PASI fil-linja bażi, artrite psorjatika konkurrenti, kura sistemika mhux bijoloġika preċedenti, kura bijoloġika preċedenti, u nuqqas preċedenti ta' bijoloġiku ma identifikatx differenzi fir-rispons għal risankizumab fost dawn issottogruppi.
English: ADA/ADA: Subjects randomised to adalimumab and continued on adalimumab ADA/RZB: Subjects randomised to adalimumab and switched to risankizumab p<0.05 at week 4 and p<0.001 at each time point beginning at week 8
Maltese: Individwi randomizzati għal adalimumab u li komplew fuq adalimumab ADA/RZB: Individwi randomizzati għal adalimumab u li qelbu għal risankizumab p<0.05 f'ġimgħa 4 u p<0.001 f'kull punt taż-żmien li jibda minn ġimgħa 8
English: • 2 pre-filled syringes and 2 alcohol pads (included in the carton)
Maltese: • 2 siringi mimlijin għal-lest u 2 kuxxinetti bl-alkoħol (inklużi fil-kartuna)
English: IL-23 is a cytokine that is involved in inflammatory and immune responses.
Maltese: IL-23 hija ċitokina li hija involuta f'risponsi infjammatorji u immunitarji.
English: Figure 2: Time course of PASI 90 after re-randomisation in IMMVENT
Maltese: Figura 2: Varjetà fl-attività maż-żmien ta' PASI 90 wara r-randomizzazzjon mill-ġdid f'IMMVENT
English: STEP 3
Maltese: PASS 3
English: Continued on Adalimumab (N=56) n (%)
Maltese: Komplew fuq Adalimumab (N=56) n (%)
English: Week 16 89 (29.3) Week 52 173 (56.9) All comparisons of risankizumab versus ustekinumab and placebo achieved p<0.001 except for PASI 75 at week 52 in ULTIMMA-2 where p=0.001
Maltese: Ġimgħa 16 89 (29.3) Ġimgħa 52 It-tqabbil kollu ta' risankizumab kontra ustekinumab u plaċebo laħaq p<0.001 ħlief għal PASI 75 f'ġimgħa 52 f'ULTIMMA-2 fejn p=0.001
English: The most frequently reported adverse reactions were upper respiratory infections, which occurred in 13% of patients.
Maltese: Ir-reazzjonijiet avversi li ġew irrappurtati bl-aktar mod frekwenti kienu infezzjonijiet fil-parti respiratorja ta' fuq, li seħħew fi 13 % tal-pazjenti.
English: Skyrizi is indicated for the treatment of moderate to severe plaque psoriasis in adults who are candidates for systemic therapy.
Maltese: Skyrizi huwa indikat għall-kura ta' psorjażi bil-qoxra moderata sa severa fl-adulti li huma kandidati għal terapija sistemika.
English: Table 5: Efficacy results 28 weeks after re-randomisation in IMMVENT Switched to Risankizumab (N=53) n (%)
Maltese: Riżultati tal-effikaċja 28 ġimgħa wara randomizzazzjoni mill-ġdid f'IMMVENT Qelbu għal Risankizumab (N=53) n (%)
English: The mean (±standard deviation) systemic clearance (CL) of risankizumab was 0.3 (±0.1) L/day in Phase 3 studies in subjects with psoriasis.
Maltese: It-tneħħija sistemika (CL) medja (±devjazzjoni standard) ta' risankizumab kienet 0.3 (±0.1) L/jum fi studji ta' Fażi 3 f'individwi bil-psorjażi.
English: STEP 7
Maltese: PASS 7
English: STEP 6
Maltese: PASS 6
English: For subjects who had PASI 50 to <PASI 90 with adalimumab at week 16 and were re-randomised, differences in PASI 90 response rates between switching to risankizumab and continuing adalimumab were noted 4 weeks after re-randomisation (49.1% vs 26.8%, respectively).
Maltese: Għal individwi li kellhom PASI 50 sa <PASI 90 b'adalimumab f'ġimgħa 16 u li ġew randomizzati mill-ġdid, id-differenzi fir-rati tar-rispons ta' PASI 90 bejn li jaqilbu għal risankizumab u li jkomplu fuq adalimumab ġew innutati sa minn kmieni daqs 4 ġimgħat wara r-randomizzazzjoni (49.1% vs 26.
English: The additive effect of concomitantly administered products containing sorbitol (or fructose) and dietary intake of sorbitol (or fructose) should be taken into account.
Maltese: L-effett addittiv ta' prodotti li fihom sorbitol (jew fructose) amministrati b'mod konkomittanti u tteħid ta' sorbitol (jew fructose) mad-dieta, għandu jitqies.
English: Skyrizi is not recommended for children and adolescents under 18 years of age.
Maltese: Skyrizi mhuwiex rakkomandat għal tfal u adolexxenti taħt l-età ta' 18.
English: This medicinal product contains 68.0 mg sorbitol per 150 mg dose.
Maltese: Dan il-prodott mediċinali fih 68.0 mg sorbitol għal kull doża ta' 150 mg.
English: Elderly (aged 65 years and over)
Maltese: Anzjani (ta' 65 sena u iktar)
English: Risankizumab is a humanised immunoglobulin G1 (IgG1) monoclonal antibody that selectively binds with high affinity to the p19 subunit of human interleukin 23 (IL-23) cytokine without binding to IL12 and inhibits its interaction with the IL-23 receptor complex.
Maltese: Risankizumab huwa antikorp monoklonali ta' immunoglobina umanizzata G1 (IgG1) li b'mod selettiv jeħel b'affinità għolja mas-subunità p19 taċ-ċitokina ta' interleukin 23 (IL-23) umana mingħajr ma jeħel ma' IL-12 u jinibixxi l-interazzjoni tagħha mal-kumpless tar-riċettur ta' IL-23.
English: No dose adjustment is required (see section 5.2).
Maltese: Ma hemm bżonn ta' ebda aġġustament tad-doża (ara sezzjoni 5.2).
English: LABEL
Maltese: LISTA
English: A drug interaction study was conducted in subjects with plaque psoriasis to assess the effect of repeated administration of risankizumab on the pharmacokinetics of cytochrome P450 (CYP) sensitive probe substrates.
Maltese: Sar studju ta' interazzjoni mediċinali f'individwi bi psorjażi bil-qoxra biex jiġi vvalutat l-effett ta' għoti ripetut ta' risankizumab fuq il-farmakokinetika ta' substrati sondi sensittivi għaċ-ċitokromu P450 (CYP).
English: • if you have recently received or plan to receive an immunisation (vaccine).
Maltese: • jekk dan l-aħħar irċivejt jew qed tippjana li tirċievi immunizzazzjoni (vaċċin).
English: Check liquid
Maltese: Iċċekkja l-likwidu
English: Among the few subjects (approximately 1%; 7/1,000 at week 16 and 6/598 at week 52) with high antibody titers (>128), clinical response appeared to be reduced.
Maltese: Fost il-ftit individwi (bejn wieħed u ieħor 1%; 7/1,000 f'ġimgħa 16 u 6/598 f'ġimgħa 52) b'titers tal-antikorpi għoljin (>128), ir-rispons kliniku deher li kien imnaqqas.
English: Therapeutic IgG monoclonal antibodies are typically degraded into small peptides and amino acids via catabolic pathways in the same manner as endogenous IgGs.
Maltese: IgG terapewtiċi normalment jiġu degradati f'peptidi żgħar u amminoaċidi permezz ta' passaġġi kataboliċi bl-istess mod bħal IgGs endoġeni.
English: Figure 1: Time course of mean percent change from baseline of PASI in ULTIMMA-1 and ULTIMMA-2
Maltese: Figura 1: Varjetà fl-attività maż-żmien ta' bidla perċentwali medja mil-linja bażi ta' PASI f'ULTIMMA-1 u ULTIMMA-2
English: The safety profile of risankizumab with up to 77 weeks of exposure was consistent with the profile observed up to 16 weeks.
Maltese: Il-profil ta' sigurtà ta' risankizumab b'massimu ta' 77 ġimgħa ta' esponiment kien konsistenti malprofil osservat sa 16-il ġimgħa.
English: Over the entire psoriasis programme including long-term exposure to risankizumab, the rate of infections was 75.5 events per 100 subject-years.
Maltese: Matul il-programm kollu tal-psorjażi, inkluż esponiment fit-tul għal risankizumab, ir-rata ta' infezzjonijiet kienet 75.5 avvenimenti għal kull 100 sena tal-individwu.
English: Patients receiving risankizumab should be monitored for signs and symptoms of active TB.
Maltese: Il-pazjenti li jirċievu risankizumab għandhom jiġu mmonitorjati għal sinjali u sintomi ta' TB attiva.
English: Other medicines and Skyrizi
Maltese: Mediċini oħra u Skyrizi
English: The two co-primary endpoints in ULTIMMA-1 and ULTIMMA-2 were the proportion of subjects who achieved 1) PASI 90 response and 2) sPGA score of clear or almost clear (sPGA 0 or 1) at week 16 versus placebo.
Maltese: Iż-żewġ end-points koprimarji f'ULTIMMA-1 u ULTIMMA-2 kienu l-proporzjon ta' individwi li kisbu 1) rispons PASI 90 u 2) punteġġ sPGA ta' xejn jew kważi xejn (sPGA 0 jew 1) f'ġimgħa 16 kontra l-plaċebo.
English: Risankizumab is not expected to be metabolised by cytochrome P450 enzymes.
Maltese: Risankizumab mhuwiex mistenni li jiġi metabolizzat minn enzimi taċ-ċitokromu P450.
English: Enrolled subjects were 18 years of age and older with plaque psoriasis who had a body surface area (BSA) involvement of ≥10%, a static Physician Global Assessment (sPGA) score of ≥3 in the overall assessment (plaque thickness/induration, erythema, and scaling) of psoriasis on a severity scale of 0 to 4, a Psoriasis Area and Severity Index (PASI) score ≥12, and who were candidates for systemic therapy or phototherapy.
Maltese: L-individwi li ġew irreġistrati kellhom 18-il sena u aktar bi psorjażi bil-qoxra li kellhom involviment tal-erja tas-superfiċe tal-ġisem (BSA) ta' ≥10 %, punteġġ statiku tal-Valutazzjoni Globali tat-Tobba (sPGA) ta' ≥3 fil-valutazzjoni globali (ħxuna/ebusija talqoxra, eritema, u tqaxxir tal-ġilda) tal-psorjażi fuq skala ta' severità ta' 0 sa 4, punteġġ tal-Parti talPsorjażi u l-Indiċi tas-Severità (PASI)
English: 150 mg (two 75 mg injections) 4 weeks after 1
Maltese: 150 mg (żewġ injezzjonijiet ta' 75 mg)
English: This is because Skyrizi has not been studied in this age group.
Maltese: Dan għaliex Skyrizi ma ġiex studjat f'dan il-grupp tal-età.
English: The safety and efficacy of Skyrizi in children and adolescents aged 6 to 18 years have not yet been established.
Maltese: Is-sigurtà u l-effikaċja ta' Skyrizi fit-tfal u fl-adolexxenti minn età 6 sa 18-il sena ma ġewx determinati s'issa.
English: Risankizumab (N=294) n (%)
Maltese: Risankizumab (N=294)
English: The rate of serious infections was 1.7 events per 100 subject-years (see section 4.4).
Maltese: Ir-rata ta' infezzjonijiet serji kienet ta' 1.7 avveniment għal kull 100 sena tal-individwu (ara sezzjoni 4.4).
English: Of the 2,234 subjects with plaque psoriasis exposed to risankizumab, 243 were 65 years or older and 24 subjects were 75 years or older.
Maltese: Mill-2,234 individwu bil-psorjażi bil-qoxra esposti għal risankizumab, 243 kellhom 65 sena jew aktar u 24 individwu kellhom 75 sena jew aktar.
English: Of these subjects, 63.1% (70/111) of subjects re-randomised to continued treatment with risankizumab achieved a sPGA clear response at week 104 compared to 2.2% (5/225) who were re-randomised to withdrawal from risankizumab.
Maltese: Minn dawn l-individwi, 63.1% (70/111) tal-individwi randomizzati mill-ġdid għal kura kontinwata b'risankizumab kisbu rispons ċar ta' sPGA f'ġimgħa 104 meta mqabbel ma' 2.2% (5/225) li ġew randomizzati mill-ġdid għal irtirar minn risankizumab.
English: • 2 cotton balls or gauze pads (not included in the carton)
Maltese: • 2 biċċiet tat-tajjar jew gareż (mhux inklużi fil-kartuna)
English: Anxiety and depression, as measured by the Hospital Anxiety and Depression Scale (HADS), improved in the risankizumab group at week 16 compared with the placebo group.
Maltese: Ansejtà u depressjoni, kif imkejla mill-Iskala tal-Ansjetà u Depressjoni tal-Isptar (HADS, Hospital Anxiety and Depression Scale), tjiebet fil-grupp ta' risankizumab fil-ġimgħa 16 meta mqabbel malgrupp tal-plaċebo.
English: Week 16
Maltese: Ġimgħa 16
English: Body of syringe
Maltese: Korp tas-siringa
English: Press a cotton ball or gauze pad where you have injected and hold for 10 seconds.
Maltese: Poġġi biċċa tajjara jew garża fejn injettajt u żommha għal 10 sekondi.
English: Subjects randomised to adalimumab received 80 mg at week 0, 40 mg at week 1 and 40 mg every other week through week 15.
Maltese: L-individwi li ġew randomizzati għal adalimumab irċivew 80 mg f''ġimgħa 0, 40 mg f'ġimgħa 1, u 40 mg kull ġimagħtejn sa ġimgħa 15.
English: The incidence of injection site reactions is numerically higher in the anti-drug antibodypositive compared with anti-drug antibody-negative groups over short-term (16 weeks: 2.7% vs 1.3%) and longer term treatment (>52 weeks: 5.0% vs 3.3%).
Maltese: 2.7% vs 1.3%) u kura fuq perjodu ta' żmien itwal (>52 ġimgħa: 5.0% vs 3.3%).
English: In a 26-week chronic toxicology study in cynomolgus monkeys at doses of up to 50 mg/kg/week (about 70 times the clinical exposure at the MRHD), there were no pre-neoplastic or neoplastic lesions observed and no adverse immunotoxicity or cardiovascular effects were noted .
Maltese: Fi studju tat-tossikoloġija kronika ta' 26 ġimgħa f'xadini cynomolgus b'dożi sa 50 mg/kg/ġimgħa (madwar 70 darba lesponiment kliniku bil-MRHD), ma kien hemm l-ebda leżjoni preneoplastika jew neoplastika li ġiet osservata u ma ġiet innutata l-ebda immunotossicità avversa jew effetti kardjovaskulari.
English: Maintenance of response
Maltese: Manteniment tar-rispons
English: In an integrated analysis of subjects receiving risankizumab in ULTIMMA-1 and ULTIMMA-2 for PASI 100 responders at week 16, 79.8% (206/258) of the subjects who continued on risankizumab maintained the response at week 52.
Maltese: F'analiżi integrata tal-individwi li rċivew risankizumab f'ULTIMMA-1 u ULTIMMA-2 għal rispondenti b'PASI 100 f'ġimgħa 16, 79.8 % (206/258) tal-individwi li komplew fuq risankizumab żammew ir-rispons f'ġimgħa 52.
English: The mean terminal elimination half-life of risankizumab ranged from 28 to 29 days in Phase 3 studies in subjects with psoriasis.
Maltese: In-nofs ħajja ta' eliminazzjoni terminali medja ta' risankizumab varjat minn 28 sa 29 jum fi studji ta' Fażi 3 f'individwi bil-psorjażi.
English: Each pack contains 2 pre-filled syringes and 2 alcohol pads.
Maltese: Kull pakkett fih 2 siringi mimlijin għal-lest u 2 kuxxinetti bl-alkoħol.
English: This medicine contains less than 1 mmol sodium (23 mg) per 150 mg dose, that is to say essentially ‘sodium-free'.
Maltese: Dan il-prodott mediċinali fih inqas minn 1 mmol sodium (23 mg) għal kull doża ta' 150 mg, jiġifieri, essenzjalment huwa “mingħajr sodium”.
English: The dose is 150 mg given as two 75 mg injections.
Maltese: el doża 150 mg (żewġ injezzjonijiet ta' 75 mg)
English: Belgique/Belgien Tél/Tel: +32 10 477811
Maltese: AbbVie Polska Sp. z o.o. Tel: +48 22 372 78 00
English: • if you have an infection, including active tuberculosis, which your doctor thinks is important.
Maltese: • jekk għandek infezzjoni, inkluż tuberkulożi attiva, li t-tabib tiegħek jaħseb li hija importanti.
English: The results for the co-primary and other endpoints are presented in Table 2 and Figure 1.
Maltese: Irriżultati għall-end-points koprimarji u oħrajn huma ppreżentati f'Tabella 2 u f'Figura 1.
English: Drug interactions between risankizumab and inhibitors, inducers, or substrates of drug metabolising enzymes are not expected and no dose adjustment is needed (see section 5.2).
Maltese: Mhumiex mistennija interazzjonijiet mediċinali bejn risankizumab u inibituri, indutturi, jew substrati ta' enzimi li jimmetabolizzaw il-mediċina u mhu meħtieġ l-ebda aġġustament fid-doża (ara sezzjoni 5.2).
English: Upper respiratory infections
Maltese: Infezzjonijiet fil-parti respiratorja ta' fuq
English: Headache
Maltese: Prurite
English: Table 2: Efficacy and quality of life results in adults with plaque psoriasis in ULTIMMA-1 and ULTIMMA-2
Maltese: Ir-riżultati tal-effikaċja u l-kwalità tal-hajja f‘ adulti bil-psorjażi bil-qoxra f'ULTIMMA-1 u ULTIMMA-2
English: ANNEX II
Maltese: It-2
English: Risankizumab exhibited linear pharmacokinetics with approximately dose-proportional increases in systemic exposure (Cmax and AUC) in the evaluated dose ranges of 18 to 300 mg or 0.25 to 1 mg/kg subcutaneous administration in healthy subjects or subjects with psoriasis.
Maltese: Risankizumab wera farmakokinetika lineari b'bejn wieħed u ieħor żidiet proporzjonali għad-doża f'esponiment sistemiku (Cmax u AUC) fil-meded tad-doża li ġew evalwati ta' 18 sa 300 mg jew 0.25 sa 1 mg/kg għoti taħt il-ġilda f'individwi b'saħħithom jew f'individwi bil-psorjażi.
English: Animal studies do not indicate direct or indirect harmful effects with respect to fertility.
Maltese: Studji f'annimali ma urewx effetti diretti jew indiretti tossiċi fuq il-fertilità.
English: All comparisons achieved p<0.001
Maltese: It-tqabbil kollu miksub p<0.001
English: Anti-TB therapy should be considered prior to initiating risankizumab in patients with a past history of latent or active TB in whom an adequate course of treatment cannot be confirmed.
Maltese: Għandha tiġi kkunsidrata terapija kontra t-TB qabel il-bidu ta' risankizumab f'pazjenti bi storja mgħoddija ta' TB latenti jew attiva li fihom ma jistax jiġi kkonfermat kors adegwat ta' kura.
English: In 270 patients who switched from adalimumab to risankizumab without a washout period, the safety profile of risankizumab was similar to that in patients who initiated risankizumab after wash out of any prior systemic therapies.
Maltese: F'270 pazjent li qelbu minn adalimumab għal risankizumab mingħajr perjodu biex tiġi eliminata lmediċina mill-ġisem, il-profil tas-sigurtà ta' risankizumab kien simili għal dak f'pazjenti li bdew risankizumab wara li ġiet eliminata mill-ġisem kwalunkwe terapija sistemika preċedenti.
English: QR code to be included
Maltese: Kodiċi QR li għandu jiġi inkluż
English: 20 and water for injections.
Maltese: polysorbate 20 u ilma għall-injezzjonijiet.
English: A total of 9.8% of study subjects had a history of diagnosed psoriatic arthritis.
Maltese: Total ta' 9.8 % tal-individwi tal-istudju kellhom storja ta' artrite psorjatika li ġiet dijanjostikata.
English: The mean (±standard deviation) steady-state volume of distribution (Vss) of risankizumab was 11.4 (±2.7) L in Phase 3 studies in subjects with psoriasis, indicating that the distribution of risankizumab is primarily confined to the vascular and interstitial spaces.
Maltese: (±2.7) L fl-istudji ta' Fażi 3 f'individwi bil-psorjażi, li jindika li d-distribuzzjoni ta' risankizumab hija primarjament limitata għall-ispazji vaskulari u interstizjali.
English: With dosing of 150 mg at week 0, week 4 and every 12 weeks thereafter, estimated steady-state peak and trough plasma concentrations are 12 and 2 µg/mL, respectively.
Maltese: ġimgħa 4 u kull 12-il ġimgħa wara dan, il-konċentrazzjonijiet massimi fi stat fiss stmati u lkonċentrazzjonijiet minimi fil-plażma huma 12 u 2 µg/mL, rispettivament.
English: How to store Skyrizi
Maltese: X'fih Skyrizi
English: Among subjects with sPGA of clear or almost clear at week 28 in IMMHANCE, 81.1% (90/111) of subjects re-randomised to continued treatment with risankizumab maintained this response at week 104 compared to 7.1% (16/225) who were re-randomised to withdrawal from risankizumab.
Maltese: Fost l-individwi b'sPGA ta' xejn jew kważi xejn f'ġimgħa 28 f'IMMHANCE, 81.1 % (90/111) talindividwi li ġew randomizzati mill-ġdid għal kura kontinwa b'risankizumab żammew dan ir-rispons f'ġimgħa 104 meta mqabbel ma' 7.1 % (16/225) li ġew randomised mill-ġdid għal irtirar minn risankizumab.
English: Skyrizi is available in packs containing 2 pre-filled syringes and 2 alcohol pads.
Maltese: Skyrizi huwa disponibbli f'pakketti li fihom 2 siringi mimlijin għal-lest u 2 kuxxinetti bl-alkoħol.
English: Week 16 200 (65.8) Week 52 229 (75.3) PSS 0 (symptom-free)
Maltese: Ġimgħa 52 PSS 0 (mingħajr sintomi)
English: As an IgG1 monoclonal antibody, risankizumab is not expected to be filtered by glomerular filtration in the kidneys or to be excreted as an intact molecule in the urine.
Maltese: IgG1, risankizumab mhuwiex misenni li jiġi ffiltrat minn filtrazzjoni glomerulari fil-kliewi jew li jiġi eliminat bħala molekula intatta fl-awrina.
English: Results 28 weeks after re-randomisation are presented in Table 5 and Figure 2.
Maltese: Riżultati 28 ġimgħa wara r-randomizzazzjoni mill-ġdid huma ppreżentati fit-Tabella 5 u fil-Figura 2.
English: Based on population pharmacokinetic analyses, serum creatinine levels, creatinine clearance, or hepatic function markers (ALT/AST/bilirubin) did not have a meaningful impact on risankizumab clearance in subjects with psoriasis.
Maltese: Abbażi tal-analiżijiet tal-farmakokinetika tal-popolazzjoni, illivelli tal-kreatinina fis-seru, it-tneħħija tal-kreatinina, jew il-markaturi tal-funzjoni tal-fwied (ALT/AST/bilirubina) ma kellhomx impatt sinifikanti fuq it-tneħħija ta' risankizumab f'individwi bilpsorjażi.
English: As an IgG1 monoclonal antibody, risankizumab is mainly eliminated via intracellular catabolism and is not expected to undergo metabolism via hepatic cytochrome P450 enzymes or renal elimination.
Maltese: IgG1, risankizumab jiġi eliminat prinċipalment permezz ta' kataboliżmu intraċellualri u mhuwiex mistenni li jgħaddi minn metaboliżmu permezz tal-enzimi taċ-ċitokromu P450 jew minn eliminazzjoni mill-kliewi.
English: Table 4: Efficacy and quality of life results at week 16 in adults with plaque psoriasis in IMMVENT
Maltese: Tabella 4: Ir-riżultati tal-effikaċja u tal-kwalità tal-ħajja f'ġimgħa 16 fl-adulti bil-psorjażi bilqoxra f'IMMVENT
English: Co-primary endpoints versus placebo No impact on health-related quality of life c Psoriasis Symptom Scale (PSS) of 0 means no symptoms of pain, itching, redness, and burning during the last 24 hours
Maltese: End-points koprimarji kontra plaċebo Ebda impatt fuq il-kwalità tal-ħajja relatata mas-saħħa c Skala tas-Sintomu ta' Psorjażi (PSS) ta' 0 tfisser ebda sintomu ta' uġigħ, ħakk, ħmura u ħruq matul laħħar 24 siegħa
English: Prior to initiating treatment with risankizumab, patients should be evaluated for tuberculosis (TB) infection.
Maltese: Qabel il-bidu tal-kura b'risankizumab, il-pazjenti għandhom jiġu evalwati għal infezzjoni tattuberkulożi (TB).
English: Risankizumab (N=304) n (%)
Maltese: Risanki zumab (N=304) n (%)