FrancophonIA/ELRC3.0 huggingface dataset:
English: Laboratory assessment of neutropenia and thrombocytopenia In plaque psoriasis studies, 9% of patients receiving Taltz developed neutropenia.
Danish: Laboratoriebestemmelse af neutropeni og trombocytopeni I studier med plaque-psoriasis, udviklede 9 % af patienterne behandlet med Taltz neutropeni.
English: The percentage of patients achieving PASI 75 was significantly greater for Taltz compared with placebo and etanercept as early as Week 1.
Danish: Procentdelen af patienter, der opnåede PASI 75, var signifikant højere for Taltz sammenlignet med placebo og etanercept så tidligt som i uge 1.
English: Q. What if I cannot push in the plunger?
Danish: Hvad nu hvis jeg ikke kan trykke stemplet ned?
English: Maintenance of Response and Efficacy at Week 60 (Studies UNCOVER-1 and UNCOVER-2)
Danish: Tabel 5 Opretholdelse af respons og effekt ved uge 60 (studierne UNCOVER-1 og UNCOVER-2)
English: The pen must not be shaken.
Danish: Pennen må ikke rystes.
English: Patients in all treatment groups with an inadequate response at week 16 received rescue therapy (modification to background therapy).
Danish: I alle behandlingsgrupperne modtog patienterne med et utilstrækkeligt respons ved uge 16, en supplerende behandling (ændring af standardbehandling).
English: Serious infections occurred in 13 (0.6 %) of patients treated with Taltz and in 3 (0.4 %) of patients treated with placebo (see section 4.4).
Danish: Alvorlige infektioner forekom hos 13 (0,6 %) af de patienter, der blev behandlet med Taltz, og hos 3 (0,4 % ) af de patienter, der fik placebo (se pkt.
English: The European Medicines Agency has deferred the obligation to submit the results of studies with Taltz in one or more subsets of the paediatric population in the treatment of plaque psoriasis and psoriatic arthritis (see section 4.2 for information on paediatric use).
Danish: Det Europæiske Lægemiddelagentur har udsat forpligtelsen til at fremlægge resultaterne af studier med Taltz i en eller flere undergrupper af den pædiatriske population ved behandling af plaquepsoriasis og psoriasisartrit (se pkt.
English: Taltz, alone or in combination with methotrexate, is indicated for the treatment of active psoriatic arthritis in adult patients who have responded inadequately to, or who are intolerant to one or more disease-modifying anti-rheumatic drug (DMARD) therapies (see section 5.1).
Danish: Taltz, alene eller i kombination med methotrexat, er indiceret til behandling af aktiv psoriasisartrit hos voksne patienter, der ikke har responderet tilstrækkeligt på eller ikke tåler et eller flere sygdomsmodificerende antireumatiske lægemidler (DMARD) (se pkt.
English: • The pre-filled pen contains 1 dose of Taltz.
Danish: • Den fyldte pen indeholder 1 dosis Taltz.
English: UNCOVER-1 enrolled 1,296 patients.
Danish: I UNCOVER-1 blev der inkluderet 1.296 patienter.
English: As a direct consequence treatment with ixekizumab reduces erythema, induration and desquamation present in plaque psoriasis lesions.
Danish: Som en direkte konsekvens reducerer behandling med ixekizumab erytem, induration og afskalning, der ses ved plaque-psoriasis-læsioner.
English: Wait 30 minutes to let the syringe warm to room temperature before you use it.
Danish: Vent i 30 minutter for at lade den fyldte pen opnå stuetemperatur, før du bruger den.
English: Choose your injection site.
Danish: Vælg et injektionssted.
English: The mean elimination half-life, as estimated from population pharmacokinetic analysis, is 13 days in patients with plaque psoriasis.
Danish: Den gennemsnitlige eliminationshalveringstid estimeret fra populationsfarmakokinetiske analyser er 13 dage hos patienter med plaque-psoriasis.
English: Thrombocytopenia may persist, fluctuate or be transient.
Danish: Trombocytopeni kan være vedvarende, svingende eller forbigående.
English: A. It is normal to have air bubbles in the pre-filled pen.
Danish: Det er helt normalt, at der er luftbobler i den fyldte pen.
English: In SPIRIT-P1, efficacy was maintained up to Week 52 as assessed by ACR 20/50/70, MDA, enthesitis resolution, dactylitis resolution, and PASI 75/90/100 response rates.
Danish: I SPIRIT-P1, var effekten opretholdt indtil uge 52, som vurderet ved ACR 20/50/70, MDA, enthesitisophør, dactylitis-ophør og PASI 75/90/100 responsrater.
English: Each pen contains one dose of Taltz (80 mg).
Danish: Hver pen indeholder én dosis af Taltz (80 mg).
English: • If you have vision problems, DO NOT use the pre-filled pen without help from a person trained to use it.
Danish: • Hvis du har problemer med dit syn, MÅ DU IKKE bruge den fyldte pen uden hjælp fra en person, der er oplært i at bruge den.
English: Check the label.
Danish: Kontroller, hvad der står på etiketten.
English: Results from a drug-drug interaction study in patients with moderate-to-severe psoriasis determined that 12 weeks of administration of ixekizumab with drugs metabolized by CYP3A4 (i.e., midazolam), CYP2C9 (i.e., warfarin), CYP2C19 (i.e., omeprazole), CYP1A2 (i.e., caffeine) or CYP2D6 (i.e., dextromethorphan) does not have a clinically significant impact on the pharmacokinetics of these drugs.
Danish: Resultater fra et lægemiddelinteraktionsstudie hos patienter med moderat til svær psoriasis har vist at 12 ugers administration af ixekizumab i kombination med lægemidler som metaboliseres af CYP3A4 (dvs. midazolam), CYP2C9 (dvs. warfarin), CYP2C19 (dvs. omeprazol), CYP1A2 (dvs. koffein) eller CYP2D6 (dvs. dextromethorfan) ikke har en klinisk signifikant påvirkning på farmakokinetikken af disse lægemidler.
English: • If you have vision problems, DO NOT use the pre-filled syringe without help from a person trained to use it.
Danish: • Hvis du har problemer med dit syn, MÅ DU IKKE bruge den fyldte injektionssprøjte uden hjælp fra en person, der er oplært i at bruge den.
English: Of the 3,866 patients enrolled in these placebo-controlled studies, 64 % had received prior systemic therapy (biologic, conventional systemic or psoralen and ultraviolet A (PUVA)), 43.5 % had received prior phototherapy, 49.3 % had received prior conventional systemic therapy, and 26.4 % had received prior biologic therapy for the treatment of psoriasis.
Danish: Af de 3.866 patienter, som var inkluderet i disse placebokontrollerede studier, havde 64 % tidligere fået systemisk behandling (biologisk, konventionel systemisk eller psoralen og ultraviolet A (PUVA)), 43,5 % havde tidligere fået lysbehandling, 49,3 % havde tidligere fået konventionel systemisk behandling, og 26,4 % havde tidligere fået biologisk behandling mod psoriasis.
English: Its colour may vary from colourless to slightly yellow.
Danish: Medicinens farve kan variere fra farveløs til svagt gul.
English: “1” (rarely limited) a Abbreviations: NRI = Non-Responder Imputation; sPGA = static Physician Global Assessment; GPSS = Genital Psoriasis Symptom Scale; SFQ = Sexual Frequency Questionnaire; DLQI = Dermatology Quality of Life Index; b Total DLQI score of 0,1 indicates skin condition has no effect at all on patient's life.
Danish: eller “1” (sjældent begrænset) a Forkortelser: NRI = Non-Responder Imputation; sPGA = statisk Physician Global Assessment; GPSS = Genital Psoriasis Symptom Scale; SFQ = Sexual Frequency Questionnaire; DLQI = Dermatology Quality of Life Index; b Samlet DLQI score på 0,1 indikerer, at hudens tilstand ikke påvirker patientens liv.
English: Both Taltz regimens included a 160 mg starting dose.
Danish: Begge Taltz regimer inkluderede en 160 mg startdosis.
English: The treatment responses on Taltz were significantly greater than those on placebo as early as week 1 for ACR 20, week 4 for ACR 50 and week 8 for ACR 70 and persisted through week 24.
Danish: Behandlingsrespons var signifikant højere for Taltz end for placebo, så tidligt som uge 1 for ACR20, uge 4 for ARC50 og uge 8 for ACR70 og forsatte gennem uge 24.
English: However, approximately 1% of patients treated with Taltz had confirmed neutralising antibodies associated with low drug concentrations and reduced clinical response.
Danish: Hos ca. 1 % af de patienter, der blev behandlet med Taltz, var de neutraliserende antistoffer forbundet med lav lægemiddelkoncentration og reduceret klinisk respons.
English: • The pre-filled pen must not be shaken.
Danish: • Den fyldte pen må ikke rystes.
English: In SPIRIT-P1 and SPIRIT-P2, similar responses for ACR 20/50/70 were seen in patients with psoriatic arthritis regardless of whether they were on concomitant cDMARDs, including MTX treatment, or not.
Danish: SPIRIT-P1 og SPIRIT-P2, viste samme respons for ACR 20/50/70 hos patienter med psoriasisartrit, uanset om patienterne var i samtidig behandling med cDMARDs, med eller uden MTX.
English: In the placebo-controlled period of the phase III clinical studies in plaque psoriasis, infections were reported in 27.2 % of patients treated with Taltz for up to 12 weeks compared with 22.9 % of patients treated with placebo.
Danish: I den placebokontrollerede periode af de kliniske fase III-studier med plaque-psoriasis blev der indrapporteret infektioner hos 27,2 % af de patienter, der blev behandlet med Taltz i op til 12 uger, sammenlignet med 22,9 % af de patienter, der fik placebo.
English: PASI score, percent improvement at each post baseline visit (mBOCF)) in the Intentto-Treat Population during the Induction Dosing Period - UNCOVER-2 and UNCOVER-3
Danish: Figur 1 PASI-score, procentvis forbedring fra baseline (mBOCF) hos intent-to-treatpopulationen i perioden med induktionsdosering - UNCOVER-2 og UNCOVER-3
English: Press a cotton ball or gauze over the injection site.
Danish: Pres en vattot eller et stykke gaze mod injektionsstedet.
English: Week 24 data are presented in Table 9.
Danish: Data for uge 24 er vist i tabel
English: Always use this medicine exactly as your doctor or nurse has told you.
Danish: Brug altid lægemidlet nøjagtigt efter lægens eller sygeplejerskens anvisning.
English: Mean (SD) Cmax,ss, and Ctrough,ss estimates are 14.6 (6.04) µg/ml, and 1.87 (1.30) µg/ml.
Danish: Estimater af den gennemsnitlige (SD) Cmax,ss, og Ctrough,ss er 14,6 (6,04) µg/ml og 1,87 (1,30) µg/ml.
English: See leaflet for further information.
Danish: Se indlægssedlen for at få yderligere oplysninger.
English: Patients in all treatment groups had a median baseline PASI score ranging from 17.4 to 18.3; 48.3 % to 51.2 % of patients had a baseline sPGA score of severe or very severe, and mean baseline itch Numeric Rating Scale (itch NRS) ranging from 6.3 to 7.1.
Danish: I alle behandlingsgrupper havde patienterne en median-PASI-score ved baseline i intervallet 17,4-18,3; 48,3 % til 51,2 % af patienterne havde en sPGA-score ved baseline på svær eller meget svær og en gennemsnitlig Itch Numeric Rating Scale (Itch NRS) ved baseline i intervallet 6,3-7,1.
English: Expiration date
Danish: Udløbsdato
English: Alternate your injection sites.
Danish: Skift injektionssteder.
English: However, ixekizumab is excreted at low levels in the milk of cynomolgus monkeys.
Danish: Ixekizumab udskilles dog i små mængder i mælken hos cynomolgusaber.
English: Maintained or Achieved PASI 90
Danish: Opretholdt eller opnået PASI 90
English: Syringe body with medicine
Danish: Sprøjtecylinder med medicin
English: In psoriatic arthritis patients treated with Taltz at the recommended dosing regimen up to 52 weeks, approximately 11% developed anti-drug antibodies, the majority of which were low titre, and approximately 8% had confirmed neutralising antibodies.
Danish: Hos patienter med psoriasisartrit, der blev behandlet med Taltz med det anbefalede doseringsregime i op til 52 uger, udviklede ca. 11% antistoffer mod lægemidlet, hvoraf størstedelen var i lave titre, og ca. 8% havde konfirmerede neutraliserende antistoffer.
English: Other medicines and Taltz
Danish: Brug af anden medicin sammen med Taltz
English: In the 2 clinical studies that included an active comparator (UNCOVER-2 and UNCOVER-3), the rate of serious adverse events was 1.9 % for both etanercept and for Taltz, and the rate of discontinuation due to adverse events was 1.2 % for etanercept and 2.0 % for Taltz.
Danish: I de to kliniske studier, der inkluderede en aktiv komparator (UNCOVER-2 og UNCOVER-3), var forekomsten af alvorlige bivirkninger 1,9 % for både etanercept og Taltz, og henholdsvis 1,2 % i etanercept-armen og 2,0 % i Taltz-armene seponerede behandlingen som følge af bivirkninger.
English: • 1 cotton ball or piece of gauze
Danish: • 1 stykke vat eller gaze
English: Ixekizumab administration to cynomolgus monkeys for 39 weeks at subcutaneous doses up to 50 mg/kg weekly produced no organ toxicity or undesirable effects on immune function (e.g. T-cell dependent antibody response and NK cell activity).
Danish: Administration af ixekizumab i subkutane doser på op til 50 mg/kg ugentligt i 39 uger til cynomolgusaber medførte ingen organtoksicitet eller uønskede virkninger på immunfunktionen (f.eks. T-celle-afhængigt antistofrespons og NK-celle-aktivitet).
English: At Week 24 the proportion of patients achieving a modified Psoriatic Arthritis Response Criteria (PsARC) response was greater in the Taltz-treated patients compared to placebo.
Danish: Ved uge 24 var patientandelen, som opnåede et modificeret PsARC respons (Psoriatic Arthritis Response Criteria) større hos patienter behandlet med Taltz sammenlignet med placebo.
English: Efficacy and safety of Taltz was investigated in a multicenter, randomized, open-label, rater-blinded, parallel-group study (SPIRIT-H2H) compared to adalimumab (ADA) in 566 patients with PsA who were naïve to biologic disease-modifying anti-rheumatic drugs (bDMARD).
Danish: Taltz' virkning og sikkerhed blev undersøgt i et multicenter, randomiseret, open-label, rater-blindet, parallel-gruppe studie (SPIRIT-H2H) og sammenlignet med adalimumab (ADA) i 566 patienter med PsA, som var naive til biologisk sygdomsmodificerende antireumatiske lægemidler (bDMARD).
English: This may be given by your doctor or nurse.
Danish: Indsprøjtningerne kan gives af lægen eller sygeplejersken.
English: Randomised patients also had current plaque psoriasis skin lesions (94.0%) or a documented history of plaque psoriasis, with 12.1% of patients with moderate to severe plaque psoriasis at baseline.
Danish: Randomiserede patienter havde samtidig plaque-psoriasis hudlæsioner (94,0%) eller dokumenteret plaque-psoriasis i anamnesen, hvoraf 12,1% patienter havde moderat til svær plaque-psoriasis ved baseline.
English: Safety tips
Danish: Sikkerhedstips
English: Of the 1,118 psoriatic arthritis patients exposed to Taltz in clinical studies, a total of 122 patients were 65 years of age or older and 6 patients were 75 years of age or older.
Danish: Af de 1.118 patienter med psoriasisartrit, der blev eksponeret for Taltz i kliniske studier, var i alt 122 patienter 65 år eller ældre, og 6 patienter var 75 år eller ældre.
English: They will not harm you or affect your dose.
Danish: De vil ikke skade dig eller påvirke din dosis.
English: Maintained or Achieved PASI 100
Danish: Opretholdt eller opnået PASI 100
English: As a precautionary measure, it is preferable to avoid the use of Taltz during pregnancy.
Danish: Som en sikkerhedsforanstaltning bør behandling med Taltz undgås under graviditet.
English: The safety and efficacy of Taltz in children and adolescents aged 2 to less than 18 years in the treatment of psoriatic arthritis (a category of juvenile idiopathic arthritis) have not yet been established.
Danish: Taltz' sikkerhed og virkning hos børn og unge i alderen 2 år til under 18 år i behandlingen af psoriasisartrit (en kategori af juvenil idiopatisk artrit) er endnu ikke klarlagt.
English: (Based on adverse reactions data from 4,204 patients with moderate to severe plaque psoriasis [4,729.7 patient years] and 1,117 patients with active psoriatic arthritis [1,050.6 patient years] who have received at least 1 dose of ixekizumab.)
Danish: (Baseret på bivirkningsdata fra 4.204 patienter med moderat til svær plaque-psoriasis [4.729,7 patientår] og 1.117 patienter med aktiv psoriasisartrit [1.050,6 patientår] som har modtaget mindst en dosis ixekizumab.)
English: There is no relevant use of Taltz in children below 2 years for the indication of psoriatic arthritis.
Danish: Det er ikke relevant at anvende Taltz til børn under 2 år for indikationen psoriasisartrit.
English: Taltz is a solution in a clear glass syringe.
Danish: Taltz er en injektionsvæske i en klar glassprøjte.
English: Read the “Instructions for Use” for the pen carefully before using Taltz.
Danish: Læs omhyggeligt “Brugervejledning” til pennen, inden du bruger Taltz.
English: Of the 4,204 plaque psoriasis patients exposed to Taltz in clinical studies, a total of 301 were 65 years of age or older and 36 patients were 75 years of age or older.
Danish: Af de 4.204 patienter med plaque-psoriasis, der blev eksponeret for Taltz i kliniske studier, var i alt 301 patienter 65 år eller ældre, og 36 patienter var 75 år eller ældre.
English: Contact your doctor, pharmacist or nurse.
Danish: Kontakt lægen, sygeplejersken eller apotekspersonalet.
English: Place the clear base flat and firmly against your skin.
Danish: Pres den klare endeflade fladt og fast ind mod huden.
English: Approximately 9-17% of plaque psoriasis patients treated with Taltz at the recommended dosing regimen developed anti-drug antibodies, the majority of which were low titres and not associated with reduced clinical response up to 60 weeks of treatment.
Danish: Ca. 9-17 % af de patienter med plaque-psoriasis, der blev behandlet med Taltz med det anbefalede doseringsregime, udviklede antistoffer mod lægemidlet, hvoraf størstedelen var i lave titre og ikke forbundet med reduceret klinisk respons ved op til 60 ugers behandling.
English: - After the first dose, you will use an 80 mg dose (one injection) at Weeks 2, 4, 6, 8, 10, and 12.
Danish: - Efter den første dosis skal du have en 80 mg dosis (én indsprøjtning) i uge 2, 4, 6, 8, 10 og 12.
English: Keep holding the clear base firmly against your skin.
Danish: Fortsæt med at holde den klare endeflade fast ind mod huden.
English: Taltz is indicated for the treatment of moderate to severe plaque psoriasis in adults who are candidates for systemic therapy.
Danish: Taltz er indiceret til behandling af moderat til svær plaque-psoriasis hos voksne, der er kandidater til systemisk behandling.
English: Within each frequency grouping, adverse drug reactions are presented in order of decreasing seriousness.
Danish: Inden for hver hyppighedsgruppe er bivirkningerne opstillet efter, hvor alvorlige de er.
English: Taltz is unlikely to influence your ability to drive and use machines.
Danish: Trafik- og arbejdssikkerhed Det er ikke sandsynligt, at Taltz påvirker din evne til at føre motorkøretøj og betjene maskiner.
English: Patients in these studies had a diagnosis of psoriatic arthritis (Classification Criteria for Psoriatic Arthritis [CASPAR] criteria) for a median of 5.33 years.
Danish: Patienter i disse studier havde diagnosen psoriasisartrit, defineret ved klassifikationskriterierne for psoriasisartritis (CASPAR) med en varighed på 5,33 år (median).
English: 292 (83.2)a sPGA of “0” (clear)
Danish: 292 (83,2)a sPGA på “0” (clear)
English: Mean (SD) Cmax,ss, and C trough,ss estimates are 21.5 (9.16) µg/ml, and 5.23 (3.19) µg/ml.
Danish: Estimater af den gennemsnitlige (SD) Cmax,ss, og Ctrough,ss er 21,5 (9,16) µg/ml og 5,23 (3,19) µg/ml.
English: Psoriatic Arthritis Study 2 (SPIRIT-P2) enrolled patients who were previously treated with an anti-TNF agent and discontinued the anti-TNF agent for either lack of efficacy or intolerance (anti-TNF-IR patients).
Danish: Psoriatic Arthritis Study 2 (SPIRIT-P2) inkluderede patienter som tidligere havde været behandlet med anti-TNF og som havde afbrudt anti-TNF-behandlingen enten pga. mangel på virkning eller pga. intolerans (anti-TNF-IR-patienter).
English: Taltz should not be used if particles appear or if the solution is cloudy and/or distinctly brown.
Danish: Taltz må ikke anvendes, hvis injektionsvæsken indeholder partikler eller er uklar og/eller tydeligt brun.
English: Serious hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
Danish: Alvorlig overfølsomhed over for det aktive stof eller over for et eller flere af hjælpestofferne anført i pkt.
English: - if you are allergic to ixekizumab or any of the other ingredients of this medicine (listed in section 6).
Danish: Brug ikke Taltz - hvis du er allergisk over for ixekizumab eller et af de øvrige indholdsstoffer i Taltz (angivet i afsnit 6).
English: The safety and efficacy of Taltz were assessed in two randomised, double-blind, placebo-controlled phase III studies in 780 patients with active psoriatic arthritis (≥3 swollen and ≥3 tender joints).
Danish: Taltz' virkning og sikkerhed blev vurderet i to randomiserede, dobbeltblindede, placebokontrollerede fase III-studier hos 780 patienter med aktiv psoriasisartrit (≥3 hævede og ≥3 ømme led).
English: Sodium citrate Citric acid, anhydrous Sodium chloride Polysorbate 80
Danish: Natriumcitrat Citronsyre, vandfri Natriumchlorid Polysorbat 80
English: sPGA of Genitalia “0” or “1” sPGA “0” or “1” DLQI 0,1b
Danish: sPGA of Genitalia “0” eller “1” sPGA “0” eller “1”
English: Consider anti-TB therapy prior to initiation of Taltz in patients with latent TB.
Danish: Hos patienter med latent TB skal behandling mod TB overvejes, før behandling med Taltz indledes.
English: ACR 20 response in SPIRIT-P1 over time up to Week 24
Danish: ACR20 respons over tid op til uge 24 i SPIRIT-P1
English: 159 (41.6)a sPGA of “0” (clear)
Danish: 159 (41,6)a sPGA på “0” (clear)
English: These improvements in nail, scalp and palmoplantar psoriasis were maintained at Week 60 in patients treated with Taltz who were sPGA (0,1) responders at Week 12.
Danish: Forbedringerne i neglepsoriasis, psoriasis i hovedbunden og palmoplantar psoriasis var opretholdt ved uge 60 hos patienter, der blev behandlet med Taltz, og som var sPGA (0,1)-responderende ved uge 12.
English: Q. How can I tell if my injection is complete?
Danish: Hvordan kan jeg se, om indsprøjtningen er gennemført?
English: Subjects randomized to TALTZ received an initial dose of 160 mg followed by 80 mg every 2 weeks for 12 weeks.
Danish: Patienter randomiseret til Taltz fik en startdosis på 160 mg efterfulgt af 80 mg hver 2. uge i 12 uger.
English: Specific clinical pharmacology studies to evaluate the effects of renal impairment and hepatic impairment on the PK of ixekizumab have not been conducted.
Danish: Der er ikke udført specifikke klinisk farmakologiske studier til vurdering af virkningerne af nedsat nyrefunktion og nedsat leverfunktion på ixekizumabs farmakokinetik.
English: Patients (n) PASI 75, n (%) 120 (88.2 %) 114 (68.7 %) PASI 90, n (%) PASI 100, n (%) 49 (36.0 %) * Ixekizumab 160 mg was given as a loading dose followed by 80 mg at week 2,4,6,8,10 and 12, and 80 mg Q4W thereafter ** Weight based dosing: Patients treated with ustekinumab received 45 mg or 90 mg at Weeks 0 and 4, then every 12 weeks until Week 52 (dosed by weight as per approved posology) §p < 0.001 versus ustekinumab (p value only provided for primary endpoint)
Danish: Patienter (n) PASI 75, n (%) 120 (88,2 %) 114 (68,7 %) PASI 90, n (%) 99 (72,8 %)§ PASI 100, n (%) 49 (36,0 %) * Ixekizumab 160 mg blev givet som en loading dosis efterfulgt af 80 mg ved uge 2,4,6,8,10 og 12, samt 80 mg Q4W derefter ** Vægtbaseret dosering: Patienter behandlet med ustekinumab fik 45 mg eller 90 mg ved uge 0 og 4, og derefter hver 12. uge indtil uge 52 (doseret efter vægt pr. godkendt dosering) §p < 0,001 versus ustekinumab (p-værdi kun angivet for det primære endepunkt)
English: In patients with pre-existing dactylitis or enthesitis, treatment with Taltz Q4W resulted in improvement in dactylitis and enthesitis at Week 24 compared to placebo (resolution: 78% vs. 24%; p<0.001, and 39% vs. 21%; p<0.01, respectively).
Danish: Hos patienter med dactylitis eller enthesitis i anamnesen, resulterede behandling med Taltz Q4W i en forbedring i dactylitis og enthesitis ved uge 24 sammenlignet med placebo (henholdsvis en resolution på 78% vs. 24%; p<0,001, og 39% vs 21%; p<0,01).