natgillin/translations-raw huggingface dataset:
Uncommon (may affect up to 1 in 100 people): tuberculosis, kidney infection, skin infection, herpes simplex or cold sores (oral herpes), low white blood cell counts, increased liver enzymes in the blood (sign of liver problems), blood creatinine increased (a possible sign of kidney problems), increased cholesterol, weight gain, dehydration, muscle strain, pain in the muscles and joints, tendonitis, joint swelling, abnormal sensations, poor sleep, sinus congestion, shortness of breath or difficulty breathing, skin redness, itching, fatty liver, painful inflammation of small pockets in the lining of your intestine (diverticulitis), viral infections, viral infections affecting the gut, some types of skin cancers (non-melanoma-types).
Manje često (može se javiti u manje od 1 na 100 osoba): tuberkuloza, infekcija bubrega, infekcija kože, herpes simplex ili herpes usta, nizak broj bijelih krvnih stanica, povišeni jetreni enzimi u krvi (znak problema s jetrom), porast kreatinina u krvi (mogući znak problema s bubrezima), povišeni kolesterol, porast tjelesne težine, dehidracija, istegnuće mišića, bol u mišićima i zglobovima, upala tetive (tendinitis), oticanje zgloba, neuobičajeni osjeti, loš san, začepljenje sinusa, nedostatak zraka ili otežano disanje, crvenilo kože, svrbež, masna jetra, bolna upala stijenke malih „džepova“ tankog crijeva (divertikulitis), virusne infekcije, virusne infekcije koje zahvaćaju probavni sustav, neke vrste raka kože (nemelanomski tip).
2 years 6 months 2 years
6 mjeseci 1 godina 1 godina 2 godine 6 mjeseci 2 godine 1 godina
Time to onset was rapid (as early as week 2 in studies ORAL Solo, ORAL Sync, and ORAL Step) and the magnitude of response continued to improve with duration of treatment.
Sync i ORAL Step) i magnituda odgovora nastavila se poboljšavati s trajanjem liječenja.
Treatment with tofacitinib was associated with an increased incidence of neutropenia (less than 2,000 cells/mm3) compared to placebo.
U usporedbi s placebom, liječenje tofacitinibom bilo je povezano s povećanom incidencijom neutropenije (manje od 2000 stanica/m3).
Greater than 2 g/dL decrease or less than 8.0 g/dL (confirmed by repeat testing)
Pad veći od 2 g/dl ili vrijednost manja od 8,0 g/dl
*p <0.05, ***p<0.0001 versus placebo, SC=subcutaneous, QOW=every other week, N=number of subjects analysed, DAS28=Disease Activity Scale 28 joints, ESR=Erythrocyte Sedimentation Rate.
6. mjesec *p < 0,05, ***p < 0,0001 naspram placeba, s.c.=supkutano, N=broj analiziranih ispitanika, DAS28=Indeks aktivnosti bolesti za 28 zglobova, ESR=brzina sedimentacije eritrocita
In the placebo plus MTX group, 78% of patients experienced no radiographic progression (mTSS change less than or equal to 0.5) at month 6 compared to 89% and 87% of patients treated with tofacitinib 5 or 10 mg (plus MTX) twice daily respectively, (both significant versus placebo plus MTX).
U skupini koja je primala placebo uz MTX, u 78% bolesnika radiološki nalaz u 6. mjesecu nije pokazao progresiju (mTSS promjena manja ili jednaka 0,5) u usporedbi s 89% bolesnika liječenih s 5 mg, odnosno 87% bolesnika liječenih s 10 mg tofacitiniba dva puta dnevno (uz MTX) (oboje signifikantno naspram placeba uz MTX).
It is not recommended to initiate or continue tofacitinib treatment in patients with a confirmed lymphocyte count less than 750 cells/mm3.
Ne preporučuje se započeti ili nastaviti liječenje tofacitinibom u bolesnika čiji je dokazani broj limfocita manji od 750 stanica/mm3.
d. Clinical response was defined as a decrease from baseline in Mayo score of ≥ 3 points and ≥ 30%, with an accompanying decrease in the subscore for rectal bleeding of ≥ 1 point or absolute subscore for rectal bleeding of 0 or 1.
Klinički odgovor bio je definiran kao smanjenje početne vrijednosti Mayo rezultata za ≥ 3 boda i ≥ 30 % uz popratno smanjenje podrezultata rektalnog krvarenja za ≥ 1 bod ili apsolutni podrezultat rektalnog krvarenja od 0 ili 1.
Noneb csDMARDs MTX MTX MTX Noneb
MTX MTX MTX Nemab
QUALITATIVE AND QUANTITATIVE COMPOSITION XELJANZ 5 mg film-coated tablets
KVALITATIVNI I KVANTITATIVNI SASTAV XELJANZ 5 mg filmom obložene tablete
Active control (ADA)
Aktivna kontrola (adalimuma b)
Table 18: Proportion of Patients Meeting Primary and Key Secondary Efficacy Endpoints at Week 52 by TNF Inhibitor Therapy Subgroup (OCTAVE Sustain, Central Endoscopy Read)
Tablica 18: Udio bolesnika koji su ostvarili primarne i ključne sekundarne ishode djelotvornosti u 52. tjednu u podskupini liječenoj inhibitorom TNF-a (ispitivanje OCTAVE Sustain, centralno očitani endoskopski nalazi)
Table 7: Phase 3 Clinical Trials of Tofacitinib 5 and 10 mg Twice Daily Doses in Patients with RA
Tablica 7: Klinička ispitivanja faze 3 tofacitiniba u dozama od 5 i 10 mg dva puta dnevno u bolesnika s RA
Placebo + MTX N=156
ishoda Vrijeme Placebo + MTX N=156
Tofacitinib, alone or in combination with MTX, has shown improvements in physical function, as measured by the HAQ-DI.
Tofacitinib, sam ili u kombinaciji s metotreksatom, pokazao je poboljšanje fizičke funkcije mjereno pomoću Upitnika o zdravstvenom stanju - indeksa onesposobljenosti (engl.
Clinical responsed
Klinički odgovord
*** p<0.0001, tofacitinib versus placebo + MTX, LS = least squares, N = number of patients, QOW = every other week, NA = not applicable, HAQ-DI = Health Assessment Questionnaire Disability Index
p < 0,0001, tofacitinib naspram placebo + MTX, N = broj bolesnika, NP = nije primjenjivo, HAQ-DI = Upitnik o zdravstvenom stanju - indeks onesposobljenosti
Improvements were also observed in the EuroQoL 5-Dimension (EQ-5D) and various domains of the Work Productivity and Activity Impairment (WPAI-UC) questionnaire in both induction and maintenance studies compared to placebo.
Poboljšanja su ujedno opažena i u upitniku EuroQoL 5-Dimension (EQ-5D) i raznim područjima
Tofacitinib 10 mg Twice Daily + DMARD(s) ORAL Sync: DMARD Inadequate Responders
Tofacitinib 10 mg dva puta dnevno + DMARD(ovi) ORAL Sync: Bolesnici s neodgovarajućim odgovorom na DMARD
Table 15: Proportion of Patients Meeting Efficacy Endpoints at Week 8 (OCTAVE Induction Study 1 and OCTAVE Induction Study 2) OCTAVE Induction Study 1 Central Endoscopy Read
Tablica 15: Udio bolesnika koji su ostvarili ishode djelotvornosti u 8. tjednu (ispitivanja uvodnog liječenja OCTAVE Induction 1 i OCTAVE Induction 2) Ispitivanje uvodnog liječenja OCTAVE Induction 1 Centralno očitani endoskopski nalazi
A significantly greater proportion of patients in both the tofacitinib 5 mg twice daily and tofacitinib 10 mg twice daily treatment groups achieved the following endpoints at week 52 as compared to placebo: remission, improvement of endoscopic appearance of the mucosa, normalization of endoscopic appearance of the mucosa, maintenance of clinical response, remission among patients in remission at baseline, and sustained corticosteroid-free remission at both week 24 and week 52 among patients in remission at baseline, as shown in Table 17.
U ispitivanim skupinama koje su uzimale 5 mg tofacitiniba dva puta dnevno i 10 mg tofacitiniba dva puta dnevno, značajno je veći udio bolesnika ostvario sljedeće ishode u 52. tjednu u usporedbi s placebom: remisiju, poboljšanje endoskopskog izgleda sluznice, normalizaciju endoskopskog izgleda sluznice, održavanje kliničkog odgovora, remisiju među bolesnicima koji su bili u remisiji prije početka terapije i održanu remisiju bez kortikosteroida u 24. i 52. tjednu među bolesnicima koji su bili u remisiji prije početka terapije, kako je prikazano u tablici 17.
Vaccinations
Tuberkuloza
PHARMACEUTICAL FORM AND CONTENTS 60 film-coated tablets
OBLIK I SADRŽAJ 60 filmom obloženih tableta 180 filmom obloženih tableta
Confirmed ALC less than 750 cells/mm3 were associated with an increased incidence of serious infections (see section 4.4).
Potvrđeni ALC manji od 750/mm3 bio je povezan s povećanom incidencijom ozbiljnih infekcija
The most common serious infections reported with tofacitinib were pneumonia, cellulitis, herpes zoster, urinary tract infection, diverticulitis, and appendicitis.
Najčešće ozbiljne nuspojave prijavljene uz tofacitinib bile su pneumonija, celulitis, herpes zoster, infekcija urinarnog trakta,
Achieved statistical significance globally at p≤ 0.05 per the pre-specified step-down testing procedure.
d Globalno postignuta statistička značajnost pri p ≤ 0,05 po unaprijed određenom step-down postupku testiranja.
Tofacitinib is indicated for the treatment of adult patients with moderately to severely active ulcerative colitis (UC) who have had an inadequate response, lost response, or were intolerant to either conventional therapy or a biologic agent (see section 5.1).
ulcerative colitis, UC) u odraslih bolesnika koji su na liječenje konvencionalnom terapijom ili biološkim lijekom imali neadekvatan odgovor, izgubili odgovor ili ta liječenja nisu podnosili (vidjeti dio 5.1).
It is recommended not to initiate dosing in patients with an absolute lymphocyte count (ALC) less than 750 cells/mm3.
Preporuča se ne započinjati doziranje u bolesnika čiji je apsolutan broj limfocita (engl. absolute lymphocyte count, ALC) manji od 750 stanica/mm3.
improvement, NA=not applicable, MTX=methotrexate.
ADA=adalimumab, MTX=metotreksat.
Common (may affect up to 1 in 10 people): lung infection (pneumonia and bronchitis), shingles (herpes zoster), infections of nose, throat or the windpipe (nasopharyngitis), influenza, sinusitis, urinary bladder infection (cystitis), sore throat (pharyngitis), increased muscle enzymes in the blood (sign of muscle problems), stomach (belly) pain (which may be from inflammation of the stomach lining), vomiting, diarrhoea, feeling sick (nausea), indigestion, joint sprain, low red blood cell count (anaemia), fever, fatigue (tiredness), swelling of the feet and hands, headache, high blood pressure (hypertension), cough, rash.
Često (mogu se javiti u manje od 1 na 10 osoba): plućna infekcija (pneumonija i bronhitis), herpes zoster, infekcija nosa, grla ili ždrijela (nazofaringitis), gripa, upala sinusa, infekcija mokraćnog mjehura (cistitis), bol u ždrijelu (faringitis), povišeni mišićni enzimi u krvi (znak problema s mišićima), bol u želucu (trbuhu) (koji može biti od upale želučane sluznice), povraćanje, proljev, mučnina, loša probava, istegnuće zgloba, nizak broj crvenih krvnih stanica (anemija), vrućica, umor,
70% improvement; csDMARD=conventional synthetic disease-modifying antirheumatic drug; N=number of randomised and treated patients; NA=Not applicable, as data for placebo treatment is not available beyond month 3 due to placebo advanced to tofacitinib 5 mg twice daily or tofacitinib 10 mg twice daily; SC q2w=subcutaneously once every 2 weeks; TNFi=tumour necrosis factor inhibitor; PASI=Psoriasis Area and
Dactylitis Severity Score, DSS); ACR20/50/70 = poboljšanje od ≥ 20%, 50%, 70% prema kriterijima Američkog reumatološkog društva; csDMARD = konvencionalni sintetski antireumatik koji modificira tijek bolesti; N = broj randomiziranih i liječenih bolesnika; NP = nije primjenjivo budući da nema podataka za liječenje placebom nakon 3. mjeseca zbog prelaska s placeba na 5 mg tofacitiniba dva puta dnevno ili 10 mg tofacitiniba dva puta dnevno; TNFi = inhibitor čimbenika nekroze tumora (engl. tumour necrosis factor inhibitor); PASI = indeks zahvaćenosti i težine psorijaze (engl.
Table 2: Low Absolute Neutrophil Count Low Absolute Neutrophil Count (ANC) (see section 4.4)
Tablica 2: _Nizak apsolutni broj neutrofila Nizak apsolutni broj neutrofila (ABN) (dio 4.4) Laboratorijska vrijednost (broj stanica/mm3)
Dose adjustment No dose adjustment is required when used in combination with MTX.
Kada se koristi u kombinaciji s MTX-om, prilagodba doze nije potrebna.
Nominal p<0.0001 for active treatment versus placebo at month 3.
NP * Nominalni p ≤ 0,05; *** Nominalni p < 0,0001 za aktivno liječenje u odnosu na placebo u 3. mjesecu.
Driving and using machines XELJANZ has no or limited effect on your ability to drive or use machines.
XELJANZ ne utječe ili zanemarivo utječe na sposobnost upravljanja vozilima i rada sa strojevima.
Patients in the Phase 3 studies had a mean Disease Activity Score (DAS28-4[ESR]) of 6.1-6.7 at baseline.
Disease Activity Score, DAS28-4[ESR]) od 6,1 do 6,7.
It is recommended not to initiate dosing in patients with an absolute neutrophil count (ANC) less than 1,000 cells/mm3.
Preporuča se ne započinjati doziranje u bolesnika čiji je apsolutni broj neutrofila (ABN) manji od 1000 stanica/mm3.
Patients who achieved clinical response in 1 of the induction studies (OCTAVE Induction 1 or OCTAVE Induction 2) with tofacitinib 10 mg twice daily but experienced treatment failure after their dose was reduced to tofacitinib 5 mg twice daily or following treatment interruption in OCTAVE Sustain (i.e., were randomised to placebo), had their dose increased to tofacitinib 10 mg twice daily in OCTAVE Open.
Induction 1 ili OCTAVE Induction 2) postigli uz 10 mg tofacitiniba dva puta dnevno, ali su imali neuspješno liječenje nakon što je doza bila snižena na 5 mg tofacitiniba dva puta dnevno ili nakon prekida liječenja u ispitivanju OCTAVE Sustain (odnosno nakon što su bili randomizirani za primanje placeba).
ACR20 mTSS DAS284(ESR)<2.6 Month 3:
6. mjesec: ACR20 mTSS DAS284(ESR) < 2
Month 6 ORAL Standard: MTX Inadequate Responders Tofacitinib 5 mg twice daily + MTX
6. mjesec ORAL Standard: Bolesnici s neodgovarajućim odgovorom na MTX Tofacitinib 5 mg dva puta dnevno + MTX
In ORAL Standard and ORAL Scan, mean improvements in both scales were maintained to 12 months in tofacitinib-treated patients.
U ispitivanjima ORAL Standard i ORAL Scan, srednja vrijednost poboljšanja na obje ljestvice održana su do 12 mjeseci u bolesnika liječenih tofacitinibom.
At baseline, 80.7% and 49.2% of patients had enthesitis and dactylitis, respectively.
Prije početka terapije 80,7% odnosno 49,2% bolesnika imalo je entezitis i daktilitis.
Hepatic steatosis
Steatoza jetre
Table 13: Change From Baseline in HAQ-DI in PsA Studies OPAL BROADEN and OPAL BEYOND
PsA-a OPAL BROADEN i OPAL BEYOND
Tofacitinib total daily dose should be reduced by half in patients receiving potent inhibitors of cytochrome P450 (CYP) 3A4 (e.g., ketoconazole) and in patients receiving 1 or more concomitant medicinal products that result in both moderate inhibition of CYP3A4 as well as potent inhibition of CYP2C19 (e.g., fluconazole) (see sections 4.4 and 4.5) as follows:
Ukupnu dnevnu dozu tofacitiniba treba sniziti za pola u bolesnika koji primaju snažne inhibitore citokroma P450 (CYP) 3A4 (npr. ketokonazol) i u bolesnika koji istodobno primaju jedan ili više lijekova čija primjena rezultira umjerenom inhibicijom CYP3A4, kao i potentnom inhibicijom
Events of gastrointestinal perforation have been reported in clinical trials although the role of JAK inhibition in these events is not known.
Slučajevi gastrointestinalne perforacije prijavljeni su u kliničkim ispitivanjima, iako uloga JAK
• Patients undergoing major surgery
• Maligna bolest • Bolesnici koji se podvrgavaju velikom operativnom zahvatu.
Inadequate response to a least one TNF inhibitor (TNFi) due to lack of efficacy and/or intolerability.
b Neadekvatan odgovor na najmanje jedan inhibitor TNF-a (TNFi) zbog izostanka djelotvornosti i/ili zbog nepodnošenja.
N ORAL Step: TNF Inhibitor Inadequate Responders Tofacitinib 5 mg twice daily + MTX
N % ORAL Step: Bolesnici s neodgovarajućim odgovorom na TNF inhibitor Tofacitinib 5 mg dva puta dnevno + MTX
• who have resided or travelled in areas of endemic mycoses,
• s anamnezom ozbiljne ili oportunističke infekcije, • koji su boravili ili putovali u područja s endemskom mikozom,
• For patients, who have previously taken biologic medicines to treat ulcerative colitis (such as those that block the activity of tumour necrosis factor in the body) and these medicines did not work, the doctor may decide to continue giving 10 mg twice a day.
(poput onih koji sprječavaju aktivnost čimbenika nekroze tumora u tijelu), a ti im lijekovi nisu djelovali, liječnik može odlučiti da trebaju nastaviti s primjenom 10 mg dva puta dnevno.
Serious and sometimes fatal infections due to bacterial, mycobacterial, invasive fungal, viral, or other opportunistic pathogens have been reported in patients receiving tofacitinib.
Ozbiljne i ponekad smrtonosne infekcije zbog bakterijskih, mikobakterijskih, invazivnih gljivičnih,
Encephalitis Atypical mycobacterial infection Cytomegalovirus infection Arthritis bacterial
Atipična mikobakterijska infekcija Infekcija citomegalovirus om
Maintenance of clinical responsed
Održavanje kliničkog odgovorad
In general, fewer side effects were seen when XELJANZ was used alone in rheumatoid arthritis.
Općenito, kod reumatoidnog artritisa, manje je nuspojava zabilježeno uz primjenu lijeka XELJANZ samog.
Month 3 ORAL Sync: DMARD Inadequate Responders Tofacitinib 5 mg twice daily
3. mjesec ORAL Sync: Bolesnici s neodgovarajućim odgovorom na DMARD Tofacitinib 5 mg dva puta dnevno
Laboratory tests
Laboratorijski testovi Limfociti
• Physician educational material
• Edukacijski materijali za liječnika trebaju sadržavati:
In the RA long-term safety population, confirmed decreases in ALC below 500 cells/mm occurred in
U kontroliranim kliničkim ispitivanjima RA-a potvrđeno je smanjenje ALC-a ispod 500 stanica/mm3 u
Normalization of endoscopic appearance of the mucosac
Normalizacija endoskopskog izgleda sluznicec
Table 4: Dose Adjustment for Hepatic Impairment Hepatic
Tablica 4: Prilagodba doze kod oštećenja jetre Oštećenje jetre Klasifikacija
Table 17: Proportion of Patients Meeting Efficacy Endpoints at Week 52 (OCTAVE Sustain) Central Endoscopy Read
Tablica 17: Udio bolesnika koji su ostvarili ishode djelotvornosti u 52. tjednu (ispitivanje OCTAVE Sustain)
- if you are at high risk of developing skin cancer, your doctor may recommend that you have regular skin examinations while taking XELJANZ.
Ako dobijete rak dok se liječite lijekom XELJANZ, liječnik će razmotriti je li potrebno prekinuti uzimanje lijeka XELJANZ. - ako ste u velikom riziku od razvoja raka kože, liječnik Vam može preporučiti redovite kožne pretrage dok uzimate XELJANZ.
In studies of 6-, 12-, or 24-month duration, the rates of serious infections in the 5 mg twice daily and 10 mg twice daily tofacitinib plus DMARD groups were 3.6 and 3.4 patients with events per 100 patient-years, respectively, compared to 1.7 patients with events per 100 patient-years in the placebo plus DMARD group.
U ispitivanjima u trajanju od 6, 12 ili 24 mjeseca, zabilježene su ozbiljne infekcije u stopi od 3,6 bolesnika na 100 bolesnik-godina u skupinama koje su primale 5 mg dva puta dnevno, naspram 3,4 bolesnika na 100 bolesnik-godina u skupinama koje su primale 10 mg tofacitiniba dva puta dnevno i DMARD, odnosno 1,7 bolesnika na 100 bolesnik-godina u skupini koja je primala placebo i DMARD.
Vascular disorders Hypertension Respiratory, thoracic and mediastinal disorders
Poremećaji dišnog sustava, prsišta i sredoprsja
Tofacitinib had no effects on male fertility, sperm motility or sperm concentration.
Tofacitinib nije imao učinaka na mušku plodnost,
Table 1: Low Absolute Lymphocyte Count Low Absolute Lymphocyte Count (ALC) (see section 4.4)
Tablica 1:_ Nizak apsolutni broj limfocita Nizak apsolutni broj limfocita (ALC) (vidjeti dio 4.4) Laboratorijska vrijednost (broj stanica/mm3)
Patients who did not achieve clinical response in one of the induction studies (OCTAVE Induction 1 or OCTAVE Induction 2) after 8 weeks of tofacitinib 10 mg twice daily were allowed to enter an open-label extension study (OCTAVE Open).
Induction 1 ili OCTAVE Induction 2) nakon 8 tjedana uzimanja 10 mg tofacitiniba dva puta dnevno bilo je dozvoljeno uključiti se u otvoreni nastavak ispitivanja (OCTAVE Open).
In the randomised 52-week Phase 3 maintenance study, the proportion of patients with infections were 35.9% (71 patients) in the 5 mg twice daily and 39.8% (78 patients) in the 10 mg twice daily tofacitinib groups, compared to 24.2% (48 patients) in the placebo group.
U randomiziranom 52-tjednom ispitivanju terapije održavanja faze 3 udio bolesnika s infekcijama bio je 35,9% (71 bolesnik) u skupini koja je primala 5 mg tofacitiniba dva puta dnevno i 39,8% (78 bolesnika) u skupini koja je primala 10 mg tofacitiniba dva puta dnevno, u odnosu na 24,2% (48 bolesnika) u skupini koja je primala placebo.
MINIMUM PARTICULARS TO APPEAR ON BLISTER OR STRIPS BLISTER FOR 5 MG TABLETS
PODACI KOJE MORA NAJMANJE SADRŽAVATI BLISTER ILI STRIP BLISTER ZA TABLETE OD 5 MG
b Inadequate response to a least 1 TNFi due to lack of efficacy and/or intolerability.
b Neodgovarajući odgovor na najmanje 1 TNFi zbog izostanka djelotvornosti i/ili zbog nepodnošenja.
Impact of Other Medicinal Products on PK of Tofacitinib
Utjecaj drugih lijekova na farmakokinetiku tofacitiniba
XELJANZ may be used in combination with methotrexate or sometimes alone when used to treat rheumatoid arthritis.
Kada se koristi za liječenje reumatoidnog artritisa, XELJANZ se može koristiti u kombinaciji s metotreksatom ili ponekad sam.
Meningitis cryptococcal Mycobacterium avium complex infection
Tuberkuloza središnjeg živčanog sustava Kriptokokni meningitis Infekcija kompleksom Mycobacteriu m avium
N Month 3
N 3. mjesec
Talk to your doctor or pharmacist before taking XELJANZ: - if you think you have an infection or have symptoms of an infection such as fever, sweating, chills, muscle aches, cough, shortness of breath, new phlegm or change in phlegm, weight loss, warm or red or painful skin or sores on your body, difficulty or pain when swallowing, diarrhoea or stomach pain, burning when you urinate or urinating more often than normal, feeling very tired - if you have any condition that increases your chance of infection (e.g., diabetes, HIV/AIDS, or a weak immune system) - if you have any kind of infection, are being treated for any infection, or if you have infections that keep coming back.
- ako mislite da biste mogli imati infekciju ili imate simptome infekcije poput vrućice, znojenja, zimice, bolova u mišićima, kašlja, nedostatka zraka, nove pojave ili promjena u iskašljaju sluzi, gubitka tjelesne težine, tople, crvene ili bolne kože ili rana na Vašem tijelu, poteškoće ili boli prilikom gutanja, proljeva ili boli u trbuhu, žarenja prilikom mokrenja ili češćeg mokrenja od uobičajenog, osjećate se vrlo umorno - ako imate bilo koje stanje koje povećava Vašu šansu za infekciju (npr., šećernu bolest,
Proportion of Patients Meeting Primary and Key Secondary Efficacy Endpoints at Week 8 by TNF Inhibitor Therapy Subgroups (OCTAVE Induction Study 1 and OCTAVE Induction Study 2, Central Endoscopy Read) OCTAVE Induction Study 1
Udio bolesnika koji su ostvarili primarne i ključne sekundarne ishode djelotvornosti u 8. tjednu u podskupinama liječenim inhibitorom TNF-a (ispitivanja uvodnog liječenja OCTAVE Induction 1 i OCTAVE Induction 2, centralno očitani endoskopski nalazi)
Table 10: Radiographic Changes at Months 6 and 12 ORAL Scan: MTX Inadequate Responders
Tablica 10: Radiološke promjene u 6. i 12. mjesecu ORAL Scan: Bolesnici s neodgovarajućim odgovorom na MTX Placebo + MTX N=139 Srednja vrijednost (SD)a
Significant reductions in DAS28-4(ESR) from baseline (mean improvement) of 1.8-2.0 and 1.9-2.2 were observed in patients treated with 5 mg and 10 mg twice daily doses, respectively, compared to placebo-treated patients (0.7-1.1) at month 3.
U 3. mjesecu je zabilježeno značajno smanjenje vrijednosti DAS28(ESR) od 1,8-2,0 u bolesnika liječenih s 5 mg dva puta dnevno i 1,9-2,2 za 10 mg dva puta dnevno u odnosu na početnu vrijednost, za razliku od bolesnika koji su primali placebo (0,7-1,1).
Time of mandatory placebo rescue to tofacitinib 5 or 10 mg twice daily
Vrijeme obaveznog prebacivanj a s placeba na tofacitinib 5 mg ili 10 mg dva puta dnevno
The most commonly reported adverse reactions during the first 3 months in controlled clinical trials were headache, upper respiratory tract infections, nasopharyngitis, diarrhoea, nausea and hypertension (see Table 6, Adverse Drug Reactions [ADRs] based on all study durations).
Najčešće prijavljene nuspojave tijekom prva 3 mjeseca u kontroliranim kliničkim ispitivanjima bile su glavobolja, infekcije gornjeg respiratornog trakta, nazofaringitis, proljev, mučnina i hipertenzija