OBJECTIVE: The aim of this study was to evaluate the efficacy and safety of intravenous (IV) secukinumab in patients with active psoriatic arthritis (PsA). METHODS: INVIGORATE-2 (NCT04209205) was a randomized, placebo-controlled, phase 3 trial. Patients with active PsA were randomized 1:1 to receive IV secukinumab (6 mg/kg at baseline followed by 3 mg/kg every four weeks [q4w]) or placebo. At week 16, patients randomized to placebo were switched to IV secukinumab (3 mg/kg q4w), and patients who received IV secukinumab continued treatment through week 52. The primary efficacy endpoint was achievement of 50% improvement in American College of Rheumatology response criteria (ACR50) at week 16. Efficacy and safety were evaluated through weeks 52 and 60, respectively. RESULTS: Among 191 patients randomized to IV secukinumab and 190 to placebo/IV secukinumab, 177 (92.7%) and 170 (89.5%) completed the entire study period, respectively. A significantly higher proportion of patients who received IV secukinumab versus placebo achieved ACR50 at week 16 (31.4% vs 6.3%; adjusted P < 0.0001). All secondary efficacy endpoints were met at week 16 (all adjusted P < 0.05 using the predefined hypothesis-testing hierarchy). Patients who switched from placebo to secukinumab at week 16 showed rapid improvements in ACR50 rates; by week 52, both treatment arms experienced similar improvements in efficacy outcomes. No new or unexpected safety signals were observed with receiving IV secukinumab. One death was reported in the placebo group before week 16. CONCLUSION: IV secukinumab led to rapid and sustained improvements in clinical measures of PsA, and the safety profile was consistent with that of secukinumab administered subcutaneously.
- MeSH
- antirevmatika terapeutické užití aplikace a dávkování MeSH
- dospělí MeSH
- dvojitá slepá metoda MeSH
- humanizované monoklonální protilátky * aplikace a dávkování terapeutické užití MeSH
- intravenózní podání MeSH
- lidé středního věku MeSH
- lidé MeSH
- psoriatická artritida * farmakoterapie MeSH
- výsledek terapie MeSH
- Check Tag
- dospělí MeSH
- lidé středního věku MeSH
- lidé MeSH
- mužské pohlaví MeSH
- ženské pohlaví MeSH
- Publikační typ
- časopisecké články MeSH
- klinické zkoušky, fáze III MeSH
- multicentrická studie MeSH
- randomizované kontrolované studie MeSH
OBJECTIVES: To compare the drug survival of etanercept to monoclonal tumour necrosis factor-α inhibitors in rheumatoid arthritis, ankylosing spondylitis and psoriatic arthritis. METHODS: Patients initiating first line biological therapy with tumour necrosis factor-α were propensity score matched and compared for drug survival with a Kaplan-Meier analysis. RESULTS: We matched 657 to 657 patients in rheumatoid arthritis, the median survival time on etanercept was 44.6 months vs. 36.8 months on monoclonal antibody tumour necrosis factor-α inhibitors, with a hazard ratio of 0.94, p = 0.416 We matched 187 to 356 patients in ankylosing spondylitis, the median survival time on etanercept was 75.1 compared to 68.0 months, hazard ratio of 0.78, p = 0.087 We matched 81 to 160 psoriatic arthritis patients, the median survival time on etanercept was 35.8. compared to 65.7 months, hazard ratio 1.61, p = 0.011. Patients treated with etanercept had significantly worse psoriasis scoring during follow up. CONCLUSIONS: We found comparable survival in rheumatoid arthritis and ankylosing spondylitis. In psoriatic arthritis, we found significantly shorter survival on etanercept, possibly due to worse response of skin and nail manifestations.
- MeSH
- adalimumab terapeutické užití MeSH
- ankylózující spondylitida * farmakoterapie mortalita MeSH
- antirevmatika * terapeutické užití MeSH
- dospělí MeSH
- etanercept * terapeutické užití MeSH
- infliximab terapeutické užití MeSH
- Kaplanův-Meierův odhad MeSH
- lidé středního věku MeSH
- lidé MeSH
- monoklonální protilátky terapeutické užití MeSH
- psoriatická artritida * farmakoterapie mortalita MeSH
- registrace * MeSH
- revmatoidní artritida * farmakoterapie mortalita MeSH
- senioři MeSH
- tendenční skóre * MeSH
- TNF-alfa * antagonisté a inhibitory MeSH
- Check Tag
- dospělí MeSH
- lidé středního věku MeSH
- lidé MeSH
- mužské pohlaví MeSH
- senioři MeSH
- ženské pohlaví MeSH
- Publikační typ
- časopisecké články MeSH
- srovnávací studie MeSH
- Geografické názvy
- Česká republika MeSH
BACKGROUND: Efficacy of tumour necrosis factor inhibitors (TNFi) for peripheral arthritis in patients with psoriatic arthritis (PsA) has been established in randomized clinical trials that have used improvement in summated joint counts as an outcome. Whether joints at different anatomical locations might respond differentially to TNFi remains unknown. The aim of the study was to investigate potential variations in the responsiveness to a first tumour necrosis factor inhibitor (TNFi) among joints at distinct locations in patients with psoriatic arthritis (PsA) treated in routine clinical care. METHODS: Bionaive PsA patients from nine European countries were included in this observational cohort study if ≥ 1 joint was swollen at the initiation of a first TNFi as monotherapy or added to methotrexate. Only the 28-joint count was available without imaging data confirming the presence of synovitis. The primary outcome was time to first resolution of joint swelling at each joint level. Hazard ratios (HR) for resolution comparing different joint locations were estimated using interval-censored mixed-effects Cox proportional hazards models, including a random effect for country and patient, adjusted for age and sex. RESULTS: A total of 1729 patients with 8397 swollen joints at the start of TNFi were included. Considering the upper extremity, a higher rate of resolution of joint swelling (HR, 95% CI) was observed for the shoulder (1.65, 1.16-2.35) and elbow (1.90, 1.38-2.61), while a lower rate was found for the wrist (0.72, 0.62-0.83) compared to the joints of digit 3. Within fingers, and using the same reference, joint swelling resolved fastest in digit 4 (1.77, 1.49-2.11) and digit 5 (1.88, 1.53-2.31). A lower rate of resolution of joint swelling was found for the knee in comparison to the elbow, the corresponding joint on the upper limb (0.56, 0.40-0.78). CONCLUSION: The time to resolution of joint swelling upon treatment with TNFi in patients with PsA seems to depend on the localisation of the affected joints.
- MeSH
- antirevmatika * terapeutické užití MeSH
- dospělí MeSH
- inhibitory TNF terapeutické užití MeSH
- kohortové studie MeSH
- lidé středního věku MeSH
- lidé MeSH
- psoriatická artritida * farmakoterapie MeSH
- registrace * MeSH
- senioři MeSH
- TNF-alfa antagonisté a inhibitory MeSH
- výsledek terapie MeSH
- Check Tag
- dospělí MeSH
- lidé středního věku MeSH
- lidé MeSH
- mužské pohlaví MeSH
- senioři MeSH
- ženské pohlaví MeSH
- Publikační typ
- časopisecké články MeSH
- multicentrická studie MeSH
- pozorovací studie MeSH
- Geografické názvy
- Evropa MeSH
- Klíčová slova
- risankizumab, certolizumab,
- MeSH
- biologická terapie metody MeSH
- humanizované monoklonální protilátky * terapeutické užití MeSH
- interleukin-23 antagonisté a inhibitory MeSH
- interleukiny antagonisté a inhibitory MeSH
- kombinovaná farmakoterapie MeSH
- lidé středního věku MeSH
- lidé MeSH
- neúspěšná terapie MeSH
- progrese nemoci MeSH
- psoriatická artritida farmakoterapie komplikace MeSH
- psoriáza * farmakoterapie komplikace MeSH
- tumor nekrotizující faktory terapeutické užití MeSH
- Check Tag
- lidé středního věku MeSH
- lidé MeSH
- mužské pohlaví MeSH
- Publikační typ
- kazuistiky MeSH
- MeSH
- alkoholická steatóza jater diagnóza etiologie komplikace terapie MeSH
- azathioprin aplikace a dávkování MeSH
- biologická terapie metody MeSH
- bulózní pemfigoid * farmakoterapie komplikace MeSH
- humanizované monoklonální protilátky terapeutické užití MeSH
- komorbidita MeSH
- lidé středního věku MeSH
- lidé MeSH
- prednison aplikace a dávkování MeSH
- psoriatická artritida farmakoterapie komplikace MeSH
- psoriáza * farmakoterapie komplikace MeSH
- Check Tag
- lidé středního věku MeSH
- lidé MeSH
- mužské pohlaví MeSH
- Publikační typ
- kazuistiky MeSH
- Klíčová slova
- bimekizumab,
- MeSH
- ankylózující spondylitida * ekonomika farmakoterapie MeSH
- humanizované monoklonální protilátky * ekonomika terapeutické užití MeSH
- lidé MeSH
- náklady na léky MeSH
- psoriatická artritida * ekonomika farmakoterapie MeSH
- psoriáza * ekonomika farmakoterapie MeSH
- randomizované kontrolované studie jako téma MeSH
- zdravotní pojištění MeSH
- Check Tag
- lidé MeSH
- Klíčová slova
- bimekizumab,
- MeSH
- axiální spondyloartritida * etiologie farmakoterapie patofyziologie MeSH
- biologická terapie MeSH
- humanizované monoklonální protilátky farmakologie terapeutické užití MeSH
- interleukin-17 MeSH
- kongresy jako téma MeSH
- lidé MeSH
- psoriatická artritida * etiologie farmakoterapie patofyziologie MeSH
- zánět terapie MeSH
- Check Tag
- lidé MeSH
- Publikační typ
- zprávy MeSH
- Klíčová slova
- bimekizumab,
- MeSH
- axiální spondyloartritida * farmakoterapie MeSH
- biologická terapie MeSH
- humanizované monoklonální protilátky * ekonomika farmakologie terapeutické užití MeSH
- interleukin-17 antagonisté a inhibitory farmakologie terapeutické užití MeSH
- klinická studie jako téma MeSH
- lidé MeSH
- náklady na léky MeSH
- psoriatická artritida * farmakoterapie MeSH
- psoriáza * farmakoterapie MeSH
- zdravotní pojištění MeSH
- Check Tag
- lidé MeSH
- Publikační typ
- novinové články MeSH
OBJECTIVE: Because 66/68 joint counts are not always performed in routine care, we aimed to determine which of the modified 28-joint disease activity index for psoriatic arthritis (DAPSA28) or 28-joint disease activity score with C-reactive protein (DAS28-CRP) should be preferred for monitoring disease activity in psoriatic arthritis (PsA) when the original DAPSA (66/68 joints) is not available. METHODS: Prospectively collected real-world data of European bionaive patients with PsA initiating a first tumor necrosis factor inhibitor were pooled. Remission and response status were evaluated at 6 months by remission (DAPSA ≤ 4, DAPSA28 ≤ 4, and DAS28-CRP < 2.6), response (75% improvement for DAPSA and DAPSA28), and combined EULAR good/moderate responses for DAS28-CRP. Logistic regression analyses on multiple imputed data were used to identify baseline predictors. RESULTS: Remission and response cohorts included 3,159 and 1,866 patients, respectively. The 6-month proportions achieving remission/response were DAPSA (27%/44%), DAPSA28 (28%/44%), and DAS28-CRP (59%/80%). Of 14 possible baseline predictors, 11 predicted both DAPSA and DAPSA28 remission (8 of which also predicted their response, indicated by "*"): longer disease duration*, male sex*, and higher CRP* were positive, whereas older age*, higher body mass index*, patient fatigue*, and global, physician global, health assessment questionnaire score*, and tender and swollen* joint counts were negative predictors. Eight and five of these predicted DAS28-CRP remission and response, respectively. CONCLUSION: In patients with PsA, DAPSA28 should be preferred over DAS28-CRP as a substitute for DAPSA when 66/68 joint counts are not available because of the large overlap in remission and response status and in predictors between DAPSA and DAPSA28.
- MeSH
- antirevmatika terapeutické užití MeSH
- biologické markery krev MeSH
- C-reaktivní protein * analýza MeSH
- dospělí MeSH
- indukce remise * MeSH
- inhibitory TNF terapeutické užití MeSH
- lidé středního věku MeSH
- lidé MeSH
- prospektivní studie MeSH
- psoriatická artritida * farmakoterapie krev MeSH
- senioři MeSH
- stupeň závažnosti nemoci * MeSH
- TNF-alfa antagonisté a inhibitory MeSH
- výsledek terapie MeSH
- Check Tag
- dospělí MeSH
- lidé středního věku MeSH
- lidé MeSH
- mužské pohlaví MeSH
- senioři MeSH
- ženské pohlaví MeSH
- Publikační typ
- časopisecké články MeSH
- multicentrická studie MeSH
- srovnávací studie MeSH
- Geografické názvy
- Evropa MeSH
- MeSH
- humanizované monoklonální protilátky farmakologie terapeutické užití MeSH
- idiopatické střevní záněty etiologie MeSH
- interleukin-17 antagonisté a inhibitory škodlivé účinky terapeutické užití MeSH
- interleukin-23 antagonisté a inhibitory škodlivé účinky terapeutické užití MeSH
- klinická studie jako téma MeSH
- lidé MeSH
- mykózy etiologie MeSH
- psoriatická artritida farmakoterapie MeSH
- psoriáza * farmakoterapie MeSH
- Check Tag
- lidé MeSH