scholarly journals AB0540 COMPARISON OF EQ-5D HEALTH STATUS IN PSORIATIC ARTHRITIS PATIENTS WITH OR WITHOUT AXIAL DISEASE: RESULTS OF SUBANALYSIS OF THE PATERA STUDY

2021 ◽  
Vol 80 (Suppl 1) ◽  
pp. 1302-1302
Author(s):  
I. Gaydukova ◽  
T. Korotaeva ◽  
V. Mazurov ◽  
A. Samtsov ◽  
V. Khayrutdinov ◽  
...  
Keyword(s):  
Psoriatic Arthritis ◽  
Missing Values ◽  
Inflammatory Back Pain ◽  
Inadequate Response ◽  
Usual Activity ◽  
Double Blind ◽  
Interleukin 17A ◽  
Significant Difference ◽  
Axial Disease ◽  
Anxiety Depression

Background:Netakimab (NTK) is an anti-interleukin-17A monoclonal antibody approved for psoriasis, ankylosing spondylitis, psoriatic arthritis (PsA) in Russia and Belarus. PATERA is an ongoing phase 3 international double-blind, placebo-controlled clinical study of NTK in PsA (NCT03598751).Objectives:A subanalysis was performed to assess the effect of NTK on domains of the 5-level EuroQol 5 Dimensions questionnaire (EQ-5D-5L) in patients with inflammatory back pain (IBP) (IBP(+)) and without (IBP(-)) at baseline according to self-reported ASAS IBP criteria, 2009.Methods:194 adult patients with PsA (CASPAR criteria, 2006) with inadequate response to csDMARD or one TNFi, were randomly assigned to receive NTK 120mg or placebo at weeks 0,1,2,4,6,8,10,14,18,22. The proportion of patients reported >1 problem in each domain was evaluated. Patients with missing values were considered as non-responders in the analysis.Results:97 PsA patients (N=54 IBP(+), N=43 IBP(-)) received NTK. The subpopulations didn’t differ significantly in gender, age, and PsA activity at baseline. Comparable percentage of patients reported any problems for each domain at baseline (p≥0.05) (data not shown). IBP(-) subpopulation had a greater improvement for all domains except of anxiety/depression. The absolute declines for IBP(+) vs IBP(-) patients were as followed: 24.1% vs 41.9% (mobility), 18.5 vs 41.9% (self-care), 24.0% vs 51.1% (usual activities), 24.1% vs 37.2% (pain/discomfort), 33.3% vs 9.3% (anxiety/depression). However, the only significant difference between IBP(+) and IBP(-) was observed in usual activity (Figure 1).Conclusion:NTK resulted in the growing improvement of each EQ-5D-5L domain through 24 weeks irrespectively of the presence of IBP. IBP(-) subjects showed trend to greater benefit compared to IBP(+).Figure 1Percentage of patients reported any problems in (A) pain/discomfort, (B) in usual activity at each visitAcknowledgements:This study was sponsored by JSC BIOCAD.Disclosure of Interests:Inna Gaydukova Speakers bureau: Abbvie, Biocad, Eli Lilly, MSD, Novartis, Pfizer, Sandoz, Tatiana Korotaeva Speakers bureau: Abbvie, Biocad, Eli Lilly, Johnson & Johnson, Janssen, Novartis, Pfizer, UCB, V Mazurov: None declared., Aleksey Samtsov: None declared., Vladislav Khayrutdinov: None declared., Andrey Bakulev: None declared., Alena Kundzer: None declared., Nikolaj Soroka: None declared., Anna Eremeeva Employee of: Biocad.

scholarly journals AB0534 THE IMPACT OF AXIAL INVOLVEMENT ON ACR RESPONSE IN PATIENTS WITH PSORIATIC ARTHRITIS: RESULTS OF SUBANALYSIS OF THE PATERA STUDY

2021 ◽  
Vol 80 (Suppl 1) ◽  
pp. 1298.2-1299
Author(s):  
T. Korotaeva ◽  
I. Gaydukova ◽  
V. Mazurov ◽  
A. Samtsov ◽  
V. Khayrutdinov ◽  
...  
Keyword(s):  
Psoriatic Arthritis ◽  
Missing Values ◽  
Categorical Variables ◽  
Inflammatory Back Pain ◽  
Common Symptom ◽  
Inadequate Response ◽  
Double Blind ◽  
American College Of Rheumatology ◽  
Axial Disease ◽  
The Impact

Background:Inflammatory back pain (IBP) is a common symptom of axial disease in patients with psoriatic arthritis (PsA). The reported prevalence of axial disease in patients with PsA is quite variable and must be taken into account while choosing treatment strategy. Netakimab (NTK) is an anti-interleukin-17A monoclonal antibody approved for psoriasis, ankylosing spondylitis, PsA in Russia and Belarus.Objectives:A subanalysis was aimed to investigate the ACR (American College of Rheumatology) 20/50/70 response rate in PsA patients with/without the axial disease, defined by the presence of IBP according to self-reported ASAS IBP criteria, 2009 at baseline.Methods:PATERA is an ongoing phase 3 international double-blind, placebo-controlled clinical study (NCT03598751). 194 adult patients with PsA (CASPAR criteria, 2006) with inadequate response to csDMARD or one TNFi, were randomly assigned to receive NTK 120mg or placebo at weeks 0,1,2,4,6,8,10,14,18,22. The ACR response was calculated in NTK-treated patients with IBP (IBP(+)) and NTK-treated patients without IBP (IBP(-)) according to self-reported ASAS IBP criteria, 2009. Patients with missing values for categorical variables were considered as non-responders in the analysis.Results:97 PsA patients (N=54 IBP(+), N=43 IBP(-)) received NTK. Both subpopulations were comparable in gender, age, and PsA activity at baseline. There were no significant differences in ACR20 achievement between the groups (Figure 1). The percentage of patients with ACR50 was significantly (p<0.05) higher in the IBP(-) subpopulation at weeks 4-20 (data not shown), but not at week 24 with 63% IBP(+) and 79% IBP(-) responders (p≥0.05). Similarly, IBP(+) patients had a lower frequency of ACR70 response (Figure 1).Conclusion:NTK is effective in PsA treatment irrespectively of the presence of axial disease. Both IBP(-) and IBP(+) subpopulations achieved ACR20/50/70 as well, however, the benefit in IBP(-) patients was more pronounced.Figure 1ACR response ratesAcknowledgements:This study was sponsored by JSC BIOCAD.Disclosure of Interests:Tatiana Korotaeva Speakers bureau: Abbvie, Biocad, Eli Lilly, Johnson & Johnson, Janssen, Novartis, Pfizer, UCB, Inna Gaydukova Speakers bureau: Abbvie, Biocad, Eli Lilly, MSD, Novartis, Pfizer, Sandoz, V Mazurov: None declared., Aleksey Samtsov: None declared., Vladislav Khayrutdinov: None declared., Andrey Bakulev: None declared., Alena Kundzer: None declared., Nikolaj Soroka: None declared., Anna Eremeeva Employee of: Biocad.

scholarly journals POS1043 NETAKIMAB REDUCES PSORIATIC ARTHRITIS ACTIVITY IN PATIENTS WITH OR WITHOUT AXIAL DISEASE: SUBANALYSIS OF THE PATERA STUDY

2021 ◽  
Vol 80 (Suppl 1) ◽  
pp. 796-797
Author(s):  
T. Korotaeva ◽  
I. Gaydukova ◽  
V. Mazurov ◽  
A. Samtsov ◽  
V. Khayrutdinov ◽  
...  
Keyword(s):  
Psoriatic Arthritis ◽  
Disease Activity ◽  
Missing Values ◽  
Categorical Variables ◽  
Inflammatory Back Pain ◽  
Rapid Decline ◽  
Inadequate Response ◽  
Low Disease Activity ◽  
Axial Disease ◽  
The Impact

Background:PATERA is an ongoing phase 3 international double-blind, placebo-controlled clinical study of netakimab (NTK) in psoriatic arthritis (PsA) (NCT03598751). Netakimab (NTK) is an anti-interleukin-17A monoclonal antibody approved for psoriasis, ankylosing spondylitis, PsA in Russia and Belarus.Objectives:A subanalysis was performed to define the impact of NTK on PsA activity depending on the presence of axial disease: a subset of patients with inflammatory back pain (IBP) according to self-reported ASAS IBP criteria, 2009 (IBP(+) was compared to those without IBP (IBP(-)).Methods:194 eligible adult patients with PsA fulfilling the CASPAR criteria, with inadequate response to csDMARD or one TNFi, were randomly assigned to receive NTK 120mg or placebo at weeks 0,1,2,4,6,8,10,14,18,22. Patients with missing values for categorical variables were considered as non-responders in the analysis. For quantitative variables, missing values were replaced using the multiple imputation method.Results:97 PsA patients (N=54 IBP(+), N=43 IBP(-)) received NTK. Both subpopulations were comparable in gender, age and PsA activity at baseline. The treatment led to a pronounced decline in PsA activity in both subpopulations, significant differences between arms were observed only in DAPSA remission and very low disease activity (VLDA) at week 24 (Figure 1A). Changes from baseline in DAS28-CRP were consistent between IBP(+) and IBP(-) patients with a rapid decline during the first month with further improvement up to week 24 (Figure 1B). A similar trend was observed PsA-specific composite responder index (PSARC) (data not shown). A comparable percentage of IBP(+) and IBP(-) patients achieved PSARC at each timepoint of evaluation with 87% and 86% of responders respectively at week 24.Conclusion:NTK significantly improved PsA activity regardless of the presence of IBP.Figure 1.PsA activity after 24-week treatment with NTK. (A) Percentage of patients with DAPSA remission (0-4), very low disease activity (VLDA), minimal disease activity (MDA) at week 24; (B) change from baseline in DAS28-CRPAcknowledgements:This study was sponsored by JSC BIOCAD.Disclosure of Interests:Tatiana Korotaeva Speakers bureau: Abbvie, Biocad, Eli Lilly, Johnson & Johnson, Janssen, Novartis, Pfizer, UCB, Inna Gaydukova Speakers bureau: Abbvie, Biocad, Eli Lilly, MSD, Novartis, Pfizer, Sandoz, V Mazurov: None declared, Aleksey Samtsov: None declared, Vladislav Khayrutdinov: None declared, Andrey Bakulev: None declared, Alena Kundzer: None declared, Nikolaj Soroka: None declared, Anna Eremeeva Employee of: Biocad.

scholarly journals Secukinumab in patients with psoriatic arthritis and axial manifestations: results from the double-blind, randomised, phase 3 MAXIMISE trial

2020 ◽  
pp. annrheumdis-2020-218808
Author(s):  
Xenofon Baraliakos ◽  
Laure Gossec ◽  
Effie Pournara ◽  
Slawomir Jeka ◽  
Antonio Mera-Varela ◽  
...  
Keyword(s):  
Psoriatic Arthritis ◽  
Activity Index ◽  
Disease Activity Index ◽  
Signs And Symptoms ◽  
Visual Analogue Score ◽  
Spinal Pain ◽  
Inadequate Response ◽  
Double Blind ◽  
Registration Number ◽  
Axial Disease

ObjectivesMAXIMISE (Managing AXIal Manifestations in psorIatic arthritis with SEcukinumab) trial was designed to evaluate the efficacy of secukinumab in the management of axial manifestations of psoriatic arthritis (PsA).MethodsThis phase 3b, double-blind, placebo-controlled, multi-centre 52-week trial included patients (≥18 years) diagnosed with PsA and classified by ClASsification criteria for Psoriatic Arthritis (CASPAR) criteria, with spinal pain Visual Analogue Score ≥40/100 and Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) score ≥4 despite use of at least two non-steroidal anti-inflammatory drugs (NSAIDs). Patients were randomised (1:1:1) to secukinumab 300 mg, secukinumab 150 mg or placebo weekly for 4 weeks and every 4 weeks thereafter. At week 12, placebo patients were re-randomised to secukinumab 300/150 mg. Primary endpoint was ASAS20 (Assessment of SpondyloArthritis international Society) response with secukinumab 300 mg at week 12.ResultsPatients were randomly assigned; 167 to secukinumab 300 mg, 165 to secukinumab 150 mg and 166 to placebo. Secukinumab 300 mg and 150 mg significantly improved ASAS20 response versus placebo at week 12 (63% and 66% vs 31% placebo). The OR (95% CI) comparing secukinumab 300 mg and 150 mg versus placebo, using a logistic regression model after multiple imputation, was 3.8 (2.4 and 6.1) and 4.4 (2.7 and 7.0; p<0.0001).ConclusionsSecukinumab 300 mg and 150 mg provided significant improvement in signs and symptoms of axial disease compared with placebo in patients with PsA and axial manifestations with inadequate response to NSAIDs.Trial registration numberNCT02721966.

scholarly journals OP0053 SECUKINUMAB IMPROVES CLINICAL AND IMAGING OUTCOMES IN PATIENTS WITH PSORIATIC ARTHRITIS AND AXIAL MANIFESTATIONS WITH INADEQUATE RESPONSE TO NSAIDS: WEEK 52 RESULTS FROM THE MAXIMISE TRIAL

2020 ◽  
Vol 79 (Suppl 1) ◽  
pp. 35-36 ◽  
Author(s):  
X. Baraliakos ◽  
L. Gossec ◽  
E. Pournara ◽  
S. Jeka ◽  
R. Blanco ◽  
...  
Keyword(s):  
Psoriatic Arthritis ◽  
Controlled Trial ◽  
Spinal Pain ◽  
Inadequate Response ◽  
Imaging Data ◽  
Sacroiliac Joints ◽  
Research Support ◽  
Double Blind ◽  
Randomised Controlled ◽  
Mri Score

Background:Although axial disease may affect up to 70% of patients (pts) with Psoriatic Arthritis (PsA), evidence on the efficacy of biologics in the treatment of axial manifestations in such pts is limited,1particularly as validated classification criteria for this subtype of PsA are not yet available. MAXIMISE (NCT02721966) is the first randomised controlled trial evaluating the efficacy of a biologic in the management of the axial manifestations of PsA and showed that secukinumab (SEC) 300 and 150 mg provided rapid and significant improvement in ASAS20 responses in these pts through week (Wk) 12.2Objectives:To present 52 wks efficacy results and imaging data from the MAXIMISE trial.Methods:This phase 3b, double-blind, placebo (PBO)-controlled, multicentre 52-wk trial included 498 pts (aged ≥18 years) with a diagnosis of PsA and classified by CASPAR criteria, spinal pain VAS score ≥ 40/100 and BASDAI score ≥ 4 despite use of at least two NSAIDs. Pts were randomised to SEC 300 mg (N=167) or SEC 150 mg (N=165) or PBO (N=166) wkly for 4 wks and every 4 wks thereafter. At Wk 12, PBO pts were re-randomised to SEC 300/150 mg. The primary endpoint was ASAS20 response with SEC 300 mg at Wk 12. The key secondary endpoint was ASAS20 response with SEC 150 mg at Wk 12. Wk 52 data are presented as observed. Bone marrow oedema of the entire spine and sacroiliac joints were assessed centrally with Berlin MRI scores at Baseline, Wk 12 and Wk 52.Results:Primary and key secondary endpoints were met; ASAS20 responses were sustained and increased further through Wk 52. 75%/79.7% of the PBO pts re-randomised at Wk 12 to SEC 300/150 mg achieved ASAS20 response at Wk 52 (Figure 1). ASAS40 responses at Wk 52 were 69.1% [SEC 300 mg], 64.5% [SEC 150 mg], 62.5% [PBO-SEC 300 mg], and 54.1% [PBO-SEC 150 mg]. At baseline, 59.5% [SEC 300 mg], 53.5% [SEC 150 mg] and 64.2% [PBO] of the pts had positive MRIs for the sacroiliac joints and/or the spine with Berlin MRI score ≥1. The reductions of Berlin MRI score for entire spine and sacroiliac joints were statistically significant for pts treated with SEC 300/150 mg vs. placebo (Figure 2a and b). There were no new or unexpected safety findings.Figure 1.ASAS20 Response over 52 Wks*Figure 2.Total Berlin MRI score for the Entire Spine and Sacroiliac Joints at Wk 12Conclusion:Secukinumab improved all evaluated ASAS responses through Wk 52 in PsA pts with axial manifestations and inadequate responses to NSAIDs and led to significant reduction of inflammatory MRI lesions in the spine and the Sacroiliac Joints. The safety profile of secukinumab through Wk 52 was consistent with previous reports.3-4References:[1]McInnes IB, et al.Lancet.2015;386(9999):1137–46.[2]Baraliakos X, et al.Arthritis Rheumatol. 2019;71 (suppl 10).[3]Langley RG, et al.N Engl J Med.2014;371:326–38.[4]Sieper J, et al.Ann Rheum Dis.2016;0:1–8.Acknowledgments:The study was sponsored by Novartis Pharma AG, Basel, Switzerland.Disclosure of Interests:Xenofon Baraliakos Grant/research support from: Grant/research support from: AbbVie, BMS, Celgene, Chugai, Merck, Novartis, Pfizer, UCB and Werfen, Consultant of: AbbVie, BMS, Celgene, Chugai, Merck, Novartis, Pfizer, UCB and Werfen, Speakers bureau: AbbVie, BMS, Celgene, Chugai, Merck, Novartis, Pfizer, UCB and Werfen, Laure Gossec Grant/research support from: Lilly, Mylan, Pfizer, Sandoz, Consultant of: AbbVie, Amgen, Biogen, Celgene, Janssen, Lilly, Novartis, Pfizer, Sandoz, Sanofi-Aventis, UCB, Effie Pournara Shareholder of: Novartis, Employee of: Novartis, Sławomir Jeka Grant/research support from: AbbVie, Pfizer, Roche, Novartis, MSD, Sandoz, Eli Lilly, Egis, UCB, Celgene, Speakers bureau: AbbVie, Pfizer, Roche, Novartis, MSD, Sandoz, Eli Lilly, Egis, UCB, Celgene, Ricardo Blanco Grant/research support from: AbbVie, MSD, Roche, Consultant of: Abbvie, Eli Lilly, Pfizer, Roche, Bristol-Myers, Janssen, UCB Pharma and MSD, Speakers bureau: Abbvie, Eli Lilly, Pfizer, Roche, Bristol-Myers, Janssen, UCB Pharma. MSD, Salvatore D’Angelo Consultant of: AbbVie, Biogen, BMS, Celgene, Eli Lilly, MSD, Novartis, and UCB, Speakers bureau: AbbVie, BMS, Celgene, Eli Lilly, Novartis, Pfizer, and Sanofi, Georg Schett Speakers bureau: AbbVie, BMS, Celgene, Janssen, Eli Lilly, Novartis, Roche and UCB, Barbara Schulz Employee of: Novartis, Michael Rissler Shareholder of: Novartis, Employee of: Novartis, Kriti Nagar Employee of: Novartis, Chiara Perella Shareholder of: Novartis, Employee of: Novartis, Laura C Coates: None declared

Efficacy of a step-down regimen of oral prednisolone in axial spondyloarthritis: result of a double-blind randomized controlled trial (COBRA-AS Study)

Rheumatology ◽  
2020 ◽  
Author(s):  
Debashish Mishra ◽  
Varun Dhir ◽  
G S R S N K Naidu ◽  
Aastha Khullar ◽  
Vishal Kumar ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Controlled Trial ◽  
Oral Prednisolone ◽  
Functional Improvement ◽  
Inadequate Response ◽  
Serious Adverse Events ◽  
Double Blind ◽  
Randomized Controlled ◽  
Significant Difference ◽  
Step Down

Abstract Objectives To evaluate the efficacy and safety of a step-down regimen of oral prednisolone over 24 weeks in patients of axial SpA (axSpA). Methods This proof-of-concept double-blind randomized controlled trial enrolled patients with active axSpA (BASDAI ≥4) having predominantly axial disease (≤1 active joint currently) and inadequate response to NSAIDs. They were randomized to receive either oral prednisolone (n = 32) or placebo (n = 33) at a dose of 60, 40, 30, 20, 15 and 10 mg daily for 1 week each, following which they received 5 mg prednisolone (or placebo) daily for 18 weeks. The primary endpoint was a 50% improvement in the BASDAI (BASDAI50) at week 24. Analysis was intention to treat. Results A BASDAI50 was achieved by 12 of 32 patients (37.5%) in the prednisolone arm and 3 of 33 patients (9.1%) in the placebo arm at 24 weeks [difference 28.4% (95% CI 7.9, 46.7)]. However, there was no difference in achieving a 20 or 40% improvement in the Assessment of SpondyloArthritis international Society response between the groups. Although there was a significant intergroup difference in adjusted ΔBASDAI and ΔAnkylosing Spondylitis Disease Activity Score with CRP at 24 weeks, there was no difference at 12 weeks. There was also no significant difference in ΔBASFI, ΔBAS-G or ΔBASMI at 12 or 24 weeks. No serious adverse events were noted. There was significant weight gain in the first 12 weeks in the prednisolone group vs placebo [0.9 (s.d. 0.4) kg], but not at 24 weeks. Conclusions In this small study, oral prednisolone was efficacious in axSpA in achieving the primary outcome, but many crucial secondary outcomes such as functional improvement were not met. Its impact on bone loss was not studied. Trial registration: CTRI/2018/01/011342.

scholarly journals Efficacy and safety of netakimab in patients with psoriatic arthritis: results of the phase III PATERA clinical study

2020 ◽  
Vol 58 (5) ◽  
pp. 480-488
Author(s):  
T. V. Korotaeva ◽  
V. I. Mazurov ◽  
A. M. Lila ◽  
I. Z. Gaydukova ◽  
A. L. Bakulev ◽  
...  
Keyword(s):  
Placebo Group ◽  
Psoriatic Arthritis ◽  
Safety Profile ◽  
Phase Iii ◽  
Inadequate Response ◽  
Efficacy And Safety ◽  
Double Blind ◽  
Acr20 Response ◽  
American College Of Rheumatology ◽  
Blinded Manner

Netakimab (NTK) is a humanized anti-interleukin-17А (IL-17A) monoclonal antibody approved for the treatment of psoriatic arthritis, ankylosing spondylitis, moderate to severe psoriasis. Here, we present the results of the 24-weeks double blind period of the PATERA study.Objective. The objective of the study was to evaluate the efficacy and safety of NTK compared to placebo in patients with psoriatic arthritis (PsA).Patients and methods. 194 patients with active PsA with an inadequate response to previous therapy with nonsteroidal anti-inflammatory drugs, conventional or biologic disease-modifying antirheumatic drugs, were randomized in a 1:1 ratio to receive subcutaneous 120 mg NTK or placebo at weeks 0, 1, 2, 4, 6, 8, 10, 14, 18, 22. At week 16 ACR20 (20% improvement in the American College of Rheumatology response criteria) non-responders in placebo group were reassigned to NTK in a blinded manner. The primary endpoint was the proportion of patients achieved ACR20 response at week 24.Results. 82,5% of patients in the NTK group and 9.3% of patients in the placebo group achieved ACR20 at week 24 with the 95% CI [0,63; 0,84] (p < 0,0001). Skin manifestations and axial disease significantly improved with NTK. The safety profile of NTK was comparable to placebo. The most frequent treatment-related AEs were expected and common for all other IL-17 inhibitors: increased alanine aminotransferase (ALT), infections, lymphopenia.Conclusion. NTK in the dose of 120 mg has superior efficacy over placebo in patients with active psoriatic arthritis. The safety profile is consistent with other IL-17 inhibitors.

Inflammatory Spinal Disease in Psoriatic Arthritis: A Report from the GRAPPA 2010 Annual Meeting

2012 ◽  
Vol 39 (2) ◽  
pp. 418-420 ◽  
Author(s):  
DAFNA D. GLADMAN
Keyword(s):  
Back Pain ◽  
Psoriatic Arthritis ◽  
Clinical Symptoms ◽  
Inflammatory Back Pain ◽  
Resonance Imaging ◽  
Spinal Disease ◽  
Sacroiliac Joints ◽  
Axial Disease ◽  
Magnetic Resonance Imaging Mri ◽  
Ankylosing Spondyloarthritis

Diagnosing axial disease in patients with psoriatic arthritis (PsA) has been largely dependent on identifying inflammatory back pain (IBP), which itself has been difficult to define. We review the criteria used to identify IBP in patients with ankylosing spondylitis (AS) and other forms of spondyloarthritis. Recently, the Ankylosing SpondyloArthritis International Society (ASAS) developed a list of clinical and radiographic criteria for identifying IBP in patients with AS. However, it is more difficult to identify IBP in patients with PsA because generally they have less pain than patients with rheumatoid arthritis or AS. Further, PsA patients may have clinical symptoms of pain but negative radiographs. It may be more useful to identify sacroiliitis or syndesmophytes by magnetic resonance imaging (MRI), since MRI identifies lesions in the sacroiliac joints and the spine much earlier than can be detected on radiographs. In summary, all patients with PsA should be assessed for axial involvement with history, physical examination, and imaging. Patients with psoriasis whose history includes onset of back pain before age 40 years, the presence of night pain, and improvement with exercise but not with rest, or who have limited neck or back mobility, should be referred to a rheumatologist.

ADJUVITE: a double-blind, randomised, placebo-controlled trial of adalimumab in early onset, chronic, juvenile idiopathic arthritis-associated anterior uveitis

2017 ◽  
Vol 77 (7) ◽  
pp. 1003-1011 ◽  
Author(s):  
Pierre Quartier ◽  
Amandine Baptiste ◽  
Véronique Despert ◽  
Emma Allain-Launay ◽  
Isabelle Koné-Paut ◽  
...  
Keyword(s):  
Juvenile Idiopathic Arthritis ◽  
Anterior Uveitis ◽  
Early Onset ◽  
Controlled Trial ◽  
Topical Therapy ◽  
Topical Steroids ◽  
Inadequate Response ◽  
Serious Adverse Events ◽  
Double Blind ◽  
Significant Difference

ObjectivesTo assess the efficacy and safety of adalimumab on uveitis in patients with early onset, chronic, juvenile idiopathic arthritis (JIA)-associated or idiopathic anterior uveitis and an inadequate response to topical steroids and methotrexate (MTX).MethodsPatients aged 4 years or more with ocular inflammation quantified by laser flare photometry (LFP) ≥30 photon units/ms were double-blindly randomised (1:1) to 2 groups, one treated with placebo and one with adalimumab subcutaneously at a dose of 24 mg/m2 in patients aged <13 years, 40 mg in the others, every other week. The primary outcome was response at month 2 (M2) defined as a 30% reduction of inflammation on LFP in the assessable eye with more severe baseline inflammation and no worsening on slit lamp examination. From M2 to M12, all patients received adalimumab.ResultsAt M2, among 31 patients included in intention-to-treat analysis, there were 9/16 responders on adalimumab and 3/15 on placebo (P=0.038, Χ2 test; relative risk=2.81, 95% CI 0.94 to 8.45; risk difference: 36.3%, 95% CI 2.1 to 60.6); there was no significant difference using the Standardised Uveitis Nomenclature classification criteria of improvement. Thirty patients continued the trial after M2 and received adalimumab (open-label phase), 29 reached M12. There were seven serious adverse events none related to study treatment.ConclusionsThis trial is in favour of using adalimumab in patients with early onset, chronic anterior uveitis, which is in most cases associated with JIA, in case of inadequate response to topical therapy and MTX. LFP could be a valuable tool to assess early treatment efficacy.Trial registration numberNCT01385826.

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