scholarly journals Early and sustained efficacy with apremilast monotherapy in biological-naïve patients with psoriatic arthritis: a phase IIIB, randomised controlled trial (ACTIVE)

2018 ◽  
Vol 77 (5) ◽  
pp. 690-698 ◽  
Author(s):  
Peter Nash ◽  
Kamal Ohson ◽  
Jessica Walsh ◽  
Nikolay Delev ◽  
Dianne Nguyen ◽  
...  
Keyword(s):  
Psoriatic Arthritis ◽  
Disease Activity ◽  
Safety Profile ◽  
Controlled Trial ◽  
Health Assessment ◽  
Tender Joint ◽  
American College Of Rheumatology ◽  
Das 28 ◽  
Registration Number ◽  
Randomised Controlled

ObjectiveEvaluate apremilast efficacy across various psoriatic arthritis (PsA) manifestations beginning at week 2 in biological-naïve patients with PsA.MethodsPatients were randomised (1:1) to apremilast 30 mg twice daily or placebo. At week 16, patients whose swollen and tender joint counts had not improved by ≥10% were eligible for early escape. At week 24, all patients received apremilast through week 52.ResultsAmong 219 randomised patients (apremilast: n=110; placebo: n=109), a significantly greater American College of Rheumatology 20 response at week 16 (primary outcome) was observed with apremilast versus placebo (38.2% (42/110) vs 20.2% (22/109); P=0.004); response rates at week 2 (first assessment) were 16.4% (18/110) versus 6.4% (7/109) (P=0.025). Improvements in other efficacy outcomes, including 28-joint count Disease Activity Score (DAS-28) using C reactive protein (CRP), swollen joint count, Health Assessment Questionnaire-Disability Index (HAQ-DI), enthesitis and morning stiffness severity, were observed with apremilast at week 2. At week 16, apremilast significantly reduced PsA disease activity versus placebo, with changes in DAS-28 (CRP) (P<0.0001), HAQ-DI (P=0.023) and Gladman Enthesitis Index (P=0.001). Improvements were maintained with continued treatment through week 52. Over 52 weeks, apremilast’s safety profile was consistent with prior phase 3 studies in psoriasis and PsA. During weeks 0–24, the incidence of protocol-defined diarrhoea was 11.0% (apremilast) and 8.3% (placebo); serious adverse event rates were 2.8% (apremilast) and 4.6% (placebo).ConclusionsIn biological-naïve patients with PsA, onset of effect with apremilast was observed at week 2 and continued through week 52. The safety profile was consistent with previous reports.Trial registration numberNCT01925768; Results.

Effects of RANKL inhibition on promoting healing of bone erosion in rheumatoid arthritis using HR-pQCT: a 2-year, randomised, double-blind, placebo-controlled trial

2021 ◽  
pp. annrheumdis-2021-219846
Author(s):  
Ho So ◽  
Isaac T Cheng ◽  
Sze-Lok Lau ◽  
Evelyn Chow ◽  
Tommy Lam ◽  
...  
Keyword(s):  
Rheumatoid Arthritis ◽  
Disease Activity ◽  
Bone Erosion ◽  
Controlled Trial ◽  
Health Assessment ◽  
Joint Space ◽  
Double Blind Study ◽  
Quantitative Ct ◽  
Double Blind ◽  
Registration Number

ObjectiveTo evaluate the effects of denosumab on erosion healing at 2–4 metacarpophalangeal (MCP) head as determined by high-resolution peripheral quantitative CT (HR-pQCT) in patients with rheumatoid arthritis (RA) with stable disease.MethodsThis was a randomised, placebo-controlled, double-blind study. Patients with RA with disease activity score 28 joints (DAS28) ≤5.1 were randomised (1:1) to subcutaneous denosumab 60 mg or placebo once every 6 months for 24 months. The primary outcome was erosion healing at MCP 2–4 on HR-pQCT at 12 months. The effects of denosumab on erosion and joint space parameters on HR-pQCT and radiographs, disease activity and health assessment questionnaire-disability index (HAQ-DI) were also examined.ResultsAt 24 months, HR-pQCT images were analysed in 98 patients. One-third of the patients achieved sustained low disease activity throughout the study. At 12 months, changes in erosion parameters on HR-pQCT were similar between the two groups. At 24 months, new erosions (19% vs 9%, p=0.009) and erosion progression (18% vs 8%, p=0.019) were more common in the placebo group than the denosumab group. Erosion healing was seen in a significantly higher proportion of patients in the denosumab group (20% vs 6%, p=0.045) at 24 months. No significant changes in joint space parameters on HR-pQCT, van der Heijde-Sharp erosion score, DAS28 and HAQ-DI were observed in the two groups at 12 and 24 months.ConclusionAlthough no differences in erosion parameters were observed at 12 months, denosumab was more efficacious than placebo in erosion repair on HR-pQCT after 24 months.Trial registration numberNCT03239080.

scholarly journals Application and Modifications of Minimal Disease Activity Measures for Patients with Psoriatic Arthritis Treated with Adalimumab: Subanalyses of ADEPT

2013 ◽  
Vol 40 (5) ◽  
pp. 647-652 ◽  
Author(s):  
Philip J. Mease ◽  
Michele Heckaman ◽  
Sonja Kary ◽  
Hartmut Kupper
Keyword(s):  
Psoriatic Arthritis ◽  
Disease Activity ◽  
Global Assessment ◽  
Health Assessment ◽  
Severity Index ◽  
Tender Joint Count ◽  
Physician Global Assessment ◽  
Minimal Disease Activity ◽  
Tender Joint ◽  
Minimal Disease

Objective.This posthoc analysis evaluated the percentage of patients with psoriatic arthritis (PsA) who achieved minimal disease activity (MDA) and compared the results with a modified MDA substituting the physician global assessment (PGA) for the Psoriasis Activity and Severity Index (PASI) using data from the ADalimumab Effectiveness in Psoriatic Arthritis Trial (ADEPT; NCT00646386).Methods.Patients with active PsA were randomized to receive adalimumab 40 mg or placebo every other week for 24 weeks. MDA was defined as achieving ≥ 5 of the following criteria: tender joint count ≤ 1; swollen joint count ≤ 1; PASI ≤ 1 or body surface area ≤ 3%; patient pain score ≤ 15 [1–100 mm visual analog scale (VAS)]; patient global assessment (PGA) of disease activity ≤ 20 (1–100 mm VAS); Health Assessment Questionnaire ≤ 0.5; and tender entheseal points ≤ 1 (only heels assessed). For modification of the MDA, PASI ≤ 1 was substituted with PGA “Clear” as MDAPGA1 and PGA “Clear” or “Almost clear” as MDAPGA2.Results.Sixty-seven patients were treated with adalimumab and 69 with placebo. At Week 24, MDA, MDAPGA1, and MDAPGA2 were achieved by 39%, 37%, and 39%, respectively, of patients treated with adalimumab versus 7%, 5%, and 8% of patients on placebo (p < 0.001). Kappa coefficients indicated good agreement between PASI and PGA at Week 24.Conclusion.ADEPT results indicated that significantly more patients treated with adalimumab achieved MDA by Week 24 compared with placebo. Modification of the MDA by replacing PASI ≤ 1 with PGA assessments did not alter the results, which may improve feasibility of practical use of the index.

scholarly journals Fosdagrocorat (PF-04171327) versus prednisone or placebo in rheumatoid arthritis: a randomised, double-blind, multicentre, phase IIb study

RMD Open ◽  
2019 ◽  
Vol 5 (1) ◽  
pp. e000889 ◽  
Author(s):  
Frank Buttgereit ◽  
Vibeke Strand ◽  
Eun Bong Lee ◽  
Abraham Simon-Campos ◽  
Dorothy McCabe ◽  
...  
Keyword(s):  
Rheumatoid Arthritis ◽  
Controlled Trial ◽  
Double Blind ◽  
Multicentre Phase ◽  
Procollagen Type ◽  
Mediated Effects ◽  
American College Of Rheumatology ◽  
Primary Endpoints ◽  
Registration Number ◽  
Randomised Controlled

ObjectivesGlucocorticoids have anti-inflammatory, transrepression-mediated effects, although adverse events (AEs; transactivation-mediated effects) limit long-term use in patients with rheumatoid arthritis (RA). We evaluated the efficacy and safety of fosdagrocorat (PF-04171327), a dissociated agonist of the glucocorticoid receptor, versus prednisone or placebo.MethodsIn this 12-week, phase II, randomised controlled trial, 323 patients with moderate to severe RA were randomised 1:1:1:1:1:1:1 to fosdagrocorat (1 mg, 5 mg, 10 mg or 15 mg), prednisone (5 mg or 10 mg) or placebo, once daily. The primary endpoints (week 8) were American College of Rheumatology 20% improvement criteria (ACR20) responses, and percentage changes from baseline in biomarkers of bone formation (procollagen type 1 N-terminal peptide [P1NP]) and resorption (urinary N-telopeptide to urinary creatinine ratio [uNTx:uCr]). Safety was assessed.ResultsACR20 responses with fosdagrocorat 10 mg and 15 mg were superior to placebo, and fosdagrocorat 15 mg was non-inferior to prednisone 10 mg (week 8 model-predicted ACR20 responses: 47%, 61%, 69% and 73% vs 51%, 71% and 37% with fosdagrocorat 1 mg, 5 mg, 10 mg and 15 mg vs prednisone 5 mg, 10 mg and placebo, respectively). Percentage changes from baseline in P1NP with fosdagrocorat 1 mg, 5 mg and 10 mg met non-inferiority criteria to prednisone 5 mg. Corresponding changes in uNTx:uCr varied considerably. All fosdagrocorat doses reduced glycosylated haemoglobin levels. AEs were similar between groups; 63 (19.5%) patients reported treatment-related AEs; 9 (2.8%) patients reported serious AEs. No patients had adrenal insufficiency, treatment-related significant infections or laboratory abnormalities. No deaths were reported.ConclusionIn patients with RA, fosdagrocorat 10 mg and 15 mg demonstrated efficacy similar to prednisone 10 mg and safety similar to prednisone 5 mg.Trial registration numberNCT01393639

scholarly journals Treat-to-target in PsA: methods and necessity

RMD Open ◽  
2020 ◽  
Vol 6 (1) ◽  
pp. e001083 ◽  
Author(s):  
Emma Dures ◽  
Sasha Shepperd ◽  
Sandeep Mukherjee ◽  
Jo Robson ◽  
Ivo Vlaev ◽  
...  
Keyword(s):  
Psoriatic Arthritis ◽  
Disease Activity ◽  
Controlled Trial ◽  
Treat To Target ◽  
Routine Practice ◽  
Tight Control ◽  
Real World Data ◽  
Optimal Care ◽  
Serious Adverse Events ◽  
Randomised Controlled

With increasing recognition of the high burden and impact of psoriatic arthritis (PsA) and the growing number of therapeutic options, there has been an intensifying focus on treatment strategy in recent years. In 2015, the Tight Control of Psoriatic Arthritis study confirmed the clinical benefit of using a treat-to-target approach in PsA. This randomised controlled trial found benefits in both arthritis and psoriasis disease activity as well as lower disease impact reported by patients, although participants allocated to tight control experienced a higher rate of serious adverse events. European and international recommendations support the use of a treat-to-target approach in PsA and have offered specific advice on how to do this using outcomes such as the minimal disease activity criteria. However, implementation of this approach in routine practice is low, with real-world data highlighting undertreatment as a result. Recent qualitative work with physicians in the UK has helped researchers to understand the barriers to implementation of treat-to-target in PsA. We now need to address these barriers, provide education and support to non-specialist clinicians in routine practice, and aid the translation of optimal care to the clinic.

scholarly journals The impact of the presence of fibromyalgia on fatigue in patients with psoriatic arthritis: comparison with controls

2019 ◽  
Vol 60 (1) ◽  
Author(s):  
Yasemin Ulus ◽  
Yesim Akyol ◽  
Ayhan Bilgici ◽  
Omer Kuru
Keyword(s):  
Psoriatic Arthritis ◽  
Visual Analogue Scale ◽  
Disease Activity ◽  
Analogue Scale ◽  
Univariate Analysis ◽  
American College Of Rheumatology ◽  
Pain Scores ◽  
Das 28 ◽  
Significant Difference ◽  
The Impact

Abstract Background Coexisting fibromyalgia (FM) to psoriatic arthritis (PsA) has been identified and it has been associated with more severe symptoms, impaired function, and greater disability. It was aimed to explore the effect of the presence of FM on fatigue in patients with PsA comparing with controls. Methods Fifty patients with PsA and 34 sex-age matched controls were enrolled. In patients; pain was assessed by Visual Analogue Scale, disease activity by DAS-28, enthesitis by The Leeds Enthesitis Index. Fatigue level of all participants was evaluated by Multidimensional Assessment of Fatigue. In all participants, FM was determined according to 2010 American College of Rheumatology criteria. Results Seventeen patients with PsA (34%) and 4 controls (11.8%) were diagnosed with FM and all of them were women. There was significant difference between the patients and controls in terms of presence of FM (p < 0.05). Patients’ fatigue scores were significantly higher than controls’ (p = 0.001). There were significant differences between the PsA patients with and without FM with regard to gender, enthesitis, DAS-28 and pain scores (p < 0.05); fatigue scores (p < 0.001). The significant effect of the presence of FM on fatigue was found by univariate analysis of variance in patients (p < 0.001). Conclusion It was observed that FM presence and fatigue were more common in PsA patients than controls and comorbid FM had significant effect on fatigue in these patients. Physicians should be aware of the possibility of concomitant FM in patients with PsA.

scholarly journals Social tenants’ health: evaluating the effectiveness of landlord interventions

2018 ◽  
Vol 72 (5) ◽  
pp. 413-419
Author(s):  
Paul Charles Cheshire ◽  
Stephen Gibbons ◽  
Jemma Mouland
Keyword(s):  
Health Outcomes ◽  
Controlled Trial ◽  
Health Assessment ◽  
Treated Group ◽  
Health Problems ◽  
Control Group ◽  
Early Assessment ◽  
Disadvantaged Groups ◽  
Registration Number ◽  
Randomised Controlled

BackgroundThe National Health Service (NHS) scores well internationally on access to healthcare. But access has been measured on methods likely to undersample the more disadvantaged. Social landlords have access to more disadvantaged groups and may be able to improve health outcomes for their tenants and reduce their NHS usage by simple interventions.MethodsThis is a randomised controlled trial of 547 London social housing ‘general needs’ tenants over 50 years of age. Participants were given a health assessment, then split into a control group or one of two treated groups. Following early assessment 25 participants had to be withdrawn to receive intensive treatment because of currently untreated major health problems. Participants were followed up over 18 months and changes in health outcomes and NHS usage measured.ResultsCompared with the control the most intensively treated group showed non-significant improvements on health outcomes but a significant reduction in NHS resource use, on conventional costings worth some £760 per person. All 25 participants transferred to the most intensively treated group after their early health assessments showed improvement on all health outcomes at final assessment, but these improvements were not statistically significant.ConclusionsDrawing a sample from disadvantaged but not the most seriously disadvantaged groups in London revealed 4.5% of the population to have very serious untreated health problems. The reason for lack of treatment was mainly non-registration with a general practitioner or psychiatric issues. Simple interventions to a targeted group were found to produce significant reductions in NHS usage and other, although non-significant, health benefits.Trial registration numberID ISRCTN96259142.

scholarly journals Longterm (52-week) Results of a Phase III Randomized, Controlled Trial of Apremilast in Patients with Psoriatic Arthritis

2015 ◽  
Vol 42 (3) ◽  
pp. 479-488 ◽  
Author(s):  
Arthur Kavanaugh ◽  
Philip J. Mease ◽  
Juan J. Gomez-Reino ◽  
Adewale O. Adebajo ◽  
Jürgen Wollenhaupt ◽  
...  
Keyword(s):  
Psoriatic Arthritis ◽  
Adverse Events ◽  
Controlled Trial ◽  
Signs And Symptoms ◽  
Phase Iii ◽  
Tender Joint ◽  
Clinical Trial Registration ◽  
Acr20 Response ◽  
Phosphodiesterase 4 ◽  
American College Of Rheumatology

Objective.To evaluate the efficacy and safety of apremilast, an oral phosphodiesterase 4 inhibitor, over 52 weeks in patients with active psoriatic arthritis (PsA) despite prior treatment.Methods.Patients were randomized to placebo (n = 168), apremilast 20 mg BID (n = 168), or apremilast 30 mg BID (n = 168). Patients whose swollen and tender joint counts had not improved by ≥ 20% at Week 16 were considered nonresponders and were required to be re-randomized (1:1) to apremilast 20 mg BID or 30 mg BID if they were initially randomized to placebo, or continued their initial treatment of apremilast dose. At Week 24, all remaining patients treated with placebo were re-randomized to apremilast 20 mg BID or 30 mg BID.Results.An American College of Rheumatology 20 (ACR20) response at Week 16 was attained by significantly more patients receiving apremilast 20 mg BID (30.4%, p = 0.0166) or 30 mg BID (38.1%, p = 0.0001) than placebo (19.0%). Among patients receiving apremilast continuously for 52 weeks (n = 254), ACR20 response at Week 52 was observed in 63.0% (75/119, 20 mg BID) and 54.6% (71/130, 30 mg BID) of patients. Response was also maintained across secondary outcomes, including measures of PsA signs and symptoms, skin psoriasis severity, and physical function. The nature, incidence, and severity of adverse events were comparable over the 24-week and 52-week periods. The most common adverse events, diarrhea and nausea, generally occurred early and were self-limited.Conclusion.Continuous apremilast treatment resulted in sustained improvements in PsA for up to 52 weeks. Apremilast had an acceptable safety profile and was generally well tolerated. Clinical trial registration: NCT01172938.

scholarly journals Gradual tapering TNF inhibitors versus conventional synthetic DMARDs after achieving controlled disease in patients with rheumatoid arthritis: first-year results of the randomised controlled TARA study

2019 ◽  
Vol 78 (6) ◽  
pp. 746-753 ◽  
Author(s):  
Elise van Mulligen ◽  
Pascal Hendrik Pieter de Jong ◽  
Tjallingius Martijn Kuijper ◽  
Myrthe van der Ven ◽  
Cathelijne Appels ◽  
...  
Keyword(s):  
Rheumatoid Arthritis ◽  
Controlled Trial ◽  
Health Assessment ◽  
Tnf Inhibitors ◽  
First Year ◽  
Tnf Inhibitor ◽  
Significant Difference ◽  
Registration Number ◽  
Randomised Controlled ◽  
Over Time

ObjectivesThe aim of this study is to evaluate the effectiveness of two tapering strategies after achieving controlled disease in patients with rheumatoid arthritis (RA), during 1 year of follow-up.MethodsIn this multicentre single-blinded (research nurses) randomised controlled trial, patients with RA were included who achieved controlled disease, defined as a Disease Activity Score (DAS) ≤ 2.4 and a Swollen Joint Count (SJC) ≤ 1, treated with both a conventional synthetic disease-modifying antirheumatic drugs (csDMARD) and a TNF inhibitor. Eligible patients were randomised into gradual tapering csDMARDs or TNF inhibitors. Medication was tapered if the RA was still under control, by cutting the dosage into half, a quarter and thereafter it was stopped. Primary outcome was proportion of patients with a disease flare, defined as DAS > 2.4 and/or SJC > 1. Secondary outcomes were DAS, European Quality of Life-5 Dimensions (EQ5D) and functional ability (Health Assessment Questionnaire Disability Index [HAQ-DI]) after 1 year and over time.ResultsA total of 189 patients were randomly assigned to tapering csDMARDs (n = 94) or tapering anti-TNF (n = 95). The cumulative flare rates in the csDMARD and anti-TNF tapering group were, respectively, 33 % (95% CI,24% to 43 %) and 43 % (95% CI, 33% to 53 % (p = 0.17). Mean DAS, HAQ-DI and EQ-5D did not differ between tapering groups after 1 year and over time.ConclusionUp to 9 months, flare rates of tapering csDMARDs or TNF inhibitors were similar. After 1 year, a non-significant difference was found of 10 % favouring csDMARD tapering. Tapering TNF inhibitors was, therefore, not superior to tapering csDMARDs. From a societal perspective, it would be sensible to taper the TNF inhibitor first, because of possible cost reductions and less long-term side effects.Trial registration numberNTR2754

scholarly journals Clinical and Psychological Assessment of Patients With Rheumatoid Arthritis and Fibromyalgia

2021 ◽  
Author(s):  
Chao Gao ◽  
Hua Zhong ◽  
Lihong Chen ◽  
Li Wang ◽  
Hong Yao ◽  
...  
Keyword(s):  
Rheumatoid Arthritis ◽  
Disease Activity ◽  
Short Form ◽  
Health Assessment ◽  
Depression Scale ◽  
Psychological Status ◽  
Tender Joint ◽  
Das 28 ◽  
Sf 36 ◽  
Peking University

Abstract ObjectiveThis study aimed to assess the clinical features as well as the functional and psychological status of patients with rheumatoid arthritis and fibromyalgia in a real-world setting in China.MethodsA total of 202 inpatients with rheumatoid arthritis from the Department of Rheumatology and Immunology at Peking University People’s Hospital were enrolled between December 2018 and April 2019. These inpatients were assessed for the presence of fibromyalgia using the 1990 American College of Rheumatology’s classification criteria for fibromyalgia. Disease activity and functional and psychological status were assessed using the Disease Activity Score in 28 Joints (DAS-28), Short Form-36 health survey questionnaire (SF-36), Health Assessment Questionnaire (HAQ), Hospital Anxiety and Depression Scale, and Visual Analog Scale.ResultsOf 202 patients with rheumatoid arthritis, 42 (20.8%) had concurrent fibromyalgia. Compared to patients without fibromyalgia, those with rheumatoid arthritis and fibromyalgia had higher DAS-28 scores (6.0 vs. 4.4, P=0.011) and notably higher tender joint counts (16.5 vs. 4.5, P<0.001). Patients with rheumatoid arthritis and fibromyalgia had worse HAQ scores (1.24 vs. 0.66, P<0.001) and lower SF-36 scores (28.6 vs. 58.2, P<0.001). Additionally, patients with rheumatoid arthritis and fibromyalgia experienced more fatigue (88.1% vs. 50.6%, P<0.001) and had higher anxiety (10 vs. 4, P<0.001) and depression scores (12 vs. 6, P<0.001). No significant differences in erythrocyte sedimentation rate, C-reactive protein concentration, morning stiffness period, or swollen joint counts were identified between the groups.ConclusionsPatients with rheumatoid arthritis and fibromyalgia had higher disease activity, worse functional and psychological status, and poorer quality of life. DAS-28 scores may have been overestimated in these patients. When patients with rheumatoid arthritis do not achieve remission, the possibility of fibromyalgia should be considered.

scholarly journals Apremilast, an oral phosphodiesterase 4 inhibitor, in patients with psoriatic arthritis and current skin involvement: a phase III, randomised, controlled trial (PALACE 3)

2016 ◽  
Vol 75 (6) ◽  
pp. 1065-1073 ◽  
Author(s):  
Christopher J Edwards ◽  
Francisco J Blanco ◽  
Jeffrey Crowley ◽  
Charles A Birbara ◽  
Janusz Jaworski ◽  
...  
Keyword(s):  
Psoriatic Arthritis ◽  
Rescue Therapy ◽  
Controlled Trial ◽  
Health Assessment ◽  
Severity Index ◽  
Index Score ◽  
Phase Iii ◽  
Upper Respiratory Tract ◽  
Skin Involvement ◽  
Tender Joint

ObjectiveTo evaluate apremilast treatment in patients with active psoriatic arthritis, including current skin involvement, despite prior therapy with conventional disease-modifying antirheumatic drugs and/or biologic agents.MethodsPatients (N=505) were randomised (1:1:1) to placebo, apremilast 20 mg twice daily, or apremilast 30 mg twice daily. Rescue therapy with apremilast was designated at week 16 for placebo patients not achieving 20% improvement in swollen and tender joint counts. At week 24, the remaining placebo patients were then randomised to apremilast 20 mg twice daily or 30 mg twice daily. The efficacy and safety of apremilast were assessed over 52 weeks.ResultsAt week 16, significantly more patients receiving apremilast 20 mg twice daily (28%) and 30 mg twice daily (41%) achieved 20% improvement in American College of Rheumatology response criteria versus placebo (18%; p=0.0295 and p<0.0001, respectively), and mean decrease in the Health Assessment Questionnaire-Disability Index score was significantly greater with apremilast 30 mg twice daily (−0.20) versus placebo (−0.07; p=0.0073). In patients with baseline psoriasis body surface area involvement ≥3%, significantly more apremilast 30 mg twice daily patients achieved 50% reduction from baseline Psoriasis Area and Severity Index score (41%) versus placebo (24%; p=0.0098) at week 16. At week 52, observed improvements in these measures demonstrated sustained response with continued apremilast treatment. Most adverse events were mild to moderate in severity; the most common were diarrhoea, nausea, headache and upper respiratory tract infection.ConclusionsApremilast demonstrated clinically meaningful improvements in psoriatic arthritis and psoriasis at week 16; sustained improvements were seen with continued treatment through 52 weeks. Apremilast was generally well tolerated and demonstrated an acceptable safety profile.Trial registration numberNCT01212770.

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