Arthur Kavanaugh

La Jolla Institute for Allergy & Immunology, لا هویا, California, United States

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Publications (296)1683.07 Total impact

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    ABSTRACT: Background In a phase 2 study, the inhibition of the interleukin-17A receptor improved signs and symptoms of psoriatic arthritis. We sought to evaluate the efficacy and safety of secukinumab, an anti-interleukin-17A monoclonal antibody, in such patients. Methods In this double-blind, phase 3 study, 606 patients with psoriatic arthritis were randomly assigned in a 1:1:1 ratio to receive intravenous secukinumab (at a dose of 10 mg per kilogram) at weeks 0, 2, and 4, followed by subcutaneous secukinumab at a dose of either 150 mg or 75 mg every 4 weeks, or placebo. Patients in the placebo group were switched to subcutaneous secukinumab at a dose of 150 mg or 75 mg at week 16 or 24, depending on clinical response. The primary end point was the proportion of patients with an American College of Rheumatology 20 (ACR20) response at week 24, defined as a 20% improvement from baseline in the number of tender and swollen joints and at least three other important domains. Results ACR20 response rates at week 24 were significantly higher in the group receiving secukinumab at doses of 150 mg (50.0%) and 75 mg (50.5%) than in those receiving placebo (17.3%) (P<0.001 for both comparisons with placebo). Secondary end points, including the ACR50 response and joint structural damage, were significantly better in the secukinumab groups than in the placebo group. Improvements were sustained through 52 weeks. Infections, including candida, were more common in the secukinumab groups. Throughout the study (mean secukinumab exposure, 438.5 days; mean placebo exposure, 128.5 days), four patients in the secukinumab groups had a stroke (0.6 per 100 patient-years; 95% confidence interval [CI], 0.2 to 1.5), and two had a myocardial infarction (0.3 per 100 patient-years; 95% CI, 0.0 to 1.0), as compared with no patients in the placebo group. Conclusions Secukinumab was more effective than placebo in patients with psoriatic arthritis, which validates interleukin-17A as a therapeutic target. Infections were more common in the secukinumab groups than in the placebo group. The study was neither large enough nor long enough to evaluate uncommon serious adverse events or the risks associated with long-term use. (Funded by Novartis Pharma; number, NCT01392326 .).
    New England Journal of Medicine 09/2015; 373(14):1329-1339. DOI:10.1056/NEJMoa1412679 · 55.87 Impact Factor
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    ABSTRACT: As patients with rheumatoid arthritis (RA) receive treatment with anti-tumour necrosis factors over several years, it is important to evaluate their long-term safety and efficacy. The objective of this study was to examine the safety and benefits of certolizumab pegol (CZP)+methotrexate (MTX) treatment for almost 5 years in patients with RA. Patients who completed the 24-week Rheumatoid Arthritis Prevention of Structural Damage (RAPID) 2 randomized controlled trial (RCT; NCT00160602), or who were American College of Rheumatology (ACR) 20 non-responders at Week 16, entered the open-label extension (OLE; NCT00160641). After ≥6 months treatment with CZP 400 mg every two weeks (Q2W), dose was reduced to 200 mg Q2W, the approved maintenance dose. Safety data are presented from all patients who received ≥1 dose CZP (Safety population, n=612). Efficacy data are presented to Week 232 for the intent-to-treat (ITT, n=492) and Week 24 CZP RCT Completer (n=342) populations, and through 192 weeks of dose-reduction for the Dose-reduction population (patients whose CZP dose was reduced to 200 mg, n=369). Radiographic progression (modified total Sharp score change from RCT baseline >0.5) to Week 128 is reported for the Week 24 CZP Completers. In the RCT, 619 patients were randomized to CZP+MTX (n=492) or placebo+MTX (n=127). Overall, 567 patients (91.6%) entered the OLE: 447 CZP and 120 placebo patients. Of all randomized patients, 358 (57.8%) were ongoing at Week 232. Annual drop-out rates during the first four years ranged from 8.4–15.0%. Event rates per 100 patient-years were 163.0 for adverse events (AEs) and 15.7 for serious AEs. Nineteen patients (3.1%) had fatal AEs (incidence rate=0.8). Clinical improvements in the RCT were maintained to Week 232 in the CZP Completers: mean Disease Activity Score 28 (Erythrocyte Sedimentation Rate) change from baseline was −3.4 and ACR20/50/70 responses 68.4%/47.1%/25.1% (non-responder imputation). Similar improvements observed in the ITT were maintained following dose-reduction. 73.2% of CZP Completers had no radiographic progression at Week 128. In patients with active RA despite MTX therapy, CZP was well tolerated, with no new safety signals identified. CZP provided sustained improvements in clinical outcomes for almost 5 years. Trial registration, NCT00160602 and NCT00160641. Registered 8 September 2005.
    Arthritis Research & Therapy 09/2015; 17(1). DOI:10.1186/s13075-015-0767-2 · 3.75 Impact Factor
  • Arthritis Care and Research 09/2015; DOI:10.1002/acr.22741 · 4.71 Impact Factor
  • Arthur Kavanaugh · John J Cush
    The Journal of Rheumatology 08/2015; 42(8):1357-1358. DOI:10.3899/jrheum.150566 · 3.19 Impact Factor
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    ABSTRACT: Objective: To evaluate the long-term effectiveness and safety of 10 years of adalimumab (ADA) treatment in DMARD-refractory RA patients and to analyse efficacy based on RF status and baseline disease duration. Methods: DE020 was a multicentre, phase 3, open-label continuation study. Adult RA patients who received s.c. ADA (40 mg every other week or monthly) in one of four early assessment studies could receive ADA for ≤10 years in DE020. Assessments included the 28-joint DAS with CRP (DAS28-CRP), Simplified Disease Activity Index (SDAI), HAQ Disability Index (HAQ-DI) and safety as events per 100 patient-years. Results: Of 846 enrolled patients, mean age at baseline was 55.6 years, 78.1% were women, mean disease duration was 11.7 years and 27.0% were RF(-). Among 286 (33.8%) patients who completed 10 years of ADA, 168/236 (71.2%) achieved DAS28-CRP ≤3.2, 101/238 (42.4%) achieved HAQ-DI <0.5 and 90/241 (37.3%) achieved DAS28-CRP ≤3.2 plus HAQ-DI <0.5. DAS28-CRP- or SDAI-based remission was observed in 135/236 (57.2%) and 70/236 (29.7%) patients, respectively. Effectiveness outcomes were similar regardless of RF status. Higher proportions of patients with shorter vs longer baseline disease duration (≤2 vs >2 years) achieved HAQ-DI <0.5 (60.6% vs 39.5%; P = 0.023) and DAS28-CRP ≤3.2 plus HAQ-DI <0.5 (58.1% vs 32.5%; P = 0.006). Adverse events (317.2 events per 100 patient-years) during ADA exposure were consistent with the expected safety profile for TNF inhibitors. Conclusion: ADA led to sustained clinical and functional responses in the 33.8% of treatment-refractory RA patients who completed 10 years of treatment. Patients with shorter disease duration achieved better outcomes, highlighting the need for early treatment. No unexpected safety findings were observed. Trial registration:,, NCT00195650.
    Rheumatology (Oxford, England) 07/2015; DOI:10.1093/rheumatology/kev249 · 4.48 Impact Factor
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    ABSTRACT: Interleukin 17A is a proinflammatory cytokine that is implicated in the pathogenesis of psoriatic arthritis. We assessed the efficacy and safety of subcutaneous secukinumab, a human anti-interleukin-17A monoclonal antibody, in patients with psoriatic arthritis. In this phase 3, double-blind, placebo-controlled study undertaken at 76 centres in Asia, Australia, Canada, Europe, and the USA, adults (aged ≥18 years old) with active psoriatic arthritis were randomly allocated in a 1:1:1:1 ratio with computer-generated blocks to receive subcutaneous placebo or secukinumab 300 mg, 150 mg, or 75 mg once a week from baseline and then every 4 weeks from week 4. Patients and investigators were masked to treatment assignment. The primary endpoint was the proportion of patients achieving at least 20% improvement in the American College of Rheumatology response criteria (ACR20) at week 24. Analysis was by intention to treat. This study is registered with, number NCT01752634. Between April 14, and Nov 25, 2013, 397 patients were randomly assigned to receive secukinumab 300 mg (n=100), 150 mg (n=100), 75 mg (n=99), or placebo (n=98). A significantly higher proportion of patients achieved an ACR20 at week 24 with secukinumab 300 mg (54 [54%] patients; odds ratio versus placebo 6·81, 95% CI 3·42-13·56; p<0·0001), 150 mg (51 [51%] patients; 6·52, 3·25-13·08; p<0·0001), and 75 mg (29 [29%] patients; 2·32, 1·14-4·73; p=0·0399) versus placebo (15 [15%] patients). Up to week 16, the most common adverse events were upper respiratory tract infections (four [4%], eight [8%], ten [10%], and seven [7%] with secukinumab 300 mg, 150 mg, 75 mg, and placebo, respectively) and nasopharyngitis (six [6%], four [4%], six [6%], and eight [8%], respectively). Serious adverse events were reported by five (5%), one (1%), and four (4%) patients in the secukinumab 300 mg, 150 mg, and 75 mg groups, respectively, compared with two (2%) in the placebo group. No deaths were reported. Subcutaneous secukinumab 300 mg and 150 mg improved the signs and symptoms of psoriatic arthritis, suggesting that secukinumab is a potential future treatment option for patients with this disorder. Novartis. Copyright © 2015 Elsevier Ltd. All rights reserved.
    The Lancet 06/2015; DOI:10.1016/S0140-6736(15)61134-5 · 45.22 Impact Factor
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    ABSTRACT: To evaluate the efficacy and safety of ustekinumab through 2years in adult patients with active psoriatic arthritis (PsA). A total of 615 adult patients with active PsA were randomized to placebo, ustekinumab 45mg, or ustekinumab 90mg, at wks0, 4, and every 12 weeks through wk88 (last dose). At wk16, patients with <5% improvement in both tender/swollen joint counts entered blinded early escape (placebo to 45mg, 45mg to 90mg, 90mg to 90mg). All remaining placebo patients crossed over to ustekinumab 45mg at wk24. Clinical efficacy measures included: ≥20% improvement in the American College of Rheumatology criteria (ACR20), 28-joint count disease activity score using C-reactive protein (DAS28-CRP), and ≥75% improvement in psoriasis area and severity index (PASI75). Radiographic progression was evaluated using the van der Heijde-modified Sharp (vdH-S) score. At week100, ACR20, DAS28-CRP moderate/good response, and PASI75 rates ranged from 56.7%-63.6%, 71.9%-76.7%, and 63.9%- 72.5%, respectively, across treatment groups. In both ustekinumab groups, the median percent improvement in dactylitis and enthesitis was 100% at wk100. The mean changes in vdH-S from week52-100 were similar to those observed from wk0-52 in the ustekinumab groups. Through week108, 70.7% and 9.7% of patients had an AE or SAE, respectively. The rates and type of AEs were similar between the dose groups. Clinical and radiographic benefits from ustekinumab treatment were maintained through wk100 in PSUMMIT 1. No unexpected safety events were observed; the safety profile of ustekinumab in this population was similar to that previously observed in psoriasis patients treated with ustekinumab. This article is protected by copyright. All rights reserved. © 2015, American College of Rheumatology.
    06/2015; DOI:10.1002/acr.22645
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    ABSTRACT: Background Bone damage, including localized as well as generalized osteoporosis is a well known consequence of the inflammatory arthritides such as rheumatoid arthritis (RA). Psoriatic arthritis (PsA) can be characterized by bone destruction but also new bone formation. In PsA, the literature on osteoporosis is inconclusive and scarcer than in RA. Objectives To explore if PsA patients are at increased risk of having reduced bone mineral density (BMD) at hip and/or lumbar spine. Methods Consecutive patients from an outpatient clinic fulfilling CASPAR criteria for PsA were enrolled. We excluded PsA patients with only axial manifestation without peripheral arthritis. All patients underwent a thorough examination according to an extensive protocol. Data collection included demographics, clinical and laboratory disease measures, treatments, and previous fracture history. BMD was measured at spine (L1-4) and hip (femoral neck and total hip) by dual energy X-ray absorptiometry (DXA, Lunar Prodogy). Calibration of the DXA machine was stable during the whole measurement period. BMD was expressed as g/cm2, Z-score and T-score. The percentage of patients with T-score ≤ -2.5 SD (WHO osteoporosis definition) and with Z-score ≤ -1.0 SD was calculated. Appropriate descriptive statistics was applied for continuous and categorical variables. Results Patient characteristics among the 141 examined PsA patients (men 50.4%): mean (SD) age 52.5 (9.9) years, body mass index (BMI) 28.3 (4.4) kg/m2, disease duration 8.9 years (6.8) and current smoker 17.0%. Median (range) 68 tender joint count was 6.0 [0-55], 66 swollen joint count 0 [0-6] and CRP 2.0 [0-63] mg/dl. Mean (SD) DAS28 was 3.2 (1.2), ESR 15.9 (11.9) mm/hr, MHAQ 0.44 (0.40) and pain and fatigue on visual analogue scale 35.1 (23.5) and 45.7 (32.4) mm respectively. Biologic DMARDs were used by 33.3%, synthetic DMARDs by 56.7% and glucocorticosteroids by 9.9%. Only 11.3% of patients were using calcium and vitamin D supplementation and 2.1% antiresorptive osteoporosis treatment. Low energy fracture was reported in 8.9% of the patients. In the table below mean (SD or 95%CI) bone density values expressed as BMD, Z-score and T-score and percentage of patients with T-score ≤ -2.5 SD and Z-score ≤ -1.0 SD (by definition 16% in the reference population) is displayed. As shown the proportion of patients with Z-score ≤ -1.0 SD was comparable with the 16% seen in the reference population database. Conclusions The proportion of PsA patients with osteoporosis in our study was low. Overall BMD was comparable to that from normative bone density reference values. Disclosure of Interest G. Haugeberg Grant/research support from: Unrestricted Grant from Pfizer, B. Grandaunet: None declared, H. Høiberg: None declared, A. Diamantopoulos: None declared, A. Kavanaugh: None declared
    Annals of the Rheumatic Diseases 06/2015; 74(Suppl 2):352.2-352. DOI:10.1136/annrheumdis-2015-eular.2795 · 10.38 Impact Factor
  • L. C. Coates · A. F. Kavanaugh · P. J. Mease · C. T. Ritchlin
    The Journal of Rheumatology 06/2015; 42(6):1052-1055. DOI:10.3899/jrheum.150132 · 3.19 Impact Factor
  • Annals of the Rheumatic Diseases 06/2015; 74(Suppl 2):1165.3-1166. DOI:10.1136/annrheumdis-2015-eular.4653 · 10.38 Impact Factor
  • Annals of the Rheumatic Diseases 06/2015; 74(Suppl 2):1169.2-1169. DOI:10.1136/annrheumdis-2015-eular.5190 · 10.38 Impact Factor
  • Eun Jin Kang · Arthur Kavanaugh
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    ABSTRACT: Psoriatic arthritis (PsA) is a heterogeneous chronic inflammatory disease that may affect peripheral and axial joints, entheses, skin and nails, and other organs. Treatment with nonsteroidal anti-inflammatory drugs, steroid and disease-modifying antirheumatic drugs had been the backbone of traditional management of PsA for many years. However, improvement in our understanding of immunopathogenesis of PsA has led to new immunomodulatory therapies. Introduction of novel agents has raised the bar for treatment and helped drive research into additional therapeutic options.
    Therapeutic Advances in Chronic Disease 05/2015; 6(4). DOI:10.1177/2040622315582354
  • Sunil Das · DoQuyen Huynh · Hong Yang · Arnoldas Ceponis · Arthur Kavanaugh
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    ABSTRACT: To assess salivary gland ultrasonography (US) as a diagnostic tool for secondary Sjögren syndrome (sSS) in patients with rheumatoid arthritis (RA). Salivary gland US images from 30 patients with RA were graded using a validated semiquantitative scoring system. Sicca symptoms, oral health, and RA disease activity were assessed. US changes consistent with SS were found in 40% of patients. Patients with higher US scores had more sicca symptoms as well as higher RA activity and poorer oral health. Salivary gland US may aid the diagnosis of sSS in patients with RA.
    The Journal of Rheumatology 05/2015; 42(7). DOI:10.3899/jrheum.141149 · 3.19 Impact Factor
  • Minyoung Her · Arthur Kavanaugh
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    ABSTRACT: With the advent of biologic agents such as TNF inhibitors, the treatment paradigm for autoimmune systemic inflammatory diseases has progressed tremendously. Despite some distinct treatments, similarities exist in several aspects of the treatment of autoimmune inflammatory diseases such as rheumatoid arthritis (RA), IBD and psoriasis. With a so-called treat-to-target strategy aiming at remission, the intensive and early application of disease-modifying antirheumatic drugs within a 'window of opportunity', and in combination with TNF inhibitors, has become the overarching principle of RA therapy. In this Perspective, the concept of treatment approaches using immunomodulatory agents and the latest advances of therapies in autoimmune systemic inflammatory diseases, especially RA, are overviewed from a rheumatology perspective to provide insights into possible approaches to the treatment of inflammatory gastrointestinal disease.
    Nature Reviews Gastroenterology &#38 Hepatology 04/2015; 12(6). DOI:10.1038/nrgastro.2015.65 · 12.61 Impact Factor
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    ABSTRACT: Objective The main objective of this study was to compare disease burden in rheumatoid arthritis (RA), psoriatic arthritis (PsA) and axial spondyloarthritis (ax-SpA). Methods In this cross-sectional study, all the RA (1093), PsA (365) and ax-SpA (333) patients who visited the out-patient clinic of the Hospital of Southern Norway Trust during the year 2013 were included; the RA patients all had a RA diagnosis verified by the treating rheumatologist, the PsA patients all fulfilled the ClASsification for Psoriatic ARthritis (CASPAR) criteria and the ax-SpA patients all fulfilled the Assessment of SpondyloArthritis international Society (ASAS) classification criteria for ax-SpA. Patient-reported health status, demographic variables, medications, and composite scores of disease activity were assessed. The main analyses were performed using General Linear Models adjusted for age, sex and multiple comparisons. Correlation analyses were performed using Spearman's rho. Results The reported pain, joint pain, patient's global assessment and fatigue were similar in PsA and ax-SpA, but significantly lower in RA. The 28-joint Disease Activity Score (DAS28) (0.3±0.1, p = 0.003), Clinical Disease Activity Index (CDAI) (1.0±0.4, p = 0.028) and Routine Assessment of Patient Index Data 3 (RAPID3) (0.4±0.1, p = 0.004) were all significantly higher in PsA vs. RA. RAPID3 showed moderate to high correlation with DAS28 (rho = 0.521, p<0.001) and CDAI (rho = 0.768, p<0.001) in RA and PsA, and with Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) (rho = 0.902, p<0.001) and Bath Ankylosing Spondylitis Functional Index (BASFI) (0.865, p<0.001) in ax-SpA and PsA.
    PLoS ONE 04/2015; 10(4):e0123582. DOI:10.1371/journal.pone.0123582 · 3.23 Impact Factor
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    ABSTRACT: Adalimumab (ADA) was evaluated for its efficacy in patients with moderate to severely active psoriatic arthritis (PsA) and for the presence of correlations in disease change variables. Patients with inadequate response to standard PsA therapy were given 40 mg of ADA every other week for up to 12 weeks or 20 weeks. Outcome variables encompassed tender joint count (TJC), swollen joint count (SJC), physician's global assessment (PGA) of psoriasis, Health Assessment Questionnaire (HAQ), patient's global assessment (PtGA) of disease activity and pain, C-reactive protein, as well as composite measures of disease activity. Patients with inactive skin disease symptoms at baseline were excluded from the remission analyses. Of 268 patients with active baseline joint and skin disease and data available at Week 12 following open-label ADA therapy, 73 achieved joint remission (27.2%, TJC ≤ 1 + SJC ≤ 1) and 144 achieved skin remission criteria (53.7%, PGA = clear/almost clear). Simultaneous joint and skin remission criteria were achieved in 16.0% and 24.8% of patients at weeks 12 and 20, respectively. In patients who did not achieve skin and/or joint remission, 12-week ADA treatment improved mean clinical and functional scores. Joint remission was more frequently associated with achieving clinically relevant outcomes including HAQ, PtGA disease activity, and PtGA pain compared to skin remission. No correlation between improvement in skin and joint disease was observed. ADA was effective in achieving strict criteria for remission in joint or skin disease in many patients with active PsA within 12 weeks and sustained through 20 weeks. (NCT00235885).
    The Journal of Rheumatology 04/2015; 42(6). DOI:10.3899/jrheum.140312 · 3.19 Impact Factor
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    ABSTRACT: To compare the presence of cardiovascular (CV) risk factors and established CV disease in patients with psoriatic arthritis (PsA) and the general population and to compare the 10-year risk of a fatal CV event calculated by the Systematic Coronary Risk Evaluation (SCORE) algorithm. Patients with PsA (n=338) and controls (n=50 468) were recruited from the Nord-Trøndelag Health Study 3. Age-adjusted and sex-adjusted prevalence rates of CV risk factors and comorbidity were calculated and the SCORE algorithm was applied. There was an increased prevalence of angina pectoris (5.0% vs 3.6%, p=0.01), history of percutaneous coronary intervention (2.4% vs 1.4%, p=0.04), hypertension (45.3% vs 39.3%, p=0.01), obesity (32.0% vs 22.4%) and tobacco smoking (21.3% vs 16.4%, p=0.02) in patients with PsA compared with controls. Patients with PsA had elevated levels of C reactive protein (CRP; p<0.001), body mass index (BMI; p<0.001) and triglycerides (p=0.01). The median calculated CV risk in patients with PsA was low and comparable with controls (0.87 vs 0.83, p=0.24). The distribution across CV risk classes was similar among patients with PsA and controls. Patients with PsA have a higher risk of CV disease than the background population, although there was no difference between groups in 10-year risk of a fatal CV event estimated by SCORE. However, patients with PsA had elevated levels of CV risk factors not included in the SCORE algorithm, such as BMI, triglycerides and CRP. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to
    Annals of the rheumatic diseases 03/2015; DOI:10.1136/annrheumdis-2014-206824 · 10.38 Impact Factor
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    ABSTRACT: Evaluate long-term outcomes in psoriatic arthritis (PsA) patients who achieved or did not achieve minimal disease activity (MDA) through 5 years of golimumab treatment in GO-REVEAL. The GO-REVEAL trial was a phase 3, randomized, double-blind trial with placebo-control through wk24 followed by an open-label extension of golimumab 50/100mg treatment up to 5 years. In these post-hoc analyses, MDA was defined by the presence of ≥5/7 PsA outcome measures (≤1 swollen joint, ≤1 tender joint, Psoriasis Area and Severity Index [PASI] ≤1, patient pain score ≤15, patient global disease activity [PtGA] score ≤20 (0-100), Health Assessment Questionnaire-Disability Index [HAQ-DI] ≤0.5, and ≤1 tender enthesis point). Treatment with golimumab yielded significantly higher MDA response rates versus patients randomized to placebo at wk14 (23.5% vs. 1.0%; p<0.0001), wk24 (28.1% vs. 7.7%; p<0.0001), and wk52 (42.4% vs. 30.2%; p=0.037). MDA was achieved at least once by ∼50% of golimumab-treated patients overall. Irrespective of treatment randomisation, achievement of MDA at ≥3 and ≥4 consecutive visits was associated with significantly less radiographic progression and more improvement in MDA components allowing specific assessment of physical function (HAQ-DI) and overall disease activity (PtGA) at wk256 versus patients not achieving MDA. Logistic regression analyses indicated that a 1-unit higher baseline HAQ-DI score yielded a significantly lower likelihood of achieving MDA at ≥3 (odds ratio [95%CI]=0.514 [0.321,0.824]; p=0.006) and ≥4 (odds ratio [95%CI]=0.480 [0.290,0.795]; p=0.004) consecutive visits. Among golimumab-treated PsA patients, better long-term functional improvement, patient global assessment, and radiographic outcomes were observed when patients achieved persistent MDA. This article is protected by copyright. All rights reserved. © 2015 American College of Rheumatology.
    Arthritis Care and Research 03/2015; DOI:10.1002/acr.22576 · 4.71 Impact Factor
  • Renata Baronaite Hansen · Arthur Kavanaugh
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    ABSTRACT: Certolizumab pegol (CZP) is a TNF-α inhibitor approved for the treatment of psoriatic arthritis in 38 countries, including many European countries and the USA. It is a pegylated humanized anti-TNF-α antigen-binding fragment, administered subcutaneously. As other TNF-α antibodies, CZP binds to and neutralizes both soluble and membrane TNF-α. In contrast to whole antibodies and etanercept, CZP does not activate antibody-dependent cell-mediated cytotoxicity or complement-dependent cytotoxicity, as it does not have an Fc piece. CZP showed efficacy in improving skin scores and patient reported outcomes in a Phase II study of 176 adults with moderate-to-severe plaque psoriasis. In a Phase III study of CZP in 409 psoriatic arthritis patients, CZP treatment resulted in improvements in peripheral arthritis, as well as dactylitis, enthesitis, nail disease and quality of life. The safety profile of CZP appears to be similar to that of other TNF-α inhibitor.
    Expert Review of Clinical Immunology 02/2015; 11(3):1-12. DOI:10.1586/1744666X.2015.1009897 · 2.48 Impact Factor
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    ABSTRACT: 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. 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. 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. 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.
    The Journal of Rheumatology 01/2015; 42(3). DOI:10.3899/jrheum.140647 · 3.19 Impact Factor

Publication Stats

10k Citations
1,683.07 Total Impact Points


  • 2003–2015
    • La Jolla Institute for Allergy & Immunology
      • Division of Cell Biology
      لا هویا, California, United States
  • 2000–2015
    • University of California, San Diego
      • • Division of Rheumatology, Allergy and Immunology
      • • Division of Immunology and Allergy
      San Diego, California, United States
  • 2014
    • University Center Rochester
      Рочестер, Minnesota, United States
  • 2009
    • National University (California)
      San Diego, California, United States
  • 2008
    • CSU Mentor
      Long Beach, California, United States
    • Goethe-Universität Frankfurt am Main
      Frankfurt, Hesse, Germany
  • 2007
    • University of California, San Francisco
      San Francisco, California, United States
  • 2006
    • University of San Diego
      San Diego, California, United States
  • 2004
    • Stanford University
      • Division of Immunology
      Palo Alto, California, United States
  • 1991–2004
    • University of Texas Southwestern Medical Center
      • • Division of Rheumatic Diseases
      • • Department of Internal Medicine
      Dallas, Texas, United States
  • 1994–1998
    • University of Texas at Dallas
      Richardson, Texas, United States