LOCALLY AVAILABLE BIOLOGIC AGENTS IN THE TREATMENT OF PSORIATIC ARTHRITIS
|
|
- Dale Hood
- 5 years ago
- Views:
Transcription
1 Locally Available Biologic Agents in the Treatment of Psoriatic Arthritis 253 Phil. J. Internal Medicine, 47: , Nov.-Dec., 2009 LOCALLY AVAILABLE BIOLOGIC AGENTS IN THE TREATMENT OF PSORIATIC ARTHRITIS Sidney Erwin T. Manahan, M.D. and Bernadette Heizel D. Reyes, M.D. ABSTRACT Introduction: Traditional studies on psoriatic arthritis have evaluated the response to treatment in terms of the rheumatic condition excluding the dermatologic condition. Treatment of the disease with biologic agents has been demonstrated to be effective in the control of both the arthritis and skin condition. Objective: To systematically review the efficacy of locally available biologic agents (etanercept and infliximab) in the treatment of rheumatic and dermatologic manifestations of psoriatic arthritis. Search Strategy: A MEDLINE search (from 1966 to June 2007) was performed using the following search terms: biologic agents, infliximab, etanercept, psoriasis, psoriatic arthritis and randomized clinical trials. Likewise, the Cochrane Database was also searched for existing studies on psoriatic arthritis. This was supplemented by citation tracking of published bibliographies and conference proceedings. Selection Criteria: All randomized clinical trials evaluating the efficacy of etanercept and infliximab in Adult patients with active Psoriatic arthritis were included. Outcome assessments should include evaluation of both arthritic and dermatologic manifestations of the disease. These could be in the form of Psoriatic Arthritis Response Criteria (PsARC), American College of Rheumatology (ACR) Response Criteria (20, 50, and 70) and the Psoriatic Arthritis Severity Index (PASI) 75. Main Results: Nine studies were identified using the search strategy previously outlined. Of these, the four main clinical trials involving 569 patients were included in the quantitative analysis. Studies publishing the results of post hoc analysis were excluded if they did not assess for joint and dermatologic efficacy. Reprint request to: Sidney Erwin T. Manahan, M.D., Section of Rheumatology, Department of Medicine, UP-PGH Medical Center, Taft Ave., Manila, Philippines Quantitative analysis showed that patients treated with biologic agents were more likely to experience improvement in arthritic complaints compared to placebo [PsARC RR 0.32 favoring treatment 95% CI ( ) P<0.0001] [ACR 20 RR 0.20 favoring treatment 95%CI ( ) P< ] and were more likely to experience improvement in skin lesions [PASI 75 RR 0.06 favoring treatment 95% CI ( ) P< ]. However, adverse events tended to occur more frequently in the biologics-treated patients mostly in the form of infusion/injection-related reactions [RR % CI ( ) P 0.17] AuthorÊs Conclusion: Infliximab and Etanercept are both effective in treating psoriasis and psoriatic arthritis. INTRODUCTION Psoriatic arthritis is a chronic inflammatory condition that occurs among patients with psoriasis. Prevalence data varies depending on the population studied and the criteria used and is estimated to be percent in the general population. Among patients with arthritis, prevalence of psoriasis ranges from 2.6 to 7.0 percent. Prevalence increases among psoriasis patients, ranging from 7 to 42 percent. Despite various arguments against psoriatic arthritis being a distinct clinical entity, its clinical features differentiate it from the other arthritides. Unlike osteoarthritis, it is inflammatory in nature and tends to affect both proximal and distal joints of the hands. As opposed to rheumatoid arthritis, there is the lack of gender preference, absence of rheumatoid factor and the presence of spondyloarthropathy and a tendency for asymmetry. Furthermore, radiographic findings in psoriatic arthritis such as pencil-incup deformity, osteolysis, joint space widening, juxtaarticular periostitis and tuft resorption make it unique among the inflammatory joint diseases. Treatment of psoriatic arthritis is directed at controlling the inflammatory process. While no clear pathogenic relationship exists between the joint and skin inflammation, articular and dermatologic manifestations need to be treated simultaneously. Initial therapy consists of anti-inflammatory agents for the articular complaints and topical therapies 253
2 254 Manahan SE T and Reyes BH D for psoriasis. Patients who do not improve or worsen following initial therapy are candidates for disease modifiying anti-rheumatic drugs (DMARDs). Available agents include gold salts, anti-malarial agents, azathioprine, sulfasalazine and methotrexate. Of these, methotrexate is the standard drug treatment due to its efficacy for both articular and dermatologic manifestations of psoriatic arthritis. The meta-analysis by Jones, Crotty and Brooks (Cochrane 2000) concluded that intravenous methotrexate and sulfasalazine are effective therapies for psoriatic arthritis and based on articular assessments- joint counts, acute phase reactants, pain and global assessment of disease activity, with no reference to effects on skin psoriasis. Traditional studies have monitored patient response in terms of the rheumatic condition mainly clinical assessment of joint inflammation and damage as well as radiographic evaluations. Composite indices used to monitor patients for treatment response, such as the Psoriatic Arthritis Response Criteria (PsARC) and the American College of Rheumatology Response Criteria (ACR-N) are primarily based on joint parameters. Responses to DMARDs are extrapolated from trials involving patients with psoriasis, not necessarily manifesting with joint problems. With the entry of biologic response modifiers, also known as biologic agents or biologics, into the treatment of psoriatic arthritis, both skin and joint manifestations are measured simultaneously in clinical trials. Their use in the management of psoriatic arthritis has been the focus of much interest in the recent years. OBJECTIVE The systematic review aims to evaluate the safety and efficacy of the locally available biologic agents - infliximab (INF) and etanercept (ETN) in the treatment of articular and dermatologic manifestations of psoriatic arthritis. Criteria for Considering Studies for this Review Types of Studies For inclusion in the meta-analysis, randomized clinical trials with at least two treatment groups were included. Concomitant therapy with methotrexate, the standard drug used in the treatment of psoriatic arthritis, should be permitted in the treatment groups. Types of Patients Trials were included if patients enrolled were clinically diagnosed with active psoriatic arthritis and at least 18 years of age. Types of Interventions Studies comparing infliximab and etanercept were included in the meta-analysis. Types of Outcomes Measured Included trials assessed outcome measures for both psoriasis and psoriatic arthritis. Assessment of the rheumatic condition were in the form of any of the composite outcome measures used in previous psoriatic arthritis studies Psoriatic Arthritis Response Criteria (PsARC), American College of Rheumatology Response Criteria (ACR 20, ACR 50 or ACR 70). The Psoriatic Arthritis Response Criteria (PsARC), developed as an outcome measure for research includes four measurements of the articular component of the disease the swollen joint count (SJC), the tender joint count (TJC), physician global assessment of disease activity and patient global assessment of disease activity. The American College of Rheumatology Response Criteria (ACR- N) which was originally developed for trials on Rheumatoid Arthritis but its use has been extended to evaluation of other inflammatory arthritides consists of improvement in the SJC, the TJC, pain, disability as evaluated by health assessment questionnaires, acute phase reactants, physician global assessment of disease activity and patient global assessment of disease activity. Measurements for psoriasis were in the form of the Psoriasis Area and Severity Index (PASI 75) - which is the proportion of patients achieving a 75 percent improvement in psoriasis activity from baseline and assessments of prospectively identified skin lesions (target lesion evaluation, dermatologistês static global assessment of target lesions -percent clear or almost clear). Search Method for Identification of Studies A MEDLINE Search was performed to identify randomized placebo controlled clinical trials or systematic reviews on the efficacy of infliximab and etanercept in the treatment of psoriatic arthritis from This was supplemented by citation tracking in published bibliographies and conference proceedings. The Cochrane Database of Systematic
3 Locally Available Biologic Agents in the Treatment of Psoriatic Arthritis 255 Reviews was likewise searched for existing studies on biologic agents and psoriatic arthritis. The following terms were used in the literature search: biologic agents, etanercept, infliximab, psoriasis, psoriatic arthritis, randomized controlled trials. RESULTS Nine journal articles were identified. Of these, five were excluded: four published results of post-hoc analysis of the main studies presenting outcomes measures other than arthritis response criteria and dermatologic improvement and one study by Ritchlin, C (2006) could not be retrieved. [Table 1] The studies included in the meta-analysis were 4 randomized controlled clinical trials IMPACT 1, IMPACT 2, Mease 2000 and Mease 2004 which had a total of 569 patients randomized to receive either placebo or biologic agents. Table I. Characteristics of Included Trials Methods Participants Intervention Outcomes IMPACT 1 Randomized 104 patients Infliximab 1. ACR 20, 50 Double Blind with active PsA 5mg/kg IV vs and 70 at Placebo who had failed Placebo at week 16 Controlled at least weeks 2. PASI75 at Trial 1 DMARD O, 2, 6, 14 week PsARC at week DAS28 IMPACT 2 Randomized 200 adult Infliximab 1. ACR 20, 50 Double Blind patients with 5mg/kg IV vs and 70 at Placebo active PsA Placebo at week 24 Controlled weeks 2. PsARC at Trial O, 2, 6, 22 week PASI75 at week 24 Mease 2000 Randomized 60 adult Etanercept 1. PsARC at Double Blind patients with 25mg sc week 12 Placebo active PsA 2x/week vs 2. ACR 20, 50 Controlled Placebo sc and 70 at Trial for 12 weeks week PASI75 at week 12 Mease 2004 Randomized 205 adult Etanercept 1. ACR 20, 50 Double Blind patients with 25mg sc and 70 at Placebo active PsA 2x/week vs week 24 Controlled Placebo sc 2. PsARC at Trial for 24 weeks week PASI75 at week 24 The quality of the studies were evaluated independently by three assessors (SETM, BHMR and JOG) using the Quality Scale for Meta-analytic reviews provided by the UP-PGH Department of Medicine. IMPACT1 and IMPACT2 were evaluated to be good-quality studies by all three assessors. While the two trials by Mease, et al were assessed to be studies of fair quality (Table 2). Table II. Quality Assessment of Included Trials Selection Performance Exclusion Detection Over-all IMPACT 1 A A A A A IMPACT 2 A A A A A Mease 2000 B A A A B Mease 2004 B A A A B Table III. Summary of Comparisons Between Treatment and Placebo Groups Comparisons Studies Participants Statistical method Effect size or outcome 01 PsARC RR (fixed), 95% CI 3.06[2.44, 3.85] 02 PASI RR (fixed), 95% CI 17.69[7.88,39.70] 03 ACR RR (fixed), 95% CI 4.96[3.59,6.86] 04 ACR RR (fixed), 95% CI 16.78[6.62,42.49] 05 ACR RR (fixed), 95% CI 17.50[4.27,71.73] 06 Serious AE RR (fixed), 95% CI 0.84[0.43,1.65] 07 Adverse RR (fixed), 95% CI 1.37[1.07,1.76] Events All studies recruited adult patients (Aged years) who were clinically diagnosed with Psoriatic Arthritis and assessed to have active disease. For the studies by Mease, disease activity was determined by the presence of > 3 swollen and > 3 tender joints at the time of study enrolment. While IMPACT used a different set of criteria - at least five swollen and five tender joints and at least one of the following parameters: CRP > 15 mg/l, ESR > 28 mm/hr or morning stiffness lasting at least 45 minutes before maximal improvement. Among the patients included by the above criteria, only patients with at least a baseline PASI score of 2.5 were included in the evaluation of dermatologic response to biologic agents. Methotrexate was allowed as concomitant disease modifying anti-rheumatic drug (DMARD) in all four trials. Other DMARDs were discontinued at least four weeks before the start of the study in the studies by Mease. DMARDs other than methotrexate such as leflunomide, sulfasalazine, hydroxychloroquine, penicillamine and azathioprine
4 256 Manahan SE T and Reyes BH D were allowed in IMPACT 1 and IMPACT 2. Stable doses of corticosteroids were allowed in all four trials. Treatments for psoriasis (oral retinoids, topical vitamin A or D analog preparations and anthralin) were not allowed. However, topical therapies were permitted on the scalp, axillae and groin only as this did not affect PASI evaluation. Both studies by Mease involved the administration of ETN 25 mg subcutaneously twice weekly given for 12 or 24 weeks. INF was given at a dose of 5 mg/kg body weight at weeks 0, 2, 6 and every 8 weeks thereafter for 16 or 24 weeks. Efficacy of Biologic Agents on the Rheumatic Disease For all outcome measures, treatment with biologic agents was more effective than placebo in treating psoriatic arthritis. Patients receiving biologic agents were three times more likely to achieve the Psoriatic Arthritis Response Criteria [RR % CI (2.44, 3.85) p-value < ] which was developed specifically for evaluation of treatment response among psoriatic arthritis patients. (Comparison 01 Outcome 01). This resulted in a number needed to treat (NNT) of 2. The proportion of patients achieving the PsARC in the studies for INF and ETN were comparable (Figure 1). More patients receiving biologic treatment achieved ACR 20 (Figure 2) at the end of the study period [RR 4.96% CI (3.59, 6.86) p-value< ]. (Comparison 01 Outcome 03) Similarly, more patients in treatment groups for infliximab and etanercept achieved ACR 50 and ACR 70 (Figure 3) responses [ACR 50 RR % CI (6.62, 42.49) p-value< ] [ACR 70 RR % CI (4.27, 71.73) p-value< ] (Outcomes 04 and 05). The trend favoring treatment with biologics was seen in both groups receiving INF and ETN. These translated to number needed to treat (NNT) of 2 (95% CI 2,2) to achieve an ACR 20 response, 3 (95% CI 2,3) to achieve an ACR 50 response, and 6 (95% CI 4,8) to achieve an ACR 70 response. Efficacy of Biologic Agents on Psoriasis Only the PASI 75 was consistently reported in all four clinical trials. The proportion of patients achieving a 75 percent improvement in skin lesions was 17 times more likely to be treated with biologic agents compared to placebo [PASI 75 RR % CI (7.88, 39.70) p-value < ]. (Comparison 01 Outcome 02). This translated to a number needed to treat (NNT) of 2 (95% CI 2,3). Adverse Events Patients treated with the biologic agents experienced 37 percent more adverse events compared to the placebo groups [RR % CI (1.08, 1.93) p-value 0.01][Number needed to harm NNH 27 (95% CI 14,200)]. Serious adverse events tended to occur more in the biologics-treated patients. However, the difference did not reach statistical significance [RR % CI (0.43, 1.65) p-value 0.61][Number needed to harm NNH 74 (95% CI 20, 45). Contrary to what was expected, infections were more common in the placebo groups but was not significantly greater than the biologics group. The only significant adverse event reported among biologic treated patients was the occurrence of infusion and injection-related reactions. Other events such as flu-like syndrome and ecchymosis did not show any significant differences in the study groups. Fig. 1. Outcome of Treatment Measured by PsARC
5 Locally Available Biologic Agents in the Treatment of Psoriatic Arthritis 257 Fig. 2. Outcome of Treatment Measured by ACR 20 Fig. 2. Outcome of Treatment Measured by ACR 20
6 258 Manahan SE T and Reyes BH D Fig. 4. Adverse Events
7 Locally Available Biologic Agents in the Treatment of Psoriatic Arthritis 259 CONCLUSIONS Locally available biologic agents are effective in the treatment of both psoriasis and psoriatic arthritis. Articular and cutaneous manifestations improved similarly among patients treated with INF and ETN. Adverse events occurred more frequently among biologics-treated patients, mostly related to the drug administration. The difference in the frequency of serious adverse events between groups did not reach statistical significance. REFERENCES 1. Gladman DG, Rahman P: Psoriatic Arthritis in KelleyÊs Textbook of Rheumatology, 6 th ed. Volume II: pp Ruddy S, Harris ED and Sledge CB-eds. W.B. Saunders Company, Philadelphia, Cuellar ML, Espinoza LR: Psoriatic Arthritis: Management in Rheumatology, 3 rd ed. Volume II; pp Hochberg MC, et al-eds. Elsevier Science, Spain, Bruce IN: Psoriatic Arthritis: Clinical features in Rheumatology, 3 rd ed. Volume II; pp Hochberg MC, et al-eds. Elsevier Science, Spain, Antoni C: Psoriatic Arthritis: Etiology and Pathogenesis in Rheumatology, 3 rd ed. Volume II; pp Hochberg MC, et al-eds. Elsevier Science, Spain, Jones G, Crotty M, Brooks P: Interventions for Treating Psoriatic Arthritis. Cochrane Database of Systematic Reviews 2000, Issue 3. Art. No.: CD DOI: / CD Antoni CE, Kavanaugh A, et al.: Sustained Benefits of Infliximab Therapy for Dermatologic and Articular Manifestations of Psoriatic Arthritis: Results from the Infliximab Multinational Psoriatic Arthritis Controlled Trial (IMPACT). Arthritis and Rheum; 52(4):1227, April Kavanaugh A, Krueger GG, et al.: Infliximab Maintains A High Degree of Clinical Response in Patients with Active Psoriatic Arthritis Through 1 yr of Treatment: Results from the IMPACT 2 Trial. Ann Rheum Dis; 66:498, Mease PJ, Goffe BS, et al.: Etanercept in the Treatment of Psoriatic Arthritis and Psoriasis: A Randomized Trial. Lancet; 356: Mease PJ, Kivitz AJ, et al.: Etanercept treatment of psoriatic arthritis: safety, efficacy and effect on disease progression. Arthritis and Rheum July 2004; 50(7):
Criteria Inclusion criteria Exclusion criteria. despite treatment with csdmards, NSAIDs, and/or previous anti-tnf therapy and/or
Supplementary Material Table S1 Eligibility criteria (PICOS) for the SLR Criteria Inclusion criteria Exclusion criteria Population Adults (aged 18 years) with active PsA despite treatment with csdmards,
More informationAnnual Rheumatology & Therapeutics Review for Organizations & Societies
Annual Rheumatology & Therapeutics Review for Organizations & Societies Comparative Effectiveness Studies of Biologics Learning Objectives Understand the motivation for comparative effectiveness research
More informationRheumatology journal club October 20, 2017 Presented by: Matthew Stoll MD,PhD,PSCS
Efficacy and safety of abatacept, a T-cell modulator, in a randomised, double-blind, placebo-controlled, phase III study in psoriatic arthritis (Mease et al., 2017) Rheumatology journal club October 20,
More informationUstekinumab (Stelara) for psoriatic arthritis second line after disease modifying anti rheumatic drugs (DMARDs)
Ustekinumab (Stelara) for psoriatic arthritis second line after disease modifying anti rheumatic drugs (DMARDs) January 2010 This technology summary is based on information available at the time of research
More informationTRANSPARENCY COMMITTEE OPINION. 26 April 2006
TRANSPARENCY COMMITTEE OPINION 26 April 2006 REMICADE 100 mg powder for concentrate for solution for infusion Box of 1 (CIP code: 562 070.1) Applicant : laboratoires Schering Plough List I Drug for hospital
More informationLondon, 1 June 2006 Product name: REMICADE Procedure number: Remicade-H-240-II-73-AR SCIENTIFIC DISCUSSION 1/8
London, 1 June 2006 Product name: REMICADE Procedure number: Remicade-H-240-II-73-AR SCIENTIFIC DISCUSSION 1/8 1. Introduction Infliximab is a chimeric human-murine IgG1κ monoclonal antibody, which binds
More informationTreatment of psoria.c arthri.s: Guidelines and beyond. Pascal RICHETTE Hôpital Lariboisière, Paris
Treatment of psoria.c arthri.s: Guidelines and beyond Pascal RICHETTE Hôpital Lariboisière, Paris The pa.ent: a 37 year- old man, with a history of psoriasis for 10 years Past history: - Dyslipidemia Current
More informationCertolizumab pegol (Cimzia) for psoriatic arthritis second line
Certolizumab pegol (Cimzia) for psoriatic arthritis second line This technology summary is based on information available at the time of research and a limited literature search. It is not intended to
More informationCanadian Society of Internal Medicine Annual Meeting 2016 Montreal, QC
Canadian Society of Internal Medicine Annual Meeting 2016 Montreal, QC Update on the Treatment of Rheumatoid Arthritis Sabrina Fallavollita MDCM McGill University Canadian Society of Internal Medicine
More informationNew Evidence reports on presentations given at EULAR Tocilizumab for the Treatment of Rheumatoid Arthritis
New Evidence reports on presentations given at EULAR 2012 Tocilizumab for the Treatment of Rheumatoid Arthritis Report on EULAR 2012 presentations Tocilizumab monotherapy is superior to adalimumab monotherapy
More informationNew Evidence reports on presentations given at EULAR Safety and Efficacy of Tocilizumab as Monotherapy and in Combination with Methotrexate
New Evidence reports on presentations given at EULAR 2009 Safety and Efficacy of Tocilizumab as Monotherapy and in Combination with Methotrexate Report on EULAR 2009 presentations Tocilizumab inhibits
More informationHorizon Scanning Centre November Secukinumab for active and progressive psoriatic arthritis. SUMMARY NIHR HSC ID: 5330
Horizon Scanning Centre November 2012 Secukinumab for active and progressive psoriatic arthritis. SUMMARY NIHR HSC ID: 5330 Secukinumab is a high-affinity fully human monoclonal antibody that antagonises
More informationUniversity of California, San Diego, School of Medicine, La Jolla, CA, USA; 2
2194 Long-term (104-Week) Efficacy and Safety Profile of Apremilast, an Oral Phosphodiesterase 4 Inhibitor, in Patients With Psoriatic Arthritis: Results From a Phase III, Randomized, Controlled Trial
More informationETANERCEPT Generic Brand HICL GCN Exception/Other ETANERCEPT ENBREL GUIDELINES FOR USE INITIAL CRITERIA (NOTE: FOR RENEWAL CRITERIA SEE BELOW)
Generic Brand HICL GCN Exception/Other ETANERCEPT ENBREL 18830 GUIDELINES FOR USE INITIAL CRITERIA (NOTE: FOR RENEWAL CRITERIA SEE BELOW) 1. Does the patient have a diagnosis of moderate to severe rheumatoid
More informationHorizon Scanning Centre January Apremilast for psoriatic arthritis SUMMARY NIHR HSC ID: 3716
Horizon Scanning Centre January 2013 Apremilast for psoriatic arthritis SUMMARY NIHR HSC ID: 3716 This briefing is based on information available at the time of research and a limited literature search.
More informationAppendix 1: Frequently Asked Questions
Appendix 1: Frequently Asked Questions 1. What is the funding status of Inflectra (infliximab)? Effective February 25 2016, Inflectra (infliximab) will be added to the Ontario Drug Benefit (ODB) Formulary
More informationAbatacept (Orencia) for active rheumatoid arthritis. August 2009
Abatacept (Orencia) for active rheumatoid arthritis August 2009 This technology summary is based on information available at the time of research and a limited literature search. It is not intended to
More informationPsoriasis, Incidence, Quality of Life, Psoriatic Arthritis, Prevalence
1.0 Abstract Title Prevalence and Incidence of Articular Symptoms and Signs Related to Psoriatic Arthritis in Patients with Psoriasis Severe or Moderate with Adalimumab Treatment (TOGETHER). Keywords Psoriasis,
More informationPublic observer slides
Public observer slides Lead team presentation Certolizumab pegol and secukinumab for treating active psoriatic arthritis following inadequate response to disease modifying antirheumatic drugs Multiple
More informationOntario Public Drug Programs. Inflectra (infliximab) Frequently Asked Questions
Ontario Public Drug Programs Inflectra (infliximab) Frequently Asked Questions 1. What is the funding status of Inflectra (infliximab)? Effective February 25 2016, Inflectra (infliximab) will be added
More informationSynopsis (C0743T10) CNTO 1275 Module 5.3 C0743T10. Associated with Module 5.3 of the Dossier
Module 5.3 Protocol: EudraCT No.: 2005-003525-92 Title of the study: A Phase 2, Multicenter, Randomized, Double-blind, Placebo-controlled Trial of, a Fully Human Anti-IL-12 Monoclonal Antibody, Administered
More informationTo help you with terms and abbreviations used in this document that may be unfamiliar to you, a glossary is provided on the last pages.
ARTHRITIS CONSUMER EXPERTS 910B RICHARDS STREET VANCOUVER BC V6B 3C1 CANADA T: 604.974-1366 F: 604.974-1377 WWW.ARTHRITISCONSUMEREXPERTS.ORG Arthritis Consumer Experts In Health Care and Research Decision-making
More informationIs Methotrexate A Disease Modifying Agent In Psoriatic Arthritis?
Disclosure Statement Is Methotrexate A Disease Modifying Agent In Psoriatic Arthritis? Gabrielle H Kingsley Consultant and Reader in Rheumatology King s College London Lewisham Healthcare NHS Trust Dr
More informationWhat is Cosentyx (secukinumab)?
What is Cosentyx (secukinumab)? Cosentyx is the first of a new class of medicines called interleukin- 17A (IL- 17A) inhibitors to be approved for the treatment of moderate- to- severe plaque psoriasis,
More informationIncorporating Biologics Into Your Practice
Incorporating Biologics Into Your Practice Jeffrey M. Sobell MD Tufts University School of Medicine SkinCare Physicians Ora Clinical Research Disclosure Of Relationships With Industry Amgen AbbVie Celgene
More informationSubject: Remicade (Page 1 of 5)
Subject: Remicade (Page 1 of 5) Objective: I. To ensure that Health Share/Tuality Health Alliance (THA) has a process by which the appropriate utilization of Remicade (Infliximab) for members whose diagnosis
More informationTreatment of Rheumatoid Arthritis: The Past, the Present and the Future
Treatment of Rheumatoid Arthritis: The Past, the Present and the Future Lai-Ling Winchow FCP(SA) Cert Rheum(SA) Chris Hani Baragwanath Academic Hospital University of the Witwatersrand Outline of presentation
More informationSYNOPSIS. Issue Date: 17 Jan 2013
STELARA (ustekinumab) Clinical Study Report CNTO1275PSA3002 24-Week CSR SYNOPSIS Issue Date: 17 Jan 2013 Name of Sponsor/Company Name of Finished Product Name of Active Ingredient(s) Janssen Research &
More informationNICE DECISION SUPPORT UNIT
SEQUENTIAL TNF-α INHIBITORS AND NON BIOLOGIC DMARDS ANALYSIS OF THE NATIONAL DATABANK FOR RHEUMATIC DISEASES. NICE DECISION SUPPORT UNIT Allan Wailoo School of Health and Related Research, University of
More informationBRIEFING DOCUMENT. human, recombinant fusion protein: extracellular domain of CTLA-4 and Fc domain of human IgG1
BRIEFING DOCUMENT Application Type BLA Submission Number 125118/0 Reviewer Name Team Leader Division Director Established Name (Proposed) Trade Name Applicant Formulation Dosing Regimen Indication Intended
More informationEfficacy and Safety of Tocilizumab in the Treatment of Rheumatoid Arthritis and Juvenile Idiopathic Arthritis
New Evidence reports on presentations given at EULAR 2010 Efficacy and Safety of Tocilizumab in the Treatment of Rheumatoid Arthritis and Juvenile Idiopathic Arthritis Report on EULAR 2010 presentations
More informationNEW ZEALAND DATA SHEET
NEW ZEALAND DATA SHEET SIMPONI Solution for Injection in a pre-filled syringe Solution for Injection in a pre-filled pen, SmartJect NAME OF MEDICINE SIMPONI Solution for Injection in a pre-filled syringe
More informationClinical Policy: Etanercept (Enbrel) Reference Number: PA.CP.PHAR.250 Effective Date: 01/18 Last Review Date: 08/17 Line of Business: Medicaid
Clinical Policy: (Enbrel) Reference Number: PA.CP.PHAR.250 Effective Date: 01/18 Last Review Date: 08/17 Line of Business: Medicaid Coding Implications Revision Log Description (Enbrel ) is tumor necrosis
More informationDrug Class Review on Targeted Immune Modulators
Drug Class Review on Targeted Immune Modulators Final Report Update 1 Evidence Tables January 2007 Original Report Date: December 2005 A literature scan of this topic is done periodically The purpose of
More informationNew Evidence reports on presentations given at ACR Improving Radiographic, Clinical, and Patient-Reported Outcomes with Rituximab
New Evidence reports on presentations given at ACR 2009 Improving Radiographic, Clinical, and Patient-Reported Outcomes with Rituximab From ACR 2009: Rituximab Rituximab in combination with methotrexate
More information1 P a g e. Systemic Juvenile Idiopathic Arthritis (SJIA) (1.3) Patients 2 years of age and older with active systemic juvenile idiopathic arthritis.
LENGTH OF AUTHORIZATION: Initial: 3 months for Crohn s or Ulcerative Colitis; 1 year for all other indications. Renewal: 1 year dependent upon medical records supporting response to therapy and review
More informationGolimumab: a novel anti-tumor necrosis factor
Golimumab: a novel anti-tumor necrosis factor Rossini M, De Vita S, Ferri C, et al. Biol Ther. 2013. This slide deck represents the opinions of the authors, and not necessarily the opinions of the publisher
More informationADALIMUMAB Generic Brand HICL GCN Exception/Other ADALIMUMAB HUMIRA GUIDELINES FOR USE INITIAL CRITERIA (NOTE: FOR RENEWAL CRITERIA SEE BELOW)
Generic Brand HICL GCN Exception/Other ADALIMUMAB HUMIRA 24800 GUIDELINES FOR USE INITIAL CRITERIA (NOTE: FOR RENEWAL CRITERIA SEE BELOW) 1. Does the patient have a diagnosis of moderate to severe rheumatoid
More informationInflectra Frequently Asked Questions
Inflectra Frequently Asked Questions 1. What is the funding status of Inflectra (infliximab)? Earlier in 2016, Inflectra (infliximab) was added to the Ontario Drug Benefit (ODB) Formulary as a Limited
More informationGender differences in effectiveness of treatment in rheumatic diseases
Gender differences in effectiveness of treatment in rheumatic diseases Irene van der Horst-Bruinsma Associate Professor Rheumatology Center of Excellence of Axial Spondyloarthritis ARC/VU University Medical
More informationNew Evidence reports on presentations given at EULAR Tocilizumab for the Treatment of Rheumatoid Arthritis and Juvenile Idiopathic Arthritis
New Evidence reports on presentations given at EULAR 2011 Tocilizumab for the Treatment of Rheumatoid Arthritis and Juvenile Idiopathic Arthritis Report on EULAR 2011 presentations Benefit of continuing
More informationAPC/DTC Briefing Document
Page 1 London New Drugs Group APC/DTC Briefing Document GOLIMUMAB Contents Summary 1 Background 5 Guidelines 5 Dosing information 5 Drug interactions 6 Clinical studies 6 Ankylosing spondylitis 6 Psoriatic
More informationapremilast 10mg, 20mg, 30mg tablets (Otezla ) SMC No. (1053/15) Celgene Ltd.
apremilast 10mg, 20mg, 30mg tablets (Otezla ) SMC No. (1053/15) Celgene Ltd. 08 May 2015 The Scottish Medicines Consortium (SMC) has completed its assessment of the above product and advises NHS Boards
More informationUsing ENBREL to Treat Rheumatoid and Psoriatic Arthritis
Using ENBREL to Treat Rheumatoid and Psoriatic Arthritis Writing White Papers class Bellevue Community College TABLE OF CONTENTS TABLE OF CONTENTS...2 OVERVIEW...3 RHEUMATOID ARTHRITIS... 3 JUVENILE RHEUMATOID
More informationBiologic Therapies for Psoriasis. A Systematic Review
Biologic Therapies for Psoriasis. A Systematic Review WOLF-HENNING BOEHNCKE, JÖRG PRINZ, and ALICE B. GOTTLIEB ABSTRACT. Alefacept, efalizumab, etanercept, and infliximab are currently approved for the
More informationOpinion 1 October 2014
The legally binding text is the original French version TRANSPARENCY COMMITTEE Opinion 1 October 2014 CIMZIA 200 mg, solution for subcutaneous injection 1 B/2 1 ml prefilled syringes with needle guard
More informationRequest for Special Authorization Enbrel
Certain prescription drugs call for a more detailed assessment to help ensure that they represent reasonable treatment. Special Authorization requires that you request approval from Great-West Life for
More informationPatient #1. Rheumatoid Arthritis. Rheumatoid Arthritis. 45 y/o female Morning stiffness in her joints >1 hour
Patient #1 Rheumatoid Arthritis Essentials For The Family Medicine Physician 45 y/o female Morning stiffness in her joints >1 hour Hands, Wrists, Knees, Ankles, Feet Polyarticular, symmetrical swelling
More informationDr. Lyubomir Marinchev Chief of Rheumatology Department, MHAT SOFIAMED, Sofia, Bulgaria
Dr. Lyubomir Marinchev Chief of Rheumatology Department, MHAT SOFIAMED, Sofia, Bulgaria Inter-Balkan meeting Open the frontiers and exchange of experiences, 27 th April 2013, Rhodes, Greece Patients with
More informationCOSENTYX (secukinumab)
COSENTYX (secukinumab) Non-Discrimination Statement and Multi-Language Interpreter Services information are located at the end of this document. Coverage for services, procedures, medical devices and drugs
More informationENBREL (Etanercept) 25 mg and 50 mg powder for injection and water for injections
PRODUCT INFORMATION ENBREL Etanercept (rch) NAME OF THE MEDICINE ENBREL (Etanercept) 25 mg and 50 mg powder for injection and water for injections ENBREL (Etanercept) 25 mg and 50 mg solution for injection
More informationThe Hospital for Sick Children Technology Assessment at SickKids (TASK)
The Hospital for Sick Children Technology Assessment at SickKids (TASK) THE USE OF BIOLOGIC RESPONSE MODIFIERS IN POLYARTICULAR-COURSE JUVENILE IDIOPATHIC ARTHRITIS Report No. 2010-01 Date: January 11,
More informationTechnology appraisal guidance Published: 25 August 2010 nice.org.uk/guidance/ta199
Etanercept, infliximab and adalimumab for the treatment of psoriatic arthritis Technology appraisal guidance Published: 25 August 2010 nice.org.uk/guidance/ta199 NICE 2018. All rights reserved. Subject
More informationPsoriatic Arthritis: New and Emergent Therapies
Psoriatic Arthritis: New and Emergent Therapies Alice Bendix Gottlieb MD, PhD Professor of Dermatology New York Medical College Metropolitan Hospital New York, NY, USA DISCLOSURE OF RELEVANT RELATIONSHIPS
More informationThis is a repository copy of Psoriasis flare with corticosteroid use in psoriatic arthritis.
This is a repository copy of Psoriasis flare with corticosteroid use in psoriatic arthritis. White Rose Research Online URL for this paper: http://eprints.whiterose.ac.uk/98736/ Version: Accepted Version
More informationNEW EFFECTIVE TREATMENTS FOR PSORIATIC ARTHRITIS PATIENTS Promising data to support two new drug classes
Annual European Congress of Rheumatology (EULAR) 2017 Madrid, Spain, 14-17 June 2017 NEW EFFECTIVE TREATMENTS FOR PSORIATIC ARTHRITIS PATIENTS Promising data to support two new drug classes Madrid, Spain,
More informationTechnology appraisal guidance Published: 4 June 2015 nice.org.uk/guidance/ta340
Ustekinumab for treating active psoriatic arthritis Technology appraisal guidance Published: 4 June 2015 nice.org.uk/guidance/ta340 NICE 2017. All rights reserved. Subject to Notice of rights (https://www.nice.org.uk/terms-and-conditions#notice-ofrights).
More informationBiologic therapy for Rheumatoid arthritis. Paul Etau Ekwom Physician and Rheumatologist
Biologic therapy for Rheumatoid arthritis Paul Etau Ekwom Physician and Rheumatologist Objectives Case presentation of patient with rheumatoid arthritis on a biologic therapy. Discuss biologic therapy
More informationClinical Policy: Etanercept (Enbrel) Reference Number: CP.PHAR.250 Effective Date: 08/16 Last Review Date: 08/17 Line of Business: Medicaid
Clinical Policy: (Enbrel) Reference Number: CP.PHAR.250 Effective Date: 08/16 Last Review Date: 08/17 Line of Business: Medicaid Coding Implications Revision Log See Important Reminder at the end of this
More informationABSTRACT. Keywords: Africa; Efficacy; Etanercept; Maintenance therapy; Middle East; Rheumatoid arthritis ORIGINAL RESEARCH
Rheumatol Ther (2018) 5:149 158 https://doi.org/10.1007/s40744-018-0094-6 ORIGINAL RESEARCH Maintenance of Remission with Etanercept DMARD Combination Therapy Compared with DMARDs Alone in African and
More informationAdrenocorticotropic hormone gel in patients with refractory rheumatoid arthritis: a case series
International Journal of Clinical Rheumatology For reprint orders, please contact: reprints@futuremedicine.com Adrenocorticotropic hormone gel in patients with refractory rheumatoid arthritis: a case series
More informationPRODUCT INFORMATION HUMIRA
NAME OF THE MEDICINE Adalimumab (rch) DESCRIPTION PRODUCT INFORMATION HUMIRA (adalimumab) is a recombinant human immunoglobulin (IgG1) monoclonal antibody containing only human peptide sequences. was created
More information1. Background: Infliximab is administered parenterally; therefore, it is not covered under retail pharmacy benefits.
Subject: Infliximab (Remicade ) Original Original Committee Approval: October 13, 2006 Revised Last Committee Approval: December 3, 2008 Last Review: October 19, 2007 1. Background: Infliximab is a genetically
More informationRemicade (Infliximab)
Remicade (Infliximab) Policy Number: Original Effective Date: MM.04.016 11/18/2003 Line(s) of Business: Current Effective Date: HMO; PPO; QUEST Integration 07/26/2013 Section: Prescription Drugs Place(s)
More informationCigna Drug and Biologic Coverage Policy
Cigna Drug and Biologic Coverage Policy Subject Apremilast Table of Contents Coverage Policy... 1 General Background... 2 Coding/Billing Information... 4 References... 4 Effective Date... 1/1/2018 Next
More informationMedication Policy Manual. Topic: Otezla, apremilast Date of Origin: May 9, 2014
Medication Policy Manual Policy No: dru342 Topic: Otezla, apremilast Date of Origin: May 9, 2014 Committee Approval Date: January 19, 2015 Next Review Date: January 2016 Effective Date: April 1, 2015 IMPORTANT
More information24-Week CNTO1275PSA3001 Clinical Study Report
24-Week CNTO1275PSA3001 Clinical Study Report SYNOPSIS Issue Date: 17 Jan 2013 Name of Sponsor/Company Name of Finished Product Name of Active Ingredient(s) Janssen Research & Development, Inc Ustekinumab
More information2017 Blue Cross and Blue Shield of Louisiana
Applies to all products administered or underwritten by Blue Cross and Blue Shield of Louisiana and its subsidiary, HMO Louisiana, Inc.(collectively referred to as the Company ), unless otherwise provided
More informationA. Kopchev, S.Monov, D. Kyurkchiev, I.Ivanova, T. Georgiev (UMHAT St. Ivan Rilski, Medical University - Sofia, Bulgaria)
International Journal of Pharmaceutical Science Invention ISSN (Online): 2319 6718, ISSN (Print): 2319 670X Volume 6 Issue 7 July 2017 PP. 08-12 Vascular endothelial growth factor (VEGF), cartilage oligomeric
More informationClinical Policy: Certolizumab (Cimzia) Reference Number: PA.CP.PHAR.247 Effective Date: 01/18 Last Review Date: 08/17 Line of Business: Medicaid
Clinical Policy: (Cimzia) Reference Number: PA.CP.PHAR.247 Effective Date: 01/18 Last Review Date: 08/17 Line of Business: Medicaid Coding Implications Revision Log Description (Cimzia ) is a tumor necrosis
More informationJames R. O Dell, M.D. University of Nebraska Medical Center
Not everyone in the world needs a biologic: Lessons from TEAR and RACAT James R. O Dell, M.D. University of Nebraska Medical Center Disclosure Declaration James O Dell, MD Advisory Board for Crescendo,
More informationCLINICAL MONOGRAPH FOR SIMPONI ARIA (golimumab)
CLINICAL MONOGRAPH FOR SIMPONI ARIA (golimumab) INDICATIONS SIMPONI ARIA is indicated for the treatment of adult patients with: Moderately to severely active rheumatoid arthritis (RA), in combination with
More informationRHEUMATOID ARTHRITIS DRUGS
Rheumatology Biologics Criteria from the Exceptional Access Program RHEUMATOID ARTHRITIS DRUGS DRUG NAME BRS REIMBURSED DOSAGE FORM/ STRENGTH Adalimumab Humira 40 mg/0.8 syringe and 40mg/0.8 pen for Anakinra
More informationEvidence-based Practice Center Systematic Review Protocol
Evidence-based Practice Center Systematic Review Protocol Project Title: Comparative Effectiveness of Drug Therapy for Psoriatic Arthritis in Adults Update Amendment Date(s) if applicable: (Amendments
More informationPharmacy Medical Necessity Guidelines: Stelara (ustekinumab)
Pharmacy Medical Necessity Guidelines: Effective: January 1, 2018 Type of Review Care Prior Authorization Required Management Not Covered Type of Review Clinical Review SQ: RX/ Pharmacy (RX) or Medical
More informationPractical RA Treatment: James R. O Dell, M.D. University of Nebraska Medical Center May 24, 2014
Practical RA Treatment: 2014 James R. O Dell, M.D. University of Nebraska Medical Center May 24, 2014 Disclosures James R. O Dell PI of Multinational RA trial supported by VA and NIH (NIAMS) that receives
More informationThe 73rd Annual Meeting of the American Academy of Dermatology, San Francisco ; March 20-24, 2015 Poster ID: 909
The 73rd Annual Meeting of the American Academy of Dermatology, San Francisco ; March 2-24, 215 Poster ID: 99 Clinical Efficacy and Safety of Brodalumab (KHK4827), Anti-Interleukin-17-Receptor A Fully
More informationCorporate Medical Policy
Corporate Medical Policy File Name: Origination: Last CAP Review: Next CAP Review: Last Review: abatacept_orencia 4/2008 2/2018 2/2019 2/2018 Description of Procedure or Service Abatacept (Orencia ), a
More informationPDF of Trial CTRI Website URL -
Clinical Trial Details (PDF Generation Date :- Sun, 20 Jan 2019 21:39:27 GMT) CTRI Number CTRI/2009/091/000777 [Registered on: 11/01/2010] - Last Modified On Post Graduate Thesis Type of Trial Type of
More informationCoverage Criteria: Express Scripts, Inc. monograph dated 12/15/ months or as otherwise noted by indication
BENEFIT DESCRIPTION AND LIMITATIONS OF COVERAGE ITEM: PRODUCT LINES: COVERED UNDER: DESCRIPTION: CPT/HCPCS Code: Company Supplying: Setting: Kineret (anakinra subcutaneous injection) Commercial HMO/PPO/CDHP
More informationPsoriatic arthritis (PsA) is a form of inflammatory
243 Psoriatic Arthritis Treatment Update Philip J. Mease, M.D. Psoriatic arthritis (PsA) is a form of inflammatory arthritis that occurs in approximately 10% to 30% of individuals with psoriasis, depending
More informationCDEC FINAL RECOMMENDATION
CDEC FINAL RECOMMENDATION TOFACITINIB (Xeljanz Pfizer Canada Inc.) Indication: Rheumatoid Arthritis Recommendation: The Canadian Drug Expert Committee (CDEC) recommends that tofacitinib be listed, in combination
More informationKey Words: Rheumatoid Arthritis, etanercept, post-marketing study, comparative study
CLINICAL DATA GAP BETWEEN PHASE III CLINICAL TRIALS (PRE-MARKETING) AND PHASE IV (POST-MARKETING) STUDIES: EVALUATION OF ETANERCEPT IN RHEUMATOID ARTHRITIS Pendar Farahani 1,3, Mitchell Levine 1,2, Kathryn
More informationEffective Health Care Program
Comparative Effectiveness Review Number 55 Effective Health Care Program Drug Therapy for Rheumatoid Arthritis in Adults: An Update Executive Summary Background Rheumatoid arthritis (RA), which affects
More informationSpondyloarthropathies: Disease Perception Limits Market
Spondyloarthropathies: Disease Perception Limits Market Psoriatic arthritis and ankylosing spondylitis form part of the group of diseases known as the spondyloarthropathies. Psoriatic arthritis is a form
More informationFigure 1. Study flow diagram. Reasons for withdrawal during the extension phase are included in the flow diagram. 508 patients enrolled and randomized
508 patients enrolled and randomized 126 assigned to sequential monotherapy (group 1) 121 assigned to step-up combination therapy (group 2) 133 assigned to initial combination therapy with prednisone (group
More informationNew Medicine Report. Anakinra Classification RED (Adopted by the CCG until review and further notice) Date of Last Revision 5 th July 2002
New Medicine Report Document Status Anakinra Classification RED (Adopted by the CCG until review and further notice) Post Suffolk D&TC Date of Last Revision 5 th July 2002 Approved Name Trade Name Manufacturer
More informationSwollen joint count in psoriatic arthritis is associated with progressive radiological damage in hands and feet
Swollen joint count in psoriatic arthritis is associated with progressive radiological damage in hands and feet P. Simon 1, C. Pföhler 2, R. Bergner 3, M. Schreiber 4, M. Pfreundschuh 1, G. Assmann 1 1
More information2.0 Synopsis. Adalimumab DE019 OLE (5-year) Clinical Study Report Amendment 1 R&D/06/095. (For National Authority Use Only)
2.0 Synopsis Abbott Laboratories Name of Study Drug: Humira Name of Active Ingredient: Adalimumab Individual Study Table Referring to Part of Dossier: Volume: Page: (For National Authority Use Only) Title
More informationThe Cosentyx clinical trial programme 1-11
The Cosentyx clinical trial programme 1-11 There are eight pivotal trials (four in psoriasis, two in psoriatic arthritis, two in ankylosing spondylitis) There are two head-to-head trials in psoriasis showing
More informationSTELARA DATA SHEET NAME OF THE MEDICINE DESCRIPTION V L C L V H C H 1 C H 2 C H 3. Fab. F(ab)' 2. hinge
DATA SHEET NAME OF THE MEDICINE Ustekinumab (rmc). CAS Registry Number: 815610-63-0. DESCRIPTION (ustekinumab) is a human IgG1kappa monoclonal antibody with an approximate molecular weight of 148,600 daltons.
More informationPsoriatic Arthritis- Second Line Treatments
Psoriatic Arthritis- Second Line Treatments Second line treatments for Psoriatic Arthritis (PsA) are usually prescribed by a Rheumatologist, Dermatologist, or in a combined clinic where both the Dermatologist
More informationSupplementary Material on Treating Spondyloarthropathies to Target A Systematic Literature Review Supporting Treatment Recommendations
Supplementary Material on Treating Spondyloarthropathies to Target A Systematic Literature Review Supporting Treatment Recommendations including Supplementary Tables S1 (Search terms) and S2 (Studies,
More informationLearning Objectives and Assessment Methodologies Combined Medicine-Pediatrics Rheumatology Elective
Learning Objectives and Assessment Methodologies Combined Medicine-Pediatrics Rheumatology Elective Overview: Med-Peds PGY2 s, PGY3 s and PGY4 s can elect to spend one four-week rotation with the adult
More informationHorizon Scanning Research & Intelligence Centre. Baricitinib for moderate to severe rheumatoid arthritis. May 2015 SUMMARY NIHR HSRIC ID: 5270
May 2015 Horizon Scanning Research & Intelligence Centre Baricitinib for moderate to severe rheumatoid arthritis SUMMARY NIHR HSRIC ID: 5270 This briefing is based on information available at the time
More informationintolerance to tumour necrosis
To cite: Nash P, Behrens F, Orbai A-M, et al. Ixekizumab is efficacious when used alone or when added to conventional synthetic diseasemodifying antirheumatic drugs (cdmards) in patients with active psoriatic
More informationEffective Health Care Program
Comparative Effectiveness Review Number 28 Effective Health Care Program Disease-Modifying Antirheumatic Drugs (DMARDs) in Children With Juvenile Idiopathic Arthritis (JIA) Executive Summary Background
More information