scholarly journals Safety of synthetic and biological DMARDs: a systematic literature review informing the 2013 update of the EULAR recommendations for management of rheumatoid arthritis

2014 ◽  
Vol 73 (3) ◽  
pp. 529-535 ◽  
Author(s):  
Sofia Ramiro ◽  
Cécile Gaujoux-Viala ◽  
Jackie L Nam ◽  
Josef S Smolen ◽  
Maya Buch ◽  
...  
Keyword(s):  
Rheumatoid Arthritis ◽  
Literature Review ◽  
Systematic Literature Review ◽  
Observational Studies ◽  
Certolizumab Pegol ◽  
Eligibility Criteria ◽  
Biological Dmards ◽  
Eular Recommendations ◽  
Increased Risk ◽  
Safety Outcomes

ObjectivesTo update the evidence for the safety of synthetic disease-modifying antirheumatic drugs (sDMARDs), glucocorticoids (GC) and biological DMARDs (bDMARDs) in patients with rheumatoid arthritis (RA) to inform the European League Against Rheumatism (EULAR) recommendations for the management of RA.MethodsSystematic literature review (SLR) of observational studies (including registries). Interventions were any bDMARD (anakinra, infliximab, etanercept, adalimumab, rituximab, abatacept, tocilizumab, golimumab or certolizumab pegol) or sDMARD (methotrexate, leflunomide, hydroxychloroquine, sulfasalazine, gold/auranofin, azathioprine, chlorambucil, chloroquine, cyclosporin, cyclophosphamide, mycophenolate, minocycline, penicillamine, tacrolimus or tofacitinib) and a comparator was required. Information on GCs was collected from the included studies. All safety outcomes were included.ResultsForty-nine observational studies addressing diverse safety outcomes of therapy with bDMARDs met eligibility criteria. Substantial heterogeneity precluded meta-analysis of any of the outcomes. Patients on tumour necrosis factor inhibitors (TNFi) compared to patients on conventional sDMARDs had a higher risk of serious infections (adjusted HR (aHR) 1.1–1.8), a higher risk of tuberculosis, and an increased risk of infection by herpes zoster cannot be excluded. Patients on TNFi did not have an increased risk for malignancies in general, lymphoma or non-melanoma skin cancer, but the risk of melanoma may be slightly increased (aHR 1.5). From the studies identified on conventional sDMARDs, no new safety signals were found.ConclusionsThe findings from this SLR confirm the known safety pattern of sDMARDs and bDMARDs for the treatment of RA.

scholarly journals Safety of synthetic and biological DMARDs: a systematic literature review informing the 2016 update of the EULAR recommendations for management of rheumatoid arthritis

2017 ◽  
Vol 76 (6) ◽  
pp. 1101-1136 ◽  
Author(s):  
Sofia Ramiro ◽  
Alexandre Sepriano ◽  
Katerina Chatzidionysiou ◽  
Jackie L Nam ◽  
Josef S Smolen ◽  
...  
Keyword(s):  
Rheumatoid Arthritis ◽  
Literature Review ◽  
Systematic Literature Review ◽  
Observational Studies ◽  
Meta Analysis ◽  
Risk Of Bias ◽  
Eligibility Criteria ◽  
Increased Risk ◽  
Serious Infections ◽  
Safety Outcomes

ObjectivesTo assess the safety of synthetic (s) and biological (b) disease-modifying antirheumatic drugs (DMARDs) for the management of rheumatoid arthritis (RA) to inform the European League Against Rheumatism recommendations for the management of RA.MethodsSystematic literature review (SLR) of observational studies comparing any DMARD with another intervention for the management of patients with RA. All safety outcomes were included. A comparator group was required for the study to be included. Risk of bias was assessed with the Hayden's tool.ResultsTwenty-six observational studies addressing diverse safety outcomes of therapy with bDMARDs met eligibility criteria (15 on serious infections, 4 on malignancies). Substantial heterogeneity precluded meta-analysis. Together with the evidence from the 2013 SLR, based on 15 studies, 7 at low risk of bias, patients on bDMARDs compared with patients on conventional sDMARDs had a higher risk of serious infections (adjusted HR (aHR) 1.1 to 1.8)—without differences across bDMARDs—a higher risk of tuberculosis (aHR 2.7 to 12.5), but no increased risk of infection by herpes zoster. Patients on bDMARDs did not have an increased risk of malignancies in general, lymphoma or non-melanoma skin cancer, but the risk of melanoma may be slightly increased (aHR 1.5).ConclusionsThese findings confirm the known safety pattern of bDMARDs, including both tumour necrosis factor-α inhibitor (TNFi) and non-TNFi, for the treatment of RA.

scholarly journals Safety of synthetic and biological DMARDs: a systematic literature review informing the 2019 update of the EULAR recommendations for the management of rheumatoid arthritis

2020 ◽  
pp. annrheumdis-2019-216653 ◽  
Author(s):  
Alexandre Sepriano ◽  
Andreas Kerschbaumer ◽  
Josef S Smolen ◽  
Désirée van der Heijde ◽  
Maxime Dougados ◽  
...  
Keyword(s):  
Rheumatoid Arthritis ◽  
Literature Review ◽  
Systematic Literature Review ◽  
Observational Studies ◽  
Janus Kinase ◽  
Jak Inhibitors ◽  
Eular Recommendations ◽  
Increased Risk ◽  
Safety Outcomes ◽  
Risk Of Cancer

ObjectivesTo perform a systematic literature review (SLR) concerning the safety of synthetic (s) and biological (b) disease-modifying anti rheumatic dugs (DMARDs) to inform the 2019 update of the EULAR recommendations for the management of rheumatoid arthritis (RA).MethodsAn SLR of observational studies comparing safety outcomes of any DMARD with another intervention for the management of RA. A comparator group was required for inclusion. For treatments still without registry data (eg, sarilumab and the Janus kinase (JAK) inhibitors baricitinib, upadacitinib), randomised controlled trials (RCTs) and long-term extensions (LTEs) were used. Risk of bias (RoB) was assessed according to standard procedures.ResultsForty-two observational studies fulfilled the inclusion criteria, addressing safety outcomes with bDMARDs and sDMARDs. Nine studies showed no difference in the risk of serious infections across bDMARDs and two studies (high RoB) showed an increased risk with bDMARDs compared with conventional synthetic (cs) DMARDs (adjusted incidence rate ratio 3.1–3.9). The risk of Herpes zoster infection was similar across bDMARDs, but one study showed an increased risk with tofacitinib compared with abatacept (adjusted HR (aHR) 2.0). Five studies showed no increased risk of cancer for bDMARDs compared with csDMARDs. An increased risk of lower intestinal perforation was found for tocilizumab compared with csDMARDs (aHR 4.5) and tumour necrosis factor inhibitor (TNFi) (aHR 2.6–4.0). Sixty manuscripts reported safety data from RCTs/LTEs. Overall, no unexpected safety outcomes were found, except for the possibly increased risk of venous thromboembolism (VTE) with JAK inhibitors.ConclusionData obtained by this SLR confirm the known safety profile of bDMARDs. The risk of VTE in RA, especially in patients on JAK inhibitors, needs further evaluation.

scholarly journals POS0641 INCIDENCE OF GASTRO-INTESTINAL COMPLICATIONS IN RHEUMATOID ARTHRITIS PATIENTS RECEIVING BIOLOGICAL DMARDS IN OBSERVATIONAL COHORT STUDIES: A SYSTEMATIC LITERATURE REVIEW AND META-ANALYSIS

2021 ◽  
Vol 80 (Suppl 1) ◽  
pp. 559.1-559
Author(s):  
A. Charlotte ◽  
D. Jerome ◽  
C. Lukas ◽  
C. Rempenault ◽  
A. Constantin ◽  
...  
Keyword(s):  
Rheumatoid Arthritis ◽  
Literature Review ◽  
Cohort Studies ◽  
Systematic Literature Review ◽  
Meta Analysis ◽  
Tnf Inhibitors ◽  
Gi Tract ◽  
Biological Dmards ◽  
Increased Risk ◽  
Observational Cohort

Background:Rheumatoid arthritis (RA) patients are at increased risk of gastro-intestinal (GI) perforations compared with non-RA patients, resulting in increased mortality. Clinical trials, post-marketing studies and registries have reported an increased risk of GI perforations in RA patients treated with tocilizumab.Objectives:The aim of our study was to assess the incidence of GI complications among RA patients receiving bDMARDs in observational cohort studiesMethods:A systematic literature review was carried out through September 2020 on the Pubmed, Embase and international congress databases, selecting observational cohort studies assessing the incidence of GI complications, including perforations and diverticulitis, in RA patients receiving bDMARDS. Keywords were “gastrointestinal perforation”, “gastrointestinal disease”, “diverticulitis”, “biological DMARDs” and “rheumatoid arthritis” with no publication date limit. Studies were selected independently by two readers. Data were extracted by one investigator and independently checked by another. A meta-analysis was performed with Review Manager Software, with random-effects models, whenever methodologically possible and relevant.Results:The literature search revealed 232 articles and abstracts of potential interest, and further examination resulted in 7 studies fulfilling required criteria. Among bDMARDs, Tocilizumab was associated with an increased incidence of GI perforations, with an overall incidence of 2.40 per 1000 person-years (95% confidence interval [95% CI] 1.45-3.35). The overall incidences of GI perforations were 1.01 per 1000 PY [0.75-1.27] for TNF inhibitors, 1.07 per 1000 PY [0.53-1.62] for abatacept and 1.12 per 1000 PY [0.16-2.08] for rituximab (Figure 1). In RA patients treated with tocilizumab, most of the perforations were located in the lower GI tract, with an incidence of 2.24 per 1000 PY [1.24-3.52]. The incidences of upper GI perforations were similar across the different bDMARDs. The incidences of diverticulitis were 4.99 per 1000 PY [4.08-5.99] in RA patients receiving tocilizumab and 1.81 per 1000 PY [1.47-2.19] in those receiving TNF inhibitors.Figure 1.Meta-analysis of the incidences of gastro-intestinal perforations in RA patients receiving bDMARDs in observational cohort studiesConclusion:In our meta-analysis, focused in RA patients receiving bDMARDs in observational cohort studies, tocilizumab was associated with an increased incidence of GI perforations, mainly located in the lower GI tract. An history of diverticulitis and long-term corticosteroid therapy were associated with an increased risk of GI perforations.Acknowledgements:We cannot express enough thanks to PhD Constantin and PhD Morel for their support and encouragement.We would like to address a special word of thanks to PhD Lukas for his accuracy.Special Thanks to Claire Rempenault for her precious advices. You have been a role model for us.Disclosure of Interests:None declared

scholarly journals SAT0052 THERAPEUTIC STRATEGIES IN DIFFICULT-TO-TREAT RHEUMATOID ARTHRITIS: PRELIMINARY RESULTS OF A SYSTEMATIC LITERATURE REVIEW INFORMING THE 2020 EULAR RECOMMENDATIONS FOR THE MANAGEMENT OF DIFFICULT-TO-TREAT RHEUMATOID ARTHRITIS

2020 ◽  
Vol 79 (Suppl 1) ◽  
pp. 957-957
Author(s):  
N. M. T. Roodenrijs ◽  
A. Hamar ◽  
M. Kedves ◽  
G. Nagy ◽  
J. M. Van Laar ◽  
...  
Keyword(s):  
Rheumatoid Arthritis ◽  
Literature Review ◽  
Systematic Literature Review ◽  
Therapeutic Strategies ◽  
Eular Recommendations ◽  
Management Interventions ◽  
Fatigue Exercise ◽  
Factor Inhibitor ◽  
Management Recommendations ◽  
Sat 1

Background:Rheumatoid arthritis (RA) patients treated according to European League Against Rheumatism (EULAR) recommendations failing ≥2 biological or targeted synthetic disease-modifying antirheumatic drugs (b/tsDMARDs) with a different mode of action who still have complaints which may be suggestive of active disease may be defined as suffering from ‘difficult-to-treat RA’. Management recommendations for RA focus predominantly on the earlier phases of the disease and specific recommendations for difficult-to-treat RA patients are currently lacking.1Objectives:To systematically summarise evidence in the literature on pharmacological and non-pharmacological therapeutic strategies for difficult-to-treat RA patients, informing the 2020 EULAR recommendations for the management of difficult-to-treat RA.Methods:A systematic literature review (SLR) was performed: PubMed, Embase and Cochrane databases were searched up to December 2019. Relevant papers were selected and appraised.Results:Thirty articles were selected for therapeutic strategies in patients with limited DMARD options due to contraindications, 73 for patients in whom previous b/tsDMARDs were not effective (‘true refractory RA’), and 51 for patients with predominantly non-inflammatory complaints. For patients with limited DMARD options, limited evidence was found on effective DMARD options for patients with concomitant obesity, and on safe DMARD options for patients with concomitant hepatitis B and C. In patients who failed ≥2 bDMARDs, tocilizumab, tofacitinib, baricitinib, upadacitinib and filgotinib were found to be more effective than placebo, but evidence was insufficient to prioritise. In patients who failed ≥1 bDMARD, there was a tendency of non-tumour necrosis factor inhibitor (TNFi) bDMARDs to be more effective than TNFi (Figure 1). Generally, b/tsDMARDs become less effective when patients failed more bDMARDs, this tendency was not clear for upadacitinib and filgotinib (Figure 2). In patients with predominantly non-inflammatory complaints (mainly function, pain and fatigue), exercise, education, psychological and self-management interventions were found to be of additional benefit.Conclusion:This SLR underscores the scarcity of evidence on the optimal treatment of difficult-to-treat RA patients. As difficult-to-treat RA is a newly defined disease state, all evidence is to an extent indirect. Several b/tsDMARDs were found to be effective in patients who failed ≥2 bDMARDs and generally effectiveness decreased with a higher number of failed bDMARDs. Additionally, a beneficial effect of non-pharmacological interventions was found on non-inflammatory complaints.References:[1] Smolen JSet al. Ann Rheum Dis2020. Epub ahead of print.Disclosure of Interests:Nadia M. T. Roodenrijs: None declared, Attila Hamar: None declared, Melinda Kedves: None declared, György Nagy: None declared, Jacob M. van Laar Grant/research support from: MSD, Genentech, Consultant of: MSD, Roche, Pfizer, Eli Lilly, BMS, Désirée van der Heijde Consultant of: AbbVie, Amgen, Astellas, AstraZeneca, BMS, Boehringer Ingelheim, Celgene, Cyxone, Daiichi, Eisai, Eli-Lilly, Galapagos, Gilead Sciences, Inc., Glaxo-Smith-Kline, Janssen, Merck, Novartis, Pfizer, Regeneron, Roche, Sanofi, Takeda, UCB Pharma; Director of Imaging Rheumatology BV, Paco Welsing: None declared

scholarly journals Paracetamol: not as safe as we thought? A systematic literature review of observational studies

2015 ◽  
Vol 75 (3) ◽  
pp. 552-559 ◽  
Author(s):  
Emmert Roberts ◽  
Vanessa Delgado Nunes ◽  
Sara Buckner ◽  
Susan Latchem ◽  
Margaret Constanti ◽  
...  
Keyword(s):  
Literature Review ◽  
Systematic Literature Review ◽  
Dose Response ◽  
Observational Studies ◽  
Relative Rate ◽  
Adult Population ◽  
Assessment Development ◽  
Increased Risk ◽  
General Adult Population ◽  
Paracetamol Toxicity

ObjectivesWe conducted a systematic literature review to assess the adverse event (AE) profile of paracetamol.MethodsWe searched Medline and Embase from database inception to 1 May 2013. We screened for observational studies in English, which reported mortality, cardiovascular, gastrointestinal (GI) or renal AEs in the general adult population at standard analgesic doses of paracetamol. Study quality was assessed using Grading of Recommendations Assessment, Development and Evaluation. Pooled or adjusted summary statistics were presented for each outcome.ResultsOf 1888 studies retrieved, 8 met inclusion criteria, and all were cohort studies. Comparing paracetamol use versus no use, of two studies reporting mortality one showed a dose–response and reported an increased relative rate of mortality from 0.95 (0.92 to 0.98) to 1.63 (1.58 to 1.68). Of four studies reporting cardiovascular AEs, all showed a dose–response with one reporting an increased risk ratio of all cardiovascular AEs from 1.19 (0.81 to 1.75) to 1.68 (1.10 to 2.57). One study reporting GI AEs reported a dose–response with increased relative rate of GI AEs or bleeds from 1.11 (1.04 to 1.18) to 1.49 (1.34 to 1.66). Of four studies reporting renal AEs, three reported a dose–response with one reporting an increasing OR of ≥30% decrease in estimated glomerular filtration rate from 1.40 (0.79 to 2.48) to 2.19 (1.4 to 3.43).DiscussionGiven the observational nature of the data, channelling bias may have had an important impact. However, the dose–response seen for most endpoints suggests a considerable degree of paracetamol toxicity especially at the upper end of standard analgesic doses.

Current evidence for a strategic approach to the management of rheumatoid arthritis with disease-modifying antirheumatic drugs: a systematic literature review informing the EULAR recommendations for the management of rheumatoid arthritis

2010 ◽  
Vol 69 (6) ◽  
pp. 987-994 ◽  
Author(s):  
R Knevel ◽  
M Schoels ◽  
T W J Huizinga ◽  
D Aletaha ◽  
G R Burmester ◽  
...  
Keyword(s):  
Rheumatoid Arthritis ◽  
Literature Review ◽  
Clinical Outcome ◽  
Physical Function ◽  
Systematic Literature Review ◽  
Structural Damage ◽  
Task Force ◽  
Treatment Strategies ◽  
Current Evidence ◽  
Eular Recommendations

ObjectivesTo perform a systematic literature review of effective strategies for the treatment of rheumatoid arthritis (RA).MethodsAs part of a European League Against Rheumatism (EULAR) Task Force investigation, a literature search was carried out from January 1962 until February 2009 in PubMed/Ovid Embase/Cochrane and EULAR/American College of Rheumatism (ACR)) abstracts (2007/2008) for studies with a treatment strategy adjusted to target a predefined outcome. Articles were systematically reviewed and clinical outcome, physical function and structural damage were compared between intensive and less intensive strategies. The results were evaluated by an expert panel to consolidate evidence on treatment strategies in RA.ResultsThe search identified two different kinds of treatment strategies: strategies in which the reason for treatment adjustment differed between the study arms (‘steering strategies’, n=13) and strategies in which all trial arms used the same clinical outcome to adjust treatment with different pharmacological treatments (‘medication strategies’, n=7). Both intensive steering strategies and intensive medication strategies resulted in better outcome than less intensive strategies in patients with early active RA.ConclusionIntensive steering strategies and intensive medication strategies produce a better clinical outcome, improved physical function and less structural damage than conventional steering or treatment. Proof in favour of any steering method is lacking and the best medication sequence is still not known.

scholarly journals Efficacy of glucocorticoids, conventional and targeted synthetic disease-modifying antirheumatic drugs: a systematic literature review informing the 2016 update of the EULAR recommendations for the management of rheumatoid arthritis

2017 ◽  
Vol 76 (6) ◽  
pp. 1102-1107 ◽  
Author(s):  
Katerina Chatzidionysiou ◽  
Sharzad Emamikia ◽  
Jackie Nam ◽  
Sofia Ramiro ◽  
Josef Smolen ◽  
...  
Keyword(s):  
Rheumatoid Arthritis ◽  
Literature Review ◽  
Systematic Literature Review ◽  
Treat To Target ◽  
Tight Control ◽  
Disease Modifying Antirheumatic Drugs ◽  
Antirheumatic Drugs ◽  
Eular Recommendations ◽  
Synthetic Dmards ◽  
Disease Modifying

ObjectivesTo perform a systematic literature review (SLR) informing the 2016 update of the recommendations for the management of rheumatoid arthritis (RA).MethodsAn SLR for the period between 2013 and 2016 was undertaken to assess the efficacy of glucocorticoids (GCs), conventional synthetic disease-modifying antirheumatic drugs (csDMARDs) and targeted synthetic DMARDs (tsDMARDs) (tofacitinib and baricitinib) in randomised clinical trials.ResultsFor GCs, four studies were included in the SLR. Patients without poor prognostic factors experienced benefit when GCs were added to methotrexate (MTX). Lower doses of GCs were similar to higher doses. For csDMARDs, two new studies comparing MTX monotherapy with combination csDMARD were included in the SLR. In the tREACH trial at the end of 12 months no difference between the groups in disease activity, functional ability and radiographic progression was seen, using principles of tight control (treat-to-target). In the CareRA trial, combination therapy with csDMARDs was not superior to MTX monotherapy and monotherapy was better tolerated.For tsDMARDs, tofacitinib and baricitinib were shown to be more effective than placebo (MTX) in different patient populations.ConclusionsAddition of GCs to csDMARD therapy may be beneficial but the benefits should be balanced against the risk of toxicity. Under tight control conditions MTX monotherapy is not less effective than combination csDMARDs, but better tolerated. Tofacitinib and baricitinib are efficacious in patients with RA, including those with refractory disease.

scholarly journals Pharmacological treatment of psoriatic arthritis: a systematic literature review for the 2015 update of the EULAR recommendations for the management of psoriatic arthritis

2015 ◽  
Vol 75 (3) ◽  
pp. 490-498 ◽  
Author(s):  
Sofia Ramiro ◽  
Josef S Smolen ◽  
Robert Landewé ◽  
Désirée van der Heijde ◽  
Maxime Dougados ◽  
...  
Keyword(s):  
Psoriatic Arthritis ◽  
Literature Review ◽  
Systematic Literature Review ◽  
Certolizumab Pegol ◽  
Severity Index ◽  
New Drugs ◽  
Tight Control ◽  
Psoriasis Area Severity Index ◽  
Pharmacological Agents ◽  
Eular Recommendations

ObjectiveTo update the evidence on the efficacy and safety of pharmacological agents in psoriatic arthritis (PsA).MethodsSystematic literature review of randomised controlled trials comparing pharmacological interventions in PsA: non-steroidal anti-inflammatory drugs, glucocorticoid, synthetic disease modifying antirheumatic drugs (sDMARDs) either conventional or targeted, biologicals (bDMARDs), placebo or any combination. Main outcomes were American College of Rheumatology (ACR)20–50, Psoriasis Area Severity Index 75, radiographic progression, and withdrawals due to adverse events (AEs). Multiple studies of the same intervention were meta-analysed using random effects.ResultsIn total, 25 papers and 12 abstracts were included. The efficacy of tumour necrosis factor inhibitors (including the recently added golimumab and certolizumab pegol) was confirmed and 16 articles/abstracts focused on 3 drugs with new modes of action: ustekinumab (UST), secukinumab (SEC) and apremilast (APR). All were placebo-compared trials and met their primary end point, ACR20. In 2 studies with UST ACR20 was met by 50% and 44% of patients with UST 90 mg, 42% and 44% with UST 45 mg vs 23% and 20% with placebo, respectively. In two studies with SEC ACR20 ranged 54% (SEC 300 mg), 50–51% (SEC 150 mg), 29–51% (SEC 75 mg) and 15–17% (placebo). In four studies with APR, ACR20 ranged 32–43% (APR 30 mg), 29–38% (APR 20 mg) and 17–20% (placebo). For all three drugs, no more withdrawals due to AEs than placebo were seen and, in general, safety appeared satisfactory. A strategy trial, TIght COntrol of Psoriatic Arthritis (TICOPA), showed better ACR responses with treatment adaptations upon tight control compared with standard care.ConclusionsUST, SEC and APR are new drugs with efficacy demonstrated for the treatment of PsA. No major safety signals arise, but long-term studies are needed. This review informed about the European League Against Rheumatism recommendations for management of PsA.

scholarly journals Efficacy of biological disease-modifying antirheumatic drugs: a systematic literature review informing the 2013 update of the EULAR recommendations for the management of rheumatoid arthritis

2014 ◽  
Vol 73 (3) ◽  
pp. 516-528 ◽  
Author(s):  
Jackie L Nam ◽  
Sofia Ramiro ◽  
Cecile Gaujoux-Viala ◽  
Kaoru Takase ◽  
Mario Leon-Garcia ◽  
...  
Keyword(s):  
Rheumatoid Arthritis ◽  
Literature Review ◽  
Systematic Literature Review ◽  
Initial Treatment ◽  
Certolizumab Pegol ◽  
Treatment Strategies ◽  
Treat To Target ◽  
Disease Modifying Antirheumatic Drugs ◽  
Antirheumatic Drugs ◽  
Disease Modifying

ObjectivesTo update the evidence for the efficacy of biological disease-modifying antirheumatic drugs (bDMARD) in patients with rheumatoid arthritis (RA) to inform the European League Against Rheumatism(EULAR) Task Force treatment recommendations.MethodsMedline, Embase and Cochrane databases were searched for articles published between January 2009 and February 2013 on infliximab, etanercept, adalimumab, certolizumab-pegol, golimumab, anakinra, abatacept, rituximab, tocilizumab and biosimilar DMARDs (bsDMARDs) in phase 3 development. Abstracts from 2011 to 2012 American College of Rheumatology (ACR) and 2011–2013 EULAR conferences were obtained.ResultsFifty-one full papers, and 57 abstracts were identified. The randomised controlled trials (RCT) confirmed the efficacy of bDMARD+conventional synthetic DMARDs (csDMARDs) versus csDMARDs alone (level 1B evidence). There was some additional evidence for the use of bDMARD monotherapy, however bDMARD and MTX combination therapy for all bDMARD classes was more efficacious (1B). Clinical and radiographic responses were high with treat-to-target strategies. Earlier improvement in signs and symptoms were seen with more intensive initial treatment strategies, but outcomes were similar upon addition of bDMARDs in patients with insufficient response to MTX. In general, radiographic progression was lower with bDMARD use, mainly due to initial treatment effects. Although patients may achieve bDMARD- and drug-free remission, maintenance of clinical responses was higher with bDMARD continuation (1B), but bDMARD dose reduction could be applied (1B). There was still no RCT data for bDMARD switching.ConclusionsThe systematic literature review confirms efficacy of biological DMARDs in RA. It addresses different treatment strategies with the potential for reduction in therapy, particularly with early disease control, and highlights emerging therapies.

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