Adalimumab In Terms Research Articles

Drug survival of biologic agents in patients with psoriatic arthritis from a medical center in southern Taiwan

Background: Psoriasis is a chronic inflammatory disease involving the skin and/or joints. Till 2016, there were five biologic agents for psoriatic arthritis treatment in Taiwan: etanercept, adalimumab, golimumab, ustekinumab, and secukinumab. Although European guidelines recommend tumor necrosis factor-α (TNF-α) inhibitors as the first-line biologic agents for axial disease of psoriatic arthritis, the drug survival of biologic agents in Asian populations remains unclear. Objectives: We investigated 5-year drug survival of biologic agents in patients with psoriatic arthritis. Methods: We used Kaohsiung Medical University Hospital Research Database to evaluate real-world 5-year drug survival of biologic agents for psoriatic arthritis in a medical center from southern Taiwan. Results: The 5-year drug survival rates of ustekinumab, etanercept, and adalimumab were significantly different. Ustekinumab and etanercept showed higher 5-year survival rates for psoriatic disease than adalimumab. Golimumab and secukinumab had a short follow-up time to obtain a conclusive 5-year survival rate. Conclusion: Considering that TNF-α inhibitors are often the first-line biologic agents for psoriatic arthritis in guidelines in western countries, the finding that ustekinumab is superior to TNF-α inhibitor adalimumab in terms of 5-year survival for psoriatic disease may imply that the therapeutic response of biologic agents may differ between different ethnic groups.

Filgotinib in Rheumatoid Arthritis: A Profile of Its Use

Filgotinib (Jyseleca®), an oral Janus kinase (JAK) inhibitor, is approved as monotherapy or in combination with methotrexate to treat moderate to severe active rheumatoid arthritis (RA) in adults who have an inadequate response or intolerance to one or more disease-modifying antirheumatic drugs (DMARDs). In phase 3 trials, once-daily filgotinib was generally well tolerated and associated with an improvement in RA signs and symptoms as well as physical function in patients with an inadequate response to ongoing methotrexate, an inadequate response to ongoing conventional synthetic DMARDs plus an inadequate response or intolerance to prior biologic DMARDs, or limited or no prior exposure to methotrexate. In addition, filgotinib was noninferior to adalimumab in terms of low disease activity response rate (DAS28-CRP ≤ 3.2) in patients with an inadequate response to methotrexate. Filgotinib also appeared to inhibit the radiographic progression of joint damage and led to low disease activity or disease remission (DAS28-CRP < 2.6). Filgotinib showed sustained efficacy, and the safety profile of filgotinib longer term was similar to that in the phase 2 and 3 trials.Supplementary InformationThe online version contains supplementary material available at 10.1007/s40261-021-01055-0.

POS0630 COMPARISON OF THE EFFICACY AND SAFETY OF ORIGINAL AND BIOSIMILAR ADALIMUMAB MOLECULES IN CHILDHOOD RHEUMATIC DISEASES

Background:The TNF-α inhibitor adalimumab is a biological disease modifying anti-rheumatic drug (bDMARD) that has been used in different rheumatic diseases with a resistant course. ABP-501 is a biosimilar product (BP) of adalimumab, recently approved by the FDA and EMA. To our knowledge, there is no study assess the efficacy and safety of these two molecules on pediatric patients.Objectives:We aimed to compare the efficacy and safety of the original and biosimilar adalimumab (ABP-501) molecules in childhood rheumatic diseases.Methods:This non-interventional, retrospective, single-centre analysis carried out in Umraniye Training and Resrach Hospital, Pediatric Rheumatology Clinic, Istanbul, Turkey. The study group consisted of patients who were followed due to chronic rheumatic disease between January 1, 2016 and June 1, 2020, and received reference or biosimilar adalimumab therapy for at least three months. Demographic and clinical data of patients were collected at baseline, 3rd, 6th, and 12th months of treatment. Disease activity assessment was made with JADAS-27 in JIA patients, with SUN criteria in uveitis patients, and with Behçet’s Disease Activity Index in BD patients. Efficacy and safety of treatments were compared between reference and biosimilar adalimumab groups.Results:A total of 89 patients (65 with original and 24 with biosimilar molecule) treated with adalimumab, were included in the study. There were 45 female and 44 male in the study, and the median age at the initiation of the adalimumab was 166 months (min-max: 36-231). Of the 89 patients evaluated, the primary diagnoses of 62 were juvenile idiopathic arthritis, 13 were idiopathic uveitis, eight were Behçet’s disease, three were Blau syndrome, two were chronic recurrent multifocal osteomyelitis and one was Vogt-Koyanagi-Harada syndrome. 63 of the patients were biologic-naïve, and 13 were switched from etanercept, 11 from infliximab, and two from other bDMARDs. The median exposure time of adalimumab was 16 months (min-max:3-70) in RP and 14.5 months (min-max: 3-23) in BP. All patients had active disease before treatment. In the group treated with RP, inactive disease was achieved in 60%, 76.6% and 87.2% of the patients at the 3rd, 6th and 12th months, respectively. Also, inactive disease was achieved in 62.5%, 78.2% and 78.2% of the patients at the 3rd, 6th and 12th months in the group treated with BP, respectively. There was no statistically significant difference in efficacy between the groups at the 3rd, 6th and 12th months (p=0.83, 0.07 and 0.32). Serious adverse events were seen in one patient in each groups (lymphoma in RP group, tuberculous meningitis in BP group). Non-serious adverse events were observed in eight patients (12.3%) in the RP group and in two patients (8.3%) in the BP group, without statistically significant difference between groups (p=0.86).Conclusion:No significant difference was observed between the biosimilar adalimumab ABP-501 and RP adalimumab in terms of efficacy and safety.

Filgotinib versus placebo or adalimumab in patients with rheumatoid arthritis and inadequate response to methotrexate: a phase III randomised clinical trial

ObjectiveTo evaluate the efficacy and safety of the Janus kinase-1-preferential inhibitor filgotinib versus placebo or tumour necrosis factor-α inhibitor therapy in patients with active rheumatoid arthritis (RA) despite ongoing treatment...

Efficacy and Safety of Ixekizumab with or Without Methotrexate in Biologic-Naïve Patients with Psoriatic Arthritis: 52-Week Results from SPIRIT-H2H Study.

IntroductionIn the SPIRIT-H2H (ClinicalTrials.gov: NCT03151551) trial in biologic-naïve patients with active psoriatic arthritis (PsA), ixekizumab (IXE) was superior to adalimumab (ADA) at week 24 in terms of achieving a combined endpoint of ≥ 50% improved response in the American College of Rheumatology scale score (ACR50) and 100% improvement in the Psoriasis Areas and Severity Index (PASI100), and was non-inferior in terms of achieving ACR50. IXE resulted in similar improvements of PsA manifestations irrespective of the use of concomitant conventional synthetic disease-modifying anti-rheumatic drugs (csDMARDs), while ADA response was higher with concomitant csDMARD use. The aim of this study was to determine the efficacy and safety of treatment with IXE and ADA with or without methotrexate (MTX), the most commonly use csDMARD, through week 52 in patients with PsA.MethodsIn the open-label, rater-blinded, head-to-head SPIRIT-H2H trial, randomization of patients was stratified by concomitant use of csDMARD and moderate-to-severe plaque psoriasis involvement. In the post-hoc subgroup analysis presented here, subgroups were defined as with/without concomitant MTX use at baseline. Treatment group effects within subgroups were tested using Fisher’s exact test. Missing data were imputed using non-responder imputation.ResultsBy week 52, IXE provided similar improvements in the combined ACR50 and PASI100 endpoint, ACR50, and other PsA-related domains regardless of whether IXE was used with or without MTX, while ADA efficacy appeared to be improved with concomitant MTX use. When used without concomitant MTX, IXE resulted in significantly higher response versus ADA in terms of the combined ACR50 and PASI100 (p = 0.002) endpoint, minimal disease activity (p = 0.016), and very low disease activity (p = 0.037). The safety of both agents was consistent with their known safety profiles regardless of concomitant MTX use.ConclusionIn PsA patients with inadequate control of the disease, IXE delivers consistent efficacy in several clinical domains of the disease regardless of concomitant MTX use. The efficacy of ADA is increased by the concomitant use of MTX. These findings can inform treatment decisions when considering the need for concomitant MTX use with IXE or ADA at initiation or for long-term maintenance.Electronic supplementary materialThe online version of this article (10.1007/s40744-020-00250-3) contains supplementary material, which is available to authorized users.

Biologic Therapies in Sarcoidosis and Uveitis: A Review.

Sarcoidosis and uveitis are chronic inflammatory conditions with potentially debilitating effects on quality of life. Steroids form the mainstay standard therapy in both conditions. Biologic agents are considered to be appropriate alternatives for treatment in steroid-refractory sarcoidosis and uveitis due to the role of tumor necrosis factor (TNF) in mediating the inflammatory cascade seen in both conditions. We performed a thorough literature search using PubMed to compare the extent of use, efficacy, and safety profile of individual anti-TNF agents in the management of these conditions. Our review consists of two systematic reviews with meta-analysis, thirteen observational studies, and fifteen case series/reports. Infliximab had the widest range of organ-system usage in extra-pulmonary sarcoidosis but is equivalent to adalimumab in terms of efficacy. In uveitis, adalimumab was found to be the most efficacious agent for maintaining disease remission in adults and children with chronic non-infectious uveitis. Etanercept was neither used widely, nor was it efficacious in the management of either condition. In terms of safety profile, biologic agents were found to be well tolerated and have a similar safety profile. More randomized clinical trials are needed to inform evidence-based use of biologic agents in these conditions.

Adalimumab effectively controls both anterior and posterior noninfectious uveitis associated with systemic inflammatory diseases: focus on Behçet's syndrome.

To compare the efficacy of Adalimumab (ADA) in noninfectious anterior uveitis (AU) and posterior segment (PS) involvement, associated with different conditions, with a focus on Behçet's syndrome (BS). In this retrospective, multicenter post-hoc study, we evaluated the efficacy of ADA in terms of ocular control and relapses in 96 patients with AU and PS uveitis, either idiopathic (IU) or associated with BS or with other systemic disorders (OSD) (Juvenile Idiopathic Arthritis, Psoriatic Arthritis, Ankylosing Spondylitis, Vogt-Koyanagi-Harada, Inflammatory Bowel Disease), followed in three tertiary referral centers. Ninety-six patients (45 AU; 51 PS uveitis) were included. Eleven had IU, 58 BS, and 27 OSD. All patients with AU achieved complete long-term ocular control. In PS uveitis, 89%, 67% and 100% of patients with BS, IU and OSD achieved ocular control at the last follow-up (> 12months), respectively. The lowest ocular relapse rate occurred in patients with AU with BS (1/13) or IU (0/2). ADA accounted for long-term disease control, and no predictors of ocular control and relapse were identified; particularly, ocular relapses seemed not related to systemic ones. Macular edema resolved in 75% and 67% of PS uveitis with BS and IU, respectively. ADA controls both anterior and posterior uveitis, with an efficacy similar in IU, BS and OSD patients. In BS, the efficacy of ADA seems to be independent of demographic and clinical characteristics, and ocular relapses mostly occurred independently from systemic ones. Based on our results, ADA may represent a valid alternative in anterior refractory uveitis.

P341 Induction of response and remission: a network meta-analysis of induction studies comparing ontamalimab with other treatments for moderate-to-severe ulcerative colitis

Abstract Background Decisions regarding the treatment of ulcerative colitis (UC) should be based on appropriate, high-quality evidence. In the absence of head-to-head trials, network meta-analysis (NMA) can be used to compare the efficacy and safety of several treatments. We conducted an NMA to compare the efficacy of ontamalimab (anti-MAdCAM-1) using its phase 2 data, with all other biologics and novel small molecules for which induction study data on response and remission in patients with UC were available. Methods A systematic literature review was conducted in November 2017 to identify published randomised controlled trials of induction treatment in patients with moderate-to-severe UC. An NMA of the identified studies was performed using random-effects models and methods based on NICE guidance. Odds ratios and 95% credible intervals were calculated to describe the relative differences between all treatments and placebo in terms of efficacy in inducing response and remission. Results were generated for anti-TNF-naïve and -experienced populations. Results A total of 14 phase 2 and phase 3 induction studies of the following agents were included: adalimumab (160/80 mg), etrolizumab (100 mg and 300 mg), golimumab (200/100 mg), infliximab (5 mg), ontamalimab (22.5 mg and 75 mg), ozanimod (0.5 mg and 1 mg), tofacitinib (10 mg) and vedolizumab (300 mg). The definitions of response and remission used across trials were consistent. Between-study homogeneity was good and enabled pooling of results. Figure 1 shows odds ratios for induction of response and remission with treatments relative to placebo in anti-TNF-naïve and -experienced patients. All treatments, including ontamalimab, significantly differentiated from placebo in anti-TNF-naïve patients, with the exception of etrolizumab and ozanimod for response and remission, respectively. Tofacitinib (p = 0.0043) and infliximab (p = 0.0013) were superior to adalimumab in inducing response; whereas etrolizumab 100 mg (p = 0.0377), as well as tofacitinib (p = 0.0287) and infliximab (p = 0.0163), was superior to adalimumab in inducing remission. Conclusion This study suggests ontamalimab and most other treatments induce response and remission better than placebo. Although conducted before any large-scale head-to-head trials of these drugs, the study suggests a few treatments could be superior to adalimumab in terms of efficacy. However, varying endpoint timings, the combination of phase 2 and 3 data, and lack of control for placebo response could underscore large variances in the data and preclude firm conclusions being drawn.

Real-life Efficacy and Safety of Biosimilar Adalimumab (ZRC-3197) in Patients with Plaque Psoriasis: A Tertiary Care Center Experience.

Background:Adalimumab is proven to be safe and effective in treating plaque psoriasis. A biosimilar adalimumab (ZRC-3197; Exemptia™) - approved by Indian Regulators in 2014 - is a 'fingerprint match' of the reference adalimumab in terms of purity, potency, safety, and clinical efficacy. While reference adalimumab remains unavailable, this biosimilar adalimumab (bADA) serves as an accessible, cost-effective option for Indian patients. This is a first-hand, prospective, real-life data on the clinical use of bADA in Indian patients with plaque psoriasis.Materials and Methods:Patients with moderate-to-severe plaque psoriasis were prospectively treated with bADA therapy for 16 weeks-80 mg subcutaneously initially, followed by 40 mg every other week from week 1 in real-life setting. Psoriasis Area and Severity Index (PASI) responses, Dermatology Life Quality Index (DLQI) outcomes, and Physician's Global Assessment (PGA) for psoriasis were analyzed. Safety and tolerability evaluations included reported adverse events.Results:A total of 29 patients (15 males) with median age of 38 (25–56) years were included. After 16 weeks of bADA treatment, 93% patients achieved ≥75% reduction in their baseline PASI scores including PASI75, PASI90, and PASI100 responses in 24%, 14%, and 55% patients, respectively. About 52% patients had a DLQI score of 0/1 and 93% patients had a PGA score of 'clear or minimal' at 16 weeks. Treatment was well tolerated with no severe or serious adverse reactions requiring therapy discontinuation.Conclusions:This report serves as a real-life evidence for the efficacy and tolerability of biosimilar adalimumab administered for 16 weeks in patients with plaque psoriasis.

New alternative in the treatment of rheumatoid arthritis: clinical utility of baricitinib.

Baricitinib is an innovative small-molecule drug that reversibly inhibits continuous activation of JAK/STAT pathway, thus reducing joint inflammation. The drug was approved for use as monotherapy or in combination with methotrexate (MTX) in the treatment of adults with moderately to severely active rheumatoid arthritis (RA). The aim of this paper was to review the studies on pharmacology, mode of action, pharmacokinetics, efficacy, and safety of baricitinib in patients with RA. Baricitinib provides an innovative approach to modulating the immune and inflammatory response in patients with RA, which is especially important in individuals who do not respond to disease-modifying antirheumatic drugs or standard biologic drugs (tumor necrosis factor inhibitors) or who lose response over time. Baricitinib therapy reduces symptoms of RA and improves the quality of life. Moreover, it has shown high efficacy and an acceptable safety profile in Phase III randomized controlled trials (RCTs) and become another JAK inhibitor approved for RA treatment, providing a useful alternative option. RCTs have revealed a significant benefit of baricitinib over placebo, MTX, and adalimumab in terms of standard efficacy outcomes, especially the American College of Rheumatology ACR20, ACR50, and ACR70 response rates. Additionally, a clinically meaningful improvement in patient-reported outcomes, including the quality of life, compared with placebo has been reported. The safety profile seems acceptable, although some rare but potentially severe adverse events have been observed, such as serious infections, opportunistic infections (eg, herpes zoster), malignancies, and cardiac or hepatic disorders. Baricitinib administered at an approved dose of 2 or 4 mg once daily offers a novel and promising alternative to parenterally administered biologic drugs used in RA treatment.

ABP 501 for the treatment of rheumatoid arthritis

ABSTRACTIntroduction: Rheumatoid arthritis (RA) is an autoimmune disease, which has a negative impact on the ability to perform activities daily. Tumour necrosis factor α (TNF) is a cytokine with diverse cellular effects, and a key regulator of the inflammatory response. ABP 501 is a biosimilar to adalimumab, a TNF inhibitor.Areas covered: In this review, we examined ABP 501, as a biosimilar candidate to adalimumab in the treatment of RA focusing on the available data. Current data indicate that ABP 501 is a highly similar alternative to adalimumab in terms of safety, efficacy, tolerability and immunogenicity. ABP 501 has already been approved by health authorities in Europe and the United States of America, as a subcutaneous (s.c.) therapy option for the treatment of patients with RA, but also for the full spectrum approved for its bio-originator adalimumab.Expert opinion: Current body of evidence suggests that all biologic activities have been demonstrated to be equivalent between ABP 501 and the originator, including binding rates and affinity to TNF, and also the effector functions such as antibody-dependent cell-mediated cytotoxicity (ADCC). Therefore, it is fully expected to have same efficacy and safety in all indications.

Tofacitinib: A Review in Rheumatoid Arthritis.

Tofacitinib (Xeljanz®) is a potent, selective JAK inhibitor that preferentially inhibits Janus kinase (JAK) 1 and JAK3. In the EU, oral tofacitinib 5mg twice daily is indicated for the treatment of moderate to severe active rheumatoid arthritis (RA) in adult patients who have responded inadequately to, or who are intolerant of, one or more DMARDs. Several clinical studies of ≤24months' duration showed that tofacitinib monotherapy (as first- or second-line treatment) and combination therapy with a conventional synthetic DMARD (csDMARD; as second- or third-line treatment) was effective in reducing signs and symptoms of disease and improving health-related quality of life (HR-QOL), with benefits sustained during long-term therapy (≤96months). Tofacitinib monotherapy inhibited progression of structural damage in methotrexate-naïve patients during ≤24months' treatment, with beneficial effects also seen in patients receiving tofacitinib plus methotrexate as second-line therapy for 12months. Tofacitinib was generally well tolerated during ≤114months' treatment, with most adverse events of mild or moderate severity. The tolerability profile of tofacitinib was generally similar to that of biological DMARDs (bDMARDs), with infections and infestations the most common adverse events (AEs) in tofacitinib recipients. However, the incidence of herpes zoster (HZ) was higher with tofacitinib than in the general RA population, although infections were clinically manageable. When added to background methotrexate, tofacitinib was noninferior to adalimumab in terms of efficacy, and both combination therapies had generally similar tolerability profiles. Although additional comparative studies are needed to more definitively position tofacitinib relative to bDMARDs and other targeted synthetic DMARDs, current evidence indicates that oral tofacitinib is a useful option for the treatment of patients with RA.

Golimumab for moderately to severely active ulcerative colitis

ABSTRACTIntroduction: Anti-TNF agents are the mainstay of therapy in patients with moderate to severe ulcerative colitis (UC) not responding to 5-aminosalisylic acid, corticosteroids, immunmodulators and for patients dependent on corticosteroids. There is a therapeutic gap of 30%- 60% with infliximab and adalimumab, which is required to be bridged by newer agents. The present review summarizes the literature on the role of golimumab, a new anti TNF agent, in ulcerative colitis.Areas covered: Literature search was done on PubMed using the search terms ‘golimumab’ AND ‘ulcerative colitis’ from inception till March 2016. Golimumab, a fully human monoclonal antibody against TNF-α, was approved by FDA for clinical use in UC in 2013. In vitro studies showed golimumab to be better than infliximab and adalimumab in terms of affinity and neutralization of TNF-α and its conformational stability. Golimumab was found to be effective and safe in inducing and maintaining clinical remission, clinical response and mucosal healing in patients with UC in the two registration trials.Expert commentary: Although there is no difference in terms of efficacy between golimumab, infliximab and adalimumab, golimumab is better than infliximab in terms of route of administration (subcutaneous vs intravenous) and better than adalimumab in terms of frequency of dosing (4 weeks vs 2 weeks).

Anti-tumor necrosis factor alpha therapy (adalimumab) in Rasmussen's encephalitis: An open pilot study.

Rasmussen's encephalitis (RE) is a severe chronic inflammatory brain disease affecting one cerebral hemisphere and leading to drug-resistant epilepsy, progressive neurologic deficit, and unilateral brain atrophy. Hemispherotomy remains the gold standard treatment but causes permanent functional impairment. No standardized medical treatment protocol currently exists for patients prior to indication of hemispherotomy, although some immunotherapies have shown partial efficacy with functional preservation but poor antiseizure effect. Some studies suggest a role for tumor necrosis factor alpha (TNF-α) in RE pathophysiology. We report an open-label study evaluating the efficacy and the safety of anti-TNF-α therapy (adalimumab) in 11 patients with RE. The primary outcome criterion was the decrease of seizure frequency. The secondary outcome criteria were neurologic and cognitive outcomes and existence of side effects. Adalimumab was introduced with a median delay of 31 months after seizure onset (range 1 month to 16 years), and follow-up was for a median period of 18 months (range 9-54 months). There was a significant seizure frequency decrease after adalimumab administration (from a median of 360 to a median of 32 seizures per quarter, p ≤ 0.01). Statistical analysis showed that adalimumab had a significant intrinsic effect (p < 0.005) independent from disease fluctuations. Five patients (45%) were found to have sustained improvement over consecutive quarters in seizure frequency (decrease of 50%) on adalimumab. Three of these five patients also had no further neurocognitive deterioration. Adalimumab was well tolerated. Our study reports efficacy of adalimumab in terms of seizure frequency control. In addition, stabilization of functional decline occurred in three patients. This efficacy might be particularly relevant for atypical slowly progressive forms of RE, in which hemispherotomy is not clearly indicated. Due to our study limitations, further studies are mandatory to confirm these preliminary results.

Clinical, biological, and endoscopic responses to adalimumab in antitumor necrosis factor-naive Crohn's disease: predictors of efficacy in clinical practice.

Endoscopic healing and clinical remission are important parameters to evaluate therapeutic efficacy in Crohn's disease. The aim of this study was to investigate the clinical effectiveness of adalimumab in terms of clinical and endoscopic response and to identify predictors of efficacy in clinical practice. A prospective analysis was carried out of 68 antitumor necrosis factor-naive Crohn's disease patients treated with adalimumab for 2 years. Clinical and endoscopic response was assessed using the Harvey-Bradshaw index and the Simple Endoscopic Score for Crohn's disease, respectively. Adalimumab treatment was associated with clinical remission in 76.6, 90.6, and 87.5% of patients at 6, 12, and 24 months. Loss of efficacy occurred in 17.6% of cases after 24 months of therapy. Clinical remission with normal C-reactive protein at 2 months or with endoscopic response at 6 months was predictive of better outcomes. Mucosal healing rates were 17.2, 44.7, and 39.5% and endoscopic responses were 55.1, 76.6, and 76.3% at the respective time points. Mucosal healing was higher in the early treatment group than in the group with disease of at least 5 years' duration (64.7 vs. 19.1%, P=0.004). Inflammatory phenotype showed a higher percentage of mucosal healing (70%) than stricturing (29.4%) or penetrating (27.3%) disease. Adalimumab was effective in providing sustained clinical remission. In patients in clinical remission, the C-reactive protein level at 2 months, endoscopic response at 6 months, or inflammatory phenotype and short disease duration could be considered as good predictors of efficacy.

PGI1 - Comparative efficacy and safety of golimumab, infliximab and adalimumab for the treatment of moderate to severe ulcerative colitis: A bayesian indirect treatment comparison meta-analysis

To compare the relative efficacy and safety of golimumab, infliximab and adalimumab for the treatment of moderate-to-severe ulcerative colitis using indirect treatment comparison (ITC) meta-analysis. A systematic literature search identified five randomized controlled trials. Outcomes of interest included clinical remission, clinical response, mucosal healing, sustained remission/response, serious adverse events (SAEs), and discontinuation due to adverse events (DAEs). Data was synthesized using Bayesian indirect treatment comparison (ITC) meta-analysis. The analysis incorporated advanced intention-to-treat with baseline priors to account for the alternative design of the golimumab trial. After the induction phase, each treatment had significantly greater efficacy than placebo all endpoints, with the exception of adalimumab for mucosal healing. No statistical differences were observed between golimumab and infliximab. Adalimumab had significantly lower efficacy measures compared to infliximab for clinical remission (odds ratio [OR] 0.42, 95% credible interval [CrI] 0.17-0.97), clinical response (OR 0.45, 95% CrI 0.23-0.89), and mucosal healing (OR 0.46, 95% CrI 0.25-0.84) after the induction period. During the maintenance phase, each biologic agent exhibited significantly greater efficacy compared to placebo for clinical remission, clinical response, and mucosal healing. Golimumab 100mg was significantly better than adalimumab for clinical response (OR 1.80, 95% CrI 1.01-3.21) and mucosal healing at 54 weeks (OR 1.88, 95% CrI 1.01-3.49). No statistical differences were observed between adalimumab and infliximab. Both golimumab 100mg and infliximab were significantly better than adalimumab in terms of sustained clinical response (OR 2.40, 95% CrI 1.17-4.86 and OR 1.93, 95% CrI 1.04-4.06), respectively. For SAEs, there were no statistical differences between any of the biologics and placebo. Although all biologics were generally safe, golimumab 100mg had statistically significantly higher DAEs when compared to adalimumab (OR 2.09, 95% CrI 1.07-4.17). In the context of ITC meta-analysis, both golimumab and infliximab appear to demonstrate superior efficacy-safety profiles compared with adalimumab.

Impact of obesity on the effectiveness of adalimumab for the treatment of psoriasis: a retrospective study of 30 patients in daily practice

The relationship between obesity and psoriasis is probably bidirectional. To assess whether the effectiveness of adalimumab was affected by obesity in patients with psoriasis. Retrospective study of 30 adalimumab naïve patients (13 men, 17 women, mean age 49.5 years) with moderate to severe psoriasis. Response to treatment (PASI 50, 75, 90, 100) was assessed over the course of six clinical visits, with a median between 1.9 months for visit 1 and 20.8 months for visit 6 after the start of adalimumab treatment. Body mass index (BMI) was categorized as normal weight (18.5-24.9 kg/m(2)) (n = 13), overweight (25-29.9 kg/m(2)) (n = 7), and obese (>30 kg/m(2)) (n = 10). Patients were followed for a median of 17.2 months (minimum 2.7 months, maximum 34.4 months). The percentage of patients who were in complete remission (PASI 100) increased from 23.3% at visit 1 to 60% at visit 6. 70% of patients presented a PASI 90 response at visit 4 and this percentage remained unchanged at visits 5 and 6. Differences in response to adalimumab according to weight subgroups were not observed. The median time to achieve PASI 75, PASI 90 and PASI 100 responses was 20.1, 31.4 and 57.6 weeks, respectively. Adalimumab proved to be effective for the treatment of moderate to severe psoriasis in daily practice. Obesity did not appear to affect the efficacy of adalimumab in terms of PASI response, although patients with a BMI ≥30 kg/m(2) discontinued treatment earlier.

Grades, status, and titles

<h3>Background</h3> Adalimumab, an anti TNF-α agent, has been proven to be safe and effective in treatment of ankylosing spondylitis (AS). A biosimilar adalimumab was approved for use by Indian regulators in 2014. It is a “fingerprint match” of the reference adalimumab in terms of purity, potency, safety and clinical efficacy.^1,2 ln the absence of availability of adalimumab in India, this biosimilar adalimumab currently serves as an accessible, cost-effective option for treatment of AS patients. <h3>Objectives</h3> This retrospective analysis evaluates effectiveness of biosimilar adalimumab (bADA), in terms of disease activity, safety and outcomes in real-life Indian AS patients treated for initial 24 weeks and then followed for next 24 weeks off biologic treatment. <h3>Methods</h3> Medical records of AS patients with Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) and Bath Ankylosing Spondylitis Functional Index (BASFI) &gt;4, who were prescribed bADA therapy between January to December 2015 were analysed. For patients, who stopped bADA treatment after 24 weeks, standard AS outcome-measurement scores including ESR, CRP, BASDAI, BASFI, and Health Assessment Questionnaire (HAQ) at baseline, week 24 and at week 48 were measured to evaluate ongoing efficacy, were compared using paired Student9s T-test. Patients were allowed to continue methotrexate and salazopyrin as part of routine medical care. <h3>Results</h3> During the study period, 52 AS patients were prescribed bADA 40 mg s/c; 24 of these patients, who had stopped treatment after 6 months, were considered for this analysis. Mean age for this group was 36.57±10.81 years; 10 females. At the end of 24 weeks9 treatment, there were significant reductions in levels of inflammatory markers ESR, CRP, as well as in BASDAI, BASFI and HAQ scores. Eight patients continued to receive methotrexate and 8 patients sulfasalazine as concomitant medications. After week 48 (24 weeks post stoppage), BASDAI and BASFI scores did not deteriorate despite discontinuation of bADA treatment. The patients9 HAQ scores were also indicative of similar trends of continuing improved health status post the therapy. <h3>Conclusions</h3> Biosimilar adalimumab therapy was effective in treating AS patients. The disease activity and health assessment scores continued to remain stable with no worsening after the stoppage of treatment for 6 months, indicating a post-therapy effectiveness in these patients with no reported adverse event. <h3>References</h3> Bandyopadhyay S, et al. Biosimilars. 2015;5:1–18. Jani RH et al. int J Rheum Dis. 2015 Jul 14. <h3>Disclosure of Interest</h3> None declared