AB0217 NON MEDICAL SWITCH FROM ETANERCEPT ORIGINATOR TO BIOSIMILAR GP2015 IN PATIENTS WITH CHRONIC INFLAMMATORY ARTHROPATHIES

Background:In the last decades, new biologic drugs were introduced for the treatment of chronic inflammatory arthropathies, progressively leading to a relevant increase of medical costs. However, the introduction of biosimilars (biologic molecules similar to branded drugs with expired patent) permitted to optimize the financial resources. The non-medical switch (NMS) is the switch from a biologic originator to a biosimilar agent for economic reasons only, on the basis of the substantial equivalence as regards efficacy and safety between originator and biosimilar drugs.In literature, several evidences from clinical trials and registry studies showed that the switch from etanercept originator to biosimilar SB4 was safe [1]. Instead no sufficient data may be found regarding the biosimilar GP2015.Objectives:We aimed to evaluate efficacy, safety, and retention rate in a series of patients with chronic arthritis treated with etanercept originator who underwent to NMS towards the ETN biosimilar GP2015.Methods:From March to June 2020, all patient referred in our Centre affected by rheumatoid arthritis (RA), psoriatic arthritis (PA) and axial spondyloarthritis (axSpA) treated with etanercept originator and in remission/low disease activity for at least 6 months underwent to NMS. Data on disease activity (DAS28-PCR/CDAI/SDAI; DAPSA; BASDAI), eventual adverse events and causes of withdrawal of therapy were collected at 2, 4 and 6 months after the switch.Results:We recruited 71 consecutive patients (M/F: 24/47; mean age 55,8± 11,1 years; 39 RA; 15 PA; 17 axSpA; mean duration therapy 7.3±3.8 years). Disease activity was unchanged for almost all patients after 6 months from the switch (median ΔDAS28-PCR/CDAI/SDAI: 0,1/0/0,5; median ΔDAPSA: 0; median ΔBASDAI: 0) Moreover, the 6-month retention rate was 97.2%. Only 2 patients (2.8%) switched back to the originator due to loss of efficacy in one case and adverse events in the second case (paraesthesia, headache, dizziness and worsening of arthralgia).Conclusion:Our study confirmed that the NMS from ETN originator to GP2015 represents a safe practice that maintains the efficacy of the current treatment.References:[1]Glintborg B, AG, Omerovic E, et Al. To switch or not to switch: results of a nationwide guideline of mandatory switching from originator to biosimilar etanercept. One-year treatment outcomes in 2061 patients with inflammatory arthritis from the DANBIO registry. Ann Rheum Dis 2019; 78:192–200.Disclosure of Interests:None declared

Download Full-text

AB0218 NON MEDICAL SWITCH FROM ADALIMUMAB ORIGINATOR TO THE BIOSIMILAR GP2017 IN PATIENTS AFFECTED BY CHRONIC ARTHRITIS

Annals of the Rheumatic Diseases ◽

10.1136/annrheumdis-2021-eular.1563 ◽

2021 ◽

Vol 80 (Suppl 1) ◽

pp. 1135.2-1135

Author(s):

M. Colaci ◽

M. L. Aprile ◽

A. La Rosa ◽

A. DI Maggio ◽

L. Malatino

Keyword(s):

Adverse Events ◽

Disease Activity ◽

Retention Rate ◽

Single Case ◽

Real Life ◽

Current Treatment ◽

Chronic Arthritis ◽

Nocebo Effect ◽

Life Study ◽

Significant Difference

Background:The non-medical switch (NMS) from originator drugs to biosimilars is a possible strategy adopted by rheumatologists in order to control the expansion of pharmaceutic costs for the treatment fo patients affected by chronic arthritis. To date, few real life data on the switch from adalimumab (ADA) originator to its biosimilars are available.Objectives:We aimed to evaluate efficacy and safety in a single-Centre cohort of patients affected by chronic arthritis who switched from ADA originator to the biosimilar GP2017.Methods:Patients affected by rheumatoid arthritis (RA), psoriatic arthritis (PA) and axial spondyloarthritis (axSpA) already on therapy with ADA originator in remission or low disease activity for at least 6 months were switched to GP2017 (March- June 2020). Data on disease activity (DAS28-PCR/CDAI/SDAI; DAPSA; BASDAI), eventual adverse events and causes of withdrawal of therapy were collected at 2, 4 and 6 months after the switch.Results:88 patients were enrolled (M/F 36/52; mean age 55.8 ± 12 years; 25 RA, 32 PA, 31 axSpA, mean duration of therapy 6.3 ± 3.8 years). No statistically significant difference was observed in median DAS28-PCR/CDAI/SDAI values at the baseline and after 6 months [1.03 (0.96-3.43) vs. 1.21 (0-3.7) / 0 (0-15) vs. 0 (0-17) / 0 (0-15) vs. 0.5 (0-17.5)], DAPSA [0 (0-12.2) vs. 0 (0-15)] and BASDAI [0 (0-4.3) vs. 0 (0-6.4)]. The retention rate was 93.2%. 6/88 patients (6.8%) switched back to the originator. The causes of discontinuation were: disease reactivation in a single case (1.1%), subjective reasons/nocebo effect in 5/88 cases (5.7%), including: general malaise and transient increased of blood pressure (n.1), dizziness, paraesthesia, arthralgia, headache (n.1), itch sine materia (n.1) and subjective worsening without objective disease flare (n.2).Conclusion:This is the first real life study showing that the NMS from ADA originator to GP2017 represents a safe practice that maintains the efficacy of the current treatment. However, a few cases of switchback were described, mainly attributed to nocebo effect [1].References:[1]Fleischmann R, Jairath V, Mysler E et al. Nonmedical Switching From Originators to Biosimilars: Does the Nocebo Effect Explain Treatment Failures and Adverse Events in Rheumatology and Gastroenterology? Rheumatol Ther 7: 35–64 (2020).Disclosure of Interests:None declared

Download Full-text

P258 Real-world secukinumab retention, response rates and adverse events in the treatment of PsA and axSpA

Rheumatology ◽

10.1093/rheumatology/keaa111.251 ◽

2020 ◽

Vol 59 (Supplement_2) ◽

Author(s):

Alistair Tindell ◽

Saira Batool ◽

Andrew McGucken ◽

Stefan Siebert

Keyword(s):

Adverse Events ◽

Disease Activity ◽

Real World ◽

Retention Rate ◽

Retention Rates ◽

Hospital Death ◽

Published Data ◽

Cerebellar Haemorrhage ◽

One Year ◽

Randomised Controlled

Abstract Background Secukinumab, an IL-17A inhibitor, has been licensed for use in the United Kingdom for both axial spondyloarthritis (axSpA) and psoriatic arthritis (PsA) for several years. Despite this there is minimal published data on its use out with randomised controlled trials. We present here the collated real-world rheumatology experience of secukinumab use in Glasgow. Methods Patients who have ever received secukinumab for any rheumatology indication were identified using available medical records (from 14/05/2012 to 18/09/2019). Diagnosis, baseline demographics, disease activity at baseline and at 6 months, and whether patients are still currently on secukinumab was recorded. Primary inefficacy was defined as stopping treatment due to inefficacy ≤6 months. Reasons for discontinuation were also recorded. As disease activity scores were variably recorded, the primary outcome was retention rate as a surrogate for efficacy and lack of adverse event. Patients only included in disease scores if scores available both at baseline and 6 months. Results 352 patients (with 530 patient-years of exposure) identified. 251 (71.3%) patients currently remain on secukinumab. 301 of 336 (89.6%) patients remained on drug at six-month review (16 await review). Characteristics and response of two main diagnostic groups listed in Table 1 (Note: 3 patients had SAPHO, 5 had Juvenile Idiopathic Arthritis, 1 had reactive arthritis). Common adverse events were infections (11 patients), rash and/or pruritis (6 patients), mood change and/or fatigue (4 patients). Three patients developed inflammatory bowel disease (IBD) subsequent to starting secukinumab. Five patients had pre-existing IBD, none of which flared on secukinumab. Two patients required hospitalisation for abscesses whilst on secukinumab. One patient had a stroke and one patient had a myocardial infarction whilst on secukinumab - both patients had multiple risk factors for cardiovascular disease. No malignancies identified. Three patients died, with none felt related to secukinumab (cerebellar haemorrhage in warfarinised patient with high INR; pneumonia six months after switching from secukinumab to tocilizumab; one out of hospital death over one year after stopping secukinumab). Conclusion In this real world cohort of patients with axSpA and PsA, secukinumab retention rates at 6 months are high with no new safety signals identified. Disclosures A. Tindell None. S. Batool None. A. McGucken None. S. Siebert Consultancies; S.S. has received speaker or consultation fees or honoraria from AbbVie, UCB, Janssen, Boehringer Ingelheim, Novartis, Celgene. Honoraria: S.S. has received speaker or consultation fees or honoraria from AbbVie, UCB, Janssen, Boehringer Ingelheim, Novartis, Celgene. Grants/research support; S.S has received funding for research/ grants from Pfizer, Janssen, BMS, Celgene, UCB, Boehringer Ingelheim, Novartis, GSK.

Download Full-text

Is Treat-to-target in Lupus Nephritis Realistic in Clinical Practice?

Current Rheumatology Reviews ◽

10.2174/1573397114666180406100857 ◽

2018 ◽

Vol 15 (1) ◽

pp. 2-6 ◽

Cited By ~ 3

Author(s):

Chi Chiu Mok

Keyword(s):

Lupus Nephritis ◽

Disease Activity ◽

Safety Concern ◽

Real Life ◽

Current Treatment ◽

Treat To Target ◽

Low Disease Activity ◽

Activity State ◽

Definition Of ◽

Comparative Trials

The Treat-to-Target (T2T) principle has been advocated in a number of inflammatory and non-inflammatory medical illnesses. Tight control of disease activity has been shown to improve the outcome of rheumatoid arthritis and psoriatic arthritis as compared to the conventional approach. However, whether T2T can be applied to patients with lupus nephritis is still under emerging discussion. Treatment of lupus nephritis should target at inducing and maintaining remission of the kidney inflammation so as to preserve renal function and improve survival in the longterm. However, there is no universal agreement on the definition of remission or low disease activity state of nephritis, as well as the time points for switching of therapies. Moreover, despite the availability of objective parameters for monitoring such as proteinuria and urinary sediments, differentiation between ongoing activity and damage in some patients with persistent urinary abnormalities remains difficult without a renal biopsy. A large number of serum and urinary biomarkers have been tested in lupus nephritis but none of them have been validated for routine clinical use. In real life practice, therapeutic options for lupus nephritis are limited. As patients with lupus nephritis are more prone to infective complications, tight disease control with aggressive immunosuppressive therapies may have safety concern. Not until the feasibility, efficacy, safety and cost-effectiveness of T2T in lupus nephritis is confirmed by comparative trials, this approach should not be routinely recommended with the current treatment armamentarium and monitoring regimes.

Download Full-text

FRI0127 Suppression of radiographic progression after gradual methotrexate tapering in patients with rheumatoid arthritis patients maintaining low disease activity - Prospective multicenter study-

Annals of the Rheumatic Diseases ◽

10.1136/annrheumdis-2020-eular.1415 ◽

2020 ◽

Vol 79 (Suppl 1) ◽

pp. 645.1-645

Author(s):

K. Katayama ◽

K. Yujiro ◽

T. Okubo ◽

R. Fukai ◽

T. Sato ◽

...

Keyword(s):

Rheumatoid Arthritis ◽

Disease Activity ◽

Joint Destruction ◽

Reduction Rate ◽

Bone Destruction ◽

High Response ◽

Continuation Rate ◽

Low Disease Activity ◽

One Year ◽

Response Group

Background:Many studies have been reported to reduce/discontinue Biologics in the treatment of rheumatoid arthritis (RA). In contrast, study for tapering methotrexate (MTX) has been limited (1,2).Objectives:We prospectively examined whether bone destruction will progress at 48 weeks after tapering or discontinuing MTX (UMIN000028875).Methods:The subjects were RA patients who have maintained low disease activity or lower for 24 weeks or more in DAS28-CRP after MTX administration. Patients having PDUS Grade 2 or 3 per site by bilateral hand ultrasonography (26 area) were excluded in this study owing to risk for joint destruction. The joint destruction was evaluated by the joint X-ray evaluation by modified total Sharp scoring (mTSS) at 1 year after the start of tapering MTX. Evaluation of clinical disease activities, severe adverse events, the continuation rate during MTX tapering were also evaluated. According to tapering response, prognostic factor for good response for tapering, joint destruction was determined. Predictors for successful tapering MTX and progression of bone destruction were determined. Statistical analysis was performed by t-test or Wilcoxon rank sum test using SAS .13.2 software.Results:The subjects were 79 (16 males, 63 females). Age average 60.9 years, disease duration 4 years 4 months, MTX dose 8.43 mg / w, DAS28-CRP 1.52, DMARDs (24.3%), ACPA 192.7 U / ml (70.5%), RF 55.6 IU / ml (65.4%).MTX was tapered from an average of 8.43 mg / w before study to 5.46 mg / w one year later. In the treatment evaluation, DAS28-CRP increased from 1.52 to 1.84. 89.7% of subjects did not progress joint damage. Other disease activities significantly increased (Table 1). The one-year continuation rate was 78.2%. Since tapering effects were varied widely, we divided patients into three groups; Flared group (N=14, initial MTX dose 8.71mg/w, final MTX dose 8.42mg/w), Low response group (N=31, final MTX reduction rate< 50%, initial MTX dose 8.93mg/w, final MTX dose 6.22mg/w), High response group (N=34, final MTX reduction rate≥ 50%, initial MTX dose 8.5mg/w, final MTX dose 3.15mg/w)(Table 2).Higher RF value at baseline and higher MTX dose at 3M, 6M were predictors of whether a subject was in Low response group or High Response group. Higher RF value and mTSS at baseline and higher MTX dose at 6M were predictors whether a subject was in Flared group or High response group. Lower age was predictor of whether a subject was in Flared group or Low responder group. Finally, mean ΔmTSS /y in Flared group (0.36) was not significantly higher than in low response group (0.07) and in high response group (0.01).Table 1Table 2.Predictors for successful tapering MTX and progression of bone destructionConclusion:Patients with MTX-administered low disease activity and finger joint echo PDUS grade 1 satisfy almost no joint destruction even after MTX reduction. For tapering, predictors may be helpful for maintaining patient’s satisfaction.References:[1]Baker KF, Skelton AJ, Lendrem DW et al. Predicting drug-free remission in rheumatoid arthritis: A prospective interventional cohort study. J. Autoimmunity. 2019;105: 102298.[2]Lillegraven S, Sundlisater N, Aga A et al. Tapering of Conventional Synthetic Disease Modifying Anti-Rheumatic Drugs in Rheumatoid Arthritis Patients in Sustained Remission: Results from a Randomized Controlled Trial. American College of Rheumatology. 2019; Abstract L08.Disclosure of Interests:None declared

Download Full-text

POS0675 THE COMPARATIVE 3-YEAR RETENTION RATE OF TARGETED-SYNTHETIC AND BIOLOGIC DRUGS FOR RHEUMATOID ARTHRITIS: REAL-LIFE DATA FROM THE ITALIAN GISEA REGISTRY

Annals of the Rheumatic Diseases ◽

10.1136/annrheumdis-2021-eular.3557 ◽

2021 ◽

Vol 80 (Suppl 1) ◽

pp. 582.1-582

Author(s):

E. G. Favalli ◽

F. Iannone ◽

E. Gremese ◽

R. Gorla ◽

R. Foti ◽

...

Keyword(s):

Rheumatoid Arthritis ◽

Adverse Events ◽

Retention Rate ◽

Large Population ◽

Real Life ◽

Mechanisms Of Action ◽

Biologic Drugs ◽

Real Life Setting ◽

Study Population ◽

Targeted Drug

Background:Long-term observational data on the real-life use of JAK inhibitors (JAKis) for rheumatoid arthritis (RA) and their comparison with biological drugs are still very limited. Large population-based registries have been increasingly used to investigate the performance of targeted drugs in a real-life setting.Objectives:The aim of this study is to evaluate and compare the 3-year retention rate of JAKis, TNF inhibitors (TNFis) and biologic drugs with other mechanisms of action (OMAs) in the large cohort of RA patients included in the Italian national GISEA registry.Methods:Data of all RA patients treated with targeted synthetic or biologic drugs were prospectively collected in the Italian multicentric GISEA registry. The analysis was limited to patients who started a first- or second-line targeted drug in the period after the first JAKi was marketed in Italy (1st December 2017). The 3-year retention rate was calculated by the Kaplan-Meier method and compared between different drug classes by a log-rank test. A descriptive analysis of reasons for discontinuation was performed.Results:The study population included 1027 RA patients (79.8% females, mean age [±SD] 56.9 [±13.5] years, mean disease duration 9.8 [±9] years, mean baseline SDAI 17.5 [±11.9], ACPA positive 67.4%, RF positive 62.7%) who received JAKis (baricitinib or tofacitinib, n=297), TNFis (n=365), or OMAs (n=365) as first or second targeted drug. Main baseline characteristics of study population were overall well balanced between treatment groups. Retention rate was numerically but not statistically higher (p=0.18) in patients treated with JAKis compared with TNFis or OMAs (80.6, 78.9 and 76.4% at 1 year and 73, 56.8 and 63.8% at 3 years, respectively) (Figure 1). Drug survival was significantly higher in patients receiving concomitant methotrexate (MTX) compared with monotherapy only in TNFis (66.8 vs 47.1%, p=0.04) but not in JAKis (76.1 vs 70.1%, p=0.54) and OMAs (66.1 vs 61.9%, p=0.41) group. Therapy was discontinued in a total of 211 patients because of ineffectiveness (n=107), adverse events (n=88), or compliance/other reasons (n=16). The most frequent reason for treatment withdrawal was ineffectiveness in both JAKis (n=30 out of 56) and TNFis (n=45 out of 74) groups, whereas OMAs were discontinued more frequently because of adverse events (n=41 out of 81).Conclusion:Our data confirmed in a real-life setting a favorable 3-year retention rate of all available targeted mechanisms of action for RA therapy. As expected, concomitant MTX significantly impacted persistence on therapy of TNFis only. Discontinuations of JAKis for adverse events were infrequent overall, confirming the safety profile observed in randomized clinical trials.Figure 1.Three-year retention rate by treatment groupDisclosure of Interests:None declared

Download Full-text

Effectiveness and safety of secukinumab in 608 patients with psoriatic arthritis in real life: a 24-month prospective, multicentre study

RMD Open ◽

10.1136/rmdopen-2020-001519 ◽

2021 ◽

Vol 7 (1) ◽

pp. e001519

Author(s):

Roberta Ramonda ◽

Mariagrazia Lorenzin ◽

Antonio Carriero ◽

Maria Sole Chimenti ◽

Raffaele Scarpa ◽

...

Keyword(s):

Psoriatic Arthritis ◽

Adverse Events ◽

Disease Activity ◽

Biological Treatment ◽

Retention Rate ◽

Real Life ◽

Drug Retention ◽

Group A ◽

Group B ◽

Drug Retention Rate

ObjectivesTo evaluate in a multicentric Italian cohort of patients with psoriatic arthritis (PsA) on secukinumab followed for 24 months: (1) the long-term effectiveness and safety of secukinumab, (2) the drug retention rate and minimal disease activity (MDA), (3) diﬀerences in the outcomes according to the biological treatment line: biologic-naïve patients (group A) versus multifailure (group B) patients.MethodsConsecutive patients with PsA receiving secukinumab were evaluated prospectively. Disease characteristics, previous/ongoing treatments, comorbidities and follow-up duration were collected. Disease activity/functional/clinimetric scores and biochemical values were recorded at baseline (T0), 6(T6), 12(T12) and 24(T24) months. Effectiveness was evaluated overtime with descriptive statistics; multivariate Cox and logistic regression models were used to evaluate predictors of drug-discontinuation and MDA at T6. Infections and adverse events were recorded.Results608 patients (41.28% men; mean (SD) age 52.78 (11.33)) were enrolled; secukinumab was prescribed as first-line biological treatment in 227 (37.34%) patients, as second (or more)-line biological treatment in 381 (62.66%). Effectiveness of secukinumab was shown with an improvement in several outcomes, such as Ankylosing Spondylitis Disease Activity Score (T0=3.26 (0.88) vs T24=1.60 (0.69) ;p=0.02) and Disease Activity Index for Psoriatic Arthritis (T0=25.29 (11.14) vs T24=7.69 (4.51); p<0.01). At T24, group A showed lower Psoriasis Area Severity Index (p=0.04), erythrocyte sedimentation rate and C reactive protein (p=0.03 ;p=0.05) and joint count (p=0.03) compared with group B. At T24, MDA was achieved in 75.71% of group A and 70.37% of group B. Treatment was discontinued in 123 (20.23%) patients, mainly due to primary/secondary loss of effectiveness, and in 22 due to adverse events. Retention rate at T24 was 71% in the whole population, with some difference depending on secukinumab dosage (p=0.004) and gender (p=0.05).ConclusionsIn a real-life clinical setting, secukimumab proved safe and effective in all PsA domains, with notable drug retention rate.

Download Full-text

Evaluation of efficacy and comparative frequency of adverse events in patients with ulcerative colitis receiving the original infliximab and its biosimilar. One year of observation

Terapevticheskii arkhiv ◽

10.26442/00403660.2019.08.000331 ◽

2019 ◽

Vol 91 (8) ◽

pp. 41-46

Author(s):

O V Knyazev ◽

T V Shkurko ◽

A V Kagramanova ◽

A A Lishchinskaya ◽

M Yu Zvyaglova ◽

...

Keyword(s):

Ulcerative Colitis ◽

Adverse Events ◽

Real Life ◽

Fecal Calprotectin ◽

Biologic Drugs ◽

Real Life Data ◽

Bowel Diseases ◽

Significant Clinical Improvement ◽

One Year

Real - life data on the effectiveness and safety of biosimilar and biologic drugs licensed for treatment of inflammatory bowel diseases (IBD) is lacking. Aim. To investigate efficacy of original Infliximab (IFX) and its biosimilar in treating patients with ulcerative colitis (UC) and determine the frequency of adverse events during 1 year follow - up period. Materials and methods. Our cohort consisted of 98 ulcerative colitis patients, treated with original IFX and its biosimilar since December 2017 till December 2018 years. Original Infliximab was prescribed in 56 UC patients (57.1%) during 5 years and longer; 16 patients (16.3%) were switched to IFX biosimilar; 13 UC bio - naïve patients (13.3%) received original IFX, 29 (29.6%) patients - biosimilar IFX. In 14 patients (14.3%) original infliximab was rotated with biosimilar. We picked out 42 patients to assess efficacy of original IFX and biosimilar. Results and discussion. Twelve patients, received original IFX and 28 patients, treated with its biosimilar, showed significant clinical improvement by decreasing Mayo index from 9.7±0.4 and 10.2±0.2 points to 1.9±0.09 and 2.1±0.1 points, accordingly. Also we noticed positive change in laboratory markers - CRP decrease from 89.6±8.7 mg/l and 77.5±8.0 mg/l to 6.5±0.8 mg/l and 6.9±0.8 mg/l (p>0.05), albumin increase from 30.1±4.7 g/l and 29.6±3.6 g/l to 34.1±6.3 g/l and 32.8±5.9 g/l (p>0.05), increase of serum iron levels from 6.4±0.5 mcg/l and 7.1±0.65 mcg/l to 14.6±4.4 mcg/l and 15.9±5.1 mcg/l (p>0.05), hemoglobin increase from 104.7±9.8 g/l and 102.2±8.8 g/l till 124±11.3 g/l and 121±10.9 g/l (p>0.05), and fecal calprotectin decrease from 1680±134 mcg/g and 1720±126 mcg/g till 245.5±33.4 mcg/g and 230.5±29.8 mcg/g (p>0.05). During 1 year follow - up 12 UC patients, treated with original IFX and its biosimilar, developed adverse events. The majority of adverse events (n=8) were registered in patients, rotating administration of original IFX and its biosimilar. Conclusion. IFX biosimilar is effective as well as original IFX. Frequency of adverse events, occurred in patients, treated with original IFX, was comparable with adverse events frequency in patients, received biosimilar IFX. Frequency of adverse events was significantly higher in UC patients, rotating original IFX and its biosimilar.

Download Full-text

Anti-IL-6 Receptor Tocilizumab in Refractory Graves’ Orbitopathy: National Multicenter Observational Study of 48 Patients

Journal of Clinical Medicine ◽

10.3390/jcm9092816 ◽

2020 ◽

Vol 9 (9) ◽

pp. 2816

Author(s):

Lara Sánchez-Bilbao ◽

David Martínez-López ◽

Marcelino Revenga ◽

Ángel López-Vázquez ◽

Elia Valls-Pascual ◽

...

Keyword(s):

Intraocular Pressure ◽

Disease Activity ◽

Therapeutic Option ◽

Clinical Activity ◽

Open Label ◽

Serious Adverse Events ◽

Low Disease Activity ◽

Multicenter Observational Study ◽

Graves Orbitopathy ◽

One Year

Graves’ orbitopathy (GO) is the most common extrathyroidal manifestation of Graves’ disease (GD). Our aim was to assess the efficacy and safety of Tocilizumab (TCZ) in GO refractory to conventional therapy. This was an open-label multicenter study of glucocorticoid-resistant GO treated with TCZ. The main outcomes were the best-corrected visual acuity (BVCA), Clinical Activity Score (CAS) and intraocular pressure (IOP). These outcome variables were assessed at baseline, 1st, 3rd, 6th and 12th month after TCZ therapy onset. The severity of GO was assessed according to the European Group on Graves’ Orbitopathy (EUGOGO). We studied 48 (38 women and 10 men) patients (95 eyes); mean age ± standard deviation 51 ± 11.8 years. Before TCZ and besides oral glucocorticoids, they had received IV methylprednisolone (n = 43), or selenium (n = 11). GO disease was moderate (n =29) or severe (n = 19) and dysthyroid optic neuropathy (DON) (n = 7). TCZ was used in monotherapy (n = 45) or combined (n = 3) at a dose of 8 mg/kg IV every four weeks (n = 43) or 162 mg/s.c. every week (n = 5). TCZ yielded a significant improvement in all of the main outcomes at the 1st month that was maintained at one year. Comparing the baseline with data at 1 year all of the variables improved; BCVA (0.78 ± 0.25 vs. 0.9 ± 0.16; p = 0.0001), CAS (4.64 ± 1.5 vs. 1.05 ± 1.27; p = 0.0001) and intraocular pressure (IOP) (19.05 ± 4.1 vs. 16.73 ± 3.4 mmHg; p = 0.007). After a mean follow-up of 16.1 ± 2.1 months, low disease activity (CAS ≤ 3), was achieved in 88 eyes (92.6%) and TCZ was withdrawn in 29 cases due to low disease activity (n = 25) or inefficacy (n = 4). No serious adverse events were observed. In conclusion, TCZ is a useful and safe therapeutic option in refractory GO treatment.

Download Full-text