The Hong Kong Society of Rheumatology Biologics Registry: Updated Report (November 2017)

Rhonda Wan and Chi Chiu Mok 1
  • 1 Tuen Mun Hospital, Tuen Mun, Hong Kong
Rhonda Wan and Chi Chiu Mok

Demographic Data

Up to November 2017, a total of 4216 courses of biologics were used in 2616 patients (1517 women and 1099 men) with various rheumatic diseases in our Registry. The mean age at the commencement of treatment was 46.9 years (range 1—89 years). More than half of the patients suffered from rheumatoid arthritis, while the others were mainly patients with ankylosing spondylitis and psoriatic arthritis. Other indications of the biological agents are shown in Table 1. The longest duration of therapy was 168 months.

Table 1

Indications of the biological agents

No. of courses (%)
Rheumatoid arthritis2269 (53.8)
Ankylosing spondylitis / Spondyloarthropathy1248 (29.6)
Psoriatic arthritis478 (11.3)
Juvenile idiopathic arthritis37 (0.9)
Systemic lupus erythematosus24 (0.6)
Crohn’s disease22 (0.5)
Adult-onset Still’s disease11 (0.3)
Behcet’s disease11 (0.3)
Inflammatory myopathies6 (0.1)
Systemic vasculitides6 (0.1)
IgG4 disease2 (0.1)
Relapsing polychondritis2 (0.1)
Uveitis2 (0.1)
Monoarthritis1 (0.02)
Myositis Ossificans1 (0.02)
Sarcoidosis1 (0.02)
Sjogren’s syndrome1 (0.02)
MCTD/ Overlap Syndrome94 (2.2)
Total4216 (100)

Co-morbid Conditions

The most common co-existing medical conditions of patients who were treated with the biological agents were hypertension (18.5%), diabetes mellitus (7.1%), depression (4.4%), fatty liver (4.4%), peptic ulcer (4.3%) and chronic hepatitis B infection (4.0%). Other co-morbid conditions reported were previous pulmonary tuberculosis (3.8%), asthma (2.5%), liver disease (2.4%), renal disease (2.3%), ischemic heart disease (2.1%), hyperthyroidism (1.9%), cancer (1.7%), stroke (1.1%), congestive heart failure (0.6%), heart attack (0.6%), epilepsy (0.6%), previous extra-pulmonary tuberculosis (0.5%), COAD (0.5%), chronic hepatitis C infection (0.3%) and demyelination (0.04%).

Discontinuation of Treatment

The usage of biological agents is updated in Table 2. Twenty-seven percent of the treatment courses involved etanercept, which remained the commonest biological agent ever used. Etanercept was also the most frequent agent that was currently used by patients (26.9%). Figures 13 show the ever and current use of the biologic and targeted synthetic disease modifying anti-rheumatic drugs (DMARDs) in rheumatoid arthritis, spondyloarthritis and psoriatic arthritis.

Table 2

Biological agents used

No. of courses (%) (ever use)No. of patients (%) (current use: up to Nov 2017)
Etanercept1137 (27)496 (26.9)
Infliximab760 (18)108 (5.9)
Adalimumab715 (17)363 (19.7)
Golimumab586 (13.9)328 (17.8)
Tocilizumab466 (11.1)271 (14.7)
Rituximab179 (4.2)76 (4.1)
Abatacept177 (4.2)75 (4.1)
Certolizumab83 (2)61 (3.3)
Tofacitinib63 (1.5)41 (2.2)
Secukinumab17 (0.4)16 (0.9)
Pamidronate11 (0.3)0 (0)
Belimumab13 (0.3)4 (0.2)
Ustekinumab9 (0.2)5 (0.3)
Total4216 (100)1844 (100)

Figure 1
Figure 1

Biologic and targeted synthetic DMARDs used in rheumatoid arthritis (up to November 2017)

Citation: Hong Kong Bulletin on Rheumatic Diseases 17, 2; 10.1515/hkbrd-2017-0012

Figure 2
Figure 2

Biologic DMARDs used in spondyloarthritis (up to November 2017)

Citation: Hong Kong Bulletin on Rheumatic Diseases 17, 2; 10.1515/hkbrd-2017-0012

Figure 3
Figure 3

Biologic DMARDs used in psoriatic arthritis (up to November 2017)

Citation: Hong Kong Bulletin on Rheumatic Diseases 17, 2; 10.1515/hkbrd-2017-0012

The number of patients who withdrew from treatment at different time points is shown in Table 3. The three most commonly reported reasons for the termination of treatment are lack of efficacy (43%), serious adverse effects (23%) and cost (11%). Other reasons for stopping the treatment included marked improvement in disease activity (9%), end of research study (7%) and patients’ preference (3%).

Table 3

Withdrawal of biological therapies

Follow up duration reported to registry since the commencement of biological therapy (months)
036121824303642485460667278
No. of courses registered in FU42163945330025581875151912281006786644503407320245177
No. of courses continue4216344627992048164913661115930720599465376290223163
No. of withdrawal04995015102261531137666453831302214
Reasons for withdrawal
Lack of efficacy0165254239945746272925171214810
Cost064506033181365425131
Adverse effects0199848046332214117126650
End of sample027704869100005601
Plan for surgery / pregnancy011872152102100
Defaulted FU04111061430200000
Remission02021482720191915441241
Others016914712424230021
Dead031301300000000
Not stated000000000000000
Follow up duration reported to registry since the commencement of biological therapy (months)
849096102108114120126132138144150156162168
No. of courses registered in FU1371078356463529262216117641
No. of courses continue131977254433327252114106641
No. of withdrawal61011232211211000
Reasons for withdrawal
Lack of efficacy424211100111000
Cost012000000000000
Adverse effects153010010000000
End of sample000000000000000
Plan for surgery / pregnancy010000001000000
Defaulted FU001000000000000
Remission010010100100000
Others001001000000000
Dead100000000000000
Not stated000000000000000

Major Adverse Events Reported

Neoplasia

There were 43 cases of malignant and pre-malignant conditions reported: colon cancer (N=4), lung cancer (N=4), rectum cancer (N=4), breast cancer (N=3), ovarian cancer (N=3), tongue cancer (N=1), caecum cancer (N=1), intraductal papillary mucinous neoplasm of pancreas (N=1), prostate cancer (N=1), stomach cancer (N=1), penile cancer (N=1), gall bladder cancer (N=1), cancer of urinary bladder (N=1), cancer of small intestine (N=1), kidney cancer (N=1), cancer of ampulla of vater (N=1), thyroid cancer (N=1), mandible cancer (N=1), adenocarcinoma (N=1), myeloma (N=1), cervical intra-epithelial neoplasia (CIN) (N=1), myelodysplastic syndrome (N=1), brain tumor (N=1), malignant melanoma (N=1), renal cell carcinoma (N=1), lymphoma (N=1), nasopharyngeal cancer (N=1), cancer of nasal cavity (N=1), cervical cancer (N=1) and myeloproliferative neoplasms (N=1).

Infection Requiring Hospitalization

There were 134 episodes of infective complications requiring hospitalization. Around 61% of them (i.e., 82 cases) occurred during the first 12 months of biological therapy.

Tuberculosis

A total of 60 cases of TB were reported: 31 related to Infliximab, 12 related to Etanercept, 9 related to Adalimumab, 4 related to Golimumab, 3 related to Tocilizumab and 1 related to Tofacitinib. Nearly 40% of the cases (i.e., 23 cases) occurred in the first 6 months of treatment. There were 482 abnormal CXRs before the treatment and isoniazid chemoprophylaxis was given to 835 patients (32%) with latent TB, as defined by either positive MT2 (≥ 10mm induration) or a positive Interferon gamma release assay (IGRA) test.

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    Biologic and targeted synthetic DMARDs used in rheumatoid arthritis (up to November 2017)

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    Biologic DMARDs used in spondyloarthritis (up to November 2017)

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    Biologic DMARDs used in psoriatic arthritis (up to November 2017)